{ "article": { "LEGIARTI000021961833": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "2", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000021961833", "URL": "article/LEGI/ARTI/00/00/21/96/18/LEGIARTI000021961833.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000021964486", "@num": "L5211-1", "#text": "Code de la santé publique - art. L5211-1 (VD)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021964488", "@num": "L5211-3-2", "#text": "Code de la santé publique - art. L5211-3-2 (VD)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021964491", "@num": "L5211-4", "#text": "Code de la santé publique - art. L5211-4 (VD)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021964493", "@num": "L5211-6", "#text": "Code de la santé publique - art. L5211-6 (VD)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000021961300", "@nor": "SASX1001341R", "@num": "2010-250", "@nature": "ORDONNANCE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Ordonnance n° 2010-250 du 11 mars 2010 relative aux dispositifs médicaux", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000021961300", "@c_titre_court": "Ordonnance n° 2010-250 du 11 mars 2010" }, { "@fin": "2999-01-01", "#text": "Ordonnance n° 2010-250 du 11 mars 2010 relative aux dispositifs médicaux", "@debut": "2010-03-21", "@id_txt": "LEGITEXT000021961825", "@c_titre_court": "Ordonnance n° 2010-250 du 11 mars 2010" } ], "@ministere": "Ministère de la santé et des sports", "@date_publi": "2010-03-12", "@date_signature": "2010-03-11" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000021961833", "@fin": "2999-01-01", "@num": "2", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000021961307", "@fin": "2999-01-01", "@num": "2", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

\n
A créé les dispositions suivantes :

- Code de la santé publique
\nArt. L5211-3-2\n
\n

A modifié les dispositions suivantes :

- Code de la santé publique
\nArt. L5211-4, Art. L5211-6, Art. L5211-1\n
\n

\n
" } }, "LEGIARTI000021964486": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5211-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-04-22", "DATE_DEBUT": "2010-03-21" } }, "META_COMMUN": { "ID": "LEGIARTI000021964486", "URL": "article/LEGI/ARTI/00/00/21/96/44/LEGIARTI000021964486.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006684513", "@num": "25", "#text": "Décret n°2003-1010 du 22 octobre 2003 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000610356", "@nortexte": "SOCA0323026D", "@numtexte": "2003-1010", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2003-10-22" }, { "@id": "LEGIARTI000020350738", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000640165", "@nortexte": "SANP0623371A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020317472", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000021961833", "@num": "2", "#text": "Ordonnance n°2010-250\n du 11 mars 2010 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000021961300", "@nortexte": "SASX1001341R", "@numtexte": "2010-250", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2010-03-11" }, { "@id": "LEGIARTI000022916144", "#text": "Arrêté du 15 septembre 2010 - art. 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R165-65 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171570", "@fin": "2999-01-01", "#text": "Chapitre Ier : Régime juridique des dispositifs médicaux.", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155090", "@fin": "2999-01-01", "#text": "Titre Ier : Dispositifs médicaux", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140632", "@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": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@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": "LEGIARTI000006690281", "@fin": "2001-03-03", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690282", "@fin": "2010-03-21", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021964486", "@fin": "2022-04-22", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2010-03-21", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000045630295", "@fin": "2022-07-31", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2022-04-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046126069", "@fin": "2999-01-01", "@num": "L5211-1", "@etat": "VIGUEUR", "@debut": "2022-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

On entend par dispositif médical tout instrument, appareil, équipement, matière, produit, à l'exception des produits d'origine humaine, ou autre article utilisé seul ou en association, y compris les accessoires et logiciels nécessaires au bon fonctionnement de celui-ci, destiné par le fabricant à être utilisé chez l'homme à des fins médicales et dont l'action principale voulue n'est pas obtenue par des moyens pharmacologiques ou immunologiques ni par métabolisme, mais dont la fonction peut être assistée par de tels moyens. Constitue également un dispositif médical le logiciel destiné par le fabricant à être utilisé spécifiquement à des fins diagnostiques ou thérapeutiques.

Les dispositifs médicaux qui sont conçus pour être implantés en totalité ou en partie dans le corps humain ou placés dans un orifice naturel, et qui dépendent pour leur bon fonctionnement d'une source d'énergie électrique ou de toute source d'énergie autre que celle qui est générée directement par le corps humain ou la pesanteur, sont dénommés dispositifs médicaux implantables actifs.

