{"id":4254,"date":"2022-09-27T05:18:00","date_gmt":"2022-09-27T05:18:00","guid":{"rendered":"https:\/\/www.vistaar.ai\/?p=4254"},"modified":"2025-11-21T11:32:11","modified_gmt":"2025-11-21T11:32:11","slug":"medical-devices-usa-europe-regulatory-updates-roundup-august-2022","status":"publish","type":"post","link":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/medical-devices-usa-europe-regulatory-updates-roundup-august-2022\/","title":{"rendered":"Medical Devices\u2013USA\/Europe Regulatory Updates Roundup, August 2022"},"content":{"rendered":"\n<span id=\"europe\"><\/span><br><br>\n<h3 style=\"background:#e2e2e2;padding:12px;\">EUROPE<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>MDCG 2022-14 \u2013 Transition to the MDR and IVDR \u2013 Notified body capacity and availability of medical devices and IVDs<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017\/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure (CECP)<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This scientific opinion reflects the views of independent experts (MDR Article 106) on the clinical evaluation assessment report (CEAR) of the notified body. The advice is provided in the context of the clinical evaluation consultation procedure (CECP), which is an additional element of conformity assessment by notified bodies for specific high-risk devices (MDR Article 54 and Annex IX, section 5.1).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>MDCG 2022-13 \u2013 Designation, re-assessment and notification of conformity assessment bodies and notified bodies<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The guidance is designed to bring consistency and to align the working practices of the different designating authorities in the Member States, regarding the assessment, designation, notification and re-assessment of CABs and NBs. The processes for assessment, designation and notification are established by Articles 38 to 42 of Regulation (EU) 2017\/745 and Articles 34 to 38 of Regulation (EU) 2017\/746, the in vitro Diagnostic Medical Devices Regulation \u2013 IVDR).<\/p>\n\n\n\n<span id=\"ireland\"><\/span><br><br>\n<h3 style=\"background:#e2e2e2;padding:12px;\">IRELAND (HPRA)<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>European Commission launches public consultation \u2013 reclassification of certain active products (including aesthetic products) without a medical purpose<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The European Commission is inviting stakeholders to give their feedback on a draft implementing regulation laying down the rules for the reclassification of certain active products without a medical purpose. The consultation opened on 11 August 2022 and will run until 08 September 2022 (midnight Brussels time) and is available on the Commission\u2019s webpage.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>European Commission publishes call for European Union Reference Laboratories for IVDs designation<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The European Commission has opened its call for Member States to submit applications on behalf of candidate EU Reference Laboratories for IVDs (EURLs). EURLs will play an important role in batch testing and verifying the performance of high-risk (Class D) in vitro diagnostic medical devices (IVDs).<\/p>\n\n\n\n<span id=\"usa\"><\/span><br><br>\n<h3 style=\"background:#e2e2e2;padding:12px;\">USA (FDA)<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This guidance document identifies applicable legal requirements under the Federal Food, Drug, and Cosmetic Act (the FD&amp;C Act) for hearing aids and for personal sound amplification products (PSAPs).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">FDA released an revised guidance on the \u201cReplacement Reagent and Instrument Family Policy\u201d for in vitro diagnostic (IVD) devices.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This guidance is designed to update and provide clarity on the Replacement Reagent and Instrument Family Policy for manufacturers of IVD devices and FDA staff to promote consistent application of the concepts in this guidance.<\/p>\n\n\n\n<span id=\"canada\"><\/span><br><br>\n<h3 style=\"background:#e2e2e2;padding:12px;\">CANADA (HC)<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Health Canada will continue to issue electronic manufacturer\u2019s certificate to export<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Health Canada launched a pilot project to implement an electronic version of the manufacturer\u2019s certificate to export (eMCE). The intent is to replace the paper-based process once the project is complete.<\/p>\n\n\n\n<span id=\"new-zland\"><\/span><br><br>\n<h3 style=\"background:#e2e2e2;padding:12px;\">NEW ZEALAND (MEDSAFE)<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Updated Changed Notification Form A<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">MEDSAFE has revised 4 forms related to Medical Devices adverse events and Quality incidents.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>EUROPE MDCG 2022-14 \u2013 Transition to the MDR and IVDR \u2013 Notified body capacity and availability of medical devices and IVDs The document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017\/745. The MDCG is composed of representatives of all Member States and it is chaired [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1877,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[645],"tags":[],"class_list":["post-4254","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\r\n<title>Medical Devices\u2013USA\/Europe Regulatory Updates Roundup, August 2022 - Vistaar<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/medical-devices-usa-europe-regulatory-updates-roundup-august-2022\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:title\" content=\"Medical Devices\u2013USA\/Europe Regulatory Updates Roundup, August 2022 - Vistaar\" \/>\r\n<meta property=\"og:description\" content=\"EUROPE MDCG 2022-14 \u2013 Transition to the MDR and IVDR \u2013 Notified body capacity and availability of medical devices and IVDs The document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017\/745. 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