{ "article": { "LEGIARTI000028352333": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5461-5", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-04-22", "DATE_DEBUT": "2014-02-01" } }, "META_COMMUN": { "ID": "LEGIARTI000028352333", "URL": "article/LEGI/ARTI/00/00/28/35/23/LEGIARTI000028352333.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000028348474", "@num": "14", "#text": "Ordonnance n°2013-1183\n du 19 décembre 2013 - art. 14", "@sens": "cible", "@cidtexte": "JORFTEXT000028346594", "@nortexte": "AFSX1327872R", "@numtexte": "2013-1183", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2013-12-19" }, { "@id": "LEGIARTI000006690305", "@num": "L5212-1", "#text": "Code de la santé publique - art. L5212-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000028352314", "@fin": "2999-01-01", "#text": "Section 1 : Sanctions pénales", "@debut": "2014-02-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006171571", "@fin": "2999-01-01", "#text": "Chapitre Ier : Dispositifs médicaux.", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155101", "@fin": "2999-01-01", "#text": "Titre VI : 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": "LEGISCTA000006140634", "@fin": "2012-07-21", "#text": "Livre IV : Dispositions pénales", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000025139359", "@fin": "2999-01-01", "#text": "Livre IV : Sanctions pénales et financières", "@debut": "2012-07-21" } ] }, "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": "LEGIARTI000019227600", "@fin": "2014-02-01", "@num": "L5461-5", "@etat": "MODIFIE", "@debut": "2008-07-20", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000028352333", "@fin": "2022-04-22", "@num": "L5461-5", "@etat": "MODIFIE", "@debut": "2014-02-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045630401", "@fin": "2999-01-01", "@num": "L5461-5", "@etat": "VIGUEUR", "@debut": "2022-04-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Le fait, pour l'exploitant de ne pas soumettre un dispositif médical aux obligations de maintenance et aux contrôles de qualité en application de l'article L. 5212-1, est puni de deux ans d'emprisonnement et de 150 000 € d'amende.

