{"id":11776,"date":"2021-12-11T15:15:58","date_gmt":"2021-12-11T15:15:58","guid":{"rendered":"https:\/\/amb.se\/?p=11776"},"modified":"2022-12-15T20:49:19","modified_gmt":"2022-12-15T20:49:19","slug":"help-how-do-i-give-my-medical-device-a-ce-mark","status":"publish","type":"post","link":"https:\/\/amb.se\/en\/2021\/12\/11\/help-how-do-i-give-my-medical-device-a-ce-mark\/","title":{"rendered":"Help! How do I give my medical device a CE mark?"},"content":{"rendered":"<div class=\"wpb-content-wrapper\">[vc_row][vc_column][vc_column_text]\n<h4>The 10 most important steps to get approval for the European market.<\/h4>\n[\/vc_column_text][vc_column_text]\n<h3>The VDE CE roadmap<\/h3>\n<p>The\u00a0German technical-scientific association <a href=\"https:\/\/www.vde.com\/en\/topics-en\" target=\"_blank\" rel=\"noopener\">VDE<\/a> has published a CE roadmap for medical devices.<\/p>\n<p>Every time a medical device is developed, the question comes up at some point which regulatory requirements must be fulfilled. If the new medical device is to be marketed in Europe, it requires a CE marking, i.e., the requirements of the European Medical Device Regulation (MDR) apply.<\/p>\n<p>VDE is repeatedly asked 2 questions at this point:<\/p>\n<ul>\n<li>What requirements must a product fulfil in detail?<\/li>\n<li>What does it cost to implement these requirements?<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>A \u201cquick answer\u201d to these important questions is not possible in most cases. The product-specific requirements differ too much from one medical device to another. In addition, there are differences between the companies and the processes, experience and competences available there.<\/p>\n<p>For this reason, VDE has developed the \u201cCE Roadmap\u201d. The roadmap allows a precise statement of the regulatory requirements for a particular product. This requirement profile is supplemented by a corresponding cost planning for implementation and approval. In addition, the roadmap gives practical recommendations on the market access of a medical device, on processing periods or also on the cooperation with Notified Bodies.<\/p>\n<p><a href=\"https:\/\/meso.vde.com\/ce-roadmap-medical-devices\/\" target=\"_blank\" rel=\"noopener\">In this article<\/a>, VDE presents the process of CE road mapping and the benefits for manufacturers of medical devices.[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]\n<h3>VDE<\/h3>\n<p><strong><a href=\"https:\/\/www.vde.com\/en\" target=\"_blank\" rel=\"noopener\">VDE<\/a> <\/strong>(<em>Verband der Elektrotechnik, Elektronik und Informationstechnik<\/em>) is one of Europe\u2019s largest technical-scientific associations with 36,000 members, including 1,300 corporate and institutional members and 8,000 students.<\/p>\n<p>VDE has been supporting the medical device industry for many years. During this time, the challenges for all those involved have constantly increased.[\/vc_column_text][\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"<p>VDE presents the process of CE road mapping in 10 steps.<\/p>\n","protected":false},"author":3,"featured_media":12070,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[10,12],"tags":[],"class_list":["post-11776","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-knowledge-blog","category-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>How do I give my medical device a CE mark? - AMB<\/title>\n<meta name=\"description\" content=\"VDE presents the process of CE road mapping in 10 steps and the benefits for manufacturers of medical devices.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/amb.se\/en\/2021\/12\/11\/help-how-do-i-give-my-medical-device-a-ce-mark\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How do I give my medical device a CE mark? - AMB\" \/>\n<meta property=\"og:description\" content=\"VDE presents the process of CE road mapping in 10 steps and the benefits for manufacturers of medical devices.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/amb.se\/en\/2021\/12\/11\/help-how-do-i-give-my-medical-device-a-ce-mark\/\" \/>\n<meta property=\"og:site_name\" content=\"AMB Industri AB\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/amb1946\/\" \/>\n<meta property=\"article:published_time\" content=\"2021-12-11T15:15:58+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-12-15T20:49:19+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/amb.se\/wp-content\/uploads\/2021\/12\/ce-city.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2000\" \/>\n\t<meta property=\"og:image:height\" content=\"800\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"J\u00f6rg Hinz\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"J\u00f6rg Hinz\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/amb.se\\\/en\\\/2021\\\/12\\\/11\\\/help-how-do-i-give-my-medical-device-a-ce-mark\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/amb.se\\\/en\\\/2021\\\/12\\\/11\\\/help-how-do-i-give-my-medical-device-a-ce-mark\\\/\"},\"author\":{\"name\":\"J\u00f6rg Hinz\",\"@id\":\"https:\\\/\\\/amb.se\\\/#\\\/schema\\\/person\\\/5792df5e84eb0ee17aedd44e57eaa9ef\"},\"headline\":\"Help! 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