{ "article": { "LEGIARTI000025104724": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5211-2", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-04-22", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025104724", "URL": "article/LEGI/ARTI/00/00/25/10/47/LEGIARTI000025104724.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 mentionnée au premier alinéa du présent III, 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.

" }, "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": "LEGIARTI000025071134", "@num": "5", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@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": "LEGIARTI000045630355", "@num": "L5211-6", "#text": "Code de la santé publique - art. L5211-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045630308", "@num": "L5213-5", "#text": "Code de la santé publique - art. L5213-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694051", "@num": "L665-8", "#text": "Code de la santé publique - art. L665-8 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694050", "@num": "L665-8", "#text": "Code de la santé publique - art. L665-8 (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": "LEGIARTI000006690283", "@fin": "2001-03-03", "@num": "L5211-2", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690284", "@fin": "2012-05-01", "@num": "L5211-2", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104724", "@fin": "2022-04-22", "@num": "L5211-2", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045630285", "@fin": "2999-01-01", "@num": "L5211-2", "@etat": "VIGUEUR", "@debut": "2022-04-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Sans préjudice des dispositions de l'article L. 5211-3, les systèmes et éléments destinés à être assemblés en vue de constituer un dispositif médical doivent satisfaire à des conditions de compatibilité technique définies par l'Agence nationale de sécurité du médicament et des produits de santé.