" } }, "LEGIARTI000021964488": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5211-3-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-04-22", "DATE_DEBUT": "2010-03-21" } }, "META_COMMUN": { "ID": "LEGIARTI000021964488", "URL": "article/LEGI/ARTI/00/00/21/96/44/LEGIARTI000021964488.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000021961833", "@num": "2", "#text": "Ordonnance n°2010-250\n du 11 mars 2010 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000021961300", "@nortexte": "SASX1001341R", "@numtexte": "2010-250", "@typelien": "CREE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2010-03-11" }, { "@id": "LEGIARTI000047291613", "@num": "L1333-25", "#text": "Code de la santé publique - art. L1333-25 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690286", "@num": "L5211-3", "#text": "Code de la santé publique - art. L5211-3", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031930396", "@num": "L5211-6", "#text": "Code de la santé publique - art. L5211-6 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021978381", "@num": "R5211-36", "#text": "Code de la santé publique - art. R5211-36 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171570", "@fin": "2999-01-01", "#text": "Chapitre Ier : Régime juridique des dispositifs médicaux.", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155090", "@fin": "2999-01-01", "#text": "Titre Ier : Dispositifs médicaux", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140632", "@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": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@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": "LEGIARTI000021964488", "@fin": "2022-04-22", "@num": "L5211-3-2", "@etat": "MODIFIE", "@debut": "2010-03-21", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045630280", "@fin": "2999-01-01", "@num": "L5211-3-2", "@etat": "VIGUEUR", "@debut": "2022-04-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "L'appréciation du respect des exigences essentielles mentionnées à l'article L. 5211-3, ainsi que l'évaluation des effets indésirables et du caractère acceptable du rapport entre les bénéfices et les risques sont fondées sur des données cliniques ou des investigations cliniques. Un décret en Conseil d'Etat détermine les catégories de dispositifs pour lesquelles des investigations cliniques sont requises et les conditions d'application du présent article." } }, "LEGIARTI000021964491": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5211-4", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2010-03-21" } }, "META_COMMUN": { "ID": "LEGIARTI000021964491", "URL": "article/LEGI/ARTI/00/00/21/96/44/LEGIARTI000021964491.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000021961833", "@num": "2", "#text": "Ordonnance n°2010-250\n du 11 mars 2010 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000021961300", "@nortexte": "SASX1001341R", "@numtexte": "2010-250", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2010-03-11" }, { "@id": "LEGIARTI000025035398", "@num": "3", "#text": "Arrêté du 20 décembre 2011 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000025030722", "@nortexte": "ETSP1134861A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2011-12-20" }, { "@id": "LEGIARTI000006685913", "@num": "L1125-3", "#text": "Code de la santé publique - art. L1125-3 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031930396", "@num": "L5211-6", "#text": "Code de la santé publique - art. L5211-6 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028352308", "@num": "L5461-1", "#text": "Code de la santé publique - art. L5461-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028352337", "@num": "L5461-4", "#text": "Code de la santé publique - art. L5461-4 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031930394", "@num": "L5461-9", "#text": "Code de la santé publique - art. L5461-9 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694041", "@num": "L665-4-1", "#text": "Code de la santé publique - art. L665-4-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694041", "@num": "L665-4-1", "#text": "Code de la santé publique - art. L665-4-1 (Ab)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025787223", "@num": "R5211-66", "#text": "Code de la santé publique - art. R5211-66 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006917373", "@num": "R6134-5", "#text": "Code de la santé publique - art. R6134-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801596", "@num": "R665-8-1", "#text": "Code de la santé publique - art. R665-8-1 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006803058", "@num": "R713-3-26", "#text": "Code de la santé publique - art. R713-3-26 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041397067", "@num": "L165-5", "#text": "Code de la sécurité sociale. - art. L165-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171570", "@fin": "2999-01-01", "#text": "Chapitre Ier : Régime juridique des dispositifs médicaux.", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155090", "@fin": "2999-01-01", "#text": "Titre Ier : Dispositifs médicaux", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140632", "@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": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@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": "LEGIARTI000006690289", "@fin": "2001-03-03", "@num": "L5211-4", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690290", "@fin": "2002-03-05", "@num": "L5211-4", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690291", "@fin": "2010-03-21", "@num": "L5211-4", "@etat": "MODIFIE", "@debut": "2002-03-05", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021964491", "@fin": "2012-05-01", "@num": "L5211-4", "@etat": "MODIFIE", "@debut": "2010-03-21", "@origine": "LEGI" } }, { "@etat": "ABROGE", "LIEN_ART": { "@id": "LEGIARTI000025104468", "@fin": "2022-04-22", "@num": "L5211-4", "@etat": "ABROGE", "@debut": "2012-05-01", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Lors de la mise en service sur le territoire national de catégories de dispositifs médicaux, définies en fonction de leur degré de risque pour la santé humaine, toutes les données permettant d'identifier ces dispositifs, avec un exemplaire de l'étiquetage et de la notice d'instruction, doivent être communiquées à l'Agence française de sécurité sanitaire des produits de santé.

