{"id":33901,"date":"2025-04-15T10:37:27","date_gmt":"2025-04-15T08:37:27","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=33901"},"modified":"2025-06-16T16:30:16","modified_gmt":"2025-06-16T14:30:16","slug":"terminology-other-medical-devices-imdrf-2025","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2025\/04\/15\/terminology-other-medical-devices-imdrf-2025\/","title":{"rendered":"Update of MDCG Guidance 2020-16 on the Classification of IVDs in the EU"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p>On <strong>March 18, 2025<\/strong>, the Commission&#8217;s Directorate-General for Health and Food Safety published <strong>Revision 4 <\/strong>of<strong> MDCG Guidance 2020-16<\/strong>, dedicated to the <strong>classification of in vitro diagnostic Medical Devices (IVDs)<\/strong> according to the IVDR Regulation (EU) 2017\/746<strong>.<\/strong><\/p>\n<p>The document clarifies the application of <strong>Annex VIII<\/strong> rules, helping manufacturers, notified bodies and health institutions to correctly determine the <strong>risk class of IVDs<\/strong> (Class A, B, C and D, where Class D represents the highest risk) before placing them on the market.<\/p>\n<p>Accurate <strong>IVD classification<\/strong> is the <strong>first essential step<\/strong> in defining the applicable regulatory requirements, including technical documentation, compliance procedures and post-market surveillance obligations for IVDs.<\/p>\n<p>The publication of<strong> Revision 4 <\/strong>(March 2025), just a few months<strong> after Revision 3 <\/strong>(July 2024), underlines the <strong>dynamic nature<\/strong> of IVDR implementation and the importance for manufacturers to adapt promptly.<\/p>\n<p>Although the guidance is not legally binding, practitioners, in particular manufacturers, should consider it as a key reference point for <strong>good practice for compliance <\/strong>with the legally binding <strong>IVDR Regulation (EU) 2017\/746<\/strong>.<\/p>\n<p>The guidance promotes a consistent and harmonised application of <strong>classification rules<\/strong> throughout the European Union.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.25;\" data-fontsize=\"32\" data-lineheight=\"40px\">IVD classification: Key Updates in Revision 4 of MDCG 2020-16<\/h3>\n<ul>\n<li><strong>Reclassification of SARS-Cov-2<\/strong> tests: self-diagnostic tests for SARS-Cov-2 were reclassified to Class C (previously Class D), while tests for professional use were reclassified to Class B (previously Class D). Note that IVDs for the detection of SARS-Cov and its emerging strains, as well as for vulnerable groups, remain in Class D, the highest.<br \/>\nThis reclassification reflects a significant change in the population&#8217;s perception of the risk associated with SARS-Cov-2.<\/li>\n<li><strong>Revision of examples for Rule 1 (Transmissible Agents):<\/strong> the examples for IVD devices for the detection of transmissible infectious agents such as viruses, bacteria and other pathogens have been updated.<\/li>\n<li><strong>Revision of examples for Rule 4(a) (Self-testing):<\/strong> updated examples for self-testing devices to better clarify classification according to <strong>biomarkers.<\/strong><\/li>\n<li><strong>Amendment of <\/strong><strong>footnote 8 in Rule 3 (m) (Congenital Diseases):<\/strong> The footnote has been amended to better clarify the interpretation of the rule; in particular, more precise information has been provided for neonatal screening, in the direction of greater consistency with clinical practice.<\/li>\n<li><strong>Minor editorial changes to Annexes 1 and 2:<\/strong> minor wording and structure changes were made to improve the overall readability of the document.<\/li>\n<li><strong>Strengthened emphasis on intended use:<\/strong> Revision 4 reaffirms the critical and fundamental role of the intended use declared by the manufacturer for the IVD in determining its classification.<\/li>\n<\/ul>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.25;\" data-fontsize=\"32\" data-lineheight=\"40px\">The importance of IVD classification given the upcoming IVDR deadlines<\/h3>\n<p>With the approaching<a href=\"https:\/\/www.thema-med.com\/en\/2025\/04\/23\/deadlines-ivdr-legacy-non-legacy\/\"> deadlines introduced by IVDR (EU) 2023\/607<\/a>, the correct <strong>classification of<\/strong> <strong>Legacy IVDs<\/strong> becomes a strategic step. <strong>By<\/strong> <strong>May 26, 2025<\/strong>, manufacturers must have adapted their quality management system to IVDR and submitted a formal request to a notified body. The timing for the conformity assessment varies according to the risk class of the device.<\/p>\n<p>In this scenario, <strong>Revision 4 of the MDCG 2020-16<\/strong> is an essential tool for navigating the regulatory transition. Indeed, a <strong>correct IVD classification<\/strong> directly influences the level of evidence required and the timeframe for CE marking.<\/p>\n<p>The MDCG guidelines, while not legally binding, are the gold standard for a correct interpretation of the IVDR Regulation (EU) 2017\/746. Competent authorities and notified bodies expect them to be followed as <strong>proof of good practice<\/strong>. Deviating from these indications is possible, but requires solid and well-documented technical justifications, with the risk of incurring stricter controls and non-compliance.<br \/>\nFollowing the MDCG guidelines is a sure way to navigate, achieve compliance and meet the deadlines set by the IVDR and (EU) Regulations 2024\/1860.<\/p>\n<p><strong>&gt;&gt;&gt; <\/strong>Thema experts can give you <a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\">full support<\/a> in the correct application of the classification rules for in vitro diagnostic Medical Devices and the pathway to compliance with the IVDR (EU) 2017\/746.<\/p>\n<p>SOURCE:<br \/>\n<a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/update-mdcg-2020-16-rev4-guidance-classification-rules-vitro-diagnostic-medical-devices-under-2025-03-18_en\">https:\/\/health.ec.europa.eu\/latest-updates\/update-mdcg-2020-16-rev4-guidance-classification-rules-vitro-diagnostic-medical-devices-under-2025-03-18_en<\/a><\/p>\n<p><em>04\/15\/2025<\/em><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":33853,"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":[2],"tags":[1640,1656,1680],"class_list":["post-33901","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en","tag-ivd-en-2","tag-ivdr","tag-mdcg-en"],"acf":[],"yoast_head":"<!-- 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