{"id":45750,"date":"2025-09-29T15:42:26","date_gmt":"2025-09-29T13:42:26","guid":{"rendered":"https:\/\/www.dm-experts.fr\/2025\/09\/team-nb-1st-eu-regulations-discussion-day\/"},"modified":"2025-10-16T18:21:55","modified_gmt":"2025-10-16T16:21:55","slug":"team-nb-1st-eu-regulations-discussion-day","status":"publish","type":"post","link":"https:\/\/www.dm-experts.fr\/en\/2025\/09\/team-nb-1st-eu-regulations-discussion-day\/","title":{"rendered":"Team-NB: &#8220;1st EU Regulations Discussion Day&#8221;."},"content":{"rendered":"\n<p>[2025-09-19] <em>(Open access)<\/em> <a href=\"https:\/\/www.team-nb.org\/\" target=\"_blank\" rel=\"noreferrer noopener\">Team-NB<\/a> <em>(The European Association of Medical devices Notified Bodies)<\/em> announces its <a href=\"https:\/\/www.team-nb.org\/team-nb-1st-eu-regulations-discussion-day-2025-november-7th\/\" target=\"_blank\" rel=\"noreferrer noopener\">1st EU Regulations Discussion Day 2025<\/a><em>.<\/em><br\/><\/p>\n\n<p>This event is aimed at small and medium-sized enterprises (SMEs), members of notified bodies and organizations. It aims to encourage exchanges between stakeholders on the future European regulatory framework for the medical devices sector.   <\/p>\n\n<figure class=\"wp-block-image size-large\"><a href=\"https:\/\/www.dm-experts.fr\/wp-content\/uploads\/2025\/09\/slider-event-1.jpg\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"655\" src=\"https:\/\/www.dm-experts.fr\/wp-content\/uploads\/2025\/09\/slider-event-1-1024x655.jpg\" alt=\"\" class=\"wp-image-45408\" srcset=\"https:\/\/www.dm-experts.fr\/wp-content\/uploads\/2025\/09\/slider-event-1-1024x655.jpg 1024w, https:\/\/www.dm-experts.fr\/wp-content\/uploads\/2025\/09\/slider-event-1-300x192.jpg 300w, https:\/\/www.dm-experts.fr\/wp-content\/uploads\/2025\/09\/slider-event-1-768x492.jpg 768w, https:\/\/www.dm-experts.fr\/wp-content\/uploads\/2025\/09\/slider-event-1-1536x983.jpg 1536w, https:\/\/www.dm-experts.fr\/wp-content\/uploads\/2025\/09\/slider-event-1-2048x1311.jpg 2048w, https:\/\/www.dm-experts.fr\/wp-content\/uploads\/2025\/09\/slider-event-1-1320x845.jpg 1320w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n\n<p>This one-day event will take place at the Sofitel Brussels Europe (Brussels), on <strong>Friday November 7, 2025, from 9:00 am to 5:30 pm. <\/strong> <\/p>\n\n<p>According to the official program, the day is organized around three main themes:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Good practices for the preparation and submission of technical documentation in accordance with regulations (EU) 2017\/745 on medical devices (MDR) and (EU) 2017\/746 on in vitro diagnostic medical devices (IVDR);<\/li>\n\n\n\n<li>EUDAMED progress report presented by European Commission experts;  <\/li>\n\n\n\n<li>and a good part of the day will be devoted to the state of play and prospects for revising the regulations (from the viewpoints of notified bodies, regulators and industry representatives).<\/li>\n<\/ul>\n\n<p><\/p>\n\n<p>There will also be a special focus on artificial intelligence (AI) applied to medical devices.  <\/p>\n\n<p>The number of places available is not specified. You must <g id=\"gid_0\">register online<\/g> before <g id=\"gid_1\">October 28, 2025<\/g> to attend. The price is <strong>\u20ac400<\/strong> for the day, reduced to <strong>\u20ac250 for SMEs<\/strong> and notified bodies.   <\/p>\n\n<p><em>According to European Union definitions <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32003H0361\" target=\"_blank\" rel=\"noreferrer noopener\">(Recommendation 2003\/361\/EC<\/a>), micro, small and medium-sized enterprises are those employing <strong>fewer than 250 people<\/strong>, with annual sales not exceeding <strong>50 million euros<\/strong><\/em> <em>or whose annual balance sheet total does not exceed <strong>43 million euros.<\/strong><\/em><\/p>\n\n<p>The European Commission has made available an online tool, <a href=\"https:\/\/ec.europa.eu\/info\/funding-tenders\/opportunities\/portal\/sme\/public\/organisation-name\" target=\"_blank\" rel=\"noreferrer noopener\">&#8220;SME Self-assessment (SME Wizard)&#8221;,<\/a> to help participants determine whether their organization meets the criteria to be considered a small or medium-sized enterprise.<\/p>\n\n<p>The day provides an excellent opportunity to discuss ways of optimizing and modifying current European regulations for the medical devices sector.  <\/p>\n\n<p><em>Article written by Lam-X\u00e9 NOEL, Managing Director of DM Experts SAS<\/em><\/p>\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>[2025-09-19] (Open access) Team-NB (The European Association of Medical devices Notified Bodies) announces its 1st EU Regulations Discussion Day 2025. This event is aimed at small and medium-sized enterprises (SMEs), members of notified bodies and organizations. It aims to encourage exchanges between stakeholders on the future European regulatory framework for the medical devices sector. This [&hellip;]<\/p>\n","protected":false},"author":824466,"featured_media":45329,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[535,517,519],"tags":[542],"class_list":["post-45750","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-european-regulations","category-regulatory-and-standards-flash","category-other-useful-information","tag-flash_139-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Team-NB: &quot;1st EU Regulations Discussion Day&quot;. - DMEXPERTS - Veille, formation et conseil pour les dispositifs m\u00e9dicaux- R\u00e9seau de consultants<\/title>\n<meta name=\"description\" content=\"Read the article DMEXPERTS, MD\/IVDD senior consultant network, Team-NB: 1st EU Regulations Discussion Day\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.dm-experts.fr\/en\/2025\/09\/team-nb-1st-eu-regulations-discussion-day\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Team-NB: &quot;1st EU Regulations Discussion Day&quot;. - 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