{ "article": { "LEGIARTI000051060858": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "1", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000051060858", "URL": "article/LEGI/ARTI/00/00/51/06/08/LEGIARTI000051060858.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006690281", "@num": "L5211-1", "#text": "Code de la santé publique - art. L5211-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000042883255", "#text": "Code de l'environnement", "@sens": "source", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000051065035", "#text": "Code de l'environnement - Sous-section 3 : Produits en plastique à usage ... (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006074220", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000051061047", "@num": "D541-338", "#text": "Code de l'environnement - art. D541-338 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000051061049", "@num": "R541-339", "#text": "Code de l'environnement - art. R541-339 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000051058924", "@nor": "TSSH2431602D", "@num": "2025-80", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2025-80 du 28 janvier 2025 relatif aux dérogations à l'interdiction, prévue au III de l'article L. 541-15-10 du code de l'environnement, d'utiliser certains contenants alimentaires en plastique", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000051058924", "@c_titre_court": "Décret n°2025-80 du 28 janvier 2025" }, { "@fin": "2999-01-01", "#text": "Décret n° 2025-80 du 28 janvier 2025 relatif aux dérogations à l'interdiction, prévue au III de l'article L. 541-15-10 du code de l'environnement, d'utiliser certains contenants alimentaires en plastique", "@debut": "2025-01-31", "@id_txt": "LEGITEXT000051060847", "@c_titre_court": "Décret n°2025-80 du 28 janvier 2025" } ], "@ministere": "Ministère du travail, de la santé, des solidarités et des familles", "@date_publi": "2025-01-30", "@date_signature": "2025-01-28", "@num_parution_jo": "0025" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000051060858", "@fin": "2999-01-01", "@num": "1", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000051058935", "@fin": "2999-01-01", "@num": "1", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A modifié les dispositions suivantes :

- Code de l'environnement
\n Sct. Sous-section 3 : Produits en plastique à usage unique ou de contenant alimentaire\n
\n

\n
\n
A créé les dispositions suivantes :

