{"id":14020,"date":"2020-03-30T16:16:23","date_gmt":"2020-03-30T14:16:23","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=14020"},"modified":"2020-03-30T16:16:23","modified_gmt":"2020-03-30T14:16:23","slug":"covid-19-emergency-brings-european-commission-to-propose-mdr-application-delay","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2020\/03\/30\/covid-19-emergency-brings-european-commission-to-propose-mdr-application-delay\/","title":{"rendered":"COVID-19 emergency brings European Commission to propose MDR application delay"},"content":{"rendered":"\n<p>Because of the <strong>Covid-19 sanitary emergency,<\/strong> the European Commission proposed to delay the <strong>application date of the MDR (UE) 2017\/745<\/strong> by one year, cancelling the expected date of May 26, 2020 and <strong>postponing it to May 26, 2021<\/strong>.\u00a0 <\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/03\/CE-proposta-rinvio-MDR-1024x535.png\" alt=\"COVID-19 European Commission propose MDR application delay\" class=\"wp-image-14017\"\/><figcaption>COVID-19 emergency brings European Commission to propose MDR application delay<\/figcaption><\/figure>\n\n\n\n<p>The UE spokesman\nStefan de Keersmaecker declared the Commission is working hard to submit this\nproposal at the beginning of April, asking to the European Parliament and\nEuropean Council to approve it quickly before the end of the month. <\/p>\n\n\n\n<p>In the published online declaration, the European Commission explains that the request is aimed to relieve\npressure on Competent Authorities, Notified Bodies, manufacturers and the other\noperators to let them focus on the urgent priorities related to the Coronavirus\ncrisis.<\/p>\n\n\n\n<p>For further confirmation of the need to delay, six members of the\nEuropean Parliament wrote a letter to the President of the European Commission Ursula\nvon der Leyen and to the Commissioner Stella Kyriakides to explain that low\nresource are now available to grant the MDR actuation. They propose to keep the\ncurrent regulatory system and to postpone the date of implementation of the MDR\nto concentrate on the Covid-19 emergency.<\/p>\n\n\n\n<p>It is not clear what <em>\u201c<strong>postponing the application date of the MDR by one year\u201d<\/strong><\/em> means yet. Perhaps all expected dates move forward for one year, or just the application date is delayed with no changes of other deadlines. <\/p>\n\n\n\n<p>Only in case of acceptance of the new proposal by the European\nParliament and the European Council, new details and procedures will be\ndefined. <\/p>\n\n\n\n<p>At the moment the <strong>in-vitro diagnostic medical device field is not involved by the European Commission proposal<\/strong>: the expected application date remains May 26, 2022. <\/p>\n\n\n\n<p>Also, it is relevant the<strong> U.S.A. petition<\/strong> asking for a 3-year delay for the MDR and IVDR implementation.<br>In case of denial, the US proposes at least to allow putting into the market the legacy devices until 2024, because they can be considered safe and to let the Notified Bodies give priority to devices requiring a brand new certification.\u00a0 <\/p>\n\n\n\n<p><em>Source: <\/em> <br><a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/docs\/20200325_news_md_en.pdf\">https:\/\/ec.europa.eu\/health\/sites\/health\/files\/docs\/20200325_news_md_en.pdf<\/a> <\/p>\n","protected":false},"excerpt":{"rendered":"<p>Because of the Covid-19 sanitary emergency, the European Commission proposed to delay the application date of the MDR (UE) 2017\/745 by  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[679],"tags":[],"class_list":["post-14020","post","type-post","status-publish","format-standard","hentry","category-blog-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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