" } }, "LEGIARTI000006690305": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5212-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2001-03-03", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006690305", "URL": "article/LEGI/ARTI/00/00/06/69/03/LEGIARTI000006690305.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5212L01XXAA" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGITEXT000024478563", "#text": "Décret n°2011-968\n du 16 août 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024476540", "@nortexte": "ETSP1110434D", "@numtexte": "2011-968", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-08-16" }, { "@id": "LEGIARTI000038533524", "#text": "Arrêté du 23 mai 2019 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000038529178", "@nortexte": "SSAP1915191A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-05-23" }, { "@id": "LEGIARTI000043969385", "@num": "R2661-4", "#text": "Code de la commande publique - art. R2661-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000037701019", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041587839", "@num": "L123-6", "#text": "Code de la construction et de l'habitation. - art. L123-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074096", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691660", "@num": "D665-5-3", "#text": "Code de la santé publique - art. D665-5-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049573024", "@num": "L1333-30", "#text": "Code de la santé publique - art. L1333-30 (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 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028352333", "@num": "L5461-5", "#text": "Code de la santé publique - art. L5461-5 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047291570", "@num": "L5461-9", "#text": "Code de la santé publique - art. 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L6221-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694043", "@num": "L665-5", "#text": "Code de la santé publique - art. L665-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694042", "@num": "L665-5", "#text": "Code de la santé publique - art. L665-5 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910095", "@num": "R1333-43", "#text": "Code de la santé publique - art. R1333-43 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910150", "@num": "R1333-59", "#text": "Code de la santé publique - art. 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R43-54 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798564", "@num": "R43-63", "#text": "Code de la santé publique - art. R43-63 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037011280", "@num": "R5212-26", "#text": "Code de la santé publique - art. R5212-26 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000024479878", "@num": "R5212-35-1", "#text": "Code de la santé publique - art. R5212-35-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006806746", "@num": "R231-84", "#text": "Code du travail - art. R231-84 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072050", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171393", "@fin": "2001-03-03", "#text": "Chapitre II : Matériovigilance.", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155088", "@fin": "2001-03-03", "#text": "Titre Ier : Dispositifs médicaux", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140631", "@fin": "2001-03-03", "#text": "Livre II : Dispositifs médicaux et autres produits et objets réglementés dans l'intérêt de la santé publique", "@debut": "2000-06-22" } ] }, "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": "LEGIARTI000006690305", "@fin": "2001-03-03", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690306", "@fin": "2004-08-11", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690307", "@fin": "2011-03-24", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000023754995", "@fin": "2011-12-31", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2011-03-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026500017", "@fin": "2012-05-01", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2011-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104429", "@fin": "2016-07-17", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032906183", "@fin": "2022-04-22", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2016-07-17", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045630348", "@fin": "2999-01-01", "@num": "L5212-1", "@etat": "VIGUEUR", "@debut": "2022-04-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Pour les dispositifs médicaux dont la liste est fixée par le ministre chargé de la santé après avis de l'Agence française de sécurité sanitaire des produits de santé, l'exploitant est tenu de s'assurer du maintien de ces performances et de la maintenance du dispositif médical.
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Cette obligation donne lieu, le cas échéant, à un contrôle de qualité dont les modalités sont définies par décret et dont le coût est pris en charge par les exploitants des dispositifs.
\n
Pour les dispositifs médicaux dont la liste est fixée par le ministre chargé de la santé après avis de l'Agence française de sécurité sanitaire des produits de santé, la personne morale ou physique responsable d'une nouvelle mise sur le marché fait établir préalablement une attestation technique, dont les modalités sont définies par décret, garantissant que le dispositif médical concerné est toujours conforme aux exigences essentielles prévues au premier alinéa de l'article L. 5211-3.
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Le non-respect des dispositions du présent article peut entraîner la mise hors service provisoire ou définitive du dispositif médical, prononcée par l'Agence française de sécurité sanitaire des produits de santé, ainsi que, le cas échéant, le retrait ou la suspension de l'autorisation de l'installation dans les conditions prévues aux articles L. 6122-11 et L. 6122-13.
" } }, "LEGIARTI000006690306": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5212-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-11", "DATE_DEBUT": "2001-03-03" } }, "META_COMMUN": { "ID": "LEGIARTI000006690306", "URL": "article/LEGI/ARTI/00/00/06/69/03/LEGIARTI000006690306.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5212L01XXAB" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006698239", "@num": "1", "#text": "n°2001-198 du 1 mars 2001 - art. 1 () JORF 3 mars 2001", "@sens": "source", "@cidtexte": "JORFTEXT000000588097", "@nortexte": "MESX0100017R", "@numtexte": "2001-198", "@typelien": "MODIFICATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2001-03-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGITEXT000024478563", "#text": "Décret n°2011-968\n du 16 août 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024476540", "@nortexte": "ETSP1110434D", "@numtexte": "2011-968", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-08-16" }, { "@id": "LEGIARTI000038533524", "#text": "Arrêté du 23 mai 2019 - art. 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D665-5-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049573024", "@num": "L1333-30", "#text": "Code de la santé publique - art. L1333-30 (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 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028352333", "@num": "L5461-5", "#text": "Code de la santé publique - art. L5461-5 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047291570", "@num": "L5461-9", "#text": "Code de la santé publique - art. 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R43-54 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798564", "@num": "R43-63", "#text": "Code de la santé publique - art. R43-63 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037011280", "@num": "R5212-26", "#text": "Code de la santé publique - art. R5212-26 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000024479878", "@num": "R5212-35-1", "#text": "Code de la santé publique - art. R5212-35-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006806746", "@num": "R231-84", "#text": "Code du travail - art. 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Pour les dispositifs médicaux dont la liste est fixée par le ministre chargé de la santé après avis de l'Agence française de sécurité sanitaire des produits de santé, l'exploitant est tenu de s'assurer du maintien de ces performances et de la maintenance du dispositif médical.
