{"id":75449,"date":"2025-11-17T09:46:17","date_gmt":"2025-11-17T08:46:17","guid":{"rendered":"https:\/\/fhi.nl\/?page_id=75449"},"modified":"2026-01-20T13:48:28","modified_gmt":"2026-01-20T12:48:28","slug":"medical-device-regulations-in-motion-state-of-play-and-whats-next","status":"publish","type":"page","link":"https:\/\/fhi.nl\/en\/medical-device-regulations-in-motion-state-of-play-and-whats-next\/","title":{"rendered":"Medical Device Regulations in Motion: State of Play and What&#039;s Next"},"content":{"rendered":"<header id=\"header\" class=\"header header--low header--branch\">\n\n\t\n\t\t\t<div class=\"header__background header__background--graphic\"><\/div>\n\t\n\t<div class=\"container\">\n\t\t<div class=\"header__content\">\n\t\t\t<div class=\"header__first\">\n\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t<h1 class=\"header__title\" >\n\t\t\t\t\tMedical Device Regulations in Motion: State of Play and What&#039;s Next\t\t\t\t<\/h1>\n\n\t\t\t\t<div class=\"header__dots-line\">\n\t\t\t\t\t<svg width=\"431\" height=\"9\" viewbox=\"0 0 431 9\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M430.799 4.192a1.136 1.136 0 1 1-2.272-.001 1.136 1.136 0 0 1 2.272 0Zm-27.272 0a1.135 1.135 0 1 1-2.27 0 1.135 1.135 0 0 1 2.27 0Zm-27.27 0a1.136 1.136 0 1 1-2.272-.001 1.136 1.136 0 0 1 2.272 0Zm-27.272 0a1.39 1.39 0 1 1-2.78 0 1.39 1.39 0 0 1 2.78 0Zm-27.78 0a1.645 1.645 0 1 1-3.29 0 1.645 1.645 0 0 1 3.29 0Zm-28.29 0a1.9 1.9 0 1 1-3.799 0 1.9 1.9 0 0 1 3.799 0Zm-28.799 0a2.154 2.154 0 1 1-4.308 0 2.154 2.154 0 0 1 4.308 0Zm-29.308 0a2.41 2.41 0 1 1-4.819 0 2.41 2.41 0 0 1 4.819 0Zm-29.819 0a2.663 2.663 0 1 1-5.326.001 2.663 2.663 0 0 1 5.326-.001Zm-30.327 0a2.919 2.919 0 1 1-5.837 0 2.919 2.919 0 0 1 5.837 0Zm-30.837 0a3.173 3.173 0 1 1-6.345.001 3.173 3.173 0 0 1 6.345 0Zm-31.346 0a3.428 3.428 0 1 1-6.856 0 3.428 3.428 0 0 1 6.856 0Zm-31.856 0a3.683 3.683 0 1 1-7.365 0 3.683 3.683 0 0 1 7.365 0Zm-32.365 0a3.937 3.937 0 1 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0Zm38.832-.001a1.754 1.754 0 1 1 3.509.003 1.754 1.754 0 0 1-3.509-.003Zm38.848-.001a1.433 1.433 0 1 1 2.867.003 1.433 1.433 0 0 1-2.867-.003ZM0 84.037a5.29 5.29 0 0 1 5.29-5.287 5.29 5.29 0 0 1 5.29 5.287 5.29 5.29 0 0 1-5.29 5.286A5.29 5.29 0 0 1 0 84.037Zm38.848 0a4.968 4.968 0 0 1 9.937 0 4.968 4.968 0 0 1-4.969 4.966 4.968 4.968 0 0 1-4.968-4.966Zm38.828-.002a4.647 4.647 0 0 1 9.294 0 4.647 4.647 0 0 1-9.294 0Zm38.836.001a4.326 4.326 0 0 1 8.652 0 4.326 4.326 0 0 1-8.652 0Zm38.843-.001a4.005 4.005 0 0 1 8.009 0 4.004 4.004 0 0 1-8.009 0Zm38.856 0a3.682 3.682 0 0 1 7.366 0 3.682 3.682 0 0 1-7.366 0Zm38.832.001a3.361 3.361 0 0 1 6.723 0 3.361 3.361 0 0 1-6.723 0Zm38.844.001a3.04 3.04 0 0 1 6.08 0 3.04 3.04 0 0 1-6.08 0Zm38.84.001a2.718 2.718 0 1 1 5.436.002 2.718 2.718 0 0 1-5.436-.002Zm38.847-.002a2.397 2.397 0 0 1 4.795 0 2.397 2.397 0 0 1-4.795 0Zm38.832-.001a2.076 2.076 0 1 1 4.151.002 2.076 2.076 0 0 1-4.151-.002Zm38.832 0a1.754 1.754 0 1 1 3.509.002 1.754 1.754 0 0 1-3.509-.002Zm38.848-.001a1.433 1.433 0 1 1 2.866.001 1.433 1.433 0 0 1-2.866-.001Z\" fill=\"#2A5CEE\"\/><\/svg>\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/fhi.nl\/en\/medischetechnologie\/programma\/\" target=\"\" class=\"image-text-image__button\">\n\t\t\t\t\t\tBack to program\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t<div class=\"image-text-content\">\n\t\t\t\t\t\t\t\t\t<div class='heading-wrapper'><svg width=\"13\" height=\"13\" viewbox=\"0 0 13 13\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><circle cx=\"6.394\" cy=\"6.5\" r=\"6.394\" fill=\"#000\"\/><\/svg><h2 class='image-text-content__title'>2:00 PM \u2013 2:25 PM<\/h2><\/div>\t\t\t\t\n\t\t\t\t\t\t\t\t\t<div class=\"image-text-content__text\"><p>This presentation examines the evolving landscape of Medical Device Regulations (MDR), providing practical insights for companies developing both hardware and software devices, with a particular focus on startups. We will start with a brief overview of the current regulatory environment and the role of Notified Bodies, highlighting how to identify the right body based on device classification and codes. The core of the session will guide attendees through the full certification process with BSI, from initial engagement and contract setup to document review, audits, and final CE marking. We will cover considerations specific to both hardware and software devices, emphasizing practical lessons and common pitfalls to avoid. A detailed look at BSI RS Medical Devices&#039; organizational structure will illustrate the range of device technologies they assess and the expertise supporting the certification process.<\/p>\n<p>Finally, the presentation will explore regulatory updates and emerging trends, discussing potential future changes in MDR and how companies can prepare to stay compliant while innovating.<br \/>\nAttendees will leave with a clear roadmap for navigating certification, practical strategies for engaging with BSI, and a forward-looking understanding of how medical device regulations are evolving.<\/p>\n<p>Speakers: Shruti Gangwal &amp; Sreenath Sukumaran, BSI<\/p>\n<p>This presentation will be in English.<\/p>\n<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":43,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"branches":[13],"events":[],"secretariat":[],"categories":[],"themes_tax":[],"class_list":["post-75449","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - 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