{"id":18136,"date":"2026-04-10T16:12:10","date_gmt":"2026-04-10T15:12:10","guid":{"rendered":"https:\/\/www.certifiedcosmetics.com\/blog\/uncategorized-da\/saadan-sikrer-du-kosmetisk-overensstemmelse-i-slovenien-retningslinjer-fra-agenturet-for-laegemidler-og-medicinsk-udstyr\/"},"modified":"2026-04-10T16:12:10","modified_gmt":"2026-04-10T15:12:10","slug":"saadan-sikrer-du-kosmetisk-overensstemmelse-i-slovenien-retningslinjer-fra-agenturet-for-laegemidler-og-medicinsk-udstyr","status":"publish","type":"post","link":"https:\/\/www.certifiedcosmetics.com\/da\/blog\/overholdelse-af-lovgivningen\/saadan-sikrer-du-kosmetisk-overensstemmelse-i-slovenien-retningslinjer-fra-agenturet-for-laegemidler-og-medicinsk-udstyr\/","title":{"rendered":"S\u00e5dan sikrer du kosmetisk overensstemmelse i Slovenien – retningslinjer fra Agenturet for L\u00e6gemidler og Medicinsk Udstyr"},"content":{"rendered":"

Registrering af medicinsk udstyr i Slovenien<\/h2>\n

Medicinsk udstyr, der er beregnet til at blive markedsf\u00f8rt i Slovenien, skal overholde forordning (EU) 2017\/745 om medicinsk udstyr (MDR<\/strong> ) og forordning (EU) 2017\/746 om medicinsk udstyr til in vitro-diagnostik (IVDR)<\/strong>. Disse forordninger fastl\u00e6gger kravene til sikkerhed, ydeevne og markedsadgang for medicinsk udstyr inden for Den Europ\u00e6iske Union. <\/p>\n

Kompetent myndighed<\/h3>\n

Den kompetente myndighed, der er ansvarlig for regulering af medicinsk udstyr i Slovenien, er agenturet for l\u00e6gemidler og medicinsk udstyr i Republikken Slovenien (JAZMP).<\/strong> Denne myndighed er ansvarlig for at f\u00f8re tilsyn med overholdelse af lovgivningen, vedligeholde registre over medicinsk udstyr og gennemf\u00f8re markedsoverv\u00e5gningsaktiviteter. \"\"<\/p>\n

CE-m\u00e6rkning<\/h3>\n

F\u00f8r medicinsk udstyr bringes i oms\u00e6tning p\u00e5 det slovenske marked, skal det gennemg\u00e5 en overensstemmelsesvurderingsprocedure<\/strong> i overensstemmelse med de g\u00e6ldende europ\u00e6iske regler. N\u00e5r denne vurdering er gennemf\u00f8rt med succes, kan fabrikanten anbringe CE-m\u00e6rkningen<\/strong> p\u00e5 udstyret. CE-m\u00e6rkningen bekr\u00e6fter, at udstyret opfylder de relevante europ\u00e6iske lovkrav og kan markedsf\u00f8res lovligt inden for Det Europ\u00e6iske \u00d8konomiske Samarbejdsomr\u00e5de. <\/p>\n

National registrering<\/h3>\n

Fabrikanter eller autoriserede repr\u00e6sentanter skal sikre, at medicinsk udstyr er beh\u00f8rigt registreret hos den nationale myndighed, hvis det er relevant. I overgangsperioden forud for den fulde implementering af den europ\u00e6iske database for medicinsk udstyr (EUDAMED)<\/strong> kan visse nationale registreringsprocedurer fortsat finde anvendelse. <\/p>\n

Forpligtelser efter markedsf\u00f8ringen<\/h3>\n

Fabrikanterne skal overholde forpligtelserne til overv\u00e5gning, efter at udstyret er bragt i oms\u00e6tning.<\/strong> Dette ansvar omfatter l\u00f8bende overv\u00e5gning af udstyrets sikkerhed og ydeevne samt indberetning af alvorlige h\u00e6ndelser til den kompetente myndighed. <\/p>\n","protected":false},"excerpt":{"rendered":"

Registrering af medicinsk udstyr i Slovenien Medicinsk udstyr, der er beregnet til at blive markedsf\u00f8rt i Slovenien, skal overholde forordning (EU) 2017\/745 om medicinsk udstyr (MDR ) og forordning (EU) 2017\/746 om medicinsk udstyr til in vitro-diagnostik (IVDR). Disse forordninger fastl\u00e6gger kravene til sikkerhed, ydeevne og markedsadgang for medicinsk udstyr inden for Den Europ\u00e6iske Union….<\/p>\n","protected":false},"author":254,"featured_media":18138,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1966],"tags":[],"class_list":["post-18136","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-overholdelse-af-lovgivningen"],"yoast_head":"\nS\u00e5dan sikrer du kosmetisk overensstemmelse i Slovenien - retningslinjer fra Agenturet for L\u00e6gemidler og Medicinsk Udstyr - Certified Cosmetics<\/title>\n<meta name=\"description\" content=\"Registrering af medicinsk udstyr i Slovenien, herunder CE-m\u00e6rkning, overholdelse af MDR\/IVDR og nationale lovkrav.\" \/>\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\/da\/blog\/overholdelse-af-lovgivningen\/saadan-sikrer-du-kosmetisk-overensstemmelse-i-slovenien-retningslinjer-fra-agenturet-for-laegemidler-og-medicinsk-udstyr\/\" \/>\n<meta property=\"og:locale\" content=\"da_DK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"S\u00e5dan sikrer du kosmetisk overensstemmelse i Slovenien - 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