{"id":16891,"date":"2020-12-16T17:36:12","date_gmt":"2020-12-16T16:36:12","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=16891"},"modified":"2020-12-16T17:36:12","modified_gmt":"2020-12-16T16:36:12","slug":"mdcg-guidance-classification-rules-ivds","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2020\/12\/16\/mdcg-guidance-classification-rules-ivds\/","title":{"rendered":"EUROPE: MDCG guidance on classification of In Vitro Diagnostic Medical Devices (IVD)"},"content":{"rendered":"\n<p>Last November 2020, the <strong>Medical Device Coordination Group (MDCG)<\/strong> published the guideline <strong>MDCG 2020-16 \u201c<\/strong>Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017\/746\u201d to explain what are the <strong>classification rules of IVDs <\/strong>according to <strong>Annex VIII <\/strong>of the IVDR.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/12\/mdcg-regole-classificazione-ivd-1024x536.png\" alt=\"MDCG guidance on classification of In Vitro Diagnostic Medical Devices (IVD)\" class=\"wp-image-16837\"\/><figcaption>MDCG guidance on classification of In Vitro Diagnostic Medical Devices (IVD)<\/figcaption><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>MDCG 2020-16: seven classification rules of IVDs for four risk classes<\/strong><\/h2>\n\n\n\n<p>The document\nis an important guide for stakeholders in the field of in vitro diagnostics, as\nthe Regulation IVDR (EU) 2017\/746 introduces a <strong>new classification system<\/strong>\nbased on rules that will subject IVDs to a higher control level.<\/p>\n\n\n\n<p>In fact, <strong>Art. 47 <\/strong>of the IVDR establishes <strong>four new risk classes<\/strong> (A, B, C and D) for in Vitro Diagnostic Medical Devices depending on the <strong>intended use of the device<\/strong> and the <strong>risks<\/strong> associated with its use.<\/p>\n\n\n\n<p>Compared to the previous Directive IVD 98\/79\/EC (IVDD), the classification of the devices is one of the most significant changes of the new provision and, for this reason, it is necessary to analyse carefully the <strong>seven classification rules&nbsp;of&nbsp;IVDs<\/strong> included in <strong>Annex VIII of the IVDR.<\/strong> <\/p>\n\n\n\n<p>According the\nlatest statistical projections, almost 85% of the IVDs in self-certification under the IVDD will\nrequire the intervention of a Notified Body under the IVDR and many\nManufacturer will have to face the <strong>certification\nprocess<\/strong> for the first time.&nbsp;This will be a real challenge, considering\nthe novelty of the implementation, the low number of Notified Bodies available\nand the timing of transition.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Are you looking for support to\nclassify your IVD device according to the IVDR?<\/strong><strong><\/strong><\/h2>\n\n\n\n<p>Thema offers\u00a0<a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\"><strong>strategic-regulatory consulting<\/strong><\/a> services to companies that produce or distribute Medical Devices (MD) and in Vitro Diagnostic Medical Devices (IVD).<br>To know how we can help you, <a href=\"mailto:sales@thema-group.it\"><strong>contact our experts<\/strong><\/a><strong>!<\/strong> <\/p>\n\n\n\n<p>For more information on the IVDR (EU) 2017\/746, see also <a href=\"https:\/\/www.thema-med.com\/en\/regulation-ivdr-eu-2017-746-main-changes\/\">In Vitro Diagnostic Medical Devices Regulation IVDR (EU) 2017\/746: main changes<\/a><\/p>\n\n\n\n<p><em>Source:<\/em><\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/md_sector\/docs\/md_mdcg_2020_guidance_classification_ivd-md_en.pdf\">MDCG 2020-16 Guidance Classification IVD<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Last November 2020, the Medical Device Coordination Group (MDCG) published the guideline MDCG 2020-16 \u201cGuidance on Classification Rules for in vitro  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-16891","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EU MDCG guidance: classification rules of the IVDs<\/title>\n<meta name=\"description\" content=\"MDCG published the guideline MDCG 2020-16 to explain what are the classification rules of the IVDs according 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