\n
Cette obligation donne lieu, le cas échéant, à un contrôle de qualité dont les modalités sont définies par décret et dont le coût est pris en charge par les exploitants des dispositifs.
\n
Pour les dispositifs médicaux dont la liste est fixée par le ministre chargé de la santé après avis de l'Agence française de sécurité sanitaire des produits de santé, la personne morale ou physique responsable d'une nouvelle mise sur le marché fait établir préalablement une attestation technique, dont les modalités sont définies par décret, garantissant que le dispositif médical concerné est toujours conforme aux exigences essentielles prévues au premier alinéa de l'article L. 5211-3.
\n
Le non-respect des dispositions du présent article peut entraîner la mise hors service provisoire ou définitive du dispositif médical, prononcée par l'Agence française de sécurité sanitaire des produits de santé, ainsi que, le cas échéant, le retrait ou la suspension de l'autorisation de l'installation dans les conditions prévues aux articles L. 6122-11 et L. 6122-13.
" } }, "LEGIARTI000006690307": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5212-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2011-03-24", "DATE_DEBUT": "2004-08-11" } }, "META_COMMUN": { "ID": "LEGIARTI000006690307", "URL": "article/LEGI/ARTI/00/00/06/69/03/LEGIARTI000006690307.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5212L01XXAC" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000006697765", "@num": "140", "#text": "Loi n°2004-806 du 9 août 2004 - art. 140 () JORF 11 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787078", "@nortexte": "SANX0300055L", "@numtexte": "2004-806", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-09" }, { "@id": "LEGITEXT000024478563", "#text": "Décret n°2011-968\n du 16 août 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024476540", "@nortexte": "ETSP1110434D", "@numtexte": "2011-968", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-08-16" }, { "@id": "LEGIARTI000038533524", "#text": "Arrêté du 23 mai 2019 - art. 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Pour les dispositifs médicaux dont la liste est fixée par le ministre chargé de la santé après avis de l'Agence française de sécurité sanitaire des produits de santé, l'exploitant est tenu de s'assurer du maintien de ces performances et de la maintenance du dispositif médical.
\n
Cette obligation donne lieu, le cas échéant, à un contrôle de qualité dont les modalités sont définies par décret et dont le coût est pris en charge par les exploitants des dispositifs.
\n
La personne physique ou morale responsable de la revente d'un dispositif médical d'occasion figurant sur une liste fixée 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, fait établir préalablement par un organisme agréé à cet effet par décision du directeur général de l'Agence française de sécurité sanitaire des produits de santé une attestation technique justifiant d'une maintenance régulière et du maintien des performances du dispositif médical concerné. Les modalités de l'agrément des organismes et de l'attestation technique sont définies par décret.
\n
Le non-respect des dispositions du présent article peut entraîner la mise hors service provisoire ou définitive du dispositif médical, prononcée par l'Agence française de sécurité sanitaire des produits de santé, ainsi que, le cas échéant, le retrait ou la suspension de l'autorisation de l'installation dans les conditions prévues aux articles L. 6122-11 et L. 6122-13.
" } }, "LEGIARTI000023754995": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5212-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2011-12-31", "DATE_DEBUT": "2011-03-24" } }, "META_COMMUN": { "ID": "LEGIARTI000023754995", "URL": "article/LEGI/ARTI/00/00/23/75/49/LEGIARTI000023754995.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000217229", "#text": "Rapport relatif à l'ordonnance n° 2000-548 du 15 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000023752110", "@num": "2", "#text": "LOI n°2011-302\n du 22 mars 2011 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000023751262", "@nortexte": "SASX1020953L", "@numtexte": "2011-302", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2011-03-22" }, { "@id": "LEGITEXT000024478563", "#text": "Décret n°2011-968\n du 16 août 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024476540", "@nortexte": "ETSP1110434D", "@numtexte": "2011-968", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-08-16" }, { "@id": "LEGIARTI000038533524", "#text": "Arrêté du 23 mai 2019 - art. 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R43-63 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037011280", "@num": "R5212-26", "#text": "Code de la santé publique - art. R5212-26 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000024479878", "@num": "R5212-35-1", "#text": "Code de la santé publique - art. R5212-35-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006806746", "@num": "R231-84", "#text": "Code du travail - art. R231-84 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072050", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171396", "@fin": "2999-01-01", "#text": "Chapitre II : Matériovigilance.", "@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": "LEGIARTI000006690305", "@fin": "2001-03-03", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690306", "@fin": "2004-08-11", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690307", "@fin": "2011-03-24", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000023754995", "@fin": "2011-12-31", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2011-03-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026500017", "@fin": "2012-05-01", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2011-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104429", "@fin": "2016-07-17", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032906183", "@fin": "2022-04-22", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2016-07-17", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045630348", "@fin": "2999-01-01", "@num": "L5212-1", "@etat": "VIGUEUR", "@debut": "2022-04-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Pour les dispositifs médicaux dont la liste est fixée par le ministre chargé de la santé après avis de l'Agence française de sécurité sanitaire des produits de santé, l'exploitant est tenu de s'assurer du maintien de ces performances et de la maintenance du dispositif médical.

