{ "article": { "LEGIARTI000006801783": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-31", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801783", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801783.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06431XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916352", "@num": "R5221-30", "#text": "Code de la santé publique - art. R5221-30 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916352", "@num": "R5221-30", "#text": "Code de la santé publique - art. R5221-30 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801781", "@num": "R665-64-29", "#text": "Code de la santé publique - art. R665-64-29 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801782", "@num": "R665-64-30", "#text": "Code de la santé publique - art. R665-64-30 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174601", "@fin": "2004-08-08", "#text": "Section 3 : Organismes habilités", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801783", "@fin": "2004-08-08", "@num": "R665-64-31", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Si un organisme habilité cesse de remplir les conditions ou manque aux obligations mentionnées aux articles R. 665-64-29 et R. 665-64-30, l'habilitation est suspendue ou supprimée par le directeur général de l'Agence française de sécurité sanitaire des produits de santé, après que le responsable de l'organisme a été appelé à présenter ses observations.
\n
" } }, "LEGIARTI000006228409": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000006228409", "URL": "article/LEGI/ARTI/00/00/06/22/84/LEGIARTI000006228409.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SQHQYXXXXXX003AAXXXXXXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006801749", "@num": "R665-64-1", "#text": "Code de la santé publique - art. R665-64-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801760", "@num": "R665-64-10", "#text": "Code de la santé publique - art. R665-64-10 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801761", "@num": "R665-64-11", "#text": "Code de la santé publique - art. R665-64-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801762", "@num": "R665-64-12", "#text": "Code de la santé publique - art. R665-64-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801763", "@num": "R665-64-13", "#text": "Code de la santé publique - art. 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R665-64-57 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801820", "@num": "R665-64-58", "#text": "Code de la santé publique - art. R665-64-58 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801821", "@num": "R665-64-59", "#text": "Code de la santé publique - art. R665-64-59 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801756", "@num": "R665-64-6", "#text": "Code de la santé publique - art. R665-64-6 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801822", "@num": "R665-64-60", "#text": "Code de la santé publique - art. R665-64-60 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801823", "@num": "R665-64-61", "#text": "Code de la santé publique - art. R665-64-61 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801824", "@num": "R665-64-62", "#text": "Code de la santé publique - art. R665-64-62 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801825", "@num": "R665-64-63", "#text": "Code de la santé publique - art. R665-64-63 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801826", "@num": "R665-64-64", "#text": "Code de la santé publique - art. R665-64-64 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801757", "@num": "R665-64-7", "#text": "Code de la santé publique - art. R665-64-7 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801758", "@num": "R665-64-8", "#text": "Code de la santé publique - art. R665-64-8 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801759", "@num": "R665-64-9", "#text": "Code de la santé publique - art. R665-64-9 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000000416306", "@nor": "SANP0324626D", "@num": "2004-108", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2004-108 du 4 février 2004 relatif aux dispositifs médicaux de diagnostic in vitro et modifiant le code de la santé publique (deuxième partie : Décrets en Conseil d'Etat)", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000000416306", "@c_titre_court": "Décret n°2004-108 du 4 février 2004" }, { "@fin": "2999-01-01", "#text": "Décret n°2004-108 du 4 février 2004 relatif aux dispositifs médicaux de diagnostic in vitro et modifiant le code de la santé publique (deuxième partie : Décrets en Conseil d'Etat)", "@debut": "2004-02-06", "@id_txt": "LEGITEXT000005765312", "@c_titre_court": "Décret n°2004-108 du 4 février 2004" } ], "@ministere": "MINISTERE DE LA SANTE, DE LA FAMILLE ET DES PERSONNES HANDICAPEES", "@date_publi": "2004-02-06", "@date_signature": "2004-02-04" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000006228409", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000002433115", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "a modifié les dispositions suivantes
\n
" } }, "LEGIARTI000006801781": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-29", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801781", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801781.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06429XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916352", "@num": "R5221-30", "#text": "Code de la santé publique - art. R5221-30 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916352", "@num": "R5221-30", "#text": "Code de la santé publique - art. R5221-30 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801782", "@num": "R665-64-30", "#text": "Code de la santé publique - art. R665-64-30 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801783", "@num": "R665-64-31", "#text": "Code de la santé publique - art. R665-64-31 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174601", "@fin": "2004-08-08", "#text": "Section 3 : Organismes habilités", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801781", "@fin": "2004-08-08", "@num": "R665-64-29", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les organismes chargés de mettre en oeuvre les procédures d'évaluation prévues par le présent titre doivent être habilités à cet effet par une décision du directeur général de l'Agence française de sécurité sanitaire des produits de santé publiée au Journal officiel de la République française. L'habilitation précise les tâches pour lesquelles elle est accordée.
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Les organismes candidats à l'habilitation adressent à l'Agence française de sécurité sanitaire des produits de santé un dossier de candidature dont le contenu est fixé par arrêté du ministre chargé de la santé, pris sur proposition du directeur général de l'Agence française de sécurité sanitaire des produits de santé.
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Le directeur général de l'Agence française de sécurité sanitaire des produits de santé statue sur la demande dans un délai de quatre mois à compter de la date de réception du dossier complet. A défaut, le silence gardé par le directeur général de l'Agence française de sécurité sanitaire des produits de santé vaut refus d'habilitation à l'expiration de ce délai de quatre mois. Ce délai est prorogé de deux mois si le directeur général de l'Agence française de sécurité sanitaire des produits de santé requiert du demandeur des informations complémentaires qui sont nécessaires à l'instruction de la candidature.
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L'habilitation est accordée en prenant en compte les garanties d'indépendance et de compétence présentées par les organismes, l'expérience qu'ils ont acquise dans le domaine considéré et les moyens dont ils disposent pour exécuter les tâches pour lesquelles ils sont habilités.
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Les organismes qui satisfont aux normes correspondant à la catégorie dont ils relèvent et transposant les normes européennes harmonisées dont les références ont été publiées au Journal officiel de la République française sont présumés répondre à ces critères.
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Tout organisme habilité doit avoir souscrit une assurance couvrant sa responsabilité civile.
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Les organismes habilités fournissent, sur demande du directeur général de l'Agence française de sécurité sanitaire des produits de santé, toutes les informations et documents, y compris les documents budgétaires, propres à lui permettre de vérifier le respect des exigences prévues à l'article R. 665-64-30, notamment celles relatives à leur indépendance à l'égard des personnes susceptibles d'être intéressées par les résultats des essais ou examens qu'ils réalisent.
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Lorsque l'organisme habilité rencontre des difficultés dans la mise en oeuvre des procédures d'évaluation de la conformité, celui-ci doit en saisir le directeur général de l'Agence française de sécurité sanitaire des produits de santé pour obtenir des recommandations précises quant à leur application.
" } }, "LEGIARTI000006801782": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-30", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801782", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801782.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06430XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916352", "@num": "R5221-30", "#text": "Code de la santé publique - art. R5221-30 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916352", "@num": "R5221-30", "#text": "Code de la santé publique - art. R5221-30 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801781", "@num": "R665-64-29", "#text": "Code de la santé publique - art. R665-64-29 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801783", "@num": "R665-64-31", "#text": "Code de la santé publique - art. R665-64-31 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174601", "@fin": "2004-08-08", "#text": "Section 3 : Organismes habilités", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801782", "@fin": "2004-08-08", "@num": "R665-64-30", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les organismes habilités doivent satisfaire aux obligations suivantes :
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1° L'organisme habilité, son directeur et le personnel chargé d'exécuter les opérations d'évaluation et de vérification ne peuvent ni se livrer aux activités de conception, de fabrication, de commercialisation, d'entretien ou à l'utilisation des dispositifs médicaux de diagnostic in vitro qu'ils contrôlent, ni intervenir dans la conception, la construction, la commercialisation ou l'entretien de ces dispositifs médicaux de diagnostic in vitro, soit directement, soit comme mandataires des personnes se livrant à ces activités, sauf échange nécessaire d'informations techniques entre le fabricant et l'organisme.
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2° L'exécution des opérations d'évaluation et de vérification doit être conduite avec la compétence requise dans le secteur des dispositifs médicaux de diagnostic in vitro, avec la plus grande intégrité professionnelle et en toute indépendance.
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Lorsqu'un organisme habilité confie des travaux spécifiques à un sous-traitant portant sur la constatation et la vérification de faits, il doit s'assurer préalablement que le sous-traitant respecte les dispositions du titre II du livre V bis. L'organisme habilité tient à la disposition des autorités nationales les documents relatifs à l'évaluation de la compétence du sous-traitant et des travaux effectués par ce dernier dans ce cadre.
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3° L'organisme habilité doit disposer des moyens matériels et humains adaptés à l'exécution de l'ensemble des tâches pour lesquelles il a été habilité.
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4° Le personnel chargé du contrôle doit posséder une formation professionnelle portant sur l'ensemble des opérations d'évaluation et de vérification pour lesquelles l'organisme a été habilité, une connaissance des règles relatives aux contrôles qu'il effectue, une pratique suffisante des contrôles et l'aptitude requise pour rédiger les attestations, procès-verbaux et rapports qui constituent la matérialisation des contrôles effectués.
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L'indépendance du personnel chargé du contrôle doit être garantie. La rémunération de chaque agent ne doit être fonction ni du nombre de contrôles qu'il effectue, ni des résultats de ces contrôles.
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Le personnel de l'organisme habilité chargé des contrôles est lié par le secret professionnel pour tout ce qu'il apprend dans l'exercice de ses fonctions. Il en va de même pour le sous-traitant mentionné au 2° du présent article.
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Un arrêté du ministre chargé de la santé, pris sur proposition du directeur général de l'Agence française de sécurité sanitaire des produits de santé, précise les conditions d'application du présent article.
" } }, "LEGIARTI000006916352": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5221-30", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2016-06-13", "DATE_DEBUT": "2004-08-08" } }, "META_COMMUN": { "ID": "LEGIARTI000006916352", "URL": "article/LEGI/ARTI/00/00/06/91/63/LEGIARTI000006916352.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "YXXXXXXXXXX5221R0300XX0A" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916255", "@num": "R5211-62", "#text": "Code de la santé publique - art. R5211-62 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801771", "@num": "R665-64-19", "#text": "Code de la santé publique - art. R665-64-19 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801771", "@num": "R665-64-19", "#text": "Code de la santé publique - art. R665-64-19 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801781", "@num": "R665-64-29", "#text": "Code de la santé publique - art. R665-64-29 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801781", "@num": "R665-64-29", "#text": "Code de la santé publique - art. R665-64-29 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801782", "@num": "R665-64-30", "#text": "Code de la santé publique - art. R665-64-30 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801782", "@num": "R665-64-30", "#text": "Code de la santé publique - art. R665-64-30 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801783", "@num": "R665-64-31", "#text": "Code de la santé publique - art. R665-64-31 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801783", "@num": "R665-64-31", "#text": "Code de la santé publique - art. R665-64-31 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801784", "@num": "R665-64-32", "#text": "Code de la santé publique - art. R665-64-32 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801784", "@num": "R665-64-32", "#text": "Code de la santé publique - art. R665-64-32 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801788", "@num": "R665-64-33", "#text": "Code de la santé publique - art. R665-64-33 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801788", "@num": "R665-64-33", "#text": "Code de la santé publique - art. R665-64-33 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801790", "@num": "R665-64-35", "#text": "Code de la santé publique - art. R665-64-35 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801790", "@num": "R665-64-35", "#text": "Code de la santé publique - art. R665-64-35 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006190759", "@fin": "2999-01-01", "#text": "Section 7 : Organismes habilités.", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178667", "@fin": "2999-01-01", "#text": "Chapitre Ier : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161016", "@fin": "2999-01-01", "#text": "Titre II : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145490", "@fin": "2999-01-01", "#text": "Livre II : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro et autres produits et objets réglementés dans l'intérêt de la santé publique", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006916352", "@fin": "2016-06-13", "@num": "R5221-30", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000032709122", "@fin": "2999-01-01", "@num": "R5221-30", "@etat": "VIGUEUR", "@debut": "2016-06-13", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les dispositions de la section 7 du chapitre Ier du titre I, à l'exception de l'article R. 5211-62 et R. 5211-64 sont applicables aux organismes habilités pour les dispositifs médicaux de diagnostic in vitro.
\n
" } }, "LEGIARTI000032709122": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R5221-30", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2016-06-13" } }, "META_COMMUN": { "ID": "LEGIARTI000032709122", "URL": "article/LEGI/ARTI/00/00/32/70/91/LEGIARTI000032709122.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000787339", "#text": "Décret n°2004-802 du 29 juillet 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000032707553", "@num": "2", "#text": "Décret n°2016-778 du 10 juin 2016 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000032677390", "@nortexte": "AFSP1608078D", "@numtexte": "2016-778", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2016-06-10" }, { "@id": "LEGIARTI000006916255", "@num": "R5211-62", "#text": "Code de la santé publique - art. R5211-62", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801771", "@num": "R665-64-19", "#text": "Code de la santé publique - art. R665-64-19 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801781", "@num": "R665-64-29", "#text": "Code de la santé publique - art. R665-64-29 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801782", "@num": "R665-64-30", "#text": "Code de la santé publique - art. R665-64-30 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801783", "@num": "R665-64-31", "#text": "Code de la santé publique - art. R665-64-31 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801784", "@num": "R665-64-32", "#text": "Code de la santé publique - art. R665-64-32 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801788", "@num": "R665-64-33", "#text": "Code de la santé publique - art. R665-64-33 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801790", "@num": "R665-64-35", "#text": "Code de la santé publique - art. R665-64-35 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006190759", "@fin": "2999-01-01", "#text": "Section 7 : Organismes habilités.", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178667", "@fin": "2999-01-01", "#text": "Chapitre Ier : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006161016", "@fin": "2999-01-01", "#text": "Titre II : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145490", "@fin": "2999-01-01", "#text": "Livre II : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro et autres produits et objets réglementés dans l'intérêt de la santé publique", "@debut": "2004-08-08" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132399", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2004-07-29" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006916352", "@fin": "2016-06-13", "@num": "R5221-30", "@etat": "MODIFIE", "@debut": "2004-08-08", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000032709122", "@fin": "2999-01-01", "@num": "R5221-30", "@etat": "VIGUEUR", "@debut": "2016-06-13", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Les dispositions de la section 7 du chapitre Ier du titre I du présent livre, à l'exception de l'article R. 5211-54, du deuxième alinéa de l'article R. 5211-55 et des articles R. 5211-55-1, R. 5211-62 et R. 5211-64 sont applicables aux organismes habilités pour les dispositifs médicaux de diagnostic in vitro.

" } }, "LEGIARTI000006801749": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-1", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801749", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801749.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06401XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006690312", "@num": "L5221-1", "#text": "Code de la santé publique - art. L5221-1 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916323", "@num": "R5221-1", "#text": "Code de la santé publique - art. R5221-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916323", "@num": "R5221-1", "#text": "Code de la santé publique - art. R5221-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174598", "@fin": "2004-08-08", "#text": "Section 1 : Définitions", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801749", "@fin": "2004-08-08", "@num": "R665-64-1", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les dispositions du présent titre sont applicables aux dispositifs médicaux de diagnostic in vitro définis à l'article L. 5221-1.
\n
" } }, "LEGIARTI000006801750": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-2", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801750", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801750.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06402XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006690281", "@num": "L5211-1", "#text": "Code de la santé publique - art. L5211-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916324", "@num": "R5221-2", "#text": "Code de la santé publique - art. R5221-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916324", "@num": "R5221-2", "#text": "Code de la santé publique - art. R5221-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174598", "@fin": "2004-08-08", "#text": "Section 1 : Définitions", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801750", "@fin": "2004-08-08", "@num": "R665-64-2", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Lorsqu'un dispositif médical de diagnostic in vitro forme un ensemble indissociable avec un dispositif, qui, s'il est utilisé séparément, est susceptible d'être considéré comme un dispositif médical au sens de l'article L. 5211-1 et dont l'action est accessoire à celle du dispositif médical de diagnostic in vitro, celui-ci est régi par les dispositions du présent titre, sans préjudice de l'application des dispositions du titre Ier en ce qui concerne le dispositif médical.
\n
" } }, "LEGIARTI000006801751": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-3", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801751", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801751.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06403XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916325", "@num": "R5221-3", "#text": "Code de la santé publique - art. R5221-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916325", "@num": "R5221-3", "#text": "Code de la santé publique - art. R5221-3 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174598", "@fin": "2004-08-08", "#text": "Section 1 : Définitions", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801751", "@fin": "2004-08-08", "@num": "R665-64-3", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Ne sont pas régis par les dispositions du présent titre :
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1° Les instruments, appareils, équipements, matériaux ou autres articles, y compris les logiciels, destinés à être utilisés aux fins de la recherche sans poursuivre des objectifs médicaux ;
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2° Les matériaux de référence certifiés au niveau international et les matériels utilisés dans les programmes d'évaluation externe de la qualité des analyses des laboratoires d'analyses de biologie médicale, à l'exception des agents d'étalonnage et des matériaux de contrôle qui doivent permettre à l'utilisateur de constater ou de vérifier les performances des dispositifs ;
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3° Les produits destinés à des usages généraux en laboratoire à moins que, eu égard à leurs caractéristiques, ils soient spécifiquement destinés par leur fabricant à des examens de diagnostic in vitro.
