{"id":16236,"date":"2026-04-10T16:12:10","date_gmt":"2026-04-10T15:12:10","guid":{"rendered":"https:\/\/www.certifiedcosmetics.com\/blog\/non-classifiee\/comment-assurer-la-conformite-des-cosmetiques-en-slovenie-lignes-directrices-de-lagence-des-medicaments-et-des-dispositifs-medicaux\/"},"modified":"2026-04-10T16:12:10","modified_gmt":"2026-04-10T15:12:10","slug":"comment-assurer-la-conformite-des-cosmetiques-en-slovenie-lignes-directrices-de-lagence-des-medicaments-et-des-dispositifs-medicaux","status":"publish","type":"post","link":"https:\/\/www.certifiedcosmetics.com\/fr\/blog\/conformite-reglementaire\/comment-assurer-la-conformite-des-cosmetiques-en-slovenie-lignes-directrices-de-lagence-des-medicaments-et-des-dispositifs-medicaux\/","title":{"rendered":"Comment assurer la conformit\u00e9 des cosm\u00e9tiques en Slov\u00e9nie – Lignes directrices de l’Agence des m\u00e9dicaments et des dispositifs m\u00e9dicaux"},"content":{"rendered":"

Enregistrement des dispositifs m\u00e9dicaux en Slov\u00e9nie<\/h2>\n

Les dispositifs m\u00e9dicaux destin\u00e9s \u00e0 \u00eatre mis sur le march\u00e9 slov\u00e8ne doivent \u00eatre conformes au r\u00e8glement (UE) 2017\/745 relatif aux dispositifs m\u00e9dicaux (MDR)<\/strong> et au r\u00e8glement (UE) 2017\/746 relatif aux dispositifs m\u00e9dicaux de diagnostic in vitro (IVDR)<\/strong>. Ces r\u00e8glements \u00e9tablissent les exigences en mati\u00e8re de s\u00e9curit\u00e9, de performance et d’acc\u00e8s au march\u00e9 pour les dispositifs m\u00e9dicaux au sein de l’Union europ\u00e9enne. <\/p>\n

Autorit\u00e9 comp\u00e9tente<\/h3>\n

L’autorit\u00e9 comp\u00e9tente charg\u00e9e de la r\u00e9glementation des dispositifs m\u00e9dicaux en Slov\u00e9nie est l’Agence des m\u00e9dicaments et des dispositifs m\u00e9dicaux de la R\u00e9publique de Slov\u00e9nie (JAZMP)<\/strong>. Cette autorit\u00e9 est charg\u00e9e de superviser la conformit\u00e9 r\u00e9glementaire, de tenir \u00e0 jour les registres des dispositifs m\u00e9dicaux et de mener des activit\u00e9s de surveillance du march\u00e9. \"\"<\/p>\n

Marquage CE<\/h3>\n

Avant de mettre un dispositif m\u00e9dical sur le march\u00e9 slov\u00e8ne, celui-ci doit faire l’objet d’une proc\u00e9dure d’\u00e9valuation de la conformit\u00e9<\/strong> conform\u00e9ment \u00e0 la r\u00e9glementation europ\u00e9enne en vigueur. Une fois cette \u00e9valuation r\u00e9ussie, le fabricant peut apposer le marquage CE<\/strong> sur le dispositif. Le marquage CE confirme que le dispositif r\u00e9pond aux exigences r\u00e9glementaires europ\u00e9ennes pertinentes et peut \u00eatre l\u00e9galement commercialis\u00e9 au sein de l’Espace \u00e9conomique europ\u00e9en. <\/p>\n

Enregistrement national<\/h3>\n

Les fabricants ou les repr\u00e9sentants autoris\u00e9s doivent s’assurer que les dispositifs m\u00e9dicaux sont enregistr\u00e9s de mani\u00e8re appropri\u00e9e aupr\u00e8s de l’autorit\u00e9 nationale, le cas \u00e9ch\u00e9ant. Pendant la p\u00e9riode de transition pr\u00e9c\u00e9dant la mise en \u0153uvre compl\u00e8te de la base de donn\u00e9es europ\u00e9enne sur les dispositifs m\u00e9dicaux (EUDAMED)<\/strong>, certaines proc\u00e9dures nationales d’enregistrement peuvent continuer \u00e0 s’appliquer. <\/p>\n

Obligations post-march\u00e9<\/h3>\n

Les fabricants sont tenus de respecter les obligations de surveillance et de vigilance apr\u00e8s la mise sur le march\u00e9<\/strong>. Ces responsabilit\u00e9s comprennent la surveillance continue de la s\u00e9curit\u00e9 et des performances des dispositifs, ainsi que la d\u00e9claration des incidents graves \u00e0 l’autorit\u00e9 comp\u00e9tente. <\/p>\n","protected":false},"excerpt":{"rendered":"

Enregistrement des dispositifs m\u00e9dicaux en Slov\u00e9nie Les dispositifs m\u00e9dicaux destin\u00e9s \u00e0 \u00eatre mis sur le march\u00e9 slov\u00e8ne doivent \u00eatre conformes au r\u00e8glement (UE) 2017\/745 relatif aux dispositifs m\u00e9dicaux (MDR) et au r\u00e8glement (UE) 2017\/746 relatif aux dispositifs m\u00e9dicaux de diagnostic in vitro (IVDR). Ces r\u00e8glements \u00e9tablissent les exigences en mati\u00e8re de s\u00e9curit\u00e9, de performance et…<\/p>\n","protected":false},"author":254,"featured_media":15482,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[328],"tags":[],"class_list":["post-16236","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-conformite-reglementaire"],"yoast_head":"\nComment assurer la conformit\u00e9 des cosm\u00e9tiques en Slov\u00e9nie - Lignes directrices de l'Agence des m\u00e9dicaments et des dispositifs m\u00e9dicaux - Certified Cosmetics<\/title>\n<meta name=\"description\" content=\"Enregistrement des dispositifs m\u00e9dicaux en Slov\u00e9nie, y compris le marquage CE, la conformit\u00e9 MDR\/IVDR et les exigences r\u00e9glementaires nationales.\" \/>\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.certifiedcosmetics.com\/fr\/blog\/conformite-reglementaire\/comment-assurer-la-conformite-des-cosmetiques-en-slovenie-lignes-directrices-de-lagence-des-medicaments-et-des-dispositifs-medicaux\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Comment assurer la conformit\u00e9 des cosm\u00e9tiques en Slov\u00e9nie - 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