{"id":11196,"date":"2025-01-21T15:37:50","date_gmt":"2025-01-21T14:37:50","guid":{"rendered":"https:\/\/www.aglatech14.com\/clinical-investigations-the-outlook-towards-2028\/"},"modified":"2025-04-05T09:45:49","modified_gmt":"2025-04-05T09:45:49","slug":"clinical-investigations-the-outlook-towards-2028","status":"publish","type":"post","link":"https:\/\/www.aglatech14.com\/en\/clinical-investigations-the-outlook-towards-2028\/","title":{"rendered":"Clinical Investigations: The Outlook Towards 2028"},"content":{"rendered":"<p>With the enforcement of the <strong>European Medical Devices Regulation (MDR)<\/strong>, <strong>clinical evidence<\/strong> has become a cornerstone for regulatory compliance, as highlighted by <em>Pietro Calamea, Director of Office VI \u2013 Clinical Investigation of Medical Devices, Directorate General of Medical Devices and Pharmaceutical Services, Ministry of Health<\/em>, during the <em>AboutMedicalDevices<\/em> conference. However, contrary to expectations, there has not been a significant increase in <strong>clinical investigations<\/strong>. A more marked growth is observed in <strong>post-market investigations<\/strong>, while <strong>pre-market investigations<\/strong> remain less prevalent.<\/p>\n<h3><strong>Dichotomy Between Large Companies and SMEs<\/strong><\/h3>\n<p>An analysis of manufacturers&#8217; behavior reveals a clear division based on company size:<\/p>\n<ul>\n<li><strong>Large International Companies:<\/strong><br \/>\nThese established manufacturers continue to conduct <strong>multicentre clinical investigations<\/strong> globally, including in Italy. This approach reflects a greater awareness of the importance of generating <strong>rigorous, detailed, and comprehensive clinical data<\/strong>, necessary to demonstrate the safety and performance of devices.<\/li>\n<li><strong>Small and Medium Enterprises (SMEs):<br \/>\n<\/strong>For SMEs, often at the forefront of developing <strong>emerging technologies<\/strong> such as <strong>AI<\/strong>-based software and <strong>robotics<\/strong>, the approach to clinical investigations is less structured. This shortfall is compounded by:<\/p>\n<ul>\n<li><strong>Limited awareness<\/strong> of the importance of clinical evidence.<\/li>\n<li><strong>Inexperience<\/strong> in designing and producing medical devices, further complicating compliance with regulatory requirements.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h3><strong>Role of Clinical and Academic Research<\/strong><\/h3>\n<p>In the field of emerging technologies, SMEs are supported by clinical and academic research, which plays a crucial role in developing new solutions. However, without adequate planning and increased awareness of regulations, SMEs risk not fully leveraging the opportunities provided by the new regulation.<\/p>\n<h3><strong>Future Outlook<\/strong><\/h3>\n<p>As the 2028 deadline approaches, it is essential for SMEs to adopt a more structured approach to clinical investigations. Investing in training, collaboration with academic institutions, and strategic planning could enable them to compete effectively in the regulated market, contributing to technological progress and patient safety.<\/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>With the enforcement of the European Medical Devices Regulation (MDR), clinical evidence has become a cornerstone for regulatory compliance, as highlighted by Pietro Calamea, Director of Office VI \u2013 Clinical Investigation of Medical Devices, Directorate General of Medical Devices and Pharmaceutical Services, Ministry of Health, during the AboutMedicalDevices conference. However, contrary to expectations, there has [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":10492,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,75],"tags":[],"class_list":["post-11196","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>Clinical investigations the outlook towards 2028<\/title>\n<meta name=\"description\" content=\"With the enforcement of the European Medical Devices Regulation (MDR), clinical investigations have become a cornerstone for regulatory compliance\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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