" } }, "LEGIARTI000006801752": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-4", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801752", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801752.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06404XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916326", "@num": "R5221-4", "#text": "Code de la santé publique - art. R5221-4 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916326", "@num": "R5221-4", "#text": "Code de la santé publique - art. R5221-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916327", "@num": "R5221-5", "#text": "Code de la santé publique - art. R5221-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916327", "@num": "R5221-5", "#text": "Code de la santé publique - art. R5221-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174598", "@fin": "2004-08-08", "#text": "Section 1 : Définitions", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801752", "@fin": "2004-08-08", "@num": "R665-64-4", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Pour l'application des dispositions du présent titre, on entend par :
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1° \"accessoire\", tout article qui est destiné principalement par son fabricant à être utilisé avec un dispositif médical de diagnostic in vitro afin de permettre l'utilisation de ce dernier conformément à sa destination, à l'exception des dispositifs médicaux invasifs destinés à prélever des échantillons ainsi que des dispositifs médicaux placés en contact direct avec le corps humain dans le but d'obtenir un échantillon ;
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2° \"récipient pour échantillons\", tout dispositif médical de diagnostic in vitro, qu'il soit sous vide ou non, principalement destiné par son fabricant à recevoir directement l'échantillon provenant du corps humain et à le conserver en vue d'un examen de diagnostic in vitro ;
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3° \"dispositif destiné à des autodiagnostics\", tout dispositif médical de diagnostic in vitro destiné par le fabricant à être utilisé par le public dans un environnement domestique ;
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4° \"dispositif faisant l'objet d'une évaluation de ses performances\", tout dispositif médical de diagnostic in vitro soumis par le fabricant à une ou plusieurs études d'évaluation de ses performances dans des laboratoires d'analyses de biologie médicale ou dans d'autres environnements appropriés extérieurs à ses propres installations ;
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5° \"dispositif nouveau\", tout dispositif médical de diagnostic in vitro :
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a) Lorsque, pour la substance à analyser ou un autre paramètre, la disponibilité permanente d'un tel dispositif n'a pas été assurée sur le marché communautaire durant les trois années précédentes ;
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b) Qui recourt à une technologie analytique qui, sur le marché communautaire, n'a pas été utilisée en permanence, durant les trois années précédentes, en liaison avec une substance déterminée à analyser ou un autre paramètre donné ;
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6° \"destination\", l'utilisation à laquelle un dispositif médical de diagnostic in vitro est destiné d'après les indications fournies par le fabricant dans l'étiquetage, la notice d'utilisation ou les matériels promotionnels ;
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7° \"mise sur le marché\", la première mise à disposition à titre onéreux ou gratuit d'un dispositif médical de diagnostic in vitro autre qu'un dispositif faisant l'objet d'une évaluation de ses performances, en vue de sa distribution ou de son utilisation dans un Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen, qu'il s'agisse d'un dispositif neuf ou remis à neuf ;
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8° \"mise en service\", la mise à disposition de l'utilisateur d'un dispositif médical de diagnostic in vitro prêt à être utilisé pour la première fois sur le marché communautaire conformément à sa destination ;
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9° \"importation\", l'importation d'un dispositif médical de diagnostic in vitro en provenance d'un Etat non membre de la Communauté européenne ou non partie à l'accord sur l'Espace économique européen en vue de sa mise sur le marché ;
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10° \"fabricant\", la personne physique ou morale responsable de la conception, de la fabrication, du conditionnement et de l'étiquetage d'un dispositif médical de diagnostic in vitro en vue de sa mise sur le marché en son nom propre, que ces opérations soient effectuées par cette personne ou pour son compte par une autre personne ;
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11° \"mandataire\", toute personne physique ou morale établie dans un Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen qui, après avoir été expressément désignée par le fabricant, agit et peut être contactée par les autorités administratives compétentes en lieu et place du fabricant en ce qui concerne les obligations que le présent titre impose à ce dernier ;
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12° \"importateur\", toute personne physique ou morale établie dans un Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen se livrant à l'importation et au stockage de dispositifs médicaux de diagnostic in vitro ;
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13° \"distributeur\", toute personne physique ou morale se livrant au stockage de dispositifs médicaux de diagnostic in vitro et à leur distribution ou à leur exportation, à l'exclusion de la vente au public ;
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14° \"exportateur\", toute personne physique ou morale se livrant à l'exportation de dispositifs médicaux de diagnostic in vitro vers des Etats non membres de la Communauté européenne ou non parties à l'accord sur l'Espace économique européen.
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Les obligations qui s'imposent en vertu du présent titre au fabricant mentionné au 10° ci-dessus s'imposent également à la personne physique ou morale qui assemble, conditionne, traite, remet à neuf ou étiquette un ou plusieurs produits préfabriqués ou leur assigne la destination de dispositifs médicaux de diagnostic in vitro, en vue de les mettre sur le marché en son nom propre. Elles ne s'appliquent pas à la personne qui, sans être fabricant au sens du 10° ci-dessus, assemble ou adapte pour un patient déterminé, conformément à leur destination, des dispositifs déjà mis sur le marché.
" } }, "LEGIARTI000006801753": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-5", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801753", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801753.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06405XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916328", "@num": "R5221-6", "#text": "Code de la santé publique - art. R5221-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916328", "@num": "R5221-6", "#text": "Code de la santé publique - art. R5221-6 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801761", "@num": "R665-64-11", "#text": "Code de la santé publique - art. R665-64-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801769", "@num": "R665-64-17", "#text": "Code de la santé publique - art. R665-64-17 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801775", "@num": "R665-64-23", "#text": "Code de la santé publique - art. R665-64-23 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801778", "@num": "R665-64-26", "#text": "Code de la santé publique - art. R665-64-26 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174598", "@fin": "2004-08-08", "#text": "Section 1 : Définitions", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801753", "@fin": "2004-08-08", "@num": "R665-64-5", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Pour l'application des dispositions du présent titre, les dispositifs médicaux de diagnostic in vitro, autres que les dispositifs médicaux de diagnostic in vitro faisant l'objet d'une évaluation de leurs performances, sont classés dans deux catégories :
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1° Les dispositifs médicaux de diagnostic in vitro dont la fiabilité conditionne une bonne prise en charge du patient et dont les défaillances sont susceptibles de causer un risque grave pour la santé. Ils comprennent les dispositifs médicaux de diagnostic in vitro destinés à des autodiagnostics, ainsi que les dispositifs médicaux de diagnostic in vitro dont la liste est fixée par arrêté du ministre chargé de la santé, sur proposition du directeur général de l'Agence française de sécurité sanitaire des produits de santé. L'arrêté classe ces derniers en deux listes A et B selon le niveau d'exigence requis pour l'évaluation de leur conformité ;
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2° Les dispositifs médicaux de diagnostic in vitro autres que ceux mentionnés au 1°.
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La procédure d'évaluation de la conformité des dispositifs mentionnés au 1° comporte l'intervention d'un organisme habilité. Pour les dispositifs mentionnés au 2°, la procédure d'évaluation de la conformité se déroule sous la seule responsabilité du fabricant.
" } }, "LEGIARTI000006801756": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-6", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801756", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801756.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06406XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006690314", "@num": "L5221-2", "#text": "Code de la santé publique - art. L5221-2 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916336", "@num": "R5221-14", "#text": "Code de la santé publique - art. R5221-14 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916336", "@num": "R5221-14", "#text": "Code de la santé publique - art. R5221-14 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801768", "@num": "R665-64-16", "#text": "Code de la santé publique - art. R665-64-16 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801757", "@num": "R665-64-7", "#text": "Code de la santé publique - art. R665-64-7 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801758", "@num": "R665-64-8", "#text": "Code de la santé publique - art. R665-64-8 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187224", "@fin": "2004-08-08", "#text": "Sous-section 1 : Principes généraux", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801756", "@fin": "2004-08-08", "@num": "R665-64-6", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Tout dispositif médical de diagnostic in vitro importé, mis sur le marché ou mis en service doit être conforme aux exigences essentielles, générales et techniques, de santé et de sécurité des personnes et des biens définies aux articles R. 665-64-7 et R. 665-64-8 et qui lui sont applicables compte tenu de sa destination.
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Cette conformité fait l'objet d'une évaluation et donne lieu à l'établissement du certificat mentionné à l'article L. 5221-2. Ce certificat est établi à l'issue de la mise en oeuvre des procédures définies à la présente section ou par les dispositions transposant dans le droit interne de l'autre Etat membre où elles ont été accomplies, les dispositions de la directive 98/79/CE du Parlement européen et du Conseil du 27 octobre 1998 relative aux dispositifs médicaux de diagnostic in vitro.
" } }, "LEGIARTI000006801757": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-7", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801757", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801757.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06407XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006690312", "@num": "L5221-1", "#text": "Code de la santé publique - art. L5221-1 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690314", "@num": "L5221-2", "#text": "Code de la santé publique - art. L5221-2 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916337", "@num": "R5221-15", "#text": "Code de la santé publique - art. R5221-15 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916337", "@num": "R5221-15", "#text": "Code de la santé publique - art. R5221-15 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801760", "@num": "R665-64-10", "#text": "Code de la santé publique - art. R665-64-10 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801761", "@num": "R665-64-11", "#text": "Code de la santé publique - art. R665-64-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801767", "@num": "R665-64-15", "#text": "Code de la santé publique - art. R665-64-15 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801774", "@num": "R665-64-22", "#text": "Code de la santé publique - art. R665-64-22 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801775", "@num": "R665-64-23", "#text": "Code de la santé publique - art. R665-64-23 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801776", "@num": "R665-64-24", "#text": "Code de la santé publique - art. R665-64-24 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801777", "@num": "R665-64-25", "#text": "Code de la santé publique - art. R665-64-25 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801780", "@num": "R665-64-28", "#text": "Code de la santé publique - art. R665-64-28 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801793", "@num": "R665-64-38", "#text": "Code de la santé publique - art. R665-64-38 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801803", "@num": "R665-64-45", "#text": "Code de la santé publique - art. R665-64-45 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801756", "@num": "R665-64-6", "#text": "Code de la santé publique - art. R665-64-6 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801758", "@num": "R665-64-8", "#text": "Code de la santé publique - art. R665-64-8 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187224", "@fin": "2004-08-08", "#text": "Sous-section 1 : Principes généraux", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801757", "@fin": "2004-08-08", "@num": "R665-64-7", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les dispositifs médicaux de diagnostic in vitro doivent être conçus, fabriqués et maintenus, compte tenu de l'état de la technique généralement reconnu, de telle manière que, dans des conditions normales d'utilisation, ils ne compromettent pas, directement ou indirectement, l'état clinique et la sécurité des patients, la sécurité et la santé des utilisateurs ou d'autres personnes, ni la sécurité des biens.
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Ils doivent être conçus et fabriqués, compte tenu de l'état de la technique généralement reconnu, de manière à pouvoir être utilisés aux fins prévues à l'article L. 5221-1, selon les indications du fabricant et atteindre les performances fixées par celui-ci et attestées par le certificat mentionné à l'article L. 5221-2.
" } }, "LEGIARTI000006801758": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-8", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801758", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801758.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06408XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916338", "@num": "R5221-16", "#text": "Code de la santé publique - art. R5221-16 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916338", "@num": "R5221-16", "#text": "Code de la santé publique - art. R5221-16 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801760", "@num": "R665-64-10", "#text": "Code de la santé publique - art. R665-64-10 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801761", "@num": "R665-64-11", "#text": "Code de la santé publique - art. R665-64-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801767", "@num": "R665-64-15", "#text": "Code de la santé publique - art. R665-64-15 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801774", "@num": "R665-64-22", "#text": "Code de la santé publique - art. R665-64-22 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801775", "@num": "R665-64-23", "#text": "Code de la santé publique - art. R665-64-23 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801776", "@num": "R665-64-24", "#text": "Code de la santé publique - art. R665-64-24 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801777", "@num": "R665-64-25", "#text": "Code de la santé publique - art. R665-64-25 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801780", "@num": "R665-64-28", "#text": "Code de la santé publique - art. R665-64-28 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801793", "@num": "R665-64-38", "#text": "Code de la santé publique - art. R665-64-38 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801803", "@num": "R665-64-45", "#text": "Code de la santé publique - art. R665-64-45 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801756", "@num": "R665-64-6", "#text": "Code de la santé publique - art. R665-64-6 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801757", "@num": "R665-64-7", "#text": "Code de la santé publique - art. R665-64-7 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187224", "@fin": "2004-08-08", "#text": "Sous-section 1 : Principes généraux", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801758", "@fin": "2004-08-08", "@num": "R665-64-8", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Pour respecter les exigences relatives à la conception et la fabrication, les dispositifs médicaux de diagnostic in vitro doivent être conçus, fabriqués et conditionnés de manière à répondre aux objectifs suivants :
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1° Avoir des propriétés chimiques et physiques permettant de garantir les caractéristiques et les performances visées à l'article R. 665-64-7 et réduire autant que possible le risque engendré par les fuites de produits, les produits contaminant et les résidus pour le personnel participant au transport, au stockage et à l'utilisation des dispositifs, compte tenu de leur destination ;
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2° Eliminer ou réduire au minimum le risque d'infection et de contamination microbienne pour l'utilisateur, toute autre personne ou l'échantillon provenant du corps humain et devant être examiné, en particulier lorsque le dispositif contient des substances biologiques et être maintenu dans son emballage au niveau de propreté ou dans l'état microbiologique particulier indiqué par le fabricant ;
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3° Réduire au minimum les risques liés à leur utilisation en conjonction avec les matériaux, substances et gaz avec lesquels ils peuvent entrer en contact au cours de leur utilisation normale, les risques de lésions liés à leurs caractéristiques physiques et les risques liés aux influences externes prévisibles et garantir une immunité contre les perturbations électromagnétiques permettant de fonctionner conformément à leur destination ;
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4° Fournir, s'ils constituent des dispositifs ayant une fonction primaire de mesurage analytique, une constance et une précision de mesurage adéquates, en tenant compte de la destination du dispositif et des procédures et matériaux de mesure de référence disponibles et appropriés ;
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5° Réduire au minimum, pour ce qui concerne la protection contre les rayonnements, l'exposition des utilisateurs et autres personnes aux émissions de rayonnements, assurer que les caractéristiques et la quantité des rayonnements émis puissent être contrôlées et réglées, et comporter des informations détaillées sur la nature des rayonnements émis, les moyens de protéger l'utilisateur et sur les façons d'éviter les fausses manoeuvres et d'éliminer les risques inhérents à l'installation ;
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6° Réduire au minimum, s'ils sont raccordés à une source d'énergie ou équipés d'une telle source, les risques de création de perturbations électromagnétiques, de chocs électriques accidentels ainsi que les risques mécaniques et thermiques ;
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7° Pour les dispositifs destinés à des autodiagnostics, avoir des performances en rapport avec leur destination compte tenu des aptitudes et des moyens dont disposent les utilisateurs ainsi que des variations auxquelles on peut raisonnablement s'attendre dans la technique et l'environnement des utilisateurs et présenter les informations et les instructions fournies par le fabricant de manière à les rendre faciles à comprendre et à appliquer par l'utilisateur ;
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8° Etre accompagné des informations nécessaires pour pouvoir être utilisé correctement et en toute sécurité, en tenant compte de la formation et des connaissances des utilisateurs potentiels, et pour identifier le fabricant. La liste des informations devant figurer sur l'étiquetage et dans la notice d'utilisation est fixée par arrêté du ministre chargé de la santé, sur proposition du directeur général de l'Agence française de sécurité sanitaire des produits de santé.
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" } }, "LEGIARTI000006801759": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-9", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801759", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801759.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06409XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916332", "@num": "R5221-10", "#text": "Code de la santé publique - art. R5221-10 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916332", "@num": "R5221-10", "#text": "Code de la santé publique - art. R5221-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801779", "@num": "R665-64-27", "#text": "Code de la santé publique - art. R665-64-27 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187224", "@fin": "2004-08-08", "#text": "Sous-section 1 : Principes généraux", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801759", "@fin": "2004-08-08", "@num": "R665-64-9", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Tout dispositif médical de diagnostic in vitro importé, mis sur le marché ou mis en service, doit être revêtu du marquage CE.
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Toutefois, le marquage CE n'est requis ni pour les dispositifs faisant l'objet d'une évaluation de leurs performances ni pour les dispositifs mentionnés à l'article R. 665-64-27.
" } }, "LEGIARTI000006801760": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-10", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801760", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801760.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06410XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916330", "@num": "R5221-8", "#text": "Code de la santé publique - art. R5221-8 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916330", "@num": "R5221-8", "#text": "Code de la santé publique - art. R5221-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801761", "@num": "R665-64-11", "#text": "Code de la santé publique - art. R665-64-11 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801757", "@num": "R665-64-7", "#text": "Code de la santé publique - art. R665-64-7 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801758", "@num": "R665-64-8", "#text": "Code de la santé publique - art. R665-64-8 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187224", "@fin": "2004-08-08", "#text": "Sous-section 1 : Principes généraux", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801760", "@fin": "2004-08-08", "@num": "R665-64-10", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Sans préjudice des dispositions de l'article R. 665-64-11, les dispositifs médicaux de diagnostic in vitro qui satisfont aux normes les concernant et transposant les normes européennes harmonisées dont les références ont été publiées au Journal officiel de la République française sont présumés conformes aux exigences essentielles définies aux articles R. 665-64-7 et R. 665-64-8.
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" } }, "LEGIARTI000006801761": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-11", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801761", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801761.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06411XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916331", "@num": "R5221-9", "#text": "Code de la santé publique - art. R5221-9 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916331", "@num": "R5221-9", "#text": "Code de la santé publique - art. R5221-9 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801760", "@num": "R665-64-10", "#text": "Code de la santé publique - art. R665-64-10 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801753", "@num": "R665-64-5", "#text": "Code de la santé publique - art. R665-64-5 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801757", "@num": "R665-64-7", "#text": "Code de la santé publique - art. R665-64-7 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801758", "@num": "R665-64-8", "#text": "Code de la santé publique - art. R665-64-8 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187224", "@fin": "2004-08-08", "#text": "Sous-section 1 : Principes généraux", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801761", "@fin": "2004-08-08", "@num": "R665-64-11", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les dispositifs médicaux de diagnostic in vitro figurant sur la liste fixée par l'arrêté mentionné à l'article R. 665-64-5, conçus et fabriqués conformément à des spécifications techniques communes publiées au Journal officiel de l'Union européenne et établissant les critères d'évaluation et de réévaluation des performances, les critères de libération de lots, les méthodes et les matériaux de référence, sont, dans la limite du champ d'application de ces spécifications, présumés conformes aux exigences essentielles définies aux articles R. 665-64-7 et R. 665-64-8.
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Les fabricants sont tenus de respecter ces spécifications techniques communes. Toutefois, si, pour des raisons dûment justifiées, ils ne se conforment pas à ces spécifications, ils doivent adopter des solutions de niveau au moins équivalent à celles-ci. Ils en informent l'organisme habilité.