" } }, "LEGIARTI000006690286": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5211-3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2001-03-03", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006690286", "URL": "article/LEGI/ARTI/00/00/06/69/02/LEGIARTI000006690286.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5211L03XXAA" } }, "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": "LEGIARTI000025457135", "@num": "L1123-14", "#text": "Code de la santé publique - art. L1123-14 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025104724", "@num": "L5211-2", "#text": "Code de la santé publique - art. L5211-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021964488", "@num": "L5211-3-2", "#text": "Code de la santé publique - art. L5211-3-2 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690290", "@num": "L5211-4", "#text": "Code de la santé publique - art. L5211-4 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045630355", "@num": "L5211-6", "#text": "Code de la santé publique - art. L5211-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690306", "@num": "L5212-1", "#text": "Code de la santé publique - art. L5212-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025086890", "@num": "L5213-2", "#text": "Code de la santé publique - art. L5213-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028352340", "@num": "L5461-3", "#text": "Code de la santé publique - art. L5461-3 (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": "LEGIARTI000006690661", "@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": "LEGIARTI000006690662", "@num": "L5522-2", "#text": "Code de la santé publique - art. L5522-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694040", "@num": "L665-4", "#text": "Code de la santé publique - art. L665-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694038", "@num": "L665-4", "#text": "Code de la santé publique - art. L665-4 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171392", "@fin": "2001-03-03", "#text": "Chapitre Ier : Régime juridique des dispositifs médicaux.", "@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": "LEGIARTI000006690286", "@fin": "2001-03-03", "@num": "L5211-3", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690287", "@fin": "2004-08-11", "@num": "L5211-3", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690288", "@fin": "2011-03-24", "@num": "L5211-3", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000023755001", "@fin": "2012-05-01", "@num": "L5211-3", "@etat": "MODIFIE", "@debut": "2011-03-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104425", "@fin": "2012-03-07", "@num": "L5211-3", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025453608", "@fin": "2018-01-19", "@num": "L5211-3", "@etat": "MODIFIE", "@debut": "2012-03-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000036515773", "@fin": "2022-04-22", "@num": "L5211-3", "@etat": "MODIFIE", "@debut": "2018-01-19", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045630282", "@fin": "2999-01-01", "@num": "L5211-3", "@etat": "VIGUEUR", "@debut": "2022-04-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les dispositifs médicaux ne peuvent être importés, mis sur le marché, mis en service ou utilisés, s'ils n'ont reçu, au préalable, un certificat attestant leurs performances ainsi que leur conformité à des exigences essentielles concernant la sécurité et la santé des patients, des utilisateurs et des tiers.
\n
La certification de conformité est établie par le fabricant lui-même ou par des organismes désignés par l'Agence française de sécurité sanitaire des produits de santé.
\n
Les dispositifs médicaux utilisés dans le cadre d'essais cliniques sont dispensés de certification de conformité pour les aspects qui doivent faire l'objet des essais et sous réserve de présenter, pour la sécurité et la santé des patients, des utilisateurs et des tiers, les garanties prévues par le titre I du livre II de la partie I du présent code.
" } }, "LEGIARTI000006690287": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5211-3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-11", "DATE_DEBUT": "2001-03-03" } }, "META_COMMUN": { "ID": "LEGIARTI000006690287", "URL": "article/LEGI/ARTI/00/00/06/69/02/LEGIARTI000006690287.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5211L03XXAB" } }, "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": "LEGIARTI000025457135", "@num": "L1123-14", "#text": "Code de la santé publique - art. L1123-14 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025104724", "@num": "L5211-2", "#text": "Code de la santé publique - art. L5211-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021964488", "@num": "L5211-3-2", "#text": "Code de la santé publique - art. L5211-3-2 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690290", "@num": "L5211-4", "#text": "Code de la santé publique - art. L5211-4 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045630355", "@num": "L5211-6", "#text": "Code de la santé publique - art. L5211-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690306", "@num": "L5212-1", "#text": "Code de la santé publique - art. L5212-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025086890", "@num": "L5213-2", "#text": "Code de la santé publique - art. L5213-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028352340", "@num": "L5461-3", "#text": "Code de la santé publique - art. L5461-3 (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": "LEGIARTI000006690661", "@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": "LEGIARTI000006690662", "@num": "L5522-2", "#text": "Code de la santé publique - art. L5522-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694040", "@num": "L665-4", "#text": "Code de la santé publique - art. L665-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694038", "@num": "L665-4", "#text": "Code de la santé publique - art. L665-4 (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": "LEGIARTI000006690286", "@fin": "2001-03-03", "@num": "L5211-3", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690287", "@fin": "2004-08-11", "@num": "L5211-3", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690288", "@fin": "2011-03-24", "@num": "L5211-3", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000023755001", "@fin": "2012-05-01", "@num": "L5211-3", "@etat": "MODIFIE", "@debut": "2011-03-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104425", "@fin": "2012-03-07", "@num": "L5211-3", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025453608", "@fin": "2018-01-19", "@num": "L5211-3", "@etat": "MODIFIE", "@debut": "2012-03-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000036515773", "@fin": "2022-04-22", "@num": "L5211-3", "@etat": "MODIFIE", "@debut": "2018-01-19", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045630282", "@fin": "2999-01-01", "@num": "L5211-3", "@etat": "VIGUEUR", "@debut": "2022-04-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les dispositifs médicaux ne peuvent être importés, mis sur le marché, mis en service ou utilisés, s'ils n'ont reçu, au préalable, un certificat attestant leurs performances ainsi que leur conformité à des exigences essentielles concernant la sécurité et la santé des patients, des utilisateurs et des tiers.
\n
La certification de conformité est établie par le fabricant lui-même ou par des organismes désignés par l'Agence française de sécurité sanitaire des produits de santé.
\n
Les dispositifs médicaux utilisés dans le cadre d'essais cliniques sont dispensés de certification de conformité pour les aspects qui doivent faire l'objet des essais et sous réserve de présenter, pour la sécurité et la santé des patients, des utilisateurs et des tiers, les garanties prévues par le titre I du livre II de la partie I du présent code.
" } }, "LEGIARTI000006690288": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5211-3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2011-03-24", "DATE_DEBUT": "2004-08-11" } }, "META_COMMUN": { "ID": "LEGIARTI000006690288", "URL": "article/LEGI/ARTI/00/00/06/69/02/LEGIARTI000006690288.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5211L03XXAC" } }, "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": "LEGIARTI000006697718", "@num": "96", "#text": "Loi n°2004-806 du 9 août 2004 - art. 96 () JORF 11 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787078", "@nortexte": "SANX0300055L", "@numtexte": "2004-806", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-09" }, { "@id": "LEGIARTI000025457135", "@num": "L1123-14", "#text": "Code de la santé publique - art. L1123-14 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025104724", "@num": "L5211-2", "#text": "Code de la santé publique - art. L5211-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021964488", "@num": "L5211-3-2", "#text": "Code de la santé publique - art. L5211-3-2 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690290", "@num": "L5211-4", "#text": "Code de la santé publique - art. L5211-4 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045630355", "@num": "L5211-6", "#text": "Code de la santé publique - art. L5211-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690306", "@num": "L5212-1", "#text": "Code de la santé publique - art. L5212-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025086890", "@num": "L5213-2", "#text": "Code de la santé publique - art. L5213-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028352340", "@num": "L5461-3", "#text": "Code de la santé publique - art. L5461-3 (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": "LEGIARTI000006690661", "@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": "LEGIARTI000006690662", "@num": "L5522-2", "#text": "Code de la santé publique - art. L5522-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694040", "@num": "L665-4", "#text": "Code de la santé publique - art. L665-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694038", "@num": "L665-4", "#text": "Code de la santé publique - art. L665-4 (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": "LEGIARTI000006690286", "@fin": "2001-03-03", "@num": "L5211-3", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690287", "@fin": "2004-08-11", "@num": "L5211-3", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690288", "@fin": "2011-03-24", "@num": "L5211-3", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000023755001", "@fin": "2012-05-01", "@num": "L5211-3", "@etat": "MODIFIE", "@debut": "2011-03-24", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104425", "@fin": "2012-03-07", "@num": "L5211-3", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025453608", "@fin": "2018-01-19", "@num": "L5211-3", "@etat": "MODIFIE", "@debut": "2012-03-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000036515773", "@fin": "2022-04-22", "@num": "L5211-3", "@etat": "MODIFIE", "@debut": "2018-01-19", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000045630282", "@fin": "2999-01-01", "@num": "L5211-3", "@etat": "VIGUEUR", "@debut": "2022-04-22", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Les dispositifs médicaux ne peuvent être importés, mis sur le marché, mis en service ou utilisés, s'ils n'ont reçu, au préalable, un certificat attestant leurs performances ainsi que leur conformité à des exigences essentielles concernant la sécurité et la santé des patients, des utilisateurs et des tiers.
\n
La certification de conformité est établie par le fabricant lui-même ou par des organismes désignés par l'Agence française de sécurité sanitaire des produits de santé.
\n
Les dispositifs médicaux utilisés dans le cadre de recherches biomédicales sont dispensés de certification de conformité pour les aspects qui doivent faire l'objet des recherches et sous réserve de présenter, pour la sécurité et la santé des patients, des utilisateurs et des tiers, les garanties prévues par le titre I du livre II de la partie I du présent code.
" } }, "LEGIARTI000023755001": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5211-3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2011-03-24" } }, "META_COMMUN": { "ID": "LEGIARTI000023755001", "URL": "article/LEGI/ARTI/00/00/23/75/50/LEGIARTI000023755001.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": "LEGIARTI000025457135", "@num": "L1123-14", "#text": "Code de la santé publique - art. L1123-14 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025104724", "@num": "L5211-2", "#text": "Code de la santé publique - art. L5211-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021964488", "@num": "L5211-3-2", "#text": "Code de la santé publique - art. L5211-3-2 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690290", "@num": "L5211-4", "#text": "Code de la santé publique - art. L5211-4 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045630355", "@num": "L5211-6", "#text": "Code de la santé publique - art. L5211-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690306", "@num": "L5212-1", "#text": "Code de la santé publique - art. L5212-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025086890", "@num": "L5213-2", "#text": "Code de la santé publique - art. L5213-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000028352340", "@num": "L5461-3", "#text": "Code de la santé publique - art. L5461-3 (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": "LEGIARTI000006690661", "@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": "LEGIARTI000006690662", "@num": "L5522-2", "#text": "Code de la santé publique - art. L5522-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694040", "@num": "L665-4", "#text": "Code de la santé publique - art. L665-4 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694038", "@num": "L665-4", "#text": "Code de la santé publique - art. 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Les dispositifs médicaux ne peuvent être importés, mis sur le marché, mis en service ou utilisés, s'ils n'ont reçu, au préalable, un certificat attestant leurs performances ainsi que leur conformité à des exigences essentielles concernant la sécurité et la santé des patients, des utilisateurs et des tiers.

