{"id":14681,"date":"2022-06-27T15:29:46","date_gmt":"2022-06-27T13:29:46","guid":{"rendered":"https:\/\/www.laffineur.com\/public-health-new-rules-on-in-vitro-diagnostic-medical-devices-ivdr-enter-into-force\/"},"modified":"2022-06-27T15:29:50","modified_gmt":"2022-06-27T13:29:50","slug":"public-health-new-rules-on-in-vitro-diagnostic-medical-devices-ivdr-enter-into-force","status":"publish","type":"post","link":"https:\/\/www.laffineur.com\/en\/public-health-new-rules-on-in-vitro-diagnostic-medical-devices-ivdr-enter-into-force\/","title":{"rendered":"Public health: New rules on in vitro diagnostic medical devices (IVDR) enter into force"},"content":{"rendered":"<p>As of May 26, 2022, new rules embedded in Regulation 2017\/746 on in vitro diagnostic medical devices (IVDR) have entered into force. <br \/>The new rules aim to : <br \/>\u2022 improve the quality, safety, and reliability of IVDR devices through a risk-based classification system<br \/>\u2022 strengthen transparency and information for patients, so that pertinent information is more easily found. <br \/>\u2022 enhance vigilance and market surveillance: once devices are available on the market, manufacturers will collect data about device performance. EU Member States will coordinate their vigilance and market surveillance actions. <br \/>This new Regulation replaces older Directive 98\/79\/EC and supports the regulatory framework for medical tests. This Regulation will be implemented gradually with transition periods that vary and depend on the risk level of each device. This Regulation complements the Regulation 2017\/745 on medical devices. Nearly 70% of clinical decisions are made using IVDR.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>As of May 26, 2022, new rules embedded in Regulation 2017\/746 on in vitro diagnostic medical devices (IVDR) have entered into force. The new rules aim to : \u2022 improve the quality, safety, and reliability of IVDR devices through a risk-based classification system\u2022 strengthen transparency and information for patients, so that pertinent information is more [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[151],"tags":[],"class_list":["post-14681","post","type-post","status-publish","format-standard","hentry","category-european-law"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Public health: New rules on in vitro diagnostic medical devices (IVDR) enter into force - Laffineur - Cabinet d&#039;avocats<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.laffineur.com\/en\/public-health-new-rules-on-in-vitro-diagnostic-medical-devices-ivdr-enter-into-force\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Public health: New rules on in vitro diagnostic medical devices (IVDR) enter into force - Laffineur - Cabinet d&#039;avocats\" \/>\n<meta property=\"og:description\" content=\"As of May 26, 2022, new rules embedded in Regulation 2017\/746 on in vitro diagnostic medical devices (IVDR) have entered into force. 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