" } }, "LEGIARTI000006801762": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-12", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801762", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801762.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06412XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916335", "@num": "R5221-13", "#text": "Code de la santé publique - art. R5221-13 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916335", "@num": "R5221-13", "#text": "Code de la santé publique - art. R5221-13 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801803", "@num": "R665-64-45", "#text": "Code de la santé publique - art. R665-64-45 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187224", "@fin": "2004-08-08", "#text": "Sous-section 1 : Principes généraux", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801762", "@fin": "2004-08-08", "@num": "R665-64-12", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
La présentation, lors de réunions scientifiques ou techniques, d'expositions et de démonstrations de dispositifs médicaux de diagnostic in vitro qui ne sont pas conformes aux dispositions du présent titre est autorisée à condition que ceux-ci ne soient pas utilisés sur des échantillons provenant de participants et qu'un panneau visible indique clairement que ces dispositifs ne peuvent être mis sur le marché ni mis en service avant leur mise en conformité.
\n
" } }, "LEGIARTI000006801763": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-13", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801763", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801763.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06413XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916336", "@num": "R5221-14", "#text": "Code de la santé publique - art. R5221-14 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916336", "@num": "R5221-14", "#text": "Code de la santé publique - art. R5221-14 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801768", "@num": "R665-64-16", "#text": "Code de la santé publique - art. R665-64-16 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187224", "@fin": "2004-08-08", "#text": "Sous-section 1 : Principes généraux", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801763", "@fin": "2004-08-08", "@num": "R665-64-13", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Sur demande dûment justifiée du fabricant ou de son mandataire, le directeur général de l'Agence française de sécurité sanitaire des produits de santé peut autoriser à titre dérogatoire la mise sur le marché et la mise en service d'un dispositif médical de diagnostic in vitro nommément désigné n'ayant pas fait l'objet des procédures mentionnées à l'article R. 665-64-16 et dont l'utilisation présente un intérêt pour la protection de la santé.
\n
" } }, "LEGIARTI000006801764": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-14", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801764", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801764.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06414XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916336", "@num": "R5221-14", "#text": "Code de la santé publique - art. R5221-14 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916336", "@num": "R5221-14", "#text": "Code de la santé publique - art. R5221-14 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187224", "@fin": "2004-08-08", "#text": "Sous-section 1 : Principes généraux", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801764", "@fin": "2004-08-08", "@num": "R665-64-14", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Pour tout dispositif médical de diagnostic in vitro remis à l'utilisateur, l'étiquetage du produit et la notice qui l'accompagne ainsi que toute autre information relative à son fonctionnement ou à son utilisation comportent une version rédigée en français.
\n
" } }, "LEGIARTI000006801767": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-15", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801767", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801767.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06415XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916341", "@num": "R5221-19", "#text": "Code de la santé publique - art. R5221-19 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916341", "@num": "R5221-19", "#text": "Code de la santé publique - art. R5221-19 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801768", "@num": "R665-64-16", "#text": "Code de la santé publique - art. R665-64-16 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801757", "@num": "R665-64-7", "#text": "Code de la santé publique - art. R665-64-7 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801758", "@num": "R665-64-8", "#text": "Code de la santé publique - art. R665-64-8 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187225", "@fin": "2004-08-08", "#text": "Sous-section 2 : Procédures d'évaluation de la conformité", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801767", "@fin": "2004-08-08", "@num": "R665-64-15", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
La conformité des dispositifs médicaux de diagnostic in vitro aux exigences essentielles définies aux articles R. 665-64-7 et R. 665-64-8 est évaluée par l'accomplissement d'une ou plusieurs des procédures mentionnées à l'article R. 665-64-16.
\n
" } }, "LEGIARTI000006801768": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-16", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801768", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801768.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06416XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916341", "@num": "R5221-19", "#text": "Code de la santé publique - art. R5221-19 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916342", "@num": "R5221-20", "#text": "Code de la santé publique - art. R5221-20 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801763", "@num": "R665-64-13", "#text": "Code de la santé publique - art. R665-64-13 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801767", "@num": "R665-64-15", "#text": "Code de la santé publique - art. R665-64-15 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801769", "@num": "R665-64-17", "#text": "Code de la santé publique - art. R665-64-17 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801773", "@num": "R665-64-21", "#text": "Code de la santé publique - art. R665-64-21 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801774", "@num": "R665-64-22", "#text": "Code de la santé publique - art. R665-64-22 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801775", "@num": "R665-64-23", "#text": "Code de la santé publique - art. R665-64-23 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801776", "@num": "R665-64-24", "#text": "Code de la santé publique - art. R665-64-24 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801777", "@num": "R665-64-25", "#text": "Code de la santé publique - art. R665-64-25 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801778", "@num": "R665-64-26", "#text": "Code de la santé publique - art. R665-64-26 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801784", "@num": "R665-64-32", "#text": "Code de la santé publique - art. R665-64-32 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801789", "@num": "R665-64-34", "#text": "Code de la santé publique - art. R665-64-34 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801756", "@num": "R665-64-6", "#text": "Code de la santé publique - art. R665-64-6 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187225", "@fin": "2004-08-08", "#text": "Sous-section 2 : Procédures d'évaluation de la conformité", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801768", "@fin": "2004-08-08", "@num": "R665-64-16", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les procédures d'évaluation de la conformité mentionnées à l'article R. 665-64-6 sont les suivantes :
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1° La procédure applicable aux dispositifs médicaux de diagnostic in vitro faisant l'objet d'une évaluation de leurs performances ;
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2° La déclaration CE de conformité ;
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3° La déclaration CE de conformité, système complet d'assurance de la qualité ;
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4° L'examen CE de type ;
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5° La vérification CE ;
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6° La déclaration CE de conformité, assurance de la qualité de la production.
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Le fabricant peut charger son mandataire d'engager les procédures mentionnées aux 1°, 2°, 4° et 5°.
" } }, "LEGIARTI000006801769": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-17", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801769", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801769.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06417XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916344", "@num": "R5221-22", "#text": "Code de la santé publique - art. R5221-22 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916344", "@num": "R5221-22", "#text": "Code de la santé publique - art. R5221-22 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916345", "@num": "R5221-23", "#text": "Code de la santé publique - art. R5221-23 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916345", "@num": "R5221-23", "#text": "Code de la santé publique - art. R5221-23 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801768", "@num": "R665-64-16", "#text": "Code de la santé publique - art. R665-64-16 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801753", "@num": "R665-64-5", "#text": "Code de la santé publique - art. R665-64-5 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187225", "@fin": "2004-08-08", "#text": "Sous-section 2 : Procédures d'évaluation de la conformité", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801769", "@fin": "2004-08-08", "@num": "R665-64-17", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
I. - Pour tous les dispositifs médicaux de diagnostic in vitro faisant l'objet d'une évaluation de leurs performances, le fabricant suit la procédure définie au 1° de l'article R. 665-64-16.
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II. - Aux fins de la mise sur le marché des dispositifs médicaux de diagnostic in vitro autres que ceux faisant l'objet d'une évaluation de leurs performances, les fabricants suivent les procédures suivantes :
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1° Pour les dispositifs médicaux de diagnostic in vitro qui ne figurent pas sur les listes fixées par l'arrêté mentionné à l'article R. 665-64-5, la déclaration CE de conformité mentionnée au 2° de l'article R. 665-64-16.
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Lorsqu'il s'agit de dispositifs destinés à l'autodiagnostic, le fabricant peut également suivre l'une des trois procédures définies au 3° du présent article ;
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2° Pour les dispositifs médicaux de diagnostic in vitro figurant sur la liste A de l'arrêté mentionné à l'article R. 665-64-5, au choix du fabricant :
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- la déclaration CE de conformité, système complet d'assurance de la qualité, mentionnée au 3° de l'article R. 665-64-16 ;
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- l'examen CE de type, mentionné au 4° de l'article R. 665-64-16, associé avec la déclaration CE de conformité, assurance de la qualité de la production, mentionnée au 6° de l'article R. 665-64-16 ;
\n
3° Pour les dispositifs médicaux de diagnostic in vitro figurant sur la liste B de l'arrêté mentionné à l'article R. 665-64-5, au choix du fabricant :
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- la déclaration CE de conformité, système complet d'assurance de la qualité, mentionnée au 3° de l'article R. 665-64-16 ;
\n
- l'examen CE de type, mentionné au 4° de l'article R. 665-64-16, associé avec la vérification CE mentionnée au 5° de l'article R. 665-64-16 ;
\n
- l'examen CE de type, mentionné au 4° de l'article R. 665-64-16, associé avec la déclaration CE de conformité, assurance de la qualité de la production, mentionnée au 6° de l'article R. 665-64-16.
" } }, "LEGIARTI000006801770": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-18", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801770", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801770.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06418XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006690587", "@num": "L5462-1", "#text": "Code de la santé publique - art. L5462-1 (T)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916340", "@num": "R5221-18", "#text": "Code de la santé publique - art. R5221-18 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916340", "@num": "R5221-18", "#text": "Code de la santé publique - art. R5221-18 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187225", "@fin": "2004-08-08", "#text": "Sous-section 2 : Procédures d'évaluation de la conformité", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801770", "@fin": "2004-08-08", "@num": "R665-64-18", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le fabricant ou son mandataire tient à la disposition du directeur général de l'Agence française de sécurité sanitaire des produits de santé, pendant une période de cinq ans à compter de la date de fabrication du dernier produit, les certificats de conformité et les documentations techniques qu'il a établies dans le cadre des procédures prévues par la présente section ainsi que les décisions et rapports des organismes habilités ayant participé à ces procédures.
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Ces documents doivent être présentés par le fabricant ou son mandataire sur demande des agents mentionnés à l'article L. 5462-1.
" } }, "LEGIARTI000006801771": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-19", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801771", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801771.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06419XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916340", "@num": "R5221-18", "#text": "Code de la santé publique - art. R5221-18 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916352", "@num": "R5221-30", "#text": "Code de la santé publique - art. R5221-30 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916352", "@num": "R5221-30", "#text": "Code de la santé publique - art. R5221-30 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187225", "@fin": "2004-08-08", "#text": "Sous-section 2 : Procédures d'évaluation de la conformité", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801771", "@fin": "2004-08-08", "@num": "R665-64-19", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Lorsque la procédure d'évaluation de conformité appliquée par un fabricant ou son mandataire comporte l'intervention d'un organisme habilité, le fabricant ou son mandataire peut s'adresser à l'organisme de son choix dans le cadre des tâches pour lesquelles cet organisme a été habilité.
\n
Chaque procédure liée à un dispositif médical de diagnostic in vitro ne peut faire l'objet d'une demande qu'auprès d'un seul organisme habilité.
" } }, "LEGIARTI000006801772": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-20", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801772", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801772.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06420XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916340", "@num": "R5221-18", "#text": "Code de la santé publique - art. R5221-18 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916340", "@num": "R5221-18", "#text": "Code de la santé publique - art. R5221-18 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187225", "@fin": "2004-08-08", "#text": "Sous-section 2 : Procédures d'évaluation de la conformité", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801772", "@fin": "2004-08-08", "@num": "R665-64-20", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Dans l'accomplissement des procédures d'évaluation, les fabricants et les organismes habilités tiennent compte des résultats disponibles de toute opération d'évaluation et de vérification qui a pu être effectuée, en application des dispositions du présent titre, à un stade intermédiaire de fabrication.
\n
" } }, "LEGIARTI000006801773": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-21", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801773", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801773.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06421XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916345", "@num": "R5221-23", "#text": "Code de la santé publique - art. R5221-23 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916345", "@num": "R5221-23", "#text": "Code de la santé publique - art. R5221-23 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801768", "@num": "R665-64-16", "#text": "Code de la santé publique - art. R665-64-16 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique R665-64-16, R665-64-41 à R665-64-44", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187225", "@fin": "2004-08-08", "#text": "Sous-section 2 : Procédures d'évaluation de la conformité", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801773", "@fin": "2004-08-08", "@num": "R665-64-21", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Dans le cadre de la procédure applicable aux dispositifs médicaux de diagnostic in vitro faisant l'objet d'une évaluation de leurs performances, mentionnée au 1° de l'article R. 665-64-16, le fabricant rédige une déclaration contenant les données permettant d'identifier le dispositif et le plan de l'évaluation et attestant que les dispositifs médicaux de diagnostic in vitro sont conformes aux dispositions du présent titre et des arrêtés pris pour son application qui leur sont applicables.
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Le fabricant s'engage à tenir à la disposition du directeur général de l'Agence française de sécurité sanitaire des produits de santé pendant une période de cinq ans à compter de la fin de l'évaluation une documentation permettant de comprendre la conception, la fabrication et les performances du dispositif médical de diagnostic in vitro.
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Les dispositions prévues aux articles R. 665-64-41 à R. 665-64-44 s'appliquent au fabricant d'un dispositif médical de diagnostic in vitro faisant l'objet d'une évaluation de ses performances.
" } }, "LEGIARTI000006801774": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-22", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801774", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801774.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06422XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916346", "@num": "R5221-24", "#text": "Code de la santé publique - art. R5221-24 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916346", "@num": "R5221-24", "#text": "Code de la santé publique - art. R5221-24 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801768", "@num": "R665-64-16", "#text": "Code de la santé publique - art. R665-64-16 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801779", "@num": "R665-64-27", "#text": "Code de la santé publique - art. R665-64-27 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801757", "@num": "R665-64-7", "#text": "Code de la santé publique - art. R665-64-7 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801758", "@num": "R665-64-8", "#text": "Code de la santé publique - art. R665-64-8 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187225", "@fin": "2004-08-08", "#text": "Sous-section 2 : Procédures d'évaluation de la conformité", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801774", "@fin": "2004-08-08", "@num": "R665-64-22", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Dans le cadre de la procédure de déclaration CE de conformité, mentionnée au 2° de l'article R. 665-64-16, le fabricant établit une documentation technique permettant d'évaluer la conformité du dispositif médical de diagnostic in vitro aux exigences essentielles définies aux articles R. 665-64-7 et R. 665-64-8. Il précise les principes permettant d'assurer la qualité de sa production et garantit que son procédé de fabrication respecte ces principes.
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Le fabricant met en place et tient à jour une procédure systématique d'examen des données acquises sur les dispositifs médicaux de diagnostic in vitro et applique les mesures correctives nécessaires.
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En outre, pour un dispositif destiné à des autodiagnostics, le fabricant dépose une demande d'examen de la conception de ce dispositif auprès d'un organisme habilité, à laquelle est joint un dossier permettant de comprendre la conception du dispositif et d'évaluer sa conformité aux exigences essentielles. Si la conception du dispositif est conforme aux dispositions applicables du présent titre, l'organisme habilité délivre un certificat d'examen CE de la conception. Le fabricant informe l'organisme habilité ayant délivré le certificat de toute modification ultérieure apportée à la conception du dispositif. Cette modification doit être approuvée par l'organisme habilité si elle peut remettre en cause la conformité du dispositif aux exigences essentielles ou aux conditions d'utilisation du dispositif.
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Le fabricant certifie que les dispositifs médicaux de diagnostic in vitro sont conformes aux dispositions du présent titre et des arrêtés pris pour son application qui leur sont applicables.
" } }, "LEGIARTI000006801775": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-23", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801775", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801775.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06423XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916347", "@num": "R5221-25", "#text": "Code de la santé publique - art. R5221-25 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916347", "@num": "R5221-25", "#text": "Code de la santé publique - art. R5221-25 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801768", "@num": "R665-64-16", "#text": "Code de la santé publique - art. R665-64-16 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801753", "@num": "R665-64-5", "#text": "Code de la santé publique - art. R665-64-5 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801757", "@num": "R665-64-7", "#text": "Code de la santé publique - art. R665-64-7 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801758", "@num": "R665-64-8", "#text": "Code de la santé publique - art. R665-64-8 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187225", "@fin": "2004-08-08", "#text": "Sous-section 2 : Procédures d'évaluation de la conformité", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801775", "@fin": "2004-08-08", "@num": "R665-64-23", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Dans le cadre de la procédure de déclaration CE de conformité, système complet d'assurance de la qualité, mentionnée au 3° de l'article R. 665-64-16, le fabricant soumet à la vérification d'un organisme habilité le système de qualité qu'il a mis en place pour la conception, la fabrication et le contrôle des dispositifs médicaux de diagnostic in vitro et dont l'application doit garantir le respect des dispositions du présent titre et des arrêtés pris pour son application qui leur sont applicables.
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Le fabricant introduit une demande d'évaluation de ce système de qualité auprès d'un organisme habilité et s'engage à maintenir son système de qualité adapté et efficace et à respecter les obligations résultant de celui-ci. Le fabricant s'engage également à mettre en place et tenir à jour une procédure systématique d'examen des données acquises sur les dispositifs médicaux de diagnostic in vitro et à appliquer les mesures correctives nécessaires.
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L'évaluation par l'organisme habilité du système de qualité comprend une inspection dans les locaux du fabricant et, dans les cas dûment motivés, dans les locaux des fournisseurs ou des sous-traitants pour contrôler les procédés de fabrication. La décision de l'organisme habilité est notifiée au fabricant. Elle contient les conclusions de l'inspection et une évaluation motivée.
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En outre, pour un dispositif inscrit sur la liste A de l'arrêté mentionné à l'article R. 665-64-5, le fabricant dépose une demande d'examen de la conception de ce dispositif auprès de l'organisme habilité à laquelle est joint un dossier permettant de comprendre la conception de ce dispositif et d'évaluer sa conformité aux exigences essentielles définies aux articles R. 665-64-7 et R. 665-64-8. Aux fins d'évaluation de cette conformité, l'organisme habilité peut exiger que la demande soit complétée par des essais ou des preuves supplémentaires. Si la conception du dispositif est conforme aux exigences essentielles, l'organisme habilité délivre un certificat d'examen CE de la conception. Le fabricant informe l'organisme habilité ayant délivré le certificat de toute modification ultérieure apportée à la conception du dispositif. Cette modification doit être approuvée par l'organisme habilité si elle peut remettre en cause la conformité du dispositif aux exigences essentielles ou aux conditions d'utilisation du dispositif.