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La certification de conformité est établie, selon la classe dont relève le dispositif, soit par le fabricant lui-même, soit par un organisme désigné à cet effet par l'Agence française de sécurité sanitaire des produits de santé ou par l'autorité compétente d'un autre Etat membre de l'Union européenne ou partie à l'accord sur l'Espace économique européen.

\n
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Les dispositifs médicaux utilisés dans le cadre de recherches biomédicales sont dispensés de certification de conformité pour les aspects qui doivent faire l'objet des recherches et sous réserve de présenter, pour la sécurité et la santé des patients, des utilisateurs et des tiers, les garanties prévues par le titre I du livre II de la partie I du présent code.

\n
" } }, "LEGIARTI000025071134": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "5", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025071134", "URL": "article/LEGI/ARTI/00/00/25/07/11/LEGIARTI000025071134.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000025104286", "@num": "L221-10", "#text": "Code de la consommation - art. L221-10 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006069565", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025104260", "@num": "L234-2", "#text": "Code rural et de la pêche maritime - art. L234-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006071367", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000025104258", "#text": "Code de la santé publique - Livre III : Agence nationale de sécurité du méd... 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Article L5211-2 AUTONOME MODIFIE, en vigueur du 01/05/2012 au 22/04/2022 (Code de la santé publique)