{"id":3292,"date":"2021-03-31T08:35:16","date_gmt":"2021-03-31T06:35:16","guid":{"rendered":"https:\/\/borgensgaard-consulting.dk\/?p=3292"},"modified":"2021-04-21T15:11:10","modified_gmt":"2021-04-21T13:11:10","slug":"distributoerers-kontrol-af-medicinsk-udstyr","status":"publish","type":"post","link":"https:\/\/borgensgaard-consulting.dk\/da\/distributoerers-kontrol-af-medicinsk-udstyr\/","title":{"rendered":"Distribut\u00f8rers kontrol af medicinsk udstyr"},"content":{"rendered":"<div id=\"pl-3292\"  class=\"panel-layout\" ><div id=\"pg-3292-0\"  class=\"panel-grid panel-no-style\" ><div id=\"pgc-3292-0-0\"  class=\"panel-grid-cell\" ><div id=\"panel-3292-0-0-0\" class=\"so-panel widget widget_sow-editor panel-first-child panel-last-child\" data-index=\"0\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-editor so-widget-sow-editor-base\"\n\t\t\t\n\t\t><h3 class=\"widget-title\">Forordningen for medicinsk udstyr stiller krav at distribut\u00f8rer kontrollerer m\u00e6rkningen inden udstyret s\u00e6lges videre.<\/h3>\n<div class=\"siteorigin-widget-tinymce textwidget\">\n\t<p>M\u00e6rkning skal kontrolleres p\u00e5 det medicinske udstyr, dets emballage samt alle h\u00f8jere pakkeniveauer med undtagelse af forsendelseskartoner. Det er ikke altid helt let, da man ofte ikke \u00f8nsker at bryde emballage og slet ikke hvis der er tale om et sterilt produkt.<\/p>\n<p>M\u00e6rkningen skal kontrolleres for:<\/p>\n<ul>\n<li>At der er et CE-m\u00e6rke<\/li>\n<li>At det medicinske udstyr samt emballagen er m\u00e6rket med UDI<br \/>\n(unique device identification)<\/li>\n<li>At m\u00e6rkningen er p\u00e5 lokalsprog<\/li>\n<li>At oplysningerne p\u00e5 m\u00e6rkningen ikke kan slettes samt er letl\u00e6selig<\/li>\n<li>At import\u00f8rens navn, registrerede firmanavn eller registrerede varem\u00e6rke samt adresse er p\u00e5f\u00f8rt det medicinske udstyr, dets emballage eller f\u00f8lgeseddel. Oplysningerne m\u00e5 ikke skjule oplysninger fra fabrikanten.<\/li>\n<\/ul>\n<p>UDI skal anbringes p\u00e5 m\u00e6rkningen eller p\u00e5 selve det medicinske udstyr samt p\u00e5 alle h\u00f8jere emballage niveauer med undtagelse af forsendelseskartoner.<\/p>\n<p>Hvis der ikke er plads p\u00e5 den prim\u00e6re emballage, kan m\u00e6rkningen anbringes p\u00e5 det n\u00e6ste h\u00f8jere emballageniveau.<\/p>\n<p>For engangsudstyr i klasse I og IIa, der er emballeret og m\u00e6rket enkeltvis, kr\u00e6ves det ikke at UDI-b\u00e6reren er anf\u00f8rt p\u00e5 emballagen, men den skal v\u00e6re anf\u00f8rt p\u00e5 et h\u00f8jere emballageniveau.<\/p>\n<p>Kravet til m\u00e6rkning vil l\u00f8bende blive indf\u00f8rt i henhold til denne tidsplan afh\u00e6ngig af hvilken klassificering det medicinske udstyr har:<\/p>\n<table width=\"594\">\n<tbody>\n<tr>\n<td width=\"198\"><strong>Klasse III <\/strong><\/td>\n<td width=\"198\"><strong>Klasse IIa + IIb<\/strong><\/td>\n<td width=\"198\"><strong>Klasse I <\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"198\">26 maj 2021<\/td>\n<td width=\"198\">26 maj 2023<\/td>\n<td width=\"198\">26\u00a0\u00a0 maj 2025<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h4>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<pre><a href=\"https:\/\/borgensgaard-consulting.dk\/da\/online-kursus-importoer-og-distributoer-af-medicinsk-udstyr-paa-det-europaeiske-marked\/\"> Online Kursus 26. maj 2021: Import\u00f8rer og Distribut\u00f8rer af Medicinsk Udstyr p\u00e5 det Europ\u00e6iske Marked<\/a><\/pre>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>M\u00e6rkning skal kontrolleres p\u00e5 det medicinske udstyr, dets emballage samt alle h\u00f8jere pakkeniveauer med undtagelse af forsendelseskartoner. Det er ikke [&hellip;]<\/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":[44],"tags":[],"class_list":["post-3292","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicinsk-udstyr"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.3 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Distribut\u00f8rers kontrol 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\/distributoerers-kontrol-af-medicinsk-udstyr\/\" \/>\n<meta property=\"og:locale\" content=\"da_DK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Distribut\u00f8rers kontrol af medicinsk udstyr - Borgensgaard Consulting\" \/>\n<meta property=\"og:description\" content=\"M\u00e6rkning skal kontrolleres p\u00e5 det medicinske udstyr, dets emballage samt alle h\u00f8jere pakkeniveauer med undtagelse af forsendelseskartoner. 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