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Pour les dispositifs médicaux de diagnostic in vitro inscrits sur la liste A de l'arrêté mentionné à l'article R. 665-64-5, un contrôle de la production est effectué par l'organisme habilité. A cette fin, le fabricant adresse à l'organisme les documents nécessaires au contrôle de la qualité des dispositifs ou des lots de dispositifs fabriqués et met à sa disposition dans des conditions définies d'un commun accord un échantillon de dispositifs ou de lots de dispositifs fabriqués. A l'expiration d'un délai contractuellement convenu qui ne peut excéder trente jours à compter de la réception de l'échantillon par l'organisme habilité, le fabricant peut mettre sur le marché ces dispositifs ou ces lots de dispositifs si l'organisme habilité ne lui a pas communiqué de décision contraire.
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Le fabricant veille à l'application du système de qualité tel qu'il a été approuvé et certifie que les dispositifs médicaux de diagnostic in vitro sont conformes aux dispositions du présent titre et des arrêtés pris pour son application qui leur sont applicables. Il informe l'organisme habilité qui a approuvé ce système de tout projet de modification importante. L'organisme habilité vérifie que le système ainsi modifié garantit le respect des dispositions du présent titre.
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Dès qu'il a connaissance de modifications des agents pathogènes ou des marqueurs de l'infection à rechercher, le fabricant en informe sans tarder l'organisme habilité et lui indique si ces modifications sont susceptibles d'avoir des incidences sur le fonctionnement du dispositif.
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Le fabricant fournit à l'organisme habilité les informations utiles pour s'assurer du respect des obligations attachées à son système de qualité et autorise l'organisme habilité à effectuer toutes les inspections nécessaires. L'organisme habilité procède périodiquement aux inspections et évaluations appropriées et peut lors de visites inopinées réaliser ou faire réaliser des essais pour vérifier le fonctionnement du système de qualité.
" } }, "LEGIARTI000006801776": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-24", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801776", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801776.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06424XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916348", "@num": "R5221-26", "#text": "Code de la santé publique - art. R5221-26 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916348", "@num": "R5221-26", "#text": "Code de la santé publique - art. R5221-26 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801768", "@num": "R665-64-16", "#text": "Code de la santé publique - art. R665-64-16 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801757", "@num": "R665-64-7", "#text": "Code de la santé publique - art. R665-64-7 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801758", "@num": "R665-64-8", "#text": "Code de la santé publique - art. R665-64-8 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187225", "@fin": "2004-08-08", "#text": "Sous-section 2 : Procédures d'évaluation de la conformité", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801776", "@fin": "2004-08-08", "@num": "R665-64-24", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Dans le cadre de la procédure d'examen CE de type, mentionnée au 4° de l'article R. 665-64-16, le fabricant soumet au contrôle d'un organisme habilité un échantillon représentatif, dénommé type, de la production envisagée afin que celui-ci vérifie que cet échantillon satisfait aux exigences essentielles définies aux articles R. 665-64-7 et R. 665-64-8 applicables aux dispositifs en projet.
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Le fabricant introduit auprès d'un organisme habilité une demande d'évaluation qui doit comporter notamment une documentation technique permettant de comprendre la conception, la fabrication et les performances du dispositif. Le fabricant met également un type à la disposition de l'organisme habilité, qui peut demander d'autres exemplaires en tant que de besoin.
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L'organisme habilité vérifie que le type fourni a été fabriqué en conformité avec la documentation. Il réalise ou fait réaliser les examens et essais nécessaires pour vérifier que les solutions adoptées par le fabricant assurent la conformité des dispositifs fabriqués aux exigences essentielles. Le lieu où ces examens et essais sont effectués est convenu entre l'organisme habilité et le fabricant.
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Lorsque le type satisfait aux exigences essentielles, l'organisme habilité délivre au demandeur un certificat d'examen CE de type. Une copie de ce certificat peut être obtenue par les autres organismes habilités.
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Dès qu'il a connaissance de modifications des agents pathogènes ou des marqueurs de l'infection à rechercher, le fabricant en informe sans tarder l'organisme habilité et lui indique si ces modifications sont susceptibles d'avoir des incidences sur le fonctionnement du dispositif.
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Le fabricant informe l'organisme habilité de toute modification apportée au dispositif approuvé. Cette modification doit être approuvée par l'organisme habilité si elle peut remettre en cause la conformité du dispositif aux exigences essentielles mentionnées ou aux conditions d'utilisation du dispositif.
" } }, "LEGIARTI000006801777": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-25", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801777", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801777.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06425XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916349", "@num": "R5221-27", "#text": "Code de la santé publique - art. R5221-27 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916349", "@num": "R5221-27", "#text": "Code de la santé publique - art. R5221-27 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801768", "@num": "R665-64-16", "#text": "Code de la santé publique - art. R665-64-16 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801757", "@num": "R665-64-7", "#text": "Code de la santé publique - art. R665-64-7 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801758", "@num": "R665-64-8", "#text": "Code de la santé publique - art. R665-64-8 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187225", "@fin": "2004-08-08", "#text": "Sous-section 2 : Procédures d'évaluation de la conformité", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801777", "@fin": "2004-08-08", "@num": "R665-64-25", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Dans le cadre de la procédure de vérification CE, mentionnée au 5° de l'article R. 665-64-16, le fabricant soumet au contrôle d'un organisme habilité les dispositifs fabriqués conformément à un type approuvé et décrit dans un certificat d'examen CE de type.
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Le fabricant prend toutes les mesures nécessaires pour que le procédé de fabrication garantisse la conformité des dispositifs médicaux de diagnostic in vitro fabriqués au type décrit dans le certificat d'examen CE de type et aux exigences essentielles définies aux articles R. 665-64-7 et R. 665-64-8 qui leur sont applicables. Il établit une documentation technique relative à la fabrication des dispositifs médicaux de diagnostic in vitro.
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Le fabricant s'engage à mettre en place et tenir à jour une procédure systématique d'examen des données acquises sur les dispositifs médicaux de diagnostic in vitro et à appliquer les mesures correctives nécessaires.
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L'organisme habilité saisi par le fabricant effectue les examens et essais nécessaires afin de vérifier la conformité des dispositifs avec le type décrit et les exigences essentielles. Cette vérification s'effectue, au choix du fabricant, soit par contrôle et essai de chaque produit, soit par contrôle et essai des produits sur une base statistique. Dans ce dernier cas, si la procédure de contrôle des dispositifs fabriqués n'est pas adaptée pour certains aspects, le fabricant établit avec l'accord de l'organisme habilité des méthodes d'essai, de surveillance et de contrôle en cours de fabrication. Le fabricant fournit à l'organisme habilité les informations utiles pour s'assurer du respect des obligations attachées à ces méthodes d'essai, de surveillance et de contrôle et autorise l'organisme habilité à effectuer toutes les inspections nécessaires. L'organisme habilité procède périodiquement aux inspections et évaluations appropriées et peut lors de visites inopinées réaliser ou faire réaliser des essais pour vérifier le fonctionnement du système de qualité.
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L'organisme habilité appose ou fait apposer son numéro d'identification sur chaque produit et établit une attestation de conformité relative aux essais effectués.
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Le fabricant certifie que les dispositifs médicaux de diagnostic in vitro fabriqués sont conformes au type décrit dans le certificat d'examen CE de type et respectent les dispositions du présent titre et des arrêtés pris pour son application qui leur sont applicables.
" } }, "LEGIARTI000006801778": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-26", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801778", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801778.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06426XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916350", "@num": "R5221-28", "#text": "Code de la santé publique - art. R5221-28 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916350", "@num": "R5221-28", "#text": "Code de la santé publique - art. R5221-28 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801768", "@num": "R665-64-16", "#text": "Code de la santé publique - art. R665-64-16 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801753", "@num": "R665-64-5", "#text": "Code de la santé publique - art. R665-64-5 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187225", "@fin": "2004-08-08", "#text": "Sous-section 2 : Procédures d'évaluation de la conformité", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801778", "@fin": "2004-08-08", "@num": "R665-64-26", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Dans le cadre de la procédure de déclaration CE de conformité, assurance de la qualité de la production, mentionnée au 6° de l'article R. 665-64-16, le fabricant soumet à la vérification d'un organisme habilité le système de qualité pour la fabrication qu'il a mis en place pour assurer la conformité des dispositifs médicaux de diagnostic in vitro au type approuvé et décrit dans un certificat d'examen CE de type.
\n
Le fabricant introduit auprès de l'organisme habilité une demande d'évaluation de ce système de qualité qui comporte une documentation technique dans laquelle figure l'ensemble des exigences et dispositions adoptées par le fabricant pour son système de qualité.
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Il s'engage à maintenir son système de qualité adapté et efficace et à respecter les obligations résultant de celui-ci. Le fabricant s'engage également à mettre en place et tenir à jour une procédure systématique d'examen des données acquises sur les dispositifs médicaux de diagnostic in vitro et à appliquer les mesures correctives nécessaires.
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L'évaluation par l'organisme habilité du système de qualité comprend une inspection dans les locaux du fabricant et, dans les cas dûment motivés, dans les locaux des fournisseurs ou des sous-traitants pour contrôler les procédés de fabrication.
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La décision de l'organisme habilité est notifiée au fabricant. Elle contient les conclusions de l'inspection et une évaluation motivée.
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En outre, pour les dispositifs médicaux de diagnostic in vitro inscrit sur la liste A de l'arrêté mentionné à l'article R. 665-64-5, un contrôle de la production est réalisée par l'organisme habilité. A cette fin, le fabricant adresse à l'organisme les documents nécessaires au contrôle de la qualité des dispositifs ou des lots de dispositifs fabriqués et met à sa disposition dans des conditions définies d'un commun accord un échantillon de dispositifs ou de lots de dispositifs fabriqués. A l'expiration d'un délai contractuellement convenu qui ne peut excéder trente jours à compter de la réception de l'échantillon par l'organisme habilité, le fabricant peut mettre sur le marché ces dispositifs ou ces lots de dispositifs si l'organisme habilité ne lui a pas communiqué de décision contraire.
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Le fabricant veille à l'application du système de qualité tel qu'il a été approuvé et effectue l'inspection finale des dispositifs médicaux de diagnostic in vitro.
\n
Le fabricant certifie que les dispositifs médicaux de diagnostic in vitro fabriqués sont conformes au type décrit dans le certificat d'examen CE de type et respectent les dispositions du présent titre et des arrêtés pris pour son application qui leur sont applicables.
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Il informe l'organisme habilité qui a approuvé le système de qualité de tout projet de modification importante de ce système. L'organisme habilité vérifie que le système ainsi modifié assure la conformité des dispositifs médicaux de diagnostic in vitro fabriqués au type décrit dans le certificat d'examen CE de type. L'organisme habilité notifie sa décision au fabricant.
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Le fabricant fournit à l'organisme habilité les informations utiles pour s'assurer du respect des obligations attachées à son système de qualité et autorise l'organisme habilité à effectuer toutes les inspections nécessaires. L'organisme habilité procède périodiquement aux inspections et évaluations appropriées et peut lors de visites inopinées réaliser ou faire réaliser des essais pour vérifier le fonctionnement du système de qualité.
" } }, "LEGIARTI000006801779": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-27", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801779", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801779.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06427XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006690326", "@num": "L5221-5", "#text": "Code de la santé publique - art. L5221-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916343", "@num": "R5221-21", "#text": "Code de la santé publique - art. R5221-21 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916343", "@num": "R5221-21", "#text": "Code de la santé publique - art. R5221-21 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801774", "@num": "R665-64-22", "#text": "Code de la santé publique - art. R665-64-22 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801801", "@num": "R665-64-43", "#text": "Code de la santé publique - art. R665-64-43 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801804", "@num": "R665-64-46", "#text": "Code de la santé publique - art. R665-64-46 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801759", "@num": "R665-64-9", "#text": "Code de la santé publique - art. R665-64-9 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187225", "@fin": "2004-08-08", "#text": "Sous-section 2 : Procédures d'évaluation de la conformité", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801779", "@fin": "2004-08-08", "@num": "R665-64-27", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les dispositifs médicaux de diagnostic in vitro mentionnés à l'article L. 5221-5 ne peuvent être dispensés des procédures d'évaluation de conformité que si la procédure correspondant à la catégorie du dispositif n'entraîne pas l'intervention d'un organisme habilité.
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Les établissements dispensant des soins fabriquant ces dispositifs médicaux de diagnostic in vitro pour les utiliser dans les conditions prévues à l'article L. 5221-5 sont soumis aux dispositions des deux premiers alinéas de l'article R. 665-64-22.
" } }, "LEGIARTI000006801780": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-28", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801780", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801780.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06428XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916339", "@num": "R5221-17", "#text": "Code de la santé publique - art. R5221-17 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916339", "@num": "R5221-17", "#text": "Code de la santé publique - art. R5221-17 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916351", "@num": "R5221-29", "#text": "Code de la santé publique - art. R5221-29 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916351", "@num": "R5221-29", "#text": "Code de la santé publique - art. R5221-29 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801757", "@num": "R665-64-7", "#text": "Code de la santé publique - art. R665-64-7 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801758", "@num": "R665-64-8", "#text": "Code de la santé publique - art. R665-64-8 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique R665-64-7, R665-64-8, R665-64-21 à R665-64-26", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006187225", "@fin": "2004-08-08", "#text": "Sous-section 2 : Procédures d'évaluation de la conformité", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006174599", "@fin": "2004-08-08", "#text": "Section 2 : Conditions de mise sur le marché", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801780", "@fin": "2004-08-08", "@num": "R665-64-28", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Pour l'application des dispositions de la présente section, des arrêtés du ministre chargé de la santé, pris sur proposition du directeur général de l'Agence française de sécurité sanitaire des produits de santé, précisent :
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1° Les conditions de mise en oeuvre des exigences essentielles définies aux articles R. 665-64-7 et R. 665-64-8 ;
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2° Les modalités d'application des procédures définies aux articles R. 665-64-21 à R. 665-64-26.
" } }, "LEGIARTI000006801784": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-32", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801784", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801784.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06432XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916352", "@num": "R5221-30", "#text": "Code de la santé publique - art. R5221-30 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916352", "@num": "R5221-30", "#text": "Code de la santé publique - art. R5221-30 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916329", "@num": "R5221-7", "#text": "Code de la santé publique - art. R5221-7 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916329", "@num": "R5221-7", "#text": "Code de la santé publique - art. R5221-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801768", "@num": "R665-64-16", "#text": "Code de la santé publique - art. R665-64-16 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174601", "@fin": "2004-08-08", "#text": "Section 3 : Organismes habilités", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801784", "@fin": "2004-08-08", "@num": "R665-64-32", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
L'organisme habilité s'assure, avant de procéder à l'examen de la demande d'évaluation, que le dossier comporte notamment :
\n
- les caractéristiques générales du demandeur telles que raison sociale, nom, adresse, statut juridique ;
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- une description précise de l'étendue de l'évaluation souhaitée, ainsi que la référence aux directives et aux dispositions nationales les transposant.
\n
En cas de désaccord sur l'application des règles de classification entre le fabricant d'un dispositif médical de diagnostic in vitro et un organisme habilité intervenant dans les procédures d'évaluation de conformité prévues au présent titre, le directeur général de l'Agence française de sécurité sanitaire des produits de santé détermine la procédure mentionnée à l'article R. 665-64-16 dont relève le dispositif en cause.
" } }, "LEGIARTI000006801788": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-33", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801788", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801788.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06433XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916352", "@num": "R5221-30", "#text": "Code de la santé publique - art. R5221-30 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916352", "@num": "R5221-30", "#text": "Code de la santé publique - art. R5221-30 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174601", "@fin": "2004-08-08", "#text": "Section 3 : Organismes habilités", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801788", "@fin": "2004-08-08", "@num": "R665-64-33", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
L'organisme habilité peut, lorsque cela est dûment justifié, exiger du fabricant la communication de toute information et la réalisation de tout essai ou évaluation nécessaires à la conduite des vérifications qui lui incombent dans le cadre de la procédure applicable.
\n
" } }, "LEGIARTI000006801789": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-34", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801789", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801789.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06434XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916353", "@num": "R5221-31", "#text": "Code de la santé publique - art. R5221-31 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916353", "@num": "R5221-31", "#text": "Code de la santé publique - art. R5221-31 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801768", "@num": "R665-64-16", "#text": "Code de la santé publique - art. R665-64-16 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174601", "@fin": "2004-08-08", "#text": "Section 3 : Organismes habilités", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801789", "@fin": "2004-08-08", "@num": "R665-64-34", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les décisions prises par les organismes habilités dans le cadre des procédures mentionnées aux 2°, 3° et 4° de l'article R. 665-64-16 ont une validité de cinq ans. Elles sont reconductibles par périodes de cinq ans sur demande présentée au moment contractuellement convenu entre le fabricant et l'organisme. Pour des raisons dûment justifiées, les décisions de l'organisme habilité peuvent avoir une durée de validité inférieure à cinq ans.
\n
" } }, "LEGIARTI000006801790": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-35", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801790", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801790.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06435XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916352", "@num": "R5221-30", "#text": "Code de la santé publique - art. R5221-30 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916352", "@num": "R5221-30", "#text": "Code de la santé publique - art. R5221-30 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174601", "@fin": "2004-08-08", "#text": "Section 3 : Organismes habilités", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801790", "@fin": "2004-08-08", "@num": "R665-64-35", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Lorsqu'un organisme habilité constate que les exigences du présent titre applicables à ce dispositif n'ont pas été respectées ou ne le sont plus par le fabricant ou lorsqu'un certificat n'aurait pas dû être délivré, il suspend ou annule le certificat délivré ou l'assortit de restrictions, sauf si le fabricant applique, pour que ces exigences soient respectées, des mesures correctives appropriées.
