{"id":11200,"date":"2025-01-17T11:36:45","date_gmt":"2025-01-17T10:36:45","guid":{"rendered":"https:\/\/www.aglatech14.com\/the-european-medical-devices-industry\/"},"modified":"2025-04-05T09:45:50","modified_gmt":"2025-04-05T09:45:50","slug":"the-european-medical-devices-industry","status":"publish","type":"post","link":"https:\/\/www.aglatech14.com\/en\/the-european-medical-devices-industry\/","title":{"rendered":"The European Medical Devices Industry"},"content":{"rendered":"<p><em>MedTech Europe<\/em> is the leading European association for the <strong>medical technology sector<\/strong>, including diagnostics, medical devices, and digital health. During the <em>AboutMedicalDevices<\/em> conference, <em>Merlin Rietschel, Senior Manager of Medical Devices, Industrial Policies<\/em>, analysed the state of the European medical devices industry through a <strong>survey<\/strong> conducted <strong>among medical device manufacturers<\/strong>, highlighting issues related to the implementation of MDR regulations.<\/p>\n<h3><strong>Divergence in Certification Timelines<\/strong><\/h3>\n<p>A significant divergence emerged regarding the <strong>timelines recorded by manufacturers compared to those reported by notified bodies for achieving MDR certification<\/strong> (for devices with QMS &#8211; Quality Management System certificates). The certification process takes an average of <strong>19.5 months<\/strong> for both large and small-to-medium-sized manufacturers.<\/p>\n<h3><strong>Rising Costs: A Burden on the Industry<\/strong><\/h3>\n<p><strong>Regulatory costs for MDR\/IVDR certification have doubled<\/strong>, driven by increases in notified body fees for QMS certification and technical documentation evaluation, as well as delays in the process. In addition to these fees, manufacturers face additional costs, including:<\/p>\n<ul>\n<li>FTE (Full-Time Equivalent) costs to complete and maintain certification;<\/li>\n<li>Post-market surveillance (PMS) and annual vigilance expenses;<\/li>\n<li>Five-year recertification costs.<\/li>\n<\/ul>\n<h3><strong>Innovation Drifting Away from Europe<\/strong><\/h3>\n<p>Another striking finding about the current state of the industry is the geographic preference for launching innovations. Regulatory complexity is <strong>steering companies away from Europe as a launch market for innovations<\/strong>. Large manufacturers and SMEs have reduced their choice of Europe for initial regulatory approval by <strong>33%<\/strong> and <strong>19%<\/strong>, respectively, favouring markets with less stringent rules, such as the United States.<\/p>\n<h3><strong>Urgent Solutions for a More Efficient System<\/strong><\/h3>\n<p>This scenario demands swift action to counter the negative trend. <em>MedTech Europe<\/em> proposes \u201cbridge measures\u201d with legal weight to address the current challenges:<\/p>\n<ol>\n<li><strong>Predictability in timelines and costs<\/strong>: simplifying the evaluation phases and technical documentation updates;<\/li>\n<li><strong>Accelerated pathways for innovation<\/strong>;<\/li>\n<li>Adapting certification to follow a <strong>lifecycle-based approach<\/strong> (renewals).<\/li>\n<\/ol>\n<p><em>Rietschel<\/em> also emphasized the need to push for a review and subsequent adjustment of the regulatory system by:<\/p>\n<ul>\n<li>Implementing the objectives of MDCG 2022-14 (structured and harmonized dialogue across Europe, evidence optimization, reducing the sampling burden for technical documents, etc.);<\/li>\n<li>Enabling electronic instructions for use (e-IFU) for all medical technologies;<\/li>\n<li>Supporting global regulatory convergence, particularly through the Medical Device Single Audit Program (MDSAP).<\/li>\n<\/ul>\n<h3><strong>A More Attractive Future for Innovation in Europe<\/strong><\/h3>\n<p>To ensure Europe&#8217;s competitiveness and attractiveness for innovation in medical technologies, a <strong>reform package<\/strong> is urgently needed, including:<\/p>\n<ul>\n<li>A unified governance structure to oversee the regulatory system;<\/li>\n<li>Targeted measures to increase regulatory efficiency and incentivize innovation.<\/li>\n<\/ul>\n<p>MedTech Europe\u2019s vision for the future of the medical technology industry is detailed in the document \u201c<em>The Future of Europe\u2019s Medical Technology Regulations<\/em>\u201d (available at this <a href=\"https:\/\/www.medtecheurope.org\/resource-library\/the-future-of-europes-medical-technology-regulations\/\">link<\/a> here).<\/p>\n<p>\u00a0<\/p>\n<p><em>Aglatech14 ContenTalkers<\/em><\/p>\n<p><em>Laura Legnani &#8211; Marketing Services Manager<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>MedTech Europe is the leading European association for the medical technology sector, including diagnostics, medical devices, and digital health. During the AboutMedicalDevices conference, Merlin Rietschel, Senior Manager of Medical Devices, Industrial Policies, analysed the state of the European medical devices industry through a survey conducted among medical device manufacturers, highlighting issues related to the implementation [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":10388,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,75],"tags":[],"class_list":["post-11200","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-legal-translations","category-newsletter-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>The European medical devices industry<\/title>\n<meta name=\"description\" content=\"The European medical devices industry analysed by MedTech Europe, the leading European 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