\n
\n

Cette obligation donne lieu, le cas échéant, à un contrôle de qualité dont les modalités sont définies par décret et dont le coût est pris en charge par les exploitants des dispositifs.

\n
\n

La personne physique ou morale responsable de la revente d'un dispositif médical d'occasion figurant sur une liste fixée 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, établit, selon des modalités fixées par décret en Conseil d'Etat, une attestation justifiant de la maintenance régulière et du maintien des performances du dispositif médical concerné.

\n
\n

Le non-respect des dispositions du présent article peut entraîner la mise hors service provisoire ou définitive du dispositif médical, prononcée par l'Agence française de sécurité sanitaire des produits de santé, ainsi que, le cas échéant, le retrait ou la suspension de l'autorisation de l'installation dans les conditions prévues aux articles L. 6122-11 et L. 6122-13.

\n
" } }, "LEGIARTI000025104429": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5212-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2016-07-17", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025104429", "URL": "article/LEGI/ARTI/00/00/25/10/44/LEGIARTI000025104429.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Loi n° 2011-2012 du 29 décembre 2011 article 41 III : Les présentes dispositions entrent en vigueur à une date prévue par le décret pris pour leur application et au plus tard le 1er août 2012. Dès cette entrée en vigueur, l'Agence nationale de sécurité du médicament et des produits de santé exerce l'ensemble des droits et supporte l'ensemble des obligations de l'Agence française de sécurité sanitaire des produits de santé. Jusqu'à l'entrée en vigueur de ces dispositions, les compétences et pouvoirs que la présente loi attribue à l'Agence nationale de sécurité du médicament et des produits de santé sont exercés par l'Agence française de sécurité sanitaire des produits de santé.

Le décret n° 2012-597 du 27 avril 2012 est entré en vigueur le 1er mai 2012.