\n
" } }, "LEGIARTI000006801791": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-36", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801791", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801791.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06436XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916354", "@num": "R5221-32", "#text": "Code de la santé publique - art. R5221-32 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916354", "@num": "R5221-32", "#text": "Code de la santé publique - art. R5221-32 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174601", "@fin": "2004-08-08", "#text": "Section 3 : Organismes habilités", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801791", "@fin": "2004-08-08", "@num": "R665-64-36", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les organismes habilités informent le directeur général de l'Agence française de sécurité sanitaire des produits de santé :
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1° De toute modification de nature à modifier les conditions dans lesquelles l'habilitation a été accordée ;
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2° De toutes ses décisions prises dans le cadre des procédures définies au présent chapitre ;
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3° De tous les certificats délivrés, modifiés, complétés, suspendus, refusés ou annulés ;
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4° De la nécessité d'une intervention de l'autorité compétente d'un autre Etat membre.
" } }, "LEGIARTI000006801792": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-37", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801792", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801792.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06437XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916355", "@num": "R5221-33", "#text": "Code de la santé publique - art. R5221-33 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916355", "@num": "R5221-33", "#text": "Code de la santé publique - art. R5221-33 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174601", "@fin": "2004-08-08", "#text": "Section 3 : Organismes habilités", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801792", "@fin": "2004-08-08", "@num": "R665-64-37", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
L'organisme habilité informe les autres organismes habilités en France ou dans les autres Etats membres de la Communauté européenne ou parties à l'accord sur l'Espace économique européen et ayant fait l'objet d'une publication au Journal officiel de l'Union européenne :
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- de tous les certificats suspendus ou annulés ;
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- sur demande, de toutes les décisions prises dans le cadre des procédures définies à la présente section et de tous les certificats délivrés ou refusés.
\n
Ils mettent en outre à leur disposition, sur demande, toutes les informations utiles supplémentaires.
" } }, "LEGIARTI000006801793": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-38", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801793", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801793.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06438XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916333", "@num": "R5221-11", "#text": "Code de la santé publique - art. R5221-11 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916333", "@num": "R5221-11", "#text": "Code de la santé publique - art. R5221-11 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801757", "@num": "R665-64-7", "#text": "Code de la santé publique - art. R665-64-7 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801758", "@num": "R665-64-8", "#text": "Code de la santé publique - art. R665-64-8 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174602", "@fin": "2004-08-08", "#text": "Section 4 : Marquage CE", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801793", "@fin": "2004-08-08", "@num": "R665-64-38", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le fabricant ne peut apposer le marquage CE que si le dispositif médical de diagnostic in vitro est conforme aux exigences essentielles définies aux articles R. 665-64-7 et R. 665-64-8 et a fait l'objet des procédures d'évaluation qui lui sont applicables.
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Lorsqu'un dispositif médical de diagnostic in vitro est également régi par d'autres dispositions prévoyant l'apposition d'un marquage CE, le marquage indique alors que le dispositif satisfait également à ces dispositions. Si celles-ci autorisent le fabricant, pendant une période transitoire, à choisir le régime juridique qu'il applique, le marquage CE indique que le dispositif satisfait à la seule réglementation appliquée par le fabricant. Les documents et notices d'utilisation accompagnant le produit concerné doivent alors mentionner les références de la réglementation, aux exigences de laquelle il répond.
" } }, "LEGIARTI000006801794": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-39", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801794", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801794.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06439XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916334", "@num": "R5221-12", "#text": "Code de la santé publique - art. R5221-12 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916334", "@num": "R5221-12", "#text": "Code de la santé publique - art. R5221-12 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique R665-64-22 à R665-64-26", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174602", "@fin": "2004-08-08", "#text": "Section 4 : Marquage CE", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801794", "@fin": "2004-08-08", "@num": "R665-64-39", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le marquage CE est apposé sous la responsabilité du fabricant ou de son mandataire, de façon visible, lisible et indélébile sur le dispositif médical de diagnostic in vitro lorsque cela est possible et approprié, ainsi que sur l'emballage commercial et sur les notices d'utilisation. La forme et les dimensions de ce marquage sont fixées par arrêté pris par le ministre chargé de la santé.
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Le marquage CE est accompagné, le cas échéant, du numéro d'identification, publié au Journal officiel de l'Union européenne, de l'organisme habilité auquel a été confiée, en France ou dans un autre Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen, la mise en oeuvre des procédures d'évaluation de conformité définies aux articles R. 665-64-22 à R. 665-64-26.
" } }, "LEGIARTI000006801795": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-40", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801795", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801795.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06440XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916336", "@num": "R5221-14", "#text": "Code de la santé publique - art. R5221-14 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916336", "@num": "R5221-14", "#text": "Code de la santé publique - art. R5221-14 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174602", "@fin": "2004-08-08", "#text": "Section 4 : Marquage CE", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801795", "@fin": "2004-08-08", "@num": "R665-64-40", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Il est interdit d'apposer sur un dispositif médical de diagnostic in vitro, sur l'emballage ou sur les notices d'utilisation des marques ou des inscriptions de nature à induire en erreur sur la signification ou le graphisme du marquage CE. Toute autre marque peut être apposée, à condition qu'elle ne réduise pas la visibilité ni la lisibilité du marquage CE.
\n
" } }, "LEGIARTI000006801799": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-41", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801799", "URL": "article/LEGI/ARTI/00/00/06/80/17/LEGIARTI000006801799.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06441XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916356", "@num": "R5221-34", "#text": "Code de la santé publique - art. R5221-34 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916356", "@num": "R5221-34", "#text": "Code de la santé publique - art. R5221-34 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174603", "@fin": "2004-08-08", "#text": "Section 5 : Déclaration des personnes physiques ou morales se livrant à la fabrication, à la mise sur le marché, à la distribution, à l'importation ou à l'exportation de dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801799", "@fin": "2004-08-08", "@num": "R665-64-41", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les fabricants qui mettent des dispositifs médicaux de diagnostic in vitro sur le marché français et qui n'ont pas de siège social sur le territoire d'un Etat membre de la Communauté européenne ou partie à l'accord sur l'Espace économique européen doivent avoir désigné préalablement un mandataire.
\n
" } }, "LEGIARTI000006801800": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-42", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801800", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801800.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06442XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006690324", "@num": "L5221-3", "#text": "Code de la santé publique - art. L5221-3 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916357", "@num": "R5221-35", "#text": "Code de la santé publique - art. R5221-35 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916357", "@num": "R5221-35", "#text": "Code de la santé publique - art. R5221-35 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801825", "@num": "R665-64-63", "#text": "Code de la santé publique - art. R665-64-63 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174603", "@fin": "2004-08-08", "#text": "Section 5 : Déclaration des personnes physiques ou morales se livrant à la fabrication, à la mise sur le marché, à la distribution, à l'importation ou à l'exportation de dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801800", "@fin": "2004-08-08", "@num": "R665-64-42", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
La déclaration prévue à l'article L. 5221-3 est effectuée par le fabricant ou son mandataire, l'importateur, le distributeur ou l'exportateur de dispositifs médicaux de diagnostic in vitro.
\n
Une même personne physique ou morale peut se déclarer au titre de plusieurs activités.
\n
Le fabricant ou son mandataire n'est pas tenu de se déclarer en qualité d'importateur ou de distributeur pour les dispositifs médicaux de diagnostic in vitro qu'il met sur le marché. L'importateur n'est pas tenu de se déclarer en tant que distributeur pour les dispositifs médicaux de diagnostic in vitro qu'il importe.
\n
La déclaration est adressée au directeur général de l'Agence française de sécurité sanitaire des produits de santé, par envoi recommandé avec demande d'avis de réception.
" } }, "LEGIARTI000006801801": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-43", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801801", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801801.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06443XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916358", "@num": "R5221-36", "#text": "Code de la santé publique - art. R5221-36 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916358", "@num": "R5221-36", "#text": "Code de la santé publique - art. R5221-36 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801779", "@num": "R665-64-27", "#text": "Code de la santé publique - art. R665-64-27 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174603", "@fin": "2004-08-08", "#text": "Section 5 : Déclaration des personnes physiques ou morales se livrant à la fabrication, à la mise sur le marché, à la distribution, à l'importation ou à l'exportation de dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801801", "@fin": "2004-08-08", "@num": "R665-64-43", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le contenu et modalités de présentation de la déclaration sont fixés par arrêté du ministre chargé de la santé sur proposition du directeur général de l'Agence française de sécurité sanitaire des produits de santé.
\n
Cet arrêté pourra prévoir un contenu et des modalités de présentation particuliers pour les établissements se livrant à la fabrication des dispositifs médicaux de diagnostic in vitro mentionnés à l'article R. 665-64-27.
" } }, "LEGIARTI000006801802": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-44", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801802", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801802.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06444XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916359", "@num": "R5221-37", "#text": "Code de la santé publique - art. R5221-37 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916359", "@num": "R5221-37", "#text": "Code de la santé publique - art. R5221-37 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174603", "@fin": "2004-08-08", "#text": "Section 5 : Déclaration des personnes physiques ou morales se livrant à la fabrication, à la mise sur le marché, à la distribution, à l'importation ou à l'exportation de dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801802", "@fin": "2004-08-08", "@num": "R665-64-44", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Toute modification des éléments de la déclaration doit être signalée au directeur général de l'Agence française de sécurité sanitaire des produits de santé.
\n
" } }, "LEGIARTI000006801803": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-45", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801803", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801803.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06445XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006417202", "@num": "121-2", "#text": "Code pénal - art. 121-2 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006417342", "@num": "131-41", "#text": "Code pénal - art. 131-41 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006417368", "@num": "132-11", "#text": "Code pénal - art. 132-11 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006417377", "@num": "132-15", "#text": "Code pénal - art. 132-15 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690324", "@num": "L5221-3", "#text": "Code de la santé publique - art. L5221-3 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916487", "@num": "R5461-4", "#text": "Code de la santé publique - art. R5461-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916487", "@num": "R5461-4", "#text": "Code de la santé publique - art. R5461-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916488", "@num": "R5461-5", "#text": "Code de la santé publique - art. R5461-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916488", "@num": "R5461-5", "#text": "Code de la santé publique - art. R5461-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916489", "@num": "R5461-6", "#text": "Code de la santé publique - art. R5461-6 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916489", "@num": "R5461-6", "#text": "Code de la santé publique - art. R5461-6 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801762", "@num": "R665-64-12", "#text": "Code de la santé publique - art. R665-64-12 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801757", "@num": "R665-64-7", "#text": "Code de la santé publique - art. R665-64-7 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801758", "@num": "R665-64-8", "#text": "Code de la santé publique - art. R665-64-8 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174604", "@fin": "2004-08-08", "#text": "Section 6 : Sanctions pénales", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157806", "@fin": "2004-08-08", "#text": "Chapitre 1 : Régime juridique des dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801803", "@fin": "2004-08-08", "@num": "R665-64-45", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
I. - Est puni de l'amende prévue pour les contraventions de la 5e classe le fait :
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1° De mettre sur le marché un dispositif médical de diagnostic in vitro non revêtu du marquage CE dans les cas où l'apposition de ce marquage est requise ou qui n'a pas fait l'objet d'un certificat CE de conformité ;
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2° De ne pas être en mesure de présenter, dans un délai de quinze jours, les documents justifiant que les procédures d'évaluation de la conformité prévues par les dispositions du présent chapitre, qui sont applicables, ont été accomplies ;
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3° De mettre sur le marché un dispositif médical de diagnostic in vitro non conforme aux exigences essentielles de sécurité définies aux articles R. 665-64-7 et R. 665-64-8 qui lui sont applicables ;
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4° D'apposer le marquage ou d'établir un certificat CE de conformité lorsque celui-ci ne satisfait pas aux exigences essentielles ou n'a pas fait l'objet des procédures d'évaluation de conformité prévues par les dispositions du présent chapitre qui lui sont applicables ;
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5° De présenter, lors de réunions scientifiques ou techniques, d'expositions ou de démonstrations, des dispositifs médicaux de diagnostic in vitro non conformes aux dispositions du présent titre sans respecter les conditions prévues à l'article R. 665-64-12 ;
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6° De ne pas procéder à la déclaration mentionnée à l'article L. 5221-3 auprès de l'Agence française de sécurité sanitaire des produits de santé dans les conditions prévues à la section V ou de ne pas communiquer les modifications relatives à cette déclaration.
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II. - Les personnes morales peuvent être reconnues pénalement responsables, dans les conditions prévues à l'article 121-2 du code pénal, des infractions définies au I du présent article.
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La peine encourue par les personnes morales est l'amende, dans les conditions prévues à l'article 131-41 du code pénal.
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III. - La récidive des infractions définies au I du présent article est réprimée conformément aux articles 132-11 et 132-15 du code pénal.
" } }, "LEGIARTI000006801804": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-46", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801804", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801804.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06446XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916360", "@num": "R5222-1", "#text": "Code de la santé publique - art. R5222-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916360", "@num": "R5222-1", "#text": "Code de la santé publique - art. R5222-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801779", "@num": "R665-64-27", "#text": "Code de la santé publique - art. R665-64-27 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801805", "@num": "R665-64-47", "#text": "Code de la santé publique - art. R665-64-47 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174605", "@fin": "2004-08-08", "#text": "Section 1 : Dispositions générales", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157807", "@fin": "2004-08-08", "#text": "Chapitre 2 : Réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801804", "@fin": "2004-08-08", "@num": "R665-64-46", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
La vigilance des dispositifs médicaux de diagnostic in vitro dite réactovigilance a pour objet la surveillance des incidents et des risques d'incidents définis au 1° de l'article R. 665-64-47.
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Elle s'exerce sur l'ensemble des dispositifs médicaux de diagnostic in vitro après leur mise sur le marché ainsi que sur les dispositifs médicaux de diagnostic in vitro mentionnés à l'article R. 665-64-27.
" } }, "LEGIARTI000006801805": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-47", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801805", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801805.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06447XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916361", "@num": "R5222-2", "#text": "Code de la santé publique - art. R5222-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916361", "@num": "R5222-2", "#text": "Code de la santé publique - art. R5222-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801804", "@num": "R665-64-46", "#text": "Code de la santé publique - art. R665-64-46 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174605", "@fin": "2004-08-08", "#text": "Section 1 : Dispositions générales", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157807", "@fin": "2004-08-08", "#text": "Chapitre 2 : Réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801805", "@fin": "2004-08-08", "@num": "R665-64-47", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
La réactovigilance comporte :
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1° Le signalement et la déclaration de tout incident ou risque d'incident consistant en une défaillance ou une altération des caractéristiques ou des performances d'un dispositif médical de diagnostic in vitro, ou une inadéquation dans l'étiquetage ou la notice d'utilisation susceptibles d'entraîner ou d'avoir entraîné directement ou indirectement des effets néfastes pour la santé des personnes ;
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2° L'enregistrement, l'évaluation et l'exploitation de ces informations dans un but de protection de la santé des personnes ;
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3° La réalisation de toutes études ou travaux concernant la qualité ou la sécurité d'utilisation des dispositifs médicaux de diagnostic in vitro ;
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4° La réalisation et le suivi des actions correctives décidées.
" } }, "LEGIARTI000006801808": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-48", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801808", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801808.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06448XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916362", "@num": "R5222-3", "#text": "Code de la santé publique - art. R5222-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916363", "@num": "R5222-3", "#text": "Code de la santé publique - art. R5222-3 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801810", "@num": "R665-64-50", "#text": "Code de la santé publique - art. R665-64-50 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174606", "@fin": "2004-08-08", "#text": "Section 2 : Organisation de la réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157807", "@fin": "2004-08-08", "#text": "Chapitre 2 : Réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801808", "@fin": "2004-08-08", "@num": "R665-64-48", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Il est institué un système national de réactovigilance. Ce système comprend :
\n
1° L'Agence française de sécurité sanitaire des produits de santé ;
\n
2° La Commission nationale des dispositifs médicaux de diagnostic in vitro, instituée à l'article R. 665-64-50 ;
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3° L'Etablissement français du sang ;
\n
4° Tout établissement de santé ;
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5° Les professionnels de santé utilisateurs, autres que ceux exerçant dans un établissement mentionné aux 3° et 4° ;
\n
6° Les fabricants ou leurs mandataires, les importateurs et les distributeurs de dispositifs médicaux de diagnostic in vitro.
" } }, "LEGIARTI000006801809": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-49", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801809", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801809.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06449XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916364", "@num": "R5222-4", "#text": "Code de la santé publique - art. R5222-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916364", "@num": "R5222-4", "#text": "Code de la santé publique - art. R5222-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique L5312-1 à L5312-3", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174606", "@fin": "2004-08-08", "#text": "Section 2 : Organisation de la réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157807", "@fin": "2004-08-08", "#text": "Chapitre 2 : Réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801809", "@fin": "2004-08-08", "@num": "R665-64-49", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le directeur général de l'Agence française de sécurité sanitaire des produits de santé assure la mise en oeuvre du système national de réactovigilance. Il anime et coordonne les actions des différents intervenants et veille au respect des procédures de surveillance organisées par le présent chapitre. Lorsqu'il est informé d'un incident ou risque d'incident, ou du rappel d'un dispositif médical de diagnostic in vitro, le directeur général de l'Agence française de sécurité sanitaire des produits de santé fait procéder à une évaluation. Il peut demander toute enquête nécessaire à l'exercice de la réactovigilance.
\n
Le directeur général de l'Agence française de sécurité sanitaire des produits de santé établit et tient à jour un fichier national des correspondants locaux de réactovigilance.
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Le directeur général de l'Agence française de sécurité sanitaire des produits de santé fixe les modalités d'information entre les différents intervenants du système national de réactovigilance.
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Après exploitation des informations recueillies, le directeur général de l'Agence française de sécurité sanitaire des produits de santé prend, le cas échéant, les décisions prévues aux articles L. 5312-1 à L. 5312-3.
" } }, "LEGIARTI000006801810": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-50", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801810", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801810.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06450XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006691245", "@num": "L6213-3", "#text": "Code de la santé publique - art. L6213-3 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916365", "@num": "R5222-5", "#text": "Code de la santé publique - art. R5222-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916365", "@num": "R5222-5", "#text": "Code de la santé publique - art. R5222-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801808", "@num": "R665-64-48", "#text": "Code de la santé publique - art. R665-64-48 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174606", "@fin": "2004-08-08", "#text": "Section 2 : Organisation de la réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157807", "@fin": "2004-08-08", "#text": "Chapitre 2 : Réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801810", "@fin": "2004-08-08", "@num": "R665-64-50", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
La Commission nationale des dispositifs médicaux de diagnostic in vitro siège auprès de l'Agence française de sécurité sanitaire des produits de santé.
