{"id":3283,"date":"2021-03-24T16:41:25","date_gmt":"2021-03-24T15:41:25","guid":{"rendered":"https:\/\/borgensgaard-consulting.dk\/?p=3283"},"modified":"2021-04-21T15:13:07","modified_gmt":"2021-04-21T13:13:07","slug":"krav-til-distributoerers-kontrol-af-medicinsk-udstyr","status":"publish","type":"post","link":"https:\/\/borgensgaard-consulting.dk\/da\/krav-til-distributoerers-kontrol-af-medicinsk-udstyr\/","title":{"rendered":"Krav til distribut\u00f8rers kontrol af medicinsk udstyr"},"content":{"rendered":"<div id=\"pl-3283\"  class=\"panel-layout\" ><div id=\"pg-3283-0\"  class=\"panel-grid panel-no-style\" ><div id=\"pgc-3283-0-0\"  class=\"panel-grid-cell\" ><div id=\"panel-3283-0-0-0\" 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\">Har du styr p\u00e5 kravene til distribut\u00f8rer af medicinsk udstyr?<\/h3>\n<div class=\"siteorigin-widget-tinymce textwidget\">\n\t<p>Krav til distribut\u00f8rer af medicinsk udstyr er ikke altid nemme at forst\u00e5 og giver ofte anledning til sp\u00f8rgsm\u00e5l!<\/p>\n<p>Et godt eksempel p\u00e5 dette er kravet til, at distribut\u00f8rer skal verificere, f\u00f8r de g\u00f8r udstyr tilg\u00e6ngeligt p\u00e5 markedet, at f\u00f8lgende krav er opfyldt:<\/p>\n<ol>\n<li>Udstyret er CE-m\u00e6rket, og der er udarbejdet en EU-overensstemmelseserkl\u00e6ring for udstyret<\/li>\n<li>Udstyret er ledsaget af de oplysninger, som fabrikanten skal freml\u00e6gge i overensstemmelse med artikel 10, stk. 11 (m\u00e6rkning og brugsanvisning)<\/li>\n<li>For importeret udstyr: import\u00f8ren har opfyldt kravene i artikel 13, stk 3 (import\u00f8roplysninger)<\/li>\n<li>Fabrikanten har, hvis det er relevant, tildelt udstyret en UDI<\/li>\n<\/ol>\n<p>N\u00e5r man f\u00e5r gravet sig ind i de forskellige artikler i forordningen for medicinsk udstyr, som i flere tilf\u00e6lde henviser til andre artikler eller bilag, kan man f\u00e5 sig et overblik over hvad man som distribut\u00f8r skal kontrollere.<\/p>\n<p>Men der st\u00e5r ikke s\u00e5 meget om, hvordan man skal udf\u00f8re kontrollen. Mange distribut\u00f8rer sidder med tvivl om de bare skal kontrollere deres produkter en gang eller om det er noget, som man skal g\u00f8re l\u00f8bende, hvor ofte og hvor mange produkter i et vareparti.<\/p>\n<p>Som distribut\u00f8r af medicinsk udstyr, skal man gennemf\u00f8re verifikation, f\u00f8r man g\u00f8r udstyr tilg\u00e6ngeligt p\u00e5 det europ\u00e6iske marked eller sagt p\u00e5 et lidt mere forst\u00e5eligt sprog, s\u00e5 skal man gennemf\u00f8re en verifikation inden enhver <em>levering<\/em> af medicinske udstyr.<\/p>\n<p>Det er lidt sent at opdage at det medicinske udstyr ikke overholder kravene, n\u00e5r man er ved at pakke det til forsendelse til en kunde. Derfor v\u00e6lger mange distribut\u00f8rer at foretage kontrollen i forbindelse med varemodtagelse og f\u00f8r det medicinske udstyr l\u00e6gges p\u00e5 lager. Det er nemt hvis det er f\u00e5 enheder, men en noget mere omfattende sag, hvis der er tale om store varepartier af medicinsk udstyr.<\/p>\n<p>I artikel 13 i forordningen for medicinsk udstyr, som beskriver distribut\u00f8rernes generelle forpligtelser, er der lidt hj\u00e6lp at hente i slutningen af stk. 2, hvor det st\u00e5r at distribut\u00f8ren kan anvende en pr\u00f8veudtagningsmetode, der er repr\u00e6sentativ for det udstyr, som den p\u00e5g\u00e6ldende distribut\u00f8r leverer. Det betyder at man ikke er forpligtet til at kontrollere hver eneste enhed, men at man kan udtage en stikpr\u00f8ve.<\/p>\n<p>Det rejser en nyt sp\u00f8rgsm\u00e5l. Hvor stor skal denne stikpr\u00f8ve v\u00e6re? Og hvad vil det sige at det skal v\u00e6re repr\u00e6sentativ for udstyret?<\/p>\n<p>Jeg forespurgte sidste \u00e5r l\u00e6gemiddelstyrelsen om de forventede, at man anvendte en standard for stikpr\u00f8veudtagning som fx ISO 2859-1 (Sampling procedures for inspection by attributes). Det er en standard, som er en meget benyttet i life-science industrien. Jeg fik dette svar retur fra l\u00e6gemiddelstyrelsen:<\/p>\n<p>\u201dAng\u00e5ende stikpr\u00f8vetagning er forholdet ogs\u00e5, at man skal kunne dokumentere, at der udtages tilstr\u00e6kkeligt antal pr\u00f8ver. Jeg kan ikke finde den konkrete standard, du henviser til, men umiddelbart vil vi n\u00e6ppe forvente, at alle distribut\u00f8rer har planlagt pr\u00f8veudtagning med henvisning til en standard. Igen kan der v\u00e6re forskel p\u00e5, hvilken risikoklasse et produkt er og hvad distribut\u00f8rens oms\u00e6tningsvolume af medicinsk udstyr er\u201d.<\/p>\n<p>Jeg m\u00e5 tilst\u00e5 at jeg ikke blev frygtelig klogere af svaret. Hvordan dokumenterer man at der udtages tilstr\u00e6kkelig antal pr\u00f8ver, n\u00e5r det ikke er defineret nogen steder, hvad antal tilstr\u00e6kkelige pr\u00f8ver er?<\/p>\n<p>Mit bedste bud og r\u00e5dgivning til den kunde, som jeg p\u00e5 dav\u00e6rende tidspunkt hjalp med at opbygge et kvalitetsstyringssystem, var at anvende ISO 2859-1 standarden. Standarden et godt udgangspunkt i forhold til en statistik baseret stikpr\u00f8veplan, og dermed en god argumentation for at have udtaget tilstr\u00e6kkeligt antal pr\u00f8ver.<\/p>\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<\/div>\n<\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>Krav til distribut\u00f8rer af medicinsk udstyr er ikke altid nemme at forst\u00e5 og giver ofte anledning til sp\u00f8rgsm\u00e5l! Et godt [&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-3283","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>Krav til 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\/krav-til-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=\"Krav til distribut\u00f8rers kontrol af medicinsk udstyr - Borgensgaard Consulting\" \/>\n<meta property=\"og:description\" content=\"Krav til distribut\u00f8rer af medicinsk udstyr er ikke altid nemme at forst\u00e5 og giver ofte anledning til sp\u00f8rgsm\u00e5l! 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