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R1333-68 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037017220", "@num": "R1333-78", "#text": "Code de la santé publique - art. R1333-78 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798535", "@num": "R43-38", "#text": "Code de la santé publique - art. R43-38 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798554", "@num": "R43-54", "#text": "Code de la santé publique - art. R43-54 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798564", "@num": "R43-63", "#text": "Code de la santé publique - art. 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R231-84 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072050", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171396", "@fin": "2999-01-01", "#text": "Chapitre II : Matériovigilance.", "@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": "LEGIARTI000006690305", "@fin": "2001-03-03", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690306", "@fin": "2004-08-11", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690307", "@fin": "2011-03-24", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000023754995", "@fin": "2011-12-31", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2011-03-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026500017", "@fin": "2012-05-01", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2011-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104429", "@fin": "2016-07-17", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032906183", "@fin": "2022-04-22", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2016-07-17", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045630348", "@fin": "2999-01-01", "@num": "L5212-1", "@etat": "VIGUEUR", "@debut": "2022-04-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Pour les dispositifs médicaux dont la liste est fixée par le ministre chargé de la santé après avis de l'Agence nationale de sécurité du médicament et des produits de santé, l'exploitant est tenu de s'assurer du maintien de ces performances et de la maintenance du dispositif médical.

Cette obligation donne lieu, le cas échéant, à un contrôle de qualité dont les modalités sont définies par décret et dont le coût est pris en charge par les exploitants des dispositifs.

La personne physique ou morale responsable de la cession à titre onéreux ou à titre gratuit d'un dispositif médical d'occasion figurant sur une liste fixée par arrêté du ministre chargé de la santé, pris sur proposition du directeur général de l'Agence nationale de sécurité du médicament et des produits de santé, établit, selon des modalités fixées par décret en Conseil d'Etat, une attestation justifiant de la maintenance régulière et du maintien des performances du dispositif médical concerné.

Le non-respect des dispositions du présent article peut entraîner la mise hors service provisoire ou définitive du dispositif médical, prononcée par l'Agence nationale de sécurité du médicament et des produits de santé, ainsi que, le cas échéant, le retrait ou la suspension de l'autorisation de l'installation dans les conditions prévues aux articles L. 6122-11 et L. 6122-13.

" } }, "LEGIARTI000026500017": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5212-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2011-12-31" } }, "META_COMMUN": { "ID": "LEGIARTI000026500017", "URL": "article/LEGI/ARTI/00/00/26/50/00/LEGIARTI000026500017.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGITEXT000024478563", "#text": "Décret n°2011-968\n du 16 août 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024476540", "@nortexte": "ETSP1110434D", "@numtexte": "2011-968", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-08-16" }, { "@id": "LEGIARTI000025071059", "@num": "34", "#text": "LOI n°2011-2012 du 29 décembre 2011 - art. 34", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000038533524", "#text": "Arrêté du 23 mai 2019 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000038529178", "@nortexte": "SSAP1915191A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-05-23" }, { "@id": "LEGIARTI000043969385", "@num": "R2661-4", "#text": "Code de la commande publique - art. R2661-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000037701019", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041587839", "@num": "L123-6", "#text": "Code de la construction et de l'habitation. - art. L123-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074096", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691660", "@num": "D665-5-3", "#text": "Code de la santé publique - art. D665-5-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049573024", "@num": "L1333-30", "#text": "Code de la santé publique - art. L1333-30 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028352333", "@num": "L5461-5", "#text": "Code de la santé publique - art. L5461-5 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047291570", "@num": "L5461-9", "#text": "Code de la santé publique - art. L5461-9 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047084082", "@num": "L5522-1", "#text": "Code de la santé publique - art. L5522-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690832", "@num": "L6122-11", "#text": "Code de la santé publique - art. L6122-11", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690837", "@num": "L6122-13", "#text": "Code de la santé publique - art. L6122-13", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708723", "@num": "L6221-7", "#text": "Code de la santé publique - art. L6221-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694043", "@num": "L665-5", "#text": "Code de la santé publique - art. L665-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694042", "@num": "L665-5", "#text": "Code de la santé publique - art. L665-5 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910095", "@num": "R1333-43", "#text": "Code de la santé publique - art. R1333-43 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910150", "@num": "R1333-59", "#text": "Code de la santé publique - art. R1333-59 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910178", "@num": "R1333-68", "#text": "Code de la santé publique - art. R1333-68 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037017220", "@num": "R1333-78", "#text": "Code de la santé publique - art. R1333-78 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798535", "@num": "R43-38", "#text": "Code de la santé publique - art. R43-38 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798554", "@num": "R43-54", "#text": "Code de la santé publique - art. R43-54 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798564", "@num": "R43-63", "#text": "Code de la santé publique - art. R43-63 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037011280", "@num": "R5212-26", "#text": "Code de la santé publique - art. R5212-26 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000024479878", "@num": "R5212-35-1", "#text": "Code de la santé publique - art. R5212-35-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006806746", "@num": "R231-84", "#text": "Code du travail - art. R231-84 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072050", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171396", "@fin": "2999-01-01", "#text": "Chapitre II : Matériovigilance.", "@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": "LEGIARTI000006690305", "@fin": "2001-03-03", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690306", "@fin": "2004-08-11", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690307", "@fin": "2011-03-24", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000023754995", "@fin": "2011-12-31", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2011-03-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026500017", "@fin": "2012-05-01", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2011-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104429", "@fin": "2016-07-17", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032906183", "@fin": "2022-04-22", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2016-07-17", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045630348", "@fin": "2999-01-01", "@num": "L5212-1", "@etat": "VIGUEUR", "@debut": "2022-04-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Cette obligation donne lieu, le cas échéant, à un contrôle de qualité dont les modalités sont définies par décret et dont le coût est pris en charge par les exploitants des dispositifs.

