{"id":13694,"date":"2026-04-27T11:22:16","date_gmt":"2026-04-27T09:22:16","guid":{"rendered":"https:\/\/www.entecerma.it\/74th-nbcg-med-meeting-towards-mdr-2-0-and-new-regulatory-obligations\/"},"modified":"2026-04-27T11:30:15","modified_gmt":"2026-04-27T09:30:15","slug":"74th-nbcg-med-meeting-towards-mdr-2-0-and-new-regulatory-obligations","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/74th-nbcg-med-meeting-towards-mdr-2-0-and-new-regulatory-obligations\/","title":{"rendered":"74th NBCG-Med Meeting: Towards MDR 2.0 and New Regulatory Obligations"},"content":{"rendered":"\n<p>From April 21 to 23, 2026, the 74th edition of the NBCG-Med Meeting took place\u2014a crucial event that outlined the upcoming evolutions in the medical device sector. At the heart of the debate was the update to Annex VII of the MDR via a new Implementing Act, which introduces stringent time constraints for both Notified Bodies (NBs) and manufacturers.<\/p>\n\n<div style=\"height:28px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-vivid-cyan-blue-color has-text-color has-link-color wp-elements-244f824c133c8f3b86c8b06a23f0a53c\"><strong>TIMELINES AND COMPLIANCE: THE NEW REGULATORY LANDSCAPE<\/strong><\/h3>\n\n<p>The Implementing Act mandates compliance with pre-agreed timelines for the assessment activities required for certification. For manufacturers, this poses a concrete risk of failing to demonstrate compliance within the set deadlines. Should these timelines be exceeded or the maximum number of revisions be reached, specific agreements must be established to proceed with the process. In parallel, a guidance document drafted by the NBCG-Med regarding &#8220;Changes&#8221; is currently being evaluated by the NBO; this document aims to clarify manufacturers&#8217; reporting obligations and the assessment activities to be carried out by Notified Bodies.<\/p>\n\n<div style=\"height:28px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-vivid-cyan-blue-color has-text-color has-link-color wp-elements-2ad9a272a91542479b1ba6082a8fb0b3\"><strong>THE MDR 2.0 REVOLUTION<\/strong><\/h3>\n\n<p>The Commission calls for the adoption of a regulation to govern the matter by the end of the year.<\/p>\n\n<p>The objective is ambitious: to streamline certification processes without compromising safety. Within this context, key discussion points included reduced sampling of technical documentation and the audit frequency changing from once every 12 months to once every two years.<\/p>\n\n<div style=\"height:28px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-vivid-cyan-blue-color has-text-color has-link-color wp-elements-a51f555bcce3c6633953df9b2354044f\"><strong>CONCERNS OF THE NOTIFIED BODIES<\/strong><\/h3>\n\n<p>Despite the simplifications, Notified Bodies are expressing strong concerns. On one hand, there is the fear of reduced surveillance assessments by NBs; on the other, the economic impact. The obligation to apply discounts between 25% and 50% to micro, small, and medium-sized enterprises (SMEs)\u2014which form the backbone of the EU market\u2014combined with the potential imposition of maximum fee scales by the Commission and rising insurance costs, risks destabilizing the financial health of certification bodies.<\/p>\n\n<p>The meeting therefore reaffirmed the central importance of the MDR for patient safety and industry competitiveness, while simultaneously highlighting the need to address current operational challenges with an eye toward upcoming regulatory changes.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>From April 21 to 23, 2026, the 74th edition of the NBCG-Med Meeting took place\u2014a&#8230;<\/p>\n","protected":false},"author":2,"featured_media":13687,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[13,2],"tags":[],"class_list":["post-13694","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-events","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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