{"id":3040,"date":"2021-11-23T11:27:23","date_gmt":"2021-11-23T03:27:23","guid":{"rendered":"https:\/\/regask.com\/?p=3040"},"modified":"2024-11-01T06:01:23","modified_gmt":"2024-10-31T22:01:23","slug":"guide-de-lue-sur-les-appareils-herites","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/eu-legacy-devices-guidance\/","title":{"rendered":"UE : MDCG publie un document d\u2019orientation sur \u00ab Legacy Dev\u2026"},"content":{"rendered":"<p>Le <a href=\"https:\/\/www.eumonitor.eu\/9353000\/1\/j9vvik7m1c3gyxp\/vkkx77lllly9\" target=\"_blank\" rel=\"noopener\">Groupe de coordination des dispositifs m\u00e9dicaux<\/a> (MDCG), qui est le groupe d&#039;experts des \u00c9tats membres de l&#039;UE et de la Commission europ\u00e9enne, a publi\u00e9 le 20 octobre un document d&#039;orientation \u00e0 l&#039;intention des fabricants, importateurs et distributeurs de \u00ab dispositifs h\u00e9rit\u00e9s \u00bb sur les obligations MDR auxquelles ils doivent se conformer.<\/p>\n<p>Le r\u00e8glement 2017\/745 relatif aux dispositifs m\u00e9dicaux (MDR) pr\u00e9voit que certains dispositifs certifi\u00e9s en vertu de la directive pr\u00e9c\u00e9dente (directives relatives aux dispositifs m\u00e9dicaux 93\/42\/CEE) peuvent, pendant une p\u00e9riode transitoire, continuer \u00e0 \u00eatre mis et vendus sur le march\u00e9 de l&#039;UE apr\u00e8s la date d&#039;application du MDR le 26 mai 2021 sans que ces produits soient sp\u00e9cifiquement certifi\u00e9s en vertu du MDR, \u00e0 condition que les r\u00e8gles du MDR en mati\u00e8re de surveillance et de vigilance puissent \u00eatre respect\u00e9es.<\/p>\n<p>Le guide fournit des informations d\u00e9taill\u00e9es sur l&#039;\u00e9tendue des rapports p\u00e9riodiques de mise \u00e0 jour de s\u00e9curit\u00e9 qui doivent \u00eatre cr\u00e9\u00e9s et soumis, ainsi que sur le fait qu&#039;il n&#039;est pas n\u00e9cessaire de nommer une personne responsable de la conformit\u00e9 r\u00e9glementaire (PRRC) pour ces dispositifs h\u00e9rit\u00e9s.<\/p>\n<p>Contactez RegASK pour en savoir plus sur les changements r\u00e9glementaires relatifs aux dispositifs m\u00e9dicaux. <a href=\"https:\/\/regask.com\/fr\/contact-2\/\" target=\"_blank\" rel=\"noopener\">Contactez les experts de RegASK.<\/a><\/p>\n<p>&nbsp;<\/p>\n<a href=\"https:\/\/regask.com\/fr\/contact-2\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contactez RegASK pour plus de d\u00e9tails<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_sector\/docs\/md_mdcg_2021_25_en.pdf\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>En savoir plus<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-190893856\">\n\n\t<div id=\"col-1016520616\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/fr\/etudes-de-cas\/ressources-etudes-de-cas-dispositifs-medicaux\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lire les \u00e9tudes de cas sur le secteur des dispositifs m\u00e9dicaux<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Le Groupe de coordination des dispositifs m\u00e9dicaux (MDCG), qui est le groupe d&#039;experts des \u00c9tats membres de l&#039;UE et de la Commission europ\u00e9enne, a publi\u00e9 le 20 octobre un document d&#039;orientation \u00e0 l&#039;intention des fabricants, importateurs et distributeurs de \u00ab dispositifs existants \u00bb sur les obligations du MDR auxquelles ils doivent se conformer. Le r\u00e8glement sur les dispositifs m\u00e9dicaux 2017\/745 (MDR) pr\u00e9voit que certains dispositifs certifi\u00e9s en vertu de\u2026<\/p>","protected":false},"author":39,"featured_media":2754,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[40],"class_list":["post-3040","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-devices-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>EU: Legacy Devices Guidance | RegASK<\/title>\n<meta name=\"description\" content=\"The EU MDCG publishes a guidance document on legacy devices. 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