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Elle a pour mission :
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1° De participer à l'évaluation des informations sur les incidents ou les risques d'incidents mettant en cause des dispositifs médicaux de diagnostic in vitro ;
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2° De donner un avis à la demande du directeur général de l'Agence française de sécurité sanitaire des produits de santé :
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a) Sur les mesures prises ou à prendre pour éviter que les incidents ou les risques d'incidents se reproduisent ;
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b) Sur les programmes et les résultats des contrôles et des évaluations menés dans le cadre de la surveillance du marché et organisés par l'Agence française de sécurité sanitaire des produits de santé ;
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c) Sur toute question relative à la mise sur le marché et à l'utilisation des dispositifs médicaux de diagnostic in vitro ainsi que sur les normes qui s'y appliquent ;
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3° De participer à la veille technologique ;
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Le directeur général de l'Agence française de sécurité sanitaire des produits de santé lui communique les informations relatives aux dispositifs médicaux de diagnostic in vitro recueillies dans le cadre du contrôle de qualité des analyses de biologie médicale prévu à l'article L. 6213-3.
" } }, "LEGIARTI000006801811": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-51", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801811", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801811.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06451XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006685816", "@num": "L1114-1", "#text": "Code de la santé publique - art. L1114-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916366", "@num": "R5222-6", "#text": "Code de la santé publique - art. R5222-6 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916367", "@num": "R5222-6", "#text": "Code de la santé publique - art. R5222-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174606", "@fin": "2004-08-08", "#text": "Section 2 : Organisation de la réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157807", "@fin": "2004-08-08", "#text": "Chapitre 2 : Réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801811", "@fin": "2004-08-08", "@num": "R665-64-51", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
La Commission nationale des dispositifs médicaux de diagnostic in vitro est composée de :
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1° Trois membres de droit :
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a) Le directeur général de la santé ou son représentant ;
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b) Le directeur général de l'Agence française de sécurité sanitaire des produits de santé ou son représentant ;
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c) Le directeur de l'hospitalisation et de l'organisation des soins ou son représentant.
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2° Vingt-deux membres nommés par le ministre chargé de la santé pour une durée de trois ans renouvelable :
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a) Deux personnes représentant des organismes représentatifs de l'industrie des dispositifs médicaux de diagnostic in vitro ;
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b) Un expert de l'Etablissement français du sang sur proposition de son président ;
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c) Un expert de l'Etablissement français des greffes sur proposition de son directeur général ;
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d) Une personnalité scientifique proposée par le ministre chargé de l'industrie ;
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e) Deux personnes exerçant les fonctions de correspondant local de réactovigilance en milieu hospitalier ;
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f) Quinze personnes choisies en raison de leur compétence scientifique dans le domaine des dispositifs médicaux de diagnostic in vitro.
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3° Deux membres nommés par le ministre chargé de la santé pour une durée de trois ans renouvelable :
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a) Une personne représentant les organisations de consommateurs et compétente en matière de dispositifs médicaux de diagnostic in vitro, sur proposition du ministre chargé de la consommation ;
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b) Une personne représentant les associations de patients mentionnées à l'article L. 1114-1 ;
\n
Vingt-quatre suppléants sont désignés dans les mêmes conditions que les membres titulaires mentionnés au 2° et au 3° et les remplacent en cas d'empêchement. Ils leur succèdent s'il se produit une vacance en cours de mandat, pour la durée du mandat restant à courir.
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Le président et le vice-président sont désignés parmi les membres de la commission par le ministre chargé de la santé. Le vice-président supplée le président en cas d'empêchement.
" } }, "LEGIARTI000006801812": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-52", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801812", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801812.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06452XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916368", "@num": "R5222-7", "#text": "Code de la santé publique - art. R5222-7 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916368", "@num": "R5222-7", "#text": "Code de la santé publique - art. R5222-7 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174606", "@fin": "2004-08-08", "#text": "Section 2 : Organisation de la réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157807", "@fin": "2004-08-08", "#text": "Chapitre 2 : Réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801812", "@fin": "2004-08-08", "@num": "R665-64-52", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
La commission se réunit sur convocation du directeur général de l'Agence française de sécurité sanitaire des produits de santé.
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Les délibérations ne sont valables que si la moitié au moins des membres de la commission sont présents.
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Le résultat des votes est acquis à la majorité des votes exprimés. En cas de partage égal des voix, celle du président est prépondérante.
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La commission a la faculté d'entendre toute personne qualifiée, et notamment des représentants des organisations de consommateurs. Elle peut faire appel à des rapporteurs et à des experts consultants désignés par le directeur général de l'Agence française de sécurité sanitaire des produits de santé.
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Le secrétariat de la commission est assuré par l'Agence française de sécurité sanitaire des produits de santé.
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Les frais de déplacement des membres de la commission, des rapporteurs et des experts sont remboursés dans les conditions prévues par la réglementation en vigueur applicable aux fonctionnaires de l'Etat.
" } }, "LEGIARTI000006801813": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-53", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801813", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801813.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06453XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006417944", "@num": "226-13", "#text": "Code pénal - art. 226-13 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916369", "@num": "R5222-8", "#text": "Code de la santé publique - art. R5222-8 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916369", "@num": "R5222-8", "#text": "Code de la santé publique - art. R5222-8 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174606", "@fin": "2004-08-08", "#text": "Section 2 : Organisation de la réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157807", "@fin": "2004-08-08", "#text": "Chapitre 2 : Réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801813", "@fin": "2004-08-08", "@num": "R665-64-53", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les délibérations de la Commission nationale des dispositifs médicaux de diagnostic in vitro sont confidentielles. Les membres de la commission et les personnalités leur apportant leur concours sont astreints au secret professionnel dans les conditions prévues à l'article 226-13 du code pénal.
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" } }, "LEGIARTI000006801814": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-54", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801814", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801814.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06454XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916370", "@num": "R5222-9", "#text": "Code de la santé publique - art. R5222-9 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916370", "@num": "R5222-9", "#text": "Code de la santé publique - art. R5222-9 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174606", "@fin": "2004-08-08", "#text": "Section 2 : Organisation de la réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157807", "@fin": "2004-08-08", "#text": "Chapitre 2 : Réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801814", "@fin": "2004-08-08", "@num": "R665-64-54", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le ministre chargé de la santé peut demander l'avis de la commission sur toute question ayant trait au domaine de compétence de cette commission.
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" } }, "LEGIARTI000006801815": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-55", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801815", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801815.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06455XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916371", "@num": "R5222-10", "#text": "Code de la santé publique - art. R5222-10 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916372", "@num": "R5222-10", "#text": "Code de la santé publique - art. R5222-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174606", "@fin": "2004-08-08", "#text": "Section 2 : Organisation de la réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157807", "@fin": "2004-08-08", "#text": "Chapitre 2 : Réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801815", "@fin": "2004-08-08", "@num": "R665-64-55", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Tout établissement de santé et tout établissement de transfusion sanguine doit désigner un correspondant local de réactovigilance.
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Le correspondant local de réactovigilance doit être médecin ou pharmacien, et doté d'une expérience en matière de dispositifs médicaux de diagnostic in vitro.
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Dès sa nomination, l'identité et la qualité du correspondant local de réactovigilance sont communiquées par le responsable de l'établissement dans lequel le correspondant exerce ses fonctions au directeur général de l'Agence française de sécurité sanitaire des produits de santé.
" } }, "LEGIARTI000006801816": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-56", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801816", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801816.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06456XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916373", "@num": "R5222-11", "#text": "Code de la santé publique - art. R5222-11 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916373", "@num": "R5222-11", "#text": "Code de la santé publique - art. R5222-11 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174606", "@fin": "2004-08-08", "#text": "Section 2 : Organisation de la réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157807", "@fin": "2004-08-08", "#text": "Chapitre 2 : Réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801816", "@fin": "2004-08-08", "@num": "R665-64-56", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Tout fabricant de dispositifs médicaux de diagnostic in vitro, ou son mandataire, doit désigner une personne en charge de la réactovigilance, dont l'identité et la qualité sont communiquées au directeur général de l'Agence française de sécurité sanitaire des produits de santé.
\n
" } }, "LEGIARTI000006801819": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-57", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801819", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801819.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06457XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916374", "@num": "R5222-12", "#text": "Code de la santé publique - art. R5222-12 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916375", "@num": "R5222-12", "#text": "Code de la santé publique - art. R5222-12 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801821", "@num": "R665-64-59", "#text": "Code de la santé publique - art. R665-64-59 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174607", "@fin": "2004-08-08", "#text": "Section 3 : Obligations des intervenants en réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157807", "@fin": "2004-08-08", "#text": "Chapitre 2 : Réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801819", "@fin": "2004-08-08", "@num": "R665-64-57", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les professionnels de santé utilisateurs n'exerçant pas dans un établissement de santé ou un établissement de transfusion sanguine qui ont connaissance d'incidents ou de risques d'incidents mettant en cause un dispositif médical de diagnostic in vitro doivent le déclarer sans délai à l'Agence française de sécurité sanitaire des produits de santé.
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Les professionnels de santé utilisateurs mentionnés au premier alinéa ci-dessus doivent informer les fabricants, mandataires, importateurs ou distributeurs intéressés des incidents ou risques d'incidents déclarés au directeur général de l'Agence française de sécurité sanitaire des produits de santé.
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Tout autre professionnel de santé peut également déclarer au directeur général de l'Agence française de sécurité sanitaire des produits de santé les incidents ou risques d'incidents mettant en cause un dispositif médical de diagnostic in vitro dont il a connaissance.
" } }, "LEGIARTI000006801820": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-58", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801820", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801820.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06458XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916376", "@num": "R5222-13", "#text": "Code de la santé publique - art. R5222-13 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916377", "@num": "R5222-13", "#text": "Code de la santé publique - art. R5222-13 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174607", "@fin": "2004-08-08", "#text": "Section 3 : Obligations des intervenants en réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157807", "@fin": "2004-08-08", "#text": "Chapitre 2 : Réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801820", "@fin": "2004-08-08", "@num": "R665-64-58", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les professionnels de santé utilisateurs qui exercent dans un établissement de santé ou un établissement de transfusion sanguine doivent signaler sans délai au correspondant local de réactovigilance les incidents ou risques d'incidents mettant en cause un dispositif médical de diagnostic in vitro dont ils ont connaissance. En cas d'urgence, le professionnel de santé transmet le signalement directement au directeur général de l'Agence française de sécurité sanitaire des produits de santé.
\n
" } }, "LEGIARTI000006801821": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-59", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801821", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801821.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06459XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916379", "@num": "R5222-15", "#text": "Code de la santé publique - art. R5222-15 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916380", "@num": "R5222-15", "#text": "Code de la santé publique - art. R5222-15 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801819", "@num": "R665-64-57", "#text": "Code de la santé publique - art. R665-64-57 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174607", "@fin": "2004-08-08", "#text": "Section 3 : Obligations des intervenants en réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157807", "@fin": "2004-08-08", "#text": "Chapitre 2 : Réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801821", "@fin": "2004-08-08", "@num": "R665-64-59", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les correspondants locaux de réactovigilance sont chargés :
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1° D'enregistrer et d'analyser tout incident ou risque d'incident signalé susceptible d'être dû à un dispositif médical de diagnostic in vitro ;
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2° De déclarer sans délai au directeur général de l'Agence française de sécurité sanitaire des produits de santé tout incident ou risque d'incident dont ils ont connaissance ;
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3° D'informer les fabricants, mandataires, importateurs ou distributeurs intéressés des incidents ou risques d'incidents mentionnés ci-dessus et d'en informer s'il y a lieu les responsables des autres vigilances des produits de santé dans l'établissement de santé ou l'établissement de transfusion sanguine ;
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4° De participer aux enquêtes, évaluations et expertises susceptibles d'être mises en oeuvre sur les incidents ou risques d'incidents que peuvent présenter les dispositifs médicaux de diagnostic in vitro ;
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5° De donner des avis et conseils aux professionnels de santé mentionnés à l'article R. 665-64-57 pour les aider à procéder au signalement des incidents ;
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6° De sensibiliser l'ensemble des utilisateurs à la réactovigilance et d'aider à l'évaluation des données concernant la sécurité et les performances des dispositifs médicaux de diagnostic in vitro.
" } }, "LEGIARTI000006801822": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-60", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801822", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801822.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06460XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916378", "@num": "R5222-14", "#text": "Code de la santé publique - art. R5222-14 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916378", "@num": "R5222-14", "#text": "Code de la santé publique - art. R5222-14 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174607", "@fin": "2004-08-08", "#text": "Section 3 : Obligations des intervenants en réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157807", "@fin": "2004-08-08", "#text": "Chapitre 2 : Réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801822", "@fin": "2004-08-08", "@num": "R665-64-60", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les fabricants ou leurs mandataires, les importateurs et les distributeurs déclarent sans délai au directeur général de l'Agence française de sécurité sanitaire des produits de santé les incidents ou risques d'incidents mettant en cause un dispositif médical de diagnostic in vitro dont ils ont connaissance.
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Lorsque les importateurs ou les distributeurs déclarent un incident ou un risque d'incident, ou lorsqu'ils sont informés par un correspondant local de réactovigilance ou par un professionnel de santé utilisateur d'un incident ou d'un risque d'incident déclaré au directeur général de l'Agence française de sécurité sanitaire des produits de santé, ils assurent la transmission de l'information au fabricant ou à son mandataire.
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Les fabricants ou leurs mandataires préparent un rapport de synthèse présentant les informations relatives à l'ensemble des incidents ou risques d'incidents qu'ils ont déclarés ou qui leur ont été communiqués. Ce rapport est transmis annuellement au directeur général de l'Agence française de sécurité sanitaire des produits de santé, ou immédiatement sur demande motivée.
" } }, "LEGIARTI000006801823": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-61", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801823", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801823.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06461XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916381", "@num": "R5222-16", "#text": "Code de la santé publique - art. R5222-16 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916381", "@num": "R5222-16", "#text": "Code de la santé publique - art. R5222-16 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174607", "@fin": "2004-08-08", "#text": "Section 3 : Obligations des intervenants en réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157807", "@fin": "2004-08-08", "#text": "Chapitre 2 : Réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801823", "@fin": "2004-08-08", "@num": "R665-64-61", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le fabricant ou son mandataire fournit, sur demande du directeur général de l'Agence française de sécurité sanitaire des produits de santé, toute information relative aux caractéristiques, à la conception, à la composition, au dossier d'évaluation analytique, à la fabrication, au stockage, à la distribution, à la notice d'utilisation, aux procédures et résultats de contrôle de lot avant libération et en cours d'utilisation, à la mise à disposition, à l'utilisation, à la traçabilité des dispositifs médicaux de diagnostic in vitro et à leur vente. De même, il effectue toutes enquêtes ou tous travaux nécessaires à l'exercice de la réactovigilance demandés par le directeur général de l'agence.
\n
L'importateur ou le distributeur de dispositifs médicaux de diagnostic in vitro fournit également à la demande du directeur général de l'Agence française de sécurité sanitaire des produits de santé toute information relative au stockage, à la distribution, à la mise à disposition, à l'utilisation et à la traçabilité des dispositifs médicaux de diagnostic in vitro ainsi que l'accès aux informations relatives à leur vente.
" } }, "LEGIARTI000006801824": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-62", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801824", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801824.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06462XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916382", "@num": "R5222-17", "#text": "Code de la santé publique - art. R5222-17 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916382", "@num": "R5222-17", "#text": "Code de la santé publique - art. R5222-17 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174607", "@fin": "2004-08-08", "#text": "Section 3 : Obligations des intervenants en réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157807", "@fin": "2004-08-08", "#text": "Chapitre 2 : Réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801824", "@fin": "2004-08-08", "@num": "R665-64-62", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Le fabricant ou son mandataire, l'importateur ou le distributeur est tenu de conserver, pour chaque transaction d'entrée et de sortie, au moins les informations suivantes :
\n
1° La date de transaction ;
\n
2° La dénomination du dispositif médical de diagnostic in vitro ;
\n
3° La quantité reçue ou fournie, avec les numéros de lots ;
\n
4° Le nom et l'adresse du fournisseur et du destinataire.
\n
Pour toute livraison à une personne morale ou physique, ces informations sont portées sur un document qui est joint à la livraison. Ces informations sont conservées sous la forme de factures, sur un support informatique ou sous toute autre forme appropriée et sont tenues pendant une période de cinq ans à la disposition de l'Agence française de sécurité sanitaire des produits de santé.
" } }, "LEGIARTI000006801825": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-63", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801825", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801825.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06463XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916383", "@num": "R5222-18", "#text": "Code de la santé publique - art. R5222-18 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916383", "@num": "R5222-18", "#text": "Code de la santé publique - art. R5222-18 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801800", "@num": "R665-64-42", "#text": "Code de la santé publique - art. R665-64-42 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174607", "@fin": "2004-08-08", "#text": "Section 3 : Obligations des intervenants en réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157807", "@fin": "2004-08-08", "#text": "Chapitre 2 : Réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801825", "@fin": "2004-08-08", "@num": "R665-64-63", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Pour un dispositif nouveau, le directeur général de l'Agence française de sécurité sanitaire des produits de santé peut, à tout moment et durant une période de deux ans suivant la déclaration prévue à l'article R. 665-64-42, demander au fabricant ou à son mandataire de fournir un rapport sur l'expérience acquise relative à ce dispositif après la mise sur le marché.
