{"id":4328,"date":"2022-05-11T10:45:46","date_gmt":"2022-05-11T08:45:46","guid":{"rendered":"https:\/\/www.universalmedica.com\/?p=4328"},"modified":"2022-05-11T10:47:18","modified_gmt":"2022-05-11T08:47:18","slug":"reglementation-relative-aux-dispositifs-medicaux-de-diagnostic-in-vitro-dmdiv","status":"publish","type":"post","link":"https:\/\/www.universalmedica.com\/fr\/reglementation-relative-aux-dispositifs-medicaux-de-diagnostic-in-vitro-dmdiv\/","title":{"rendered":"R\u00e9glementation relative aux dispositifs m\u00e9dicaux de diagnostic in vitro (DMDIV)"},"content":{"rendered":"

\u00c0 l\u2019approche de la fin de de la p\u00e9riode de transition de la r\u00e9glementation DMDIV qui sera effective le 26 mai 2022, tous les nouveaux dispositifs de diagnostic in vitro et les dispositifs m\u00e9dicaux de diagnostic in vitro de Classe A non st\u00e9riles devront \u00eatre conformes \u00e0 la r\u00e8glementation DMDIV pour \u00eatre commercialis\u00e9s au sein de l\u2019Union Europ\u00e9enne. Tous les fabricants de dispositifs m\u00e9dicaux de diagnostic in vitro certifi\u00e9s CE seront affect\u00e9s par cette nouvelle r\u00e8glementation. Tout dispositif m\u00e9dical ne r\u00e9pondant pas \u00e0 ces nouvelles exigences ne pourra plus \u00eatre commercialis\u00e9 en Europe.<\/p>\n

En raison du retard caus\u00e9 par le Covid-19, la Commission Europ\u00e9enne a d\u00e9cid\u00e9 d\u2019\u00e9tendreles d\u00e9lais de transition pour les produits d\u00e9j\u00e0 sur le march\u00e9 europ\u00e9en avant le 26 mai 2022 afin de garantir une continuit\u00e9 dans l\u2019approvisionnement de produits essentiels.<\/p>\n

D\u00e9lais de transition (voir infographies)<\/strong><\/p>\n

\"\"<\/p>\n

La nouvelle r\u00e9glementation relative aux dispositifs m\u00e9dicaux de diagnostic in vitro a pour objectif de garantir\u00a0 un haut niveau de s\u00e9curit\u00e9 des patients dans tous les \u00c9tats membres de l\u2019Union Europ\u00e9enne. La r\u00e9glementation DMDIV a les m\u00eames fondamentaux que la pr\u00e9c\u00e9dente directive. Des am\u00e9liorations significatives ont \u00e9t\u00e9 apport\u00e9es afin de moderniser le syst\u00e8me actuel.<\/p>\n

Compar\u00e9e \u00e0 l\u2019ancienne directive, la r\u00e8glementation DMDIV est beaucoup plus rigoureuse, notamment en ce qui concerne les cat\u00e9gories de risque et la surveillance par les organismes notifi\u00e9s. Cela signifie que tous les dispositifs de diagnostic in vitro qui ne n\u00e9cessitent actuellement que l\u2019auto-certification devront d\u00e9sormais inclure un organisme notifi\u00e9 dans le cadre du processus d’\u00e9valuation de la conformit\u00e9.<\/p>\n

Selon cette nouvelle r\u00e9gulation, tous les dispositifs de diagnostic in vitro sont r\u00e9partis dans des classes A, B, C et D en fonction de leur utilisation pr\u00e9vue et des risques qu\u2019ils comportent.\u00a0<\/strong><\/p>\n

\"\"<\/p>\n

La p\u00e9riode de transition de r\u00e9glementation DMDIV arrivant \u00e0 son terme, les fabricants de dispositifs de diagnostic in vitro doivent se tenir au fait des tous les \u00e9ventuels changements et respecter les normes.<\/p>\n

N\u2019h\u00e9sitez pas \u00e0 contacter nos experts d\u00e8s aujourd\u2019hui pour savoir comment Universal Medica peut vous guider \u00e0 comprendre les modalit\u00e9s de mise en \u0153uvre de la r\u00e8glementation du diagnostic in-vitro.<\/p>\n

Sources:<\/strong><\/p>\n

https:\/\/ansm.sante.fr\/documents\/reference\/reglementation-relative-aux-dispositifs-medicaux-dm-et-aux-dispositifs-medicaux-de-diagnostic-in-vitro-dmdiv<\/a><\/p>\n

https:\/\/ansm.sante.fr\/qui-sommes-nous\/notre-perimetre\/les-dispositifs-medicaux-et-les-dispositifs-medicaux-de-diagnostic-in-vitro\/p\/les-dispositifs-medicaux-et-les-dispositifs-medicaux-de-diagnostic-in-vitro-dmdiv<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

\u00c0 l\u2019approche de la fin de de la p\u00e9riode de transition de la r\u00e9glementation DMDIV qui sera effective le 26 mai 2022, tous les nouveaux dispositifs de diagnostic in vitro et les dispositifs m\u00e9dicaux de diagnostic in vitro de Classe A non st\u00e9riles devront \u00eatre conformes \u00e0 la r\u00e8glementation DMDIV pour \u00eatre commercialis\u00e9s au sein […]<\/p>\n","protected":false},"author":3,"featured_media":4333,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[135,133],"tags":[],"class_list":["post-4328","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-compliance-2","category-materiovigilance"],"acf":[],"yoast_head":"\nR\u00e9glementation relative aux dispositifs m\u00e9dicaux de diagnostic in vitro (DMDIV) - Universal Medica<\/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.universalmedica.com\/fr\/reglementation-relative-aux-dispositifs-medicaux-de-diagnostic-in-vitro-dmdiv\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"R\u00e9glementation relative aux dispositifs m\u00e9dicaux de diagnostic in vitro (DMDIV) - 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