La personne physique ou morale responsable de la cession à titre onéreux ou à titre gratuit d'un dispositif médical d'occasion figurant sur une liste fixée 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, établit, selon des modalités fixées par décret en Conseil d'Etat, une attestation justifiant de la maintenance régulière et du maintien des performances du dispositif médical concerné.

" } }, "LEGIARTI000028348474": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "14", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000028348474", "URL": "article/LEGI/ARTI/00/00/28/34/84/LEGIARTI000028348474.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000028352308", "@num": "L5461-1", "#text": "Code de la santé publique - art. L5461-1 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "DEPLACE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028352344", "@num": "L5461-2", "#text": "Code de la santé publique - art. L5461-2 (VD)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028350433", "@num": "L5461-2-1", "#text": "Code de la santé publique - art. L5461-2-1 (VD)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028352340", "@num": "L5461-3", "#text": "Code de la santé publique - art. L5461-3 (VD)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028352337", "@num": "L5461-4", "#text": "Code de la santé publique - art. L5461-4 (VD)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028350465", "@num": "L5461-4-1", "#text": "Code de la santé publique - art. L5461-4-1 (VD)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028352333", "@num": "L5461-5", "#text": "Code de la santé publique - art. L5461-5 (VD)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028352331", "@num": "L5461-6", "#text": "Code de la santé publique - art. L5461-6 (VD)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028352325", "@num": "L5461-7", "#text": "Code de la santé publique - art. L5461-7 (VD)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028352317", "@num": "L5461-8", "#text": "Code de la santé publique - art. L5461-8 (VD)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028350509", "@num": "L5461-9", "#text": "Code de la santé publique - art. L5461-9 (VD)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000028348428", "@fin": "2999-01-01", "#text": "Chapitre III : Dispositifs médicaux et dispositifs médicaux de diagnostic in vitro", "@debut": "2014-02-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000028348430", "@fin": "2999-01-01", "#text": "TITRE Ier : HARMONISATION DES SANCTIONS PÉNALES ET FINANCIÈRES RELATIVES AUX PRODUITS DE SANTÉ", "@debut": "2014-02-01" } ] }, "@cid": "JORFTEXT000028346594", "@nor": "AFSX1327872R", "@num": "2013-1183", "@nature": "ORDONNANCE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Ordonnance n° 2013-1183 du 19 décembre 2013 relative à l'harmonisation des sanctions pénales et financières relatives aux produits de santé et à l'adaptation des prérogatives des autorités et des agents chargés de constater les manquements", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000028346594", "@c_titre_court": "Ordonnance n° 2013-1183 du 19 décembre 2013" }, { "@fin": "2999-01-01", "#text": "Ordonnance n° 2013-1183 du 19 décembre 2013 relative à l'harmonisation des sanctions pénales et financières relatives aux produits de santé et à l'adaptation des prérogatives des autorités et des agents chargés de constater les manquements", "@debut": "2014-02-01", "@id_txt": "LEGITEXT000028348419", "@c_titre_court": "Ordonnance n°2013-1183 du 19 décembre 2013" } ], "@ministere": "Ministère des affaires sociales et de la santé", "@date_publi": "2013-12-20", "@date_signature": "2013-12-19", "@num_parution_jo": "0295" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000028348474", "@fin": "2999-01-01", "@num": "14", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000028346838", "@fin": "2999-01-01", "@num": "14", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
\n
A modifié les dispositions suivantes :

