{"id":3322,"date":"2021-04-21T15:22:31","date_gmt":"2021-04-21T13:22:31","guid":{"rendered":"https:\/\/borgensgaard-consulting.dk\/?p=3322"},"modified":"2021-04-21T15:22:31","modified_gmt":"2021-04-21T13:22:31","slug":"import-af-medicinsk-udstyr","status":"publish","type":"post","link":"https:\/\/borgensgaard-consulting.dk\/da\/import-af-medicinsk-udstyr\/","title":{"rendered":"Import af medicinsk udstyr"},"content":{"rendered":"
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Import af medicinsk udstyr<\/h1>\n

Har du\/I fundet et medicinsk udstyr, som fremstilles udenfor Europa, og som endnu ikke s\u00e6lges p\u00e5 det europ\u00e6iske marked, skal der tages stilling til hvem som skal v\u00e6re autoriseret repr\u00e6sentant.<\/p>\n

Hvis producenten af det medicinske udstyr ikke s\u00e6lger andet medicinsk udstyr p\u00e5 det europ\u00e6iske marked, kan det v\u00e6re at de ikke er bekendte med den europ\u00e6iske lovgivning, og beder dig\/jer som import\u00f8r om at s\u00f8rge for det n\u00f8dvendige.<\/p>\n

F\u00f8rst og fremmest skal der udpeges en autoriseret repr\u00e6sentant, som er etableret i den europ\u00e6iske union.<\/p>\n

Du\/I overvejer m\u00e5ske om det ud fra et konkurrencem\u00e6ssigt perspektiv er smartest, at du\/I p\u00e5tager jer denne rolle. Og det kan sagtens v\u00e6re tilf\u00e6ldet, men det kan ogs\u00e5 v\u00e6re et risikabelt valg.<\/p>\n

Det er vigtigt at jeres virksomhed er kl\u00e6dt p\u00e5 til denne rolle, s\u00e5 I kan l\u00f8fte det ansvar som f\u00f8lger med. Der skal foreligge en skriftlig aftale mellem en autoriseret repr\u00e6sentant og producent, som beskriver fordelingen af forpligtelser (mandat) i henhold til forordningen for medicinsk udstyr (Medical Device Regulation).<\/p>\n

Den autoriserede repr\u00e6sentant skal kontrollere at EU-overensstemmelseserkl\u00e6ringen og den tekniske dokumentation er udarbejdet og at der er fulgt en korrekt overensstemmelses-vurderingsprocedure.<\/p>\n

Det er vigtigt at man har den n\u00f8dvendige viden og de rigtige kompetencer til at foretage vurderingen, da man som autoriseret repr\u00e6sentant sammen med producent h\u00e6fter for defekt udstyr. Det kan blive en bekostelig aff\u00e6re, hvis det medicinske udstyr fejler og det g\u00e5r ud over patienter eller brugers helbred \u2013 og det viser sig at udstyret ikke lever op til kravene i forordningen for medicinsk udstyr (Medical Device Regulation).<\/p>\n

Man vil naturligvis tegne en produktansvarsforsikring, men jeg er sikker p\u00e5 at ens forsikringsselskab i tilf\u00e6lde af udbetaling af erstatning, vil bede om dokumentation for at man har gennemf\u00f8rt en fyldestg\u00f8rende vurdering.<\/p>\n

Vil du gerne l\u00e6re mere om dine forpligtelser som import\u00f8r og\/eller distribut\u00f8r af medicinsk udstyr samt hvordan du bedst opfylder dem, s\u00e5 tryk p\u00e5 link og tilmeld dig kursus:<\/h4>\n
 Online Kursus 26. maj 2021: Import\u00f8rer og Distribut\u00f8rer af Medicinsk Udstyr p\u00e5 det Europ\u00e6iske Marked<\/a><\/pre>\n
 <\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"
Import af medicinsk udstyr Har du\/I fundet et medicinsk udstyr, som fremstilles udenfor Europa, og som endnu ikke s\u00e6lges p\u00e5 […]<\/p>\n","protected":false},"author":1,"featured_media":471,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[17],"tags":[],"class_list":["post-3322","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized-da"],"yoast_head":"\nImport af medicinsk udstyr - Borgensgaard Consulting<\/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:\/\/borgensgaard-consulting.dk\/da\/import-af-medicinsk-udstyr\/\" \/>\n<meta property=\"og:locale\" content=\"da_DK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Import af medicinsk udstyr - 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