\n
\n

Pour les dispositifs médicaux dans la fabrication desquels intervient un produit d'origine animale, la communication prévue au premier alinéa le précise, ainsi que l'espèce d'origine.

\n
" } }, "LEGIARTI000021964493": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5211-6", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2010-03-21" } }, "META_COMMUN": { "ID": "LEGIARTI000021964493", "URL": "article/LEGI/ARTI/00/00/21/96/44/LEGIARTI000021964493.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000021961833", "@num": "2", "#text": "Ordonnance n°2010-250\n du 11 mars 2010 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000021961300", "@nortexte": "SASX1001341R", "@numtexte": "2010-250", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2010-03-11" }, { "@id": "LEGITEXT000049622627", "#text": "Décret n°2024-490 du 29 mai 2024 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000049621071", "@nortexte": "TSSP2406007D", "@numtexte": "2024-490", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2024-05-29" }, { "@id": "LEGIARTI000006690286", "@num": "L5211-3", "#text": "Code de la santé publique - art. L5211-3", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000020035160", "@num": "L5211-3-1", "#text": "Code de la santé publique - art. L5211-3-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021961956", "@num": "L5211-3-2", "#text": "Code de la santé publique - art. L5211-3-2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690289", "@num": "L5211-4", "#text": "Code de la santé publique - art. L5211-4", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045630438", "@num": "L5461-6-2", "#text": "Code de la santé publique - art. L5461-6-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694053", "@num": "L665-9", "#text": "Code de la santé publique - art. L665-9 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694052", "@num": "L665-9", "#text": "Code de la santé publique - art. L665-9 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171570", "@fin": "2999-01-01", "#text": "Chapitre Ier : Régime juridique des dispositifs médicaux.", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155090", "@fin": "2999-01-01", "#text": "Titre Ier : Dispositifs médicaux", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140632", "@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": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@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": "LEGIARTI000006690302", "@fin": "2001-03-03", "@num": "L5211-6", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690303", "@fin": "2002-03-05", "@num": "L5211-6", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690304", "@fin": "2009-01-01", "@num": "L5211-6", "@etat": "MODIFIE", "@debut": "2002-03-05", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000020039270", "@fin": "2010-03-21", "@num": "L5211-6", "@etat": "MODIFIE", "@debut": "2009-01-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021964493", "@fin": "2012-05-01", "@num": "L5211-6", "@etat": "MODIFIE", "@debut": "2010-03-21", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104462", "@fin": "2014-02-26", "@num": "L5211-6", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000028655468", "@fin": "2016-01-28", "@num": "L5211-6", "@etat": "MODIFIE", "@debut": "2014-02-26", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000031930396", "@fin": "2022-04-22", "@num": "L5211-6", "@etat": "MODIFIE", "@debut": "2016-01-28", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045630355", "@fin": "2999-01-01", "@num": "L5211-6", "@etat": "VIGUEUR", "@debut": "2022-04-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Sont déterminées, en tant que de besoin, par décret en Conseil d'Etat, les modalités d'application du présent titre, et notamment :

1° Les conditions auxquelles doivent satisfaire les organismes mentionnés au deuxième alinéa de l'article L. 5211-3 ;

2° Les modalités de la déclaration prévue à l'article L. 5211-3-1 ;
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3° Les conditions dans lesquelles les dispositifs sur mesure peuvent être dispensés de la certification de conformité prévue à l'article L. 5211-3 ;

4° Les catégories de dispositifs et les procédures de certification qui leur sont applicables, ainsi que, le cas échéant, la durée pendant laquelle la certification est valable ;

5° Les catégories de dispositifs médicaux et les modalités de la communication prévues à l'article L. 5211-4, ainsi que les données devant être transmises à l'Agence française de sécurité sanitaire des produits de santé en application de cet article ;

6° Les modalités de l'évaluation des données cliniques des dispositifs médicaux mentionnées à l'article L. 5211-3-2.\n

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Article 2 ENTIEREMENT_MODIF (Ordonnance n° 2010-250 du 11 mars 2010 relative aux dispositifs médicaux)