- Code de la santé publique
Art. L5461-1
\n

\n
\n
\n
\n
\n
\n
\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
Sct. Section, Art. L5461-2, Art. L5461-3, Art. L5461-4, Art. L5461-5, Art. L5461-6, Art. L5461-7, Art. L5461-8, Art. L5461-2-1, Art. L5461-4-1, Sct. Section, Art. L5461-9, Art. L5461-1\n
\n

\n
" } }, "LEGIARTI000032906183": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5212-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-04-22", "DATE_DEBUT": "2016-07-17" } }, "META_COMMUN": { "ID": "LEGIARTI000032906183", "URL": "article/LEGI/ARTI/00/00/32/90/61/LEGIARTI000032906183.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Le décret n° 2012-597 du 27 avril 2012 est entré en vigueur le 1er mai 2012.

" }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGITEXT000024478563", "#text": "Décret n°2011-968\n du 16 août 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024476540", "@nortexte": "ETSP1110434D", "@numtexte": "2011-968", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-08-16" }, { "@id": "LEGIARTI000032896542", "@num": "2", "#text": "Ordonnance n°2016-966 du 15 juillet 2016 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000032894018", "@nortexte": "AFSP1611753R", "@numtexte": "2016-966", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2016-07-15" }, { "@id": "LEGIARTI000038533524", "#text": "Arrêté du 23 mai 2019 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000038529178", "@nortexte": "SSAP1915191A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2019-05-23" }, { "@id": "LEGIARTI000043969385", "@num": "R2661-4", "#text": "Code de la commande publique - art. R2661-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000037701019", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041587839", "@num": "L123-6", "#text": "Code de la construction et de l'habitation. - art. L123-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074096", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006691660", "@num": "D665-5-3", "#text": "Code de la santé publique - art. D665-5-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049573024", "@num": "L1333-30", "#text": "Code de la santé publique - art. L1333-30 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028352333", "@num": "L5461-5", "#text": "Code de la santé publique - art. L5461-5 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047291570", "@num": "L5461-9", "#text": "Code de la santé publique - art. L5461-9 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000047084082", "@num": "L5522-1", "#text": "Code de la santé publique - art. L5522-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690832", "@num": "L6122-11", "#text": "Code de la santé publique - art. L6122-11", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690837", "@num": "L6122-13", "#text": "Code de la santé publique - art. L6122-13", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021708723", "@num": "L6221-7", "#text": "Code de la santé publique - art. L6221-7 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694043", "@num": "L665-5", "#text": "Code de la santé publique - art. L665-5 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694042", "@num": "L665-5", "#text": "Code de la santé publique - art. L665-5 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910095", "@num": "R1333-43", "#text": "Code de la santé publique - art. R1333-43 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910150", "@num": "R1333-59", "#text": "Code de la santé publique - art. R1333-59 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910178", "@num": "R1333-68", "#text": "Code de la santé publique - art. R1333-68 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037017220", "@num": "R1333-78", "#text": "Code de la santé publique - art. R1333-78 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798535", "@num": "R43-38", "#text": "Code de la santé publique - art. R43-38 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798554", "@num": "R43-54", "#text": "Code de la santé publique - art. R43-54 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798564", "@num": "R43-63", "#text": "Code de la santé publique - art. R43-63 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037011280", "@num": "R5212-26", "#text": "Code de la santé publique - art. R5212-26 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000024479878", "@num": "R5212-35-1", "#text": "Code de la santé publique - art. R5212-35-1 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006806746", "@num": "R231-84", "#text": "Code du travail - art. R231-84 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072050", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171396", "@fin": "2999-01-01", "#text": "Chapitre II : Matériovigilance.", "@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": "LEGIARTI000006690305", "@fin": "2001-03-03", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690306", "@fin": "2004-08-11", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690307", "@fin": "2011-03-24", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000023754995", "@fin": "2011-12-31", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2011-03-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000026500017", "@fin": "2012-05-01", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2011-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104429", "@fin": "2016-07-17", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032906183", "@fin": "2022-04-22", "@num": "L5212-1", "@etat": "MODIFIE", "@debut": "2016-07-17", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045630348", "@fin": "2999-01-01", "@num": "L5212-1", "@etat": "VIGUEUR", "@debut": "2022-04-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Pour les dispositifs médicaux dont la liste est fixée par décision du directeur général l'Agence nationale de sécurité du médicament et des produits de santé, l'exploitant est tenu de s'assurer du maintien de ces performances et de la maintenance du dispositif médical.