- Code de l'environnement
\n Art. D541-338, Art. R541-339\n
\n

\n
" } }, "LEGIARTI000006690281": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5211-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2001-03-03", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006690281", "URL": "article/LEGI/ARTI/00/00/06/69/02/LEGIARTI000006690281.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5211L01XXAA" } }, "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": "LEGIARTI000006684513", "@num": "25", "#text": "Décret n°2003-1010 du 22 octobre 2003 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000610356", "@nortexte": "SOCA0323026D", "@numtexte": "2003-1010", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2003-10-22" }, { "@id": "LEGIARTI000020350738", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000640165", "@nortexte": "SANP0623371A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020317472", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000022916144", "#text": "Arrêté du 15 septembre 2010 - art. 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R165-65 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "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": "LEGIARTI000006690281", "@fin": "2001-03-03", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690282", "@fin": "2010-03-21", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021964486", "@fin": "2022-04-22", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2010-03-21", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000045630295", "@fin": "2022-07-31", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2022-04-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046126069", "@fin": "2999-01-01", "@num": "L5211-1", "@etat": "VIGUEUR", "@debut": "2022-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
On entend par dispositif médical tout instrument, appareil, équipement, matière, produit, à l'exception des produits d'origine humaine, ou autre article utilisé seul ou en association, y compris les accessoires et logiciels intervenant dans son fonctionnement, destiné par le fabricant à être utilisé chez l'homme à des fins médicales et dont l'action principale voulue n'est pas obtenue par des moyens pharmacologiques ou immunologiques ni par métabolisme, mais dont la fonction peut être assistée par de tels moyens.
\n
Les dispositifs médicaux qui sont conçus pour être implantés en totalité ou en partie dans le corps humain ou placés dans un orifice naturel, et qui dépendent pour leur bon fonctionnement d'une source d'énergie électrique ou de toute source d'énergie autre que celle qui est générée directement par le corps humain ou la pesanteur, sont dénommés dispositifs médicaux implantables actifs.
" } }, "LEGIARTI000006690282": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5211-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2010-03-21", "DATE_DEBUT": "2001-03-03" } }, "META_COMMUN": { "ID": "LEGIARTI000006690282", "URL": "article/LEGI/ARTI/00/00/06/69/02/LEGIARTI000006690282.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X5211L01XXAB" } }, "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": "LEGIARTI000006684513", "@num": "25", "#text": "Décret n°2003-1010 du 22 octobre 2003 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000610356", "@nortexte": "SOCA0323026D", "@numtexte": "2003-1010", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2003-10-22" }, { "@id": "LEGIARTI000020350738", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000640165", "@nortexte": "SANP0623371A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020317472", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000022916144", "#text": "Arrêté du 15 septembre 2010 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000022915397", "@nortexte": "SASP1023783A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-09-15" }, { "@id": "LEGITEXT000030258990", "#text": "DÉCRET n°2015-188 du 18 février 2015 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030258165", "@nortexte": "AFSS1414563D", "@numtexte": "2015-188", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2015-02-18" }, { "@id": "LEGIARTI000030909420", "@num": "5", "#text": "DÉCRET n°2015-881 du 17 juillet 2015 - art. 5 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030907542", "@nortexte": "AFSH1506845D", "@numtexte": "2015-881", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2015-07-17" }, { "@id": "LEGIARTI000034155211", "@num": "5", "#text": "Décret n°2017-291 du 6 mars 2017 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000034154540", "@nortexte": "DEVL1702157D", "@numtexte": "2017-291", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-03-06" }, { "@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": "LEGIARTI000050090741", "@num": "2", "#text": "Arrêté du 15 juin 2021 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043673283", "@nortexte": "SSAH2116294A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-15" }, { "@id": "LEGIARTI000047690229", "@num": "1", "#text": "Arrêté du 12 juin 2023 - art. 1 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000047689131", "@nortexte": "SPRS2316031A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2023-06-12" }, { "@id": "LEGITEXT000051060847", "#text": "Décret n°2025-80 du 28 janvier 2025 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000051058924", "@nortexte": "TSSH2431602D", "@numtexte": "2025-80", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2025-01-28" }, { "@id": "LEGIARTI000051060858", "@num": "1", "#text": "Décret n°2025-80 du 28 janvier 2025 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000051058924", "@nortexte": "TSSH2431602D", "@numtexte": "2025-80", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2025-01-28" }, { "@id": "LEGIARTI000031829279", "@num": "R314-168", "#text": "Code de l'action sociale et des familles - art. R314-168 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033700163", "@num": "R314-26", "#text": "Code de l'action sociale et des familles - art. R314-26 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074069", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032775739", "@num": "D543-259", "#text": "Code de l'environnement - art. D543-259 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034155479", "@num": "D543-296-2", "#text": "Code de l'environnement - art. D543-296-2 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025021487", "@num": "L522-1", "#text": "Code de l'environnement - art. L522-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037556713", "@num": "L541-10-5", "#text": "Code de l'environnement - art. L541-10-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000051561876", "@num": "L541-15-10", "#text": "Code de l'environnement - art. L541-15-10 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000051061049", "@num": "R541-339", "#text": "Code de l'environnement - art. R541-339 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000039695081", "@num": "R543-171-2", "#text": "Code de l'environnement - art. R543-171-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000050750828", "@num": "R543-360", "#text": "Code de l'environnement - art. R543-360 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043841624", "@num": "R557-9-2", "#text": "Code de l'environnement - art. R557-9-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006074220", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021964481", "@num": "L1111-3", "#text": "Code de la santé publique - art. L1111-3 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000043895775", "@num": "L1261-1", "#text": "Code de la santé publique - art. L1261-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690183", "@num": "L513-10-1", "#text": "Code de la santé publique - art. L513-10-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006690293", "@num": "L5211-5", "#text": "Code de la santé publique - art. L5211-5 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000021941883", "@num": "L5211-5-2", "#text": "Code de la santé publique - art. L5211-5-2 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025086888", "@num": "L5213-1", "#text": "Code de la santé publique - art. L5213-1 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026831622", "@num": "L5214-2", "#text": "Code de la santé publique - art. L5214-2 (V)", "@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": "LEGIARTI000033621099", "@num": "L6147-3", "#text": "Code de la santé publique - art. L6147-3 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044841432", "@num": "L6431-4", "#text": "Code de la santé publique - art. L6431-4 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694037", "@num": "L665-3", "#text": "Code de la santé publique - art. L665-3 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006694036", "@num": "L665-3", "#text": "Code de la santé publique - art. L665-3 (M)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006909999", "@num": "R1333-17", "#text": "Code de la santé publique - art. R1333-17 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910857", "@num": "R1414-43", "#text": "Code de la santé publique - art. R1414-43 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910859", "@num": "R1414-45", "#text": "Code de la santé publique - art. R1414-45 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910860", "@num": "R1414-46", "#text": "Code de la santé publique - art. R1414-46 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006910861", "@num": "R1414-47", "#text": "Code de la santé publique - art. R1414-47 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798501", "@num": "R43-12", "#text": "Code de la santé publique - art. R43-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045187722", "@num": "R5121-210", "#text": "Code de la santé publique - art. R5121-210 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916188", "@num": "R5211-1", "#text": "Code de la santé publique - art. R5211-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916264", "@num": "R5212-1", "#text": "Code de la santé publique - art. R5212-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006916324", "@num": "R5221-2", "#text": "Code de la santé publique - art. R5221-2 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006801750", "@num": "R665-64-2", "#text": "Code de la santé publique - art. R665-64-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038887559", "@num": "L162-1-7-1", "#text": "Code de la sécurité sociale. - art. L162-1-7-1 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041396907", "@num": "L162-1-8", "#text": "Code de la sécurité sociale. - art. L162-1-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044628361", "@num": "L165-1-1", "#text": "Code de la sécurité sociale. - art. L165-1-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037064523", "@num": "L245-5-5-1", "#text": "Code de la sécurité sociale. - art. L245-5-5-1 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000036636595", "@num": "R162-50-13", "#text": "Code de la sécurité sociale. - art. R162-50-13 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032886217", "@num": "R165-65", "#text": "Code de la sécurité sociale. - art. R165-65 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171570", "@fin": "2999-01-01", "#text": "Chapitre Ier : Régime juridique des dispositifs médicaux.", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155090", "@fin": "2999-01-01", "#text": "Titre Ier : Dispositifs médicaux", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140632", "@fin": "2999-01-01", "#text": "Livre II : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro et autres produits et objets réglementés dans l'intérêt de la santé publique", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690281", "@fin": "2001-03-03", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690282", "@fin": "2010-03-21", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021964486", "@fin": "2022-04-22", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2010-03-21", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000045630295", "@fin": "2022-07-31", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2022-04-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046126069", "@fin": "2999-01-01", "@num": "L5211-1", "@etat": "VIGUEUR", "@debut": "2022-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
On entend par dispositif médical tout instrument, appareil, équipement, matière, produit, à l'exception des produits d'origine humaine, ou autre article utilisé seul ou en association, y compris les accessoires et logiciels intervenant dans son fonctionnement, destiné par le fabricant à être utilisé chez l'homme à des fins médicales et dont l'action principale voulue n'est pas obtenue par des moyens pharmacologiques ou immunologiques ni par métabolisme, mais dont la fonction peut être assistée par de tels moyens.
\n
Les dispositifs médicaux qui sont conçus pour être implantés en totalité ou en partie dans le corps humain ou placés dans un orifice naturel, et qui dépendent pour leur bon fonctionnement d'une source d'énergie électrique ou de toute source d'énergie autre que celle qui est générée directement par le corps humain ou la pesanteur, sont dénommés dispositifs médicaux implantables actifs.
" } }, "LEGIARTI000021964486": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5211-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-04-22", "DATE_DEBUT": "2010-03-21" } }, "META_COMMUN": { "ID": "LEGIARTI000021964486", "URL": "article/LEGI/ARTI/00/00/21/96/44/LEGIARTI000021964486.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006684513", "@num": "25", "#text": "Décret n°2003-1010 du 22 octobre 2003 - art. 25 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000610356", "@nortexte": "SOCA0323026D", "@numtexte": "2003-1010", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2003-10-22" }, { "@id": "LEGIARTI000020350738", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000640165", "@nortexte": "SANP0623371A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000020317472", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000639975", "@nortexte": "SANP0623370A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000021961833", "@num": "2", "#text": "Ordonnance n°2010-250\n du 11 mars 2010 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000021961300", "@nortexte": "SASX1001341R", "@numtexte": "2010-250", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2010-03-11" }, { "@id": "LEGIARTI000022916144", "#text": "Arrêté du 15 septembre 2010 - art. 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R665-64-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000038887559", "@num": "L162-1-7-1", "#text": "Code de la sécurité sociale. - art. L162-1-7-1 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000041396907", "@num": "L162-1-8", "#text": "Code de la sécurité sociale. - art. L162-1-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000044628361", "@num": "L165-1-1", "#text": "Code de la sécurité sociale. - art. L165-1-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037064523", "@num": "L245-5-5-1", "#text": "Code de la sécurité sociale. - art. L245-5-5-1 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000036636595", "@num": "R162-50-13", "#text": "Code de la sécurité sociale. - art. R162-50-13 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032886217", "@num": "R165-65", "#text": "Code de la sécurité sociale. - art. R165-65 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171570", "@fin": "2999-01-01", "#text": "Chapitre Ier : Régime juridique des dispositifs médicaux.", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155090", "@fin": "2999-01-01", "#text": "Titre Ier : Dispositifs médicaux", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140632", "@fin": "2999-01-01", "#text": "Livre II : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro et autres produits et objets réglementés dans l'intérêt de la santé publique", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690281", "@fin": "2001-03-03", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690282", "@fin": "2010-03-21", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021964486", "@fin": "2022-04-22", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2010-03-21", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000045630295", "@fin": "2022-07-31", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2022-04-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046126069", "@fin": "2999-01-01", "@num": "L5211-1", "@etat": "VIGUEUR", "@debut": "2022-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

