{"id":11529,"date":"2025-01-31T00:00:00","date_gmt":"2025-01-30T23:00:00","guid":{"rendered":"https:\/\/www.cabinet-magar.fr\/actualites\/dispositifs-medicaux-un-acces-derogatoire-facilite\/"},"modified":"2025-01-31T00:00:00","modified_gmt":"2025-01-30T23:00:00","slug":"dispositifs-medicaux-un-acces-derogatoire-facilite","status":"publish","type":"post","link":"https:\/\/www.cabinet-magar.fr\/de\/actualites\/dispositifs-medicaux-un-acces-derogatoire-facilite\/","title":{"rendered":"Dispositifs m\u00e9dicaux\u202f: un acc\u00e8s d\u00e9rogatoire facilit\u00e9"},"content":{"rendered":"<p>Afin d\u2019\u00eatre commercialis\u00e9s dans l\u2019Union europ\u00e9enne (UE), les dispositifs m\u00e9dicaux doivent obtenir un \u00ab\u202fmarquage CE\u202f\u00bb attestant du respect des r\u00e8gles europ\u00e9ennes concernant ces produits. Cependant, il existe une proc\u00e9dure pour s\u2019en passer\u2026<\/p>\n<h2>Acc\u00e8s d\u00e9rogatoire\u202f: s\u2019affranchir (temporairement) du marquage CE<\/h2>\n<p>L\u2019Union europ\u00e9enne (UE) est vigilante concernant la qualit\u00e9 des produits qui y sont commercialis\u00e9s. C\u2019est pourquoi elle a mis en place des r\u00e9glementations visant \u00e0 fixer des exigences techniques et de s\u00e9curit\u00e9 pour certaines cat\u00e9gories de produits.<\/p>\n<p>Les produits vis\u00e9s doivent donc obtenir un \u00ab\u202fmarquage CE\u202f\u00bb afin de pouvoir entrer sur les march\u00e9s de l\u2019Espace \u00e9conomique europ\u00e9en (EEE).<\/p>\n<p>C\u2019est notamment le cas des dispositifs m\u00e9dicaux qui ne peuvent th\u00e9oriquement pas \u00eatre commercialis\u00e9s sans obtenir ce marquage.<\/p>\n<p>N\u00e9anmoins, il est possible pour les professionnels exploitant ces produits de passer par une proc\u00e9dure sp\u00e9ciale pour contourner temporairement cette obligation.<\/p>\n<p>Ainsi, ils peuvent faire une demande d\u2019acc\u00e8s d\u00e9rogatoire aupr\u00e8s de l\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) lorsque l\u2019utilisation d\u2019un dispositif de sant\u00e9 serait dans l\u2019int\u00e9r\u00eat de la sant\u00e9 publique ou de la s\u00e9curit\u00e9 ou de la sant\u00e9 des patients malgr\u00e9 l\u2019absence de marquage CE.<\/p>\n<p>Il appartient alors \u00e0 l\u2019exploitant du dispositif de d\u00e9montrer dans sa demande l\u2019int\u00e9r\u00eat et l\u2019avantage clinique de son produit.<\/p>\n<p>Depuis le 27 janvier 2025, l\u2019ANSM a mis en place une nouvelle proc\u00e9dure de demande d\u2019acc\u00e8s d\u00e9rogatoire en proposant des demandes simplifi\u00e9es pour les <a href=\"https:\/\/www.demarches-simplifiees.fr\/commencer\/ansm-demande-de-derogation-individuelle-relative-aux-dispositifs-medicaux\" rel=\"noopener\" target=\"_blank\">d\u00e9rogations individuelles<\/a> et les <a href=\"https:\/\/www.demarches-simplifiees.fr\/commencer\/ansm-demande-de-derogation-globale-relative-aux-dispositifs-medicaux\" rel=\"noopener\" target=\"_blank\">d\u00e9rogations globales<\/a>.<\/p>\n<p>Il faut noter qu\u2019\u00e0 ce stade, ces d\u00e9marches simplifi\u00e9es ne sont pas possibles pour les dispositifs m\u00e9dicaux de diagnostic in vitro.<\/p>\n<div>Sources :  <\/p>\n<ul>\n<li><a href=\"https:\/\/ansm.sante.fr\/actualites\/acces-derogatoire-pour-un-dispositif-medical-depourvu-de-marquage-ce-optimisation-du-processus-de-demande-a-lansm\" rel=\"noopener\" target=\"_blank\">Actualit\u00e9 de l\u2019ANSM du 27 janvier 2025\u202f: \u00ab\u202fAcc\u00e8s d\u00e9rogatoire pour un dispositif m\u00e9dical d\u00e9pourvu de marquage CE : optimisation du processus de demande \u00e0 l\u2019ANSM\u202f\u00bb<\/a><\/li>\n<\/ul>\n<\/div>\n<p><a href=\"https:\/\/www.weblex.fr\/weblex-actualite\/dispositifs-medicaux-un-acces-derogatoire-facilite\" target=\"_blank\" rel=\"noopener\"> Dispositifs m\u00e9dicaux : un acc\u00e8s d\u00e9rogatoire facilit\u00e9 <\/a> &#8211; \u00a9 Copyright WebLex<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/www.weblex.fr\/sites\/default\/files\/actualites\/images\/Shutterstock_dispositifsmedicauxaccesderogatoirefacilite.jpg\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Afin d\u2019\u00eatre commercialis\u00e9s dans l\u2019Union europ\u00e9enne (UE), les dispositifs m\u00e9dicaux doivent obtenir un \u00ab\u202fmarquage CE\u202f\u00bb attestant du respect des r\u00e8gles europ\u00e9ennes concernant ces produits. Cependant, il existe une proc\u00e9dure pour s\u2019en passer\u2026<\/p>\n","protected":false},"author":0,"featured_media":11530,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[9,7],"tags":[],"class_list":["post-11529","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actu-juridique","category-actualites"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Dispositifs m\u00e9dicaux\u202f: un acc\u00e8s d\u00e9rogatoire facilit\u00e9 - Cabinet Magar<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.cabinet-magar.fr\/actualites\/dispositifs-medicaux-un-acces-derogatoire-facilite\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dispositifs m\u00e9dicaux\u202f: un acc\u00e8s d\u00e9rogatoire facilit\u00e9 - Cabinet Magar\" \/>\n<meta property=\"og:description\" content=\"Afin d\u2019\u00eatre commercialis\u00e9s dans l\u2019Union europ\u00e9enne (UE), les dispositifs m\u00e9dicaux doivent obtenir un \u00ab\u202fmarquage CE\u202f\u00bb attestant du respect des r\u00e8gles europ\u00e9ennes concernant ces produits. 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