Cette obligation donne lieu, le cas échéant, à un contrôle de qualité dont les modalités sont définies par décret et dont le coût est pris en charge par les exploitants des dispositifs.

La personne physique ou morale responsable de la cession à titre onéreux ou à titre gratuit d'un dispositif médical d'occasion figurant sur une liste fixée par décision du directeur général de l'Agence nationale de sécurité du médicament et des produits de santé, établit, selon des modalités fixées par décret en Conseil d'Etat, une attestation justifiant de la maintenance régulière et du maintien des performances du dispositif médical concerné.

" } }, "LEGIARTI000045630348": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5212-1", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2022-04-22" } }, "META_COMMUN": { "ID": "LEGIARTI000045630348", "URL": "article/LEGI/ARTI/00/00/45/63/03/LEGIARTI000045630348.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Se reporter aux modalités d'application prévues aux I, II et III de l'article 17 de l'ordonnance n° 2022-582 du 20 avril 2022.

" }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGITEXT000024478563", "#text": "Décret n°2011-968\n du 16 août 2011 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000024476540", "@nortexte": "ETSP1110434D", "@numtexte": "2011-968", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2011-08-16" }, { "@id": "LEGIARTI000038533524", "#text": "Arrêté du 23 mai 2019 - art. 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Pour les dispositifs mentionnés à l'article premier du règlement (UE) 2017/745 du Parlement européen et du Conseil du 5 avril 2017 dont la liste est fixée par décision du directeur général l'Agence nationale de sécurité du médicament et des produits de santé, l'exploitant est tenu de s'assurer du maintien de ces performances et de la maintenance du dispositif médical.

Cette obligation donne lieu, le cas échéant, à un contrôle de qualité dont les modalités sont définies par décret et dont le coût est pris en charge par les exploitants des dispositifs.

Le non-respect des dispositions du présent article peut entraîner la mise hors service provisoire ou définitive du dispositif, prononcée par l'Agence nationale de sécurité du médicament et des produits de santé, ainsi que, le cas échéant, le retrait ou la suspension de l'autorisation de l'installation dans les conditions prévues aux articles L. 6122-11 et L. 6122-13.

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Article L5461-5 AUTONOME MODIFIE, en vigueur du 01/02/2014 au 22/04/2022 (Code de la santé publique)