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

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

" } }, "LEGIARTI000045630295": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L5211-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-07-31", "DATE_DEBUT": "2022-04-22" } }, "META_COMMUN": { "ID": "LEGIARTI000045630295", "URL": "article/LEGI/ARTI/00/00/45/63/02/LEGIARTI000045630295.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.

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I.-La mise sur le marché, la mise en service et la mise à disposition sur le marché des dispositifs médicaux et de leurs accessoires satisfont aux dispositions du règlement (UE) 2017/745 du Parlement européen et du Conseil du 5 avril 2017 et aux dispositions du présent titre.
\n
\n Ces dispositions sont également applicables aux groupes de produits n'ayant pas de destination médicale dont la liste figure à l'annexe XVI du même règlement.
\n
\n II.-On entend par dispositif médical : tout instrument, appareil, équipement, logiciel, implant, réactif, matière ou autre article, destiné par le fabricant à être utilisé, seul ou en association, chez l'homme pour l'une ou plusieurs des fins médicales mentionnées ci-après et dont l'action principale voulue dans ou sur le corps humain n'est pas obtenue par des moyens pharmacologiques ou immunologiques ni par métabolisme, mais dont la fonction peut être assistée par de tels moyens :
\n
\n 1° Diagnostic, prévention, contrôle, prédiction, pronostic, traitement ou atténuation d'une maladie ;
\n
\n 2° Diagnostic, contrôle, traitement, atténuation d'une blessure ou d'un handicap ou compensation de ceux-ci ;
\n
\n 3° Investigation, remplacement ou modification d'une structure ou fonction anatomique ou d'un processus ou état physiologique ou pathologique ;
\n
\n 4° Communication d'informations au moyen d'un examen in vitro d'échantillons provenant du corps humain, y compris les dons d'organes, de sang et de tissus.
\n
\n Sont réputés être des dispositifs médicaux :

\n
\n-les dispositifs destinés à la maîtrise de la conception ou à l'assistance à celle-ci ;
\n
\n-les produits spécifiquement destinés au nettoyage, à la désinfection ou à la stérilisation des dispositifs médicaux, de leurs accessoires et des groupes de produits n'ayant pas de destination médicale dont la liste figure à l'annexe XVI du règlement (UE) 2017/745 précité.

\n
\n III.-On entend par accessoire de dispositif médical : tout article qui, sans être lui-même un dispositif médical, est destiné par son fabricant à être utilisé avec un dispositif médical donné, ou avec plusieurs d'entre eux, pour permettre une utilisation de ce dispositif médical conforme à sa destination, ou pour contribuer spécifiquement et directement à la fonction médicale du dispositif médical selon sa destination.

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R165-65 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171570", "@fin": "2999-01-01", "#text": "Chapitre Ier : Régime juridique des dispositifs médicaux.", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006155090", "@fin": "2999-01-01", "#text": "Titre Ier : Dispositifs médicaux", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140632", "@fin": "2999-01-01", "#text": "Livre II : Dispositifs médicaux, dispositifs médicaux de diagnostic in vitro et autres produits et objets réglementés dans l'intérêt de la santé publique", "@debut": "2001-03-03" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125349", "@fin": "2999-01-01", "#text": "Cinquième partie : Produits de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690281", "@fin": "2001-03-03", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006690282", "@fin": "2010-03-21", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2001-03-03", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021964486", "@fin": "2022-04-22", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2010-03-21", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000045630295", "@fin": "2022-07-31", "@num": "L5211-1", "@etat": "MODIFIE", "@debut": "2022-04-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046126069", "@fin": "2999-01-01", "@num": "L5211-1", "@etat": "VIGUEUR", "@debut": "2022-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

