{"id":8137,"date":"2025-02-24T11:59:56","date_gmt":"2025-02-24T11:59:56","guid":{"rendered":"https:\/\/els-solutions.com\/cms\/dev\/?p=8137"},"modified":"2025-02-24T12:00:26","modified_gmt":"2025-02-24T12:00:26","slug":"new-standard-procedure-advice-for-high-risk-medical-devices","status":"publish","type":"post","link":"https:\/\/els-solutions.com\/en\/new-standard-procedure-advice-for-high-risk-medical-devices\/","title":{"rendered":"EMA Establishes Procedure for Scientific Advice on High-Risk Medical Devices"},"content":{"rendered":"<p>The European Medicines Agency (EMA), in collaboration with the <strong>European Commission<\/strong>, has announced the implementation of a <strong>new standard procedure<\/strong> for scientific advice for <strong>manufacturers of high-risk medical devices<\/strong>.<\/p>\n<p>The measure aims to strengthen the safety and efficacy of these products, ensuring more robust clinical development and accelerating their access to the market.<\/p>\n<h3 data-start=\"290\" data-end=\"329\">Specialized Support for High-Risk Devices<\/h3>\n<p>Manufacturers of<strong> class III devices<\/strong> and <strong>active class IIb devices<\/strong> that administer or remove drugs can now submit requests for advice through a <strong>digital portal<\/strong>.<\/p>\n<p>During the process, they will have access to<strong> panels of experts<\/strong> who will assist them at various stages of clinical development, providing valuable insights into research methodologies and regulatory compliance.<\/p>\n<h3 data-start=\"742\" data-end=\"789\">Benefits of the New Procedure<\/h3>\n<ul>\n<li><strong>Improved safety and efficacy:<\/strong> Expert advice will help mitigate risks and improve the quality of devices prior to marketing.<\/li>\n<li><strong>Accelerated innovation:<\/strong> Manufacturers will be able to adjust their research strategies according to expert recommendations, reducing regulatory barriers.<\/li>\n<li><strong>Positive impact on public health:<\/strong> Patients will have faster access to innovative and safe devices.<\/li>\n<\/ul>\n<h3 data-start=\"1102\" data-end=\"1145\">Continuation of previous initiatives<\/h3>\n<p>The procedure <strong>builds on a pilot project<\/strong><strong><a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-pilots-scientific-advice-certain-high-risk-medical-devices\"> started in February 2023<\/a><\/strong>, which received positive feedback from both the manufacturers and the experts involved. The EMA plans to publish a detailed report on the results of this pilot in the coming weeks.<\/p>\n<p>In addition, medical devices targeting <strong>rare diseases<\/strong> should follow a <a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-pilots-scientific-advice-certain-high-risk-medical-devices\"><strong>specific pilot program for orphan devices<\/strong><\/a>, ensuring differentiated support for this critical segment.<\/p>\n<h3 data-start=\"1102\" data-end=\"1145\">An Important Step for Health in Europe<\/h3>\n<p>With this initiative, the <strong>EMA reinforces its commitment to medical innovation and the protection of European citizens&#8217; health<\/strong>, promoting a more agile and secure regulatory environment for the development of advanced medical technologies.<\/p>\n<p data-start=\"1831\" data-end=\"1877\">If you have any questions, <strong><a href=\"https:\/\/els-solutions.com\/en\/services\/\">ELS Group<\/a><\/strong> can help!<\/p>\n<p data-start=\"1879\" data-end=\"1954\">Contact one of our<strong> <a href=\"https:\/\/els-solutions.com\/en\/where-are-we\/\">ELS consultant<\/a>s<\/strong> or send an email to <strong><a rel=\"noopener\" data-start=\"1933\" data-end=\"1953\">info@elssolutions.pt<\/a><\/strong>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>EMA has announced the implementation of a new standard procedure for scientific advice for manufacturers of high-risk medical devices.<\/p>\n","protected":false},"author":9,"featured_media":8110,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[101,164,189,122,61,102],"tags":[62,103],"class_list":["post-8137","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-anvisa-en","category-els-group-en","category-geral-en","category-medical-devices","category-news","category-noticias-en","tag-news","tag-regulations"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - 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