\n
" } }, "LEGIARTI000006801826": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R665-64-64", "ETAT": "ABROGE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-08", "DATE_DEBUT": "2004-02-06" } }, "META_COMMUN": { "ID": "LEGIARTI000006801826", "URL": "article/LEGI/ARTI/00/00/06/80/18/LEGIARTI000006801826.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SXXXXXXXXXX665R06464XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000503843", "#text": "Décret 53-1001 1953-10-05 (DECRET DE CODIFICATION)", "@sens": "source", "@cidtexte": "JORFTEXT000000503843", "@numtexte": "53-1001", "@typelien": "CODIFICATION", "@naturetexte": "DECRET", "@datesignatexte": "1953-10-05" }, { "@id": "LEGIARTI000006228409", "@num": "3", "#text": "Décret n°2004-108 du 4 février 2004 - art. 3 () JORF 6 février 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000416306", "@nortexte": "SANP0324626D", "@numtexte": "2004-108", "@typelien": "CREATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-02-04" }, { "@id": "JORFTEXT000000787339", "#text": "Décret 2004-802 2004-07-29 art. 4 JORF 8 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787339", "@nortexte": "SANP0422530D", "@numtexte": "2004-802", "@typelien": "ABROGATION", "@naturetexte": "DECRET", "@datesignatexte": "2004-07-29" }, { "@id": "LEGIARTI000006916384", "@num": "R5222-19", "#text": "Code de la santé publique - art. R5222-19 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916384", "@num": "R5222-19", "#text": "Code de la santé publique - art. R5222-19 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "Loi 58-356 1958-04-03 (LOI DE VALIDATION)", "@sens": "source", "@typelien": "CODIFICATION" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006174608", "@fin": "2004-08-08", "#text": "Section 4 : Modalités d'application au service de santé des armées", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006157807", "@fin": "2004-08-08", "#text": "Chapitre 2 : Réactovigilance", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006142914", "@fin": "2004-08-08", "#text": "Titre 2 : Dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006128474", "@fin": "2004-08-08", "#text": "Livre 5 bis : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro", "@debut": "2004-02-06" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006107982", "@fin": "2999-01-01", "#text": "Partie réglementaire ancienne", "@debut": "1953-10-07" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000006801826", "@fin": "2004-08-08", "@num": "R665-64-64", "@etat": "ABROGE", "@debut": "2004-02-06", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Pour l'application des dispositions du présent chapitre, les hôpitaux des armées et le centre de transfusion sanguine des armées sont regardés, respectivement, comme des établissements publics de santé et comme un établissement de transfusion sanguine. Le correspondant local de réactovigilance du centre de transfusion sanguine des armées est désigné par le directeur de ce centre.
\n
" } } }, "article_lien": [ { "article_id": "LEGIARTI000006801781", "cible": true, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000006801783", "typelien": "CITATION" }, { "article_id": "LEGIARTI000006801782", "cible": true, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000006801783", "typelien": "CITATION" }, { "article_id": "LEGIARTI000006228409", "cible": true, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000006801783", "typelien": "CREATION" }, { "article_id": "LEGIARTI000006916352", "cible": true, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000006801783", "typelien": "CONCORDE" }, { "article_id": "LEGIARTI000006916352", "cible": false, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000006801783", "typelien": "CONCORDANCE" }, { "article_id": "LEGIARTI000032709122", "cible": true, "cidtexte": "LEGITEXT000006072665", "id": "LEGIARTI000006801783", "typelien": "CONCORDE" } ], "texte_version": { "JORFTEXT000000503843": { "SM": { "CONTENU": "Application de la loi n° 51-518 du 8 mai 1951.‎ Publication en annexe au code de la santé publique, ‎\n‎1) des conventions internationales énumérées à ‎l'article final (792) dudit code (pages 8902 à 8923):‎\n‎-‎ convention franco-luxembourgeoise sur l'exercice de la médecine signée à Paris le 30-09-1879 ;‎\n‎-‎ convention franco-suisse sur l'exercice de la médecine et de l'art vétérinaire signée à Paris le ‎‎29-05-‎‎‎1889 ;‎\n‎-‎ convention franco-belge sur l'exercice de la médecine signée à Bruxelles le 25-10-1910 ;‎\n‎-‎ convention internationale de l'opium signée à la Haye le 23-01-1912 ; protocoles signés à la ‎Haye ‎les ‎‎09-07-1913 et 25-06-1914 ; accords protocoles et actes signés à Genève les 11 et 19-‎‎02-1925, ‎amendés ‎à Lake Success le 11-12-1946 ; protocole signé à Genève le 13-07-1931, ‎amendé à Lake ‎Success le 11-‎‎12-1946 ; accord et acte final signés à Bangkok le 27-11-1931 ; ‎convention protocole et ‎accord signes à ‎Genève le 26-06-1936, amendé à Lake Success le 11-‎‎12-1946 ; protocole signé à Lake ‎Success le 11-12-‎‎1946 ; protocole signé à Paris le 19-11-1948 ;‎\n‎-‎ convention franco-monégasque sur l'exercice de la médecine signée à Paris le 14-12-1938 ;‎\n‎-‎ convention franco-sarroise sur l'exercice de la pharmacie signée à Paris le 03-03-1950 ;‎\n‎-‎ accord franco-sarrois sur l'exercice de la médecine signe à Sarrebruck le 01-12-1951.‎\n‎2) des tables de concordance du code (pages 8924 à 8934).‎\nAux termes de l’article 1er de la loi n° 58-346 du 3 avril 1958, les textes législatifs annexés à ‎cette loi ‎au ‎titre du code de la santé publique‎‎ sont abrogés et remplacés par ledit code. Pour ‎le ‎territoire ‎métropolitain, les dispositions contenues dans le code de la santé publique ont force ‎de ‎loi ‎à compter ‎du 05-04-1958‎‎" }, "ABRO": { "CONTENU": "Texte totalement abrogé sauf l'article 5 et incorporé au code de la santé publique" }, "META": { "META_SPEC": { "META_TEXTE_VERSION": { "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000683983", "#text": "Loi du 31 juillet 1920, v. init.", "@sens": "cible", "@cidtexte": "JORFTEXT000000683983", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "1920-07-31" }, { "@id": "JORFTEXT000000517339", "#text": "Loi n°51-518 du 8 mai 1951", "@sens": "source", "@cidtexte": "JORFTEXT000000517339", "@numtexte": "51-518", "@typelien": "APPLICATION", "@naturetexte": "LOI", "@datesignatexte": "1951-05-08" }, { "@id": "JORFTEXT000000672646", "#text": "Décret n°51-1322 du 6 novembre 1951", "@sens": "source", "@cidtexte": "JORFTEXT000000672646", "@numtexte": "51-1322", "@typelien": "ABROGE", "@naturetexte": "DECRET", "@datesignatexte": "1951-11-06" }, { "@id": "JORFTEXT000000327101", "#text": "Décret n°52-1068 du 25 août 1952", "@sens": "source", "@cidtexte": "JORFTEXT000000327101", "@numtexte": "52-1068", "@typelien": "ABROGE", "@naturetexte": "DECRET", "@datesignatexte": "1952-08-25" }, { "@id": "JORFTEXT000038385399", "#text": "Décret n° 55-512 du 11 mai 1955, v. init.", "@sens": "cible", "@cidtexte": "JORFTEXT000038385399", "@numtexte": "55-512", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "1955-05-11" }, { "@id": "JORFTEXT000029800929", "#text": "Décret n° 56-907 du 10 septembre 1966‎, v. init.", "@sens": "cible", "@cidtexte": "JORFTEXT000029800929", "@numtexte": "56-907", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "1956-09-10" }, { "@id": "JORFTEXT000000874433", "#text": "Loi n°58-91 du 4 février 1958, v. init.", "@sens": "cible", "@cidtexte": "JORFTEXT000000874433", "@numtexte": "58-91", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "1958-02-04" }, { "@id": "JORFTEXT000000217229", "#text": "Ordonnance2000-548", "@sens": "cible", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "ABROGE", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006698233", "@num": "4", "#text": "Rapport - art. 4 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000400219", "@nortexte": "MESX0000036R", "@numtexte": "2000-548", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2000-06-15" }, { "@id": "LEGIARTI000006698234", "@num": "4", "#text": "Rapport - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000400219", "@nortexte": "MESX0000036R", "@numtexte": "2000-548", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2000-06-15" }, { "@id": "LEGIARTI000006804474", "@num": "Annexe V aux articles R665-1 à R665-47", "#text": "Code de la santé publique - art. 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D712-114 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691725", "@num": "D712-115", "#text": "Code de la santé publique - art. D712-115 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691726", "@num": "D712-116", "#text": "Code de la santé publique - art. D712-116 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691727", "@num": "D712-117", "#text": "Code de la santé publique - art. D712-117 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691728", "@num": "D712-118", "#text": "Code de la santé publique - art. D712-118 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691729", "@num": "D712-119", "#text": "Code de la santé publique - art. D712-119 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691858", "@num": "D712-12", "#text": "Code de la santé publique - art. D712-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691856", "@num": "D712-12", "#text": "Code de la santé publique - art. D712-12 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691857", "@num": "D712-12", "#text": "Code de la santé publique - art. D712-12 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691730", "@num": "D712-120", "#text": "Code de la santé publique - art. D712-120 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691731", "@num": "D712-121", "#text": "Code de la santé publique - art. D712-121 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691732", "@num": "D712-122", "#text": "Code de la santé publique - art. D712-122 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691733", "@num": "D712-123", "#text": "Code de la santé publique - art. D712-123 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691734", "@num": "D712-124", "#text": "Code de la santé publique - art. D712-124 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691735", "@num": "D712-125", "#text": "Code de la santé publique - art. D712-125 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691736", "@num": "D712-126", "#text": "Code de la santé publique - art. D712-126 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691737", "@num": "D712-127", "#text": "Code de la santé publique - art. D712-127 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691738", "@num": "D712-128", "#text": "Code de la santé publique - art. D712-128 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691739", "@num": "D712-129", "#text": "Code de la santé publique - art. D712-129 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691861", "@num": "D712-13", "#text": "Code de la santé publique - art. D712-13 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691860", "@num": "D712-13", "#text": "Code de la santé publique - art. D712-13 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691859", "@num": "D712-13", "#text": "Code de la santé publique - art. D712-13 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691864", "@num": "D712-13-1", "#text": "Code de la santé publique - art. D712-13-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691863", "@num": "D712-13-1", "#text": "Code de la santé publique - art. D712-13-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691862", "@num": "D712-13-1", "#text": "Code de la santé publique - art. D712-13-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692042", "@num": "D712-13-2", "#text": "Code de la santé publique - art. D712-13-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692040", "@num": "D712-13-2", "#text": "Code de la santé publique - art. D712-13-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692039", "@num": "D712-13-2", "#text": "Code de la santé publique - art. D712-13-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692041", "@num": "D712-13-2", "#text": "Code de la santé publique - art. D712-13-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691865", "@num": "D712-13-3", "#text": "Code de la santé publique - art. D712-13-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691868", "@num": "D712-13-4", "#text": "Code de la santé publique - art. D712-13-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691867", "@num": "D712-13-4", "#text": "Code de la santé publique - art. D712-13-4 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691866", "@num": "D712-13-4", "#text": "Code de la santé publique - art. D712-13-4 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691869", "@num": "D712-13-5", "#text": "Code de la santé publique - art. D712-13-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691872", "@num": "D712-13-6", "#text": "Code de la santé publique - art. D712-13-6 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691870", "@num": "D712-13-6", "#text": "Code de la santé publique - art. D712-13-6 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691871", "@num": "D712-13-6", "#text": "Code de la santé publique - art. D712-13-6 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691740", "@num": "D712-130", "#text": "Code de la santé publique - art. D712-130 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691741", "@num": "D712-131", "#text": "Code de la santé publique - art. D712-131 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691742", "@num": "D712-132", "#text": "Code de la santé publique - art. D712-132 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691743", "@num": "D712-133", "#text": "Code de la santé publique - art. D712-133 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691744", "@num": "D712-134", "#text": "Code de la santé publique - art. D712-134 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691745", "@num": "D712-135", "#text": "Code de la santé publique - art. D712-135 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691746", "@num": "D712-136", "#text": "Code de la santé publique - art. D712-136 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691747", "@num": "D712-137", "#text": "Code de la santé publique - art. D712-137 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691748", "@num": "D712-138", "#text": "Code de la santé publique - art. D712-138 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691749", "@num": "D712-139", "#text": "Code de la santé publique - art. D712-139 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692127", "@num": "D712-14", "#text": "Code de la santé publique - art. D712-14 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692125", "@num": "D712-14", "#text": "Code de la santé publique - art. D712-14 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692126", "@num": "D712-14", "#text": "Code de la santé publique - art. D712-14 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691750", "@num": "D712-140", "#text": "Code de la santé publique - art. D712-140 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691751", "@num": "D712-141", "#text": "Code de la santé publique - art. D712-141 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692145", "@num": "D712-142", "#text": "Code de la santé publique - art. D712-142 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691752", "@num": "D712-143", "#text": "Code de la santé publique - art. D712-143 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691753", "@num": "D712-144", "#text": "Code de la santé publique - art. D712-144 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691754", "@num": "D712-145", "#text": "Code de la santé publique - art. D712-145 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691755", "@num": "D712-146", "#text": "Code de la santé publique - art. D712-146 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691756", "@num": "D712-147", "#text": "Code de la santé publique - art. D712-147 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691757", "@num": "D712-148", "#text": "Code de la santé publique - art. D712-148 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691758", "@num": "D712-149", "#text": "Code de la santé publique - art. D712-149 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691879", "@num": "D712-15", "#text": "Code de la santé publique - art. D712-15 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691876", "@num": "D712-15", "#text": "Code de la santé publique - art. D712-15 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691873", "@num": "D712-15", "#text": "Code de la santé publique - art. D712-15 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691877", "@num": "D712-15", "#text": "Code de la santé publique - art. D712-15 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691878", "@num": "D712-15", "#text": "Code de la santé publique - art. D712-15 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691875", "@num": "D712-15", "#text": "Code de la santé publique - art. D712-15 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691874", "@num": "D712-15", "#text": "Code de la santé publique - art. D712-15 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691759", "@num": "D712-150", "#text": "Code de la santé publique - art. D712-150 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691760", "@num": "D712-151", "#text": "Code de la santé publique - art. D712-151 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691761", "@num": "D712-152", "#text": "Code de la santé publique - art. D712-152 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691762", "@num": "D712-153", "#text": "Code de la santé publique - art. D712-153 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691881", "@num": "D712-16", "#text": "Code de la santé publique - art. D712-16 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691880", "@num": "D712-16", "#text": "Code de la santé publique - art. 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D712-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691843", "@num": "D712-2", "#text": "Code de la santé publique - art. D712-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692109", "@num": "D712-3", "#text": "Code de la santé publique - art. D712-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692107", "@num": "D712-3", "#text": "Code de la santé publique - art. 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L16 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692178", "@num": "L16", "#text": "Code de la santé publique - art. L16 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692428", "@num": "L160", "#text": "Code de la santé publique - art. L160 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692429", "@num": "L161", "#text": "Code de la santé publique - art. L161 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692430", "@num": "L161-1", "#text": "Code de la santé publique - art. 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L162-10 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692451", "@num": "L162-10", "#text": "Code de la santé publique - art. L162-10 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692454", "@num": "L162-11", "#text": "Code de la santé publique - art. L162-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692453", "@num": "L162-11", "#text": "Code de la santé publique - art. L162-11 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692457", "@num": "L162-12", "#text": "Code de la santé publique - art. L162-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692455", "@num": "L162-12", "#text": "Code de la santé publique - art. L162-12 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692456", "@num": "L162-12", "#text": "Code de la santé publique - art. L162-12 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692459", "@num": "L162-13", "#text": "Code de la santé publique - art. L162-13 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692458", "@num": "L162-13", "#text": "Code de la santé publique - art. L162-13 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692461", "@num": "L162-14", "#text": "Code de la santé publique - art. L162-14 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692460", "@num": "L162-14", "#text": "Code de la santé publique - art. L162-14 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692575", "@num": "L162-15", "#text": "Code de la santé publique - art. L162-15 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692576", "@num": "L162-15-1", "#text": "Code de la santé publique - art. L162-15-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692577", "@num": "L162-16", "#text": "Code de la santé publique - art. L162-16 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692578", "@num": "L162-17", "#text": "Code de la santé publique - art. L162-17 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692579", "@num": "L162-18", "#text": "Code de la santé publique - art. L162-18 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692580", "@num": "L162-19", "#text": "Code de la santé publique - art. L162-19 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692435", "@num": "L162-2", "#text": "Code de la santé publique - art. L162-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692434", "@num": "L162-2", "#text": "Code de la santé publique - art. 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L162-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692438", "@num": "L162-4", "#text": "Code de la santé publique - art. L162-4 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692439", "@num": "L162-4", "#text": "Code de la santé publique - art. L162-4 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692442", "@num": "L162-5", "#text": "Code de la santé publique - art. 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L162-8 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692447", "@num": "L162-8", "#text": "Code de la santé publique - art. L162-8 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692450", "@num": "L162-9", "#text": "Code de la santé publique - art. L162-9 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692449", "@num": "L162-9", "#text": "Code de la santé publique - art. L162-9 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692463", "@num": "L163", "#text": "Code de la santé publique - art. 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L252 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692718", "@num": "L253", "#text": "Code de la santé publique - art. L253 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692719", "@num": "L254", "#text": "Code de la santé publique - art. L254 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692720", "@num": "L255", "#text": "Code de la santé publique - art. L255 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692721", "@num": "L256", "#text": "Code de la santé publique - art. L256 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692723", "@num": "L257", "#text": "Code de la santé publique - art. L257 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692724", "@num": "L258", "#text": "Code de la santé publique - art. L258 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692725", "@num": "L259", "#text": "Code de la santé publique - art. L259 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692198", "@num": "L26", "#text": "Code de la santé publique - art. L26 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692197", "@num": "L26", "#text": "Code de la santé publique - art. L26 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692726", "@num": "L260", "#text": "Code de la santé publique - art. L260 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692727", "@num": "L261", "#text": "Code de la santé publique - art. L261 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692728", "@num": "L262", "#text": "Code de la santé publique - art. L262 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692731", "@num": "L263", "#text": "Code de la santé publique - art. L263 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692732", "@num": "L264", "#text": "Code de la santé publique - art. L264 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692733", "@num": "L265", "#text": "Code de la santé publique - art. L265 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692734", "@num": "L266", "#text": "Code de la santé publique - art. L266 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692735", "@num": "L267", "#text": "Code de la santé publique - art. L267 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692736", "@num": "L268", "#text": "Code de la santé publique - art. L268 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692737", "@num": "L269", "#text": "Code de la santé publique - art. L269 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692200", "@num": "L27", "#text": "Code de la santé publique - art. L27 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692199", "@num": "L27", "#text": "Code de la santé publique - art. L27 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692738", "@num": "L270", "#text": "Code de la santé publique - art. L270 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692739", "@num": "L271", "#text": "Code de la santé publique - art. L271 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692740", "@num": "L272", "#text": "Code de la santé publique - art. 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L302 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692777", "@num": "L303", "#text": "Code de la santé publique - art. L303 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692779", "@num": "L304", "#text": "Code de la santé publique - art. L304 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692778", "@num": "L304", "#text": "Code de la santé publique - art. L304 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692780", "@num": "L305", "#text": "Code de la santé publique - art. 