I.-La mise sur le marché, la mise en service et la mise à disposition sur le marché des dispositifs médicaux et de leurs accessoires satisfont aux dispositions du règlement (UE) 2017/745 du Parlement européen et du Conseil du 5 avril 2017 et aux dispositions du présent titre.
\n
\nCes dispositions sont également applicables aux groupes de produits n'ayant pas de destination médicale dont la liste figure à l'annexe XVI du même règlement.
\n
\nII.-On entend par dispositif médical : tout instrument, appareil, équipement, logiciel, implant, réactif, matière ou autre article, destiné par le fabricant à être utilisé, seul ou en association, chez l'homme pour l'une ou plusieurs des fins médicales mentionnées ci-après et dont l'action principale voulue dans ou sur le corps humain n'est pas obtenue par des moyens pharmacologiques ou immunologiques ni par métabolisme, mais dont la fonction peut être assistée par de tels moyens :
\n
\n1° Diagnostic, prévention, surveillance, prédiction, pronostic, traitement ou atténuation d'une maladie ;
\n
\n2° Diagnostic, contrôle, traitement, atténuation d'une blessure ou d'un handicap ou compensation de ceux-ci ;
\n
\n3° Investigation, remplacement ou modification d'une structure ou fonction anatomique ou d'un processus ou état physiologique ou pathologique ;
\n
\n4° Communication d'informations au moyen d'un examen in vitro d'échantillons provenant du corps humain, y compris les dons d'organes, de sang et de tissus.
\n
\nSont réputés être des dispositifs médicaux :

-les dispositifs destinés à la maîtrise de la conception ou à l'assistance à celle-ci ;
\n
\n-les produits spécifiquement destinés au nettoyage, à la désinfection ou à la stérilisation des dispositifs médicaux, de leurs accessoires et des groupes de produits n'ayant pas de destination médicale dont la liste figure à l'annexe XVI du règlement (UE) 2017/745 précité.

\n
\nIII.-On entend par accessoire de dispositif médical : tout article qui, sans être lui-même un dispositif médical, est destiné par son fabricant à être utilisé avec un dispositif médical donné, ou avec plusieurs d'entre eux, pour permettre une utilisation de ce dispositif médical conforme à sa destination, ou pour contribuer spécifiquement et directement à la fonction médicale du dispositif médical selon sa destination.

\n
\n
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Pour l'application des sixième et vingtième alinéas du III de l'article L. 541-15-10, on entend par :

1° “ Contenants alimentaires de cuisson, de réchauffe et de service ” : les objets destinés à contenir des denrées alimentaires et entrant en contact avec ces mêmes denrées, qui sont utilisés pour la cuisson, la préparation, la remise en température, la présentation, le service ou la consommation des plats, y compris la vaisselle et les couverts ;

2° “ Contenants en plastique ” : contenants fabriqués entièrement ou partiellement à partir de plastique tel qu'il est défini au 1° de l'article D. 541-330.

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Les services de pédiatrie, d'obstétrique et de maternité, les centres périnataux de proximité ainsi que les services de protection maternelle et infantile ne sont pas soumis à l'interdiction mentionnée au vingtième alinéa du III de l'article L. 541-15-10 pour les contenants alimentaires de cuisson, de réchauffe et de service en plastique suivants :

1° Les contenants constitutifs d'un dispositif médical défini à l'article L. 5211-1 du code de la santé publique ;

2° Les contenants utilisés afin de garantir un niveau de sécurité et d'hygiène suffisant aux personnes nécessitant une alimentation stérile ;

3° Les contenants de produits transformés préemballés, tels que définis à l'article 2 du règlement (CE) n° 852/2004 du Parlement européen et du Conseil du 29 avril 2004 relatif à l'hygiène des denrées alimentaires et à l'article 2 du règlement (UE) n° 1169/2011 du Parlement européen et du Conseil du 25 octobre 2011 concernant l'information des consommateurs sur les denrées alimentaires, dès lors qu'ils n'ont pas vocation à être réchauffés ;

4° Les contenants de denrées alimentaires et substituts définis par le règlement (UE) 609/2013 du Parlement européen et du Conseil du 12 juin 2013 concernant les denrées alimentaires destinées aux nourrissons et aux enfants en bas âge, les denrées alimentaires destinées à des fins médicales spéciales et les substituts de la ration journalière totale pour contrôle du poids, dès lors qu'ils n'ont pas vocation à être réchauffés ;

5° Les tétines et bagues de serrage des biberons ;

6° Les films utilisés comme opercules, les couvercles et autres moyens de fermeture et les joints, dès lors qu'ils n'ont pas vocation à être réchauffés ;

7° Les couverts, lorsque l'élément en matière plastique dont ils disposent a été conçu dans le but d'écarter tout risque de blessure pour les jeunes enfants ;

8° Les contenants dont l'élément en plastique conçu à des fins d'ergonomie ou de barrière thermique ou sonore n'entre pas en contact avec les denrées alimentaires.

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Article 1 ENTIEREMENT_MODIF (Décret n° 2025-80 du 28 janvier 2025 relatif aux dérogations à l'interdiction, prévue au III de l'article L. 541-15-10 du code de l'environnement, d'utiliser certains contenants alimentaires en plastique)