{"id":7980,"date":"2025-02-03T10:50:18","date_gmt":"2025-02-03T10:50:18","guid":{"rendered":"https:\/\/els-solutions.com\/cms\/dev\/?p=7980"},"modified":"2025-02-03T10:49:13","modified_gmt":"2025-02-03T10:49:13","slug":"public-consultation-on-eu-medical-device-regulations","status":"publish","type":"post","link":"https:\/\/els-solutions.com\/en\/public-consultation-on-eu-medical-device-regulations\/","title":{"rendered":"European Commission Launches Public Consultation on Medical Devices and In Vitro Diagnostics Regulations"},"content":{"rendered":"<p data-pm-slice=\"1 1 []\"><strong>The European Commission<\/strong> has launched a<strong> public consultation<\/strong> to gather contributions on<strong> European regulations 2017\/745 (medical devices)<\/strong> and <strong>2017\/746 (in vitro diagnostic medical devices)<\/strong>. This process aims to assess the effectiveness of the rules currently in place and identify possible areas for improvement.<\/p>\n<h3>Objectives of the Regulations<\/h3>\n<p data-pm-slice=\"1 1 []\">The main objective of the regulations on medical devices and in vitro diagnostics is to ensure that <strong>only safe and effective devices are made available on the market<\/strong>.<\/p>\n<p data-pm-slice=\"1 1 []\">In this way, the Commission aims to protect public health and patient safety, while promoting the competitiveness of the sector and supporting technological innovation.<\/p>\n<h3 data-pm-slice=\"1 1 []\"><strong>Purpose of the Public Consultation<\/strong><\/h3>\n<p data-pm-slice=\"1 1 []\">Participants can help<strong> identify gaps<\/strong> in the current rules and<strong> suggest improvements<\/strong> to ensure that the regulations are achieving their objectives effectively.<\/p>\n<p data-pm-slice=\"1 1 []\">This process also aims to assess the administrative costs and benefits for patients and healthcare professionals.<\/p>\n<p>&nbsp;<\/p>\n<h3 data-pm-slice=\"1 1 []\"><strong>Evaluation of the Efficiency and Impact of the Rules<\/strong><\/h3>\n<p data-pm-slice=\"1 1 []\">The evaluation taking place in this consultation will help the European Commission to take stock of the existing rules,<strong> analyzing their effectiveness and impact on the sector<\/strong>.<\/p>\n<p data-pm-slice=\"1 1 []\">It will evaluate, among other things, the effects of these rules on the supply of medical devices, including so-called \u201corphan devices\u201d, and on encouraging the development of new innovative devices.<\/p>\n<p>&nbsp;<\/p>\n<h3 data-pm-slice=\"1 1 []\"><strong>How to participate?<\/strong><\/h3>\n<p data-pm-slice=\"1 1 []\">Interested parties can submit their contributions until<strong> March 21, 2025<\/strong>.<\/p>\n<p data-pm-slice=\"1 1 []\">Comments and contributions can be submitted via the online platform available on the <strong><a href=\"https:\/\/ec.europa.eu\/info\/law\/better-regulation\/have-your-say\/initiatives\/14155-Regras-da-UE-em-materia-de-dispositivos-medicos-e-de-dispositivos-medicos-para-diagnostico-in-vitro-avaliacao-especifica_pt\">European Commission&#8217;s website<\/a><\/strong>.<\/p>\n<p>&nbsp;<\/p>\n<p>For more information about<a href=\"https:\/\/els-solutions.com\/en\/?page_id=6457\"><strong> medical devices<\/strong><\/a>, <strong>ELS can help<\/strong>.<\/p>\n<p>Please\u00a0<strong><a href=\"https:\/\/els-solutions.com\/onde-estamos\/\">contact<\/a> <\/strong>your local ELS consultant or email:<strong> info@elssolutions.pt<\/strong><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The European Commission has launched a public consultation on medical device regulations. Participate by March 21, 2025, and contribute to their evaluation.<\/p>\n","protected":false},"author":9,"featured_media":7983,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_joinchat":[],"footnotes":""},"categories":[93,67,68,91,129,54,122],"tags":[148,97,123],"class_list":["post-7980","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-consultation","category-els","category-els-group","category-eu","category-european-union","category-general","category-medical-devices","tag-consultation","tag-eu","tag-medical-devices"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Public Consultation on EU Medical Device Regulations<\/title>\n<meta name=\"description\" content=\"The European Commission has launched a public consultation on medical device regulations. 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