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L379 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692235", "@num": "L38", "#text": "Code de la santé publique - art. L38 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693029", "@num": "L380", "#text": "Code de la santé publique - art. L380 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693030", "@num": "L381", "#text": "Code de la santé publique - art. L381 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693031", "@num": "L382", "#text": "Code de la santé publique - art. L382 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693032", "@num": "L383", "#text": "Code de la santé publique - art. L383 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693033", "@num": "L384", "#text": "Code de la santé publique - art. L384 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693034", "@num": "L385", "#text": "Code de la santé publique - art. L385 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693035", "@num": "L386", "#text": "Code de la santé publique - art. L386 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693036", "@num": "L387", "#text": "Code de la santé publique - art. L387 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693037", "@num": "L388", "#text": "Code de la santé publique - art. L388 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693038", "@num": "L389", "#text": "Code de la santé publique - art. L389 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692236", "@num": "L39", "#text": "Code de la santé publique - art. L39 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693039", "@num": "L390", "#text": "Code de la santé publique - art. L390 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693040", "@num": "L391", "#text": "Code de la santé publique - art. L391 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693041", "@num": "L392", "#text": "Code de la santé publique - art. L392 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693042", "@num": "L393", "#text": "Code de la santé publique - art. L393 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693043", "@num": "L394", "#text": "Code de la santé publique - art. L394 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693045", "@num": "L395", "#text": "Code de la santé publique - art. L395 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693046", "@num": "L396", "#text": "Code de la santé publique - art. L396 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693047", "@num": "L397", "#text": "Code de la santé publique - art. L397 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693048", "@num": "L398", "#text": "Code de la santé publique - art. L398 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693049", "@num": "L399", "#text": "Code de la santé publique - art. L399 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692159", "@num": "L4", "#text": "Code de la santé publique - art. L4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692237", "@num": "L40", "#text": "Code de la santé publique - art. L40 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693050", "@num": "L400", "#text": "Code de la santé publique - art. L400 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693051", "@num": "L401", "#text": "Code de la santé publique - art. L401 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693052", "@num": "L402", "#text": "Code de la santé publique - art. L402 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693053", "@num": "L403", "#text": "Code de la santé publique - art. L403 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693056", "@num": "L404", "#text": "Code de la santé publique - art. L404 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693054", "@num": "L404", "#text": "Code de la santé publique - art. L404 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693055", "@num": "L404", "#text": "Code de la santé publique - art. L404 (MMN)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693057", "@num": "L405", "#text": "Code de la santé publique - art. L405 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693058", "@num": "L406", "#text": "Code de la santé publique - art. L406 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693235", "@num": "L407", "#text": "Code de la santé publique - art. L407 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693233", "@num": "L407", "#text": "Code de la santé publique - art. L407 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693234", "@num": "L407", "#text": "Code de la santé publique - art. L407 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693059", "@num": "L408", "#text": "Code de la santé publique - art. L408 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693060", "@num": "L409", "#text": "Code de la santé publique - art. L409 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692238", "@num": "L41", "#text": "Code de la santé publique - art. L41 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693236", "@num": "L410", "#text": "Code de la santé publique - art. L410 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693061", "@num": "L410-1", "#text": "Code de la santé publique - art. L410-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693239", "@num": "L411", "#text": "Code de la santé publique - art. L411 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693238", "@num": "L411", "#text": "Code de la santé publique - art. L411 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693242", "@num": "L412", "#text": "Code de la santé publique - art. L412 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693241", "@num": "L412", "#text": "Code de la santé publique - art. L412 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693240", "@num": "L412", "#text": "Code de la santé publique - art. L412 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693062", "@num": "L413", "#text": "Code de la santé publique - art. L413 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693064", "@num": "L414", "#text": "Code de la santé publique - art. L414 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693063", "@num": "L414", "#text": "Code de la santé publique - art. L414 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693066", "@num": "L415", "#text": "Code de la santé publique - art. L415 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693068", "@num": "L416", "#text": "Code de la santé publique - art. L416 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693067", "@num": "L416", "#text": "Code de la santé publique - art. L416 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693069", "@num": "L417", "#text": "Code de la santé publique - art. L417 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693070", "@num": "L418", "#text": "Code de la santé publique - art. L418 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693071", "@num": "L419", "#text": "Code de la santé publique - art. L419 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692239", "@num": "L42", "#text": "Code de la santé publique - art. L42 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693072", "@num": "L420", "#text": "Code de la santé publique - art. L420 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693073", "@num": "L421", "#text": "Code de la santé publique - art. L421 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693074", "@num": "L422", "#text": "Code de la santé publique - art. L422 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693078", "@num": "L423", "#text": "Code de la santé publique - art. L423 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693075", "@num": "L423", "#text": "Code de la santé publique - art. L423 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693076", "@num": "L423", "#text": "Code de la santé publique - art. L423 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693077", "@num": "L423", "#text": "Code de la santé publique - art. L423 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693080", "@num": "L424", "#text": "Code de la santé publique - art. L424 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693081", "@num": "L425", "#text": "Code de la santé publique - art. L425 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693082", "@num": "L426", "#text": "Code de la santé publique - art. L426 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693083", "@num": "L427", "#text": "Code de la santé publique - art. L427 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693084", "@num": "L428", "#text": "Code de la santé publique - art. L428 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693085", "@num": "L429", "#text": "Code de la santé publique - art. L429 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692240", "@num": "L43", "#text": "Code de la santé publique - art. L43 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692241", "@num": "L43-1", "#text": "Code de la santé publique - art. L43-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693086", "@num": "L430", "#text": "Code de la santé publique - art. L430 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693087", "@num": "L431", "#text": "Code de la santé publique - art. L431 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693089", "@num": "L432", "#text": "Code de la santé publique - art. L432 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693090", "@num": "L433", "#text": "Code de la santé publique - art. L433 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693091", "@num": "L434", "#text": "Code de la santé publique - art. 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L469 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693170", "@num": "L469-1", "#text": "Code de la santé publique - art. L469-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693182", "@num": "L469-10", "#text": "Code de la santé publique - art. L469-10 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693183", "@num": "L469-11", "#text": "Code de la santé publique - art. L469-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693184", "@num": "L469-12", "#text": "Code de la santé publique - art. L469-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693185", "@num": "L469-13", "#text": "Code de la santé publique - art. L469-13 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693186", "@num": "L469-14", "#text": "Code de la santé publique - art. L469-14 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693187", "@num": "L469-15", "#text": "Code de la santé publique - art. L469-15 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693171", "@num": "L469-2", "#text": "Code de la santé publique - art. L469-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693172", "@num": "L469-3", "#text": "Code de la santé publique - art. L469-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693173", "@num": "L469-4", "#text": "Code de la santé publique - art. L469-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693174", "@num": "L469-5", "#text": "Code de la santé publique - art. L469-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693175", "@num": "L469-6", "#text": "Code de la santé publique - art. L469-6 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693176", "@num": "L469-7", "#text": "Code de la santé publique - art. L469-7 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693180", "@num": "L469-8", "#text": "Code de la santé publique - art. L469-8 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693181", "@num": "L469-9", "#text": "Code de la santé publique - art. L469-9 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692253", "@num": "L47", "#text": "Code de la santé publique - art. L47 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692252", "@num": "L47", "#text": "Code de la santé publique - art. L47 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693159", "@num": "L470", "#text": "Code de la santé publique - art. L470 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693163", "@num": "L471", "#text": "Code de la santé publique - art. 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L474-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693250", "@num": "L474-2", "#text": "Code de la santé publique - art. L474-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693252", "@num": "L474-3", "#text": "Code de la santé publique - art. L474-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693253", "@num": "L475", "#text": "Code de la santé publique - art. L475 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693254", "@num": "L476", "#text": "Code de la santé publique - art. 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L477 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693259", "@num": "L477-1", "#text": "Code de la santé publique - art. L477-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693261", "@num": "L478", "#text": "Code de la santé publique - art. L478 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693260", "@num": "L478", "#text": "Code de la santé publique - art. L478 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693263", "@num": "L478-1", "#text": "Code de la santé publique - art. L478-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693262", "@num": "L478-1", "#text": "Code de la santé publique - art. L478-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693264", "@num": "L478-2", "#text": "Code de la santé publique - art. L478-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693265", "@num": "L478-3", "#text": "Code de la santé publique - art. L478-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693266", "@num": "L478-4", "#text": "Code de la santé publique - art. L478-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693267", "@num": "L478-5", "#text": "Code de la santé publique - art. L478-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693268", "@num": "L478-6", "#text": "Code de la santé publique - art. L478-6 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693270", "@num": "L479", "#text": "Code de la santé publique - art. L479 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693269", "@num": "L479", "#text": "Code de la santé publique - art. L479 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692254", "@num": "L48", "#text": "Code de la santé publique - art. L48 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692255", "@num": "L48-1", "#text": "Code de la santé publique - art. L48-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692256", "@num": "L48-2", "#text": "Code de la santé publique - art. L48-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692257", "@num": "L48-3", "#text": "Code de la santé publique - art. L48-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693271", "@num": "L480", "#text": "Code de la santé publique - art. L480 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693273", "@num": "L481", "#text": "Code de la santé publique - art. L481 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693272", "@num": "L481", "#text": "Code de la santé publique - art. L481 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693274", "@num": "L482", "#text": "Code de la santé publique - art. L482 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693275", "@num": "L482-1", "#text": "Code de la santé publique - art. L482-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693285", "@num": "L482-10", "#text": "Code de la santé publique - art. 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L491-7 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693314", "@num": "L491-8", "#text": "Code de la santé publique - art. L491-8 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693341", "@num": "L492", "#text": "Code de la santé publique - art. L492 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693340", "@num": "L492", "#text": "Code de la santé publique - art. L492 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693346", "@num": "L493", "#text": "Code de la santé publique - art. L493 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693345", "@num": "L493", "#text": "Code de la santé publique - art. L493 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693348", "@num": "L494", "#text": "Code de la santé publique - art. L494 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693347", "@num": "L494", "#text": "Code de la santé publique - art. L494 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693317", "@num": "L495", "#text": "Code de la santé publique - art. L495 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693350", "@num": "L496", "#text": "Code de la santé publique - art. L496 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693349", "@num": "L496", "#text": "Code de la santé publique - art. L496 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693318", "@num": "L496-1", "#text": "Code de la santé publique - art. L496-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693319", "@num": "L496-2", "#text": "Code de la santé publique - art. 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L496-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693323", "@num": "L496-6", "#text": "Code de la santé publique - art. L496-6 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693324", "@num": "L496-7", "#text": "Code de la santé publique - art. L496-7 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693325", "@num": "L496-8", "#text": "Code de la santé publique - art. L496-8 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693352", "@num": "L497", "#text": "Code de la santé publique - art. L497 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693351", "@num": "L497", "#text": "Code de la santé publique - art. L497 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693326", "@num": "L498", "#text": "Code de la santé publique - art. L498 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693328", "@num": "L499", "#text": "Code de la santé publique - art. 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L511-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693413", "@num": "L511-1", "#text": "Code de la santé publique - art. L511-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693415", "@num": "L511-1", "#text": "Code de la santé publique - art. L511-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693414", "@num": "L511-1", "#text": "Code de la santé publique - art. 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L511-3 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693420", "@num": "L511-4", "#text": "Code de la santé publique - art. L511-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693425", "@num": "L512", "#text": "Code de la santé publique - art. L512 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693421", "@num": "L512", "#text": "Code de la santé publique - art. L512 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693424", "@num": "L512", "#text": "Code de la santé publique - art. L512 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693423", "@num": "L512", "#text": "Code de la santé publique - art. L512 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693422", "@num": "L512", "#text": "Code de la santé publique - art. L512 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693426", "@num": "L512-1", "#text": "Code de la santé publique - art. L512-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693427", "@num": "L512-2", "#text": "Code de la santé publique - art. L512-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693428", "@num": "L512-3", "#text": "Code de la santé publique - art. L512-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693431", "@num": "L513", "#text": "Code de la santé publique - art. L513 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693430", "@num": "L513", "#text": "Code de la santé publique - art. L513 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693429", "@num": "L513", "#text": "Code de la santé publique - art. L513 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693432", "@num": "L513-1", "#text": "Code de la santé publique - art. L513-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693437", "@num": "L514", "#text": "Code de la santé publique - art. L514 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693434", "@num": "L514", "#text": "Code de la santé publique - art. L514 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693436", "@num": "L514", "#text": "Code de la santé publique - art. L514 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693433", "@num": "L514", "#text": "Code de la santé publique - art. L514 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693435", "@num": "L514", "#text": "Code de la santé publique - art. L514 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693438", "@num": "L514-1", "#text": "Code de la santé publique - art. L514-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693439", "@num": "L514-1", "#text": "Code de la santé publique - art. L514-1 (MMN)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693440", "@num": "L514-2", "#text": "Code de la santé publique - art. L514-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693441", "@num": "L515", "#text": "Code de la santé publique - art. L515 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693443", "@num": "L516", "#text": "Code de la santé publique - art. L516 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693444", "@num": "L517", "#text": "Code de la santé publique - art. L517 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693446", "@num": "L518", "#text": "Code de la santé publique - art. L518 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693445", "@num": "L518", "#text": "Code de la santé publique - art. L518 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693447", "@num": "L519", "#text": "Code de la santé publique - art. L519 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692272", "@num": "L52", "#text": "Code de la santé publique - art. 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L536 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693479", "@num": "L536", "#text": "Code de la santé publique - art. L536 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693481", "@num": "L537", "#text": "Code de la santé publique - art. L537 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693482", "@num": "L538", "#text": "Code de la santé publique - art. L538 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693483", "@num": "L538-1", "#text": "Code de la santé publique - art. L538-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693486", "@num": "L539", "#text": "Code de la santé publique - art. L539 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692274", "@num": "L54", "#text": "Code de la santé publique - art. L54 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693487", "@num": "L540", "#text": "Code de la santé publique - art. L540 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693490", "@num": "L541", "#text": "Code de la santé publique - art. 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L543 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693494", "@num": "L544", "#text": "Code de la santé publique - art. L544 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693493", "@num": "L544", "#text": "Code de la santé publique - art. L544 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693495", "@num": "L545", "#text": "Code de la santé publique - art. L545 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693496", "@num": "L546", "#text": "Code de la santé publique - art. L546 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693497", "@num": "L547", "#text": "Code de la santé publique - art. L547 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693498", "@num": "L548", "#text": "Code de la santé publique - art. L548 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693501", "@num": "L548-1", "#text": "Code de la santé publique - art. L548-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693502", "@num": "L548-2", "#text": "Code de la santé publique - art. 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L617-22-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693871", "@num": "L617-23", "#text": "Code de la santé publique - art. L617-23 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693873", "@num": "L617-24", "#text": "Code de la santé publique - art. L617-24 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006693872", "@num": "L617-24", "#text": "Code de la santé publique - art. 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L759 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694469", "@num": "L759", "#text": "Code de la santé publique - art. L759 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694470", "@num": "L759", "#text": "Code de la santé publique - art. L759 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692297", "@num": "L76", "#text": "Code de la santé publique - art. L76 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694477", "@num": "L760", "#text": "Code de la santé publique - art. L760 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694475", "@num": "L760", "#text": "Code de la santé publique - art. L760 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694474", "@num": "L760", "#text": "Code de la santé publique - art. L760 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694472", "@num": "L760", "#text": "Code de la santé publique - art. L760 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694473", "@num": "L760", "#text": "Code de la santé publique - art. L760 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694476", "@num": "L760", "#text": "Code de la santé publique - art. L760 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694480", "@num": "L761", "#text": "Code de la santé publique - art. L761 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694479", "@num": "L761", "#text": "Code de la santé publique - art. L761 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694478", "@num": "L761", "#text": "Code de la santé publique - art. L761 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694483", "@num": "L761-1", "#text": "Code de la santé publique - art. L761-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694482", "@num": "L761-1", "#text": "Code de la santé publique - art. L761-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694481", "@num": "L761-1", "#text": "Code de la santé publique - art. L761-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694511", "@num": "L761-10", "#text": "Code de la santé publique - art. L761-10 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694509", "@num": "L761-10", "#text": "Code de la santé publique - art. L761-10 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694510", "@num": "L761-10", "#text": "Code de la santé publique - art. L761-10 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006695176", "@num": "L761-11", "#text": "Code de la santé publique - art. L761-11 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006695172", "@num": "L761-11", "#text": "Code de la santé publique - art. L761-11 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006695174", "@num": "L761-11", "#text": "Code de la santé publique - art. L761-11 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006695175", "@num": "L761-11", "#text": "Code de la santé publique - art. L761-11 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006695171", "@num": "L761-11", "#text": "Code de la santé publique - art. L761-11 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006695173", "@num": "L761-11", "#text": "Code de la santé publique - art. L761-11 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694514", "@num": "L761-12", "#text": "Code de la santé publique - art. L761-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694512", "@num": "L761-12", "#text": "Code de la santé publique - art. L761-12 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694513", "@num": "L761-12", "#text": "Code de la santé publique - art. L761-12 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665",

Article R665-64-31 AUTONOME ABROGE, en vigueur du 06/02/2004 au 08/08/2004 (Code de la santé publique)