{"id":14418,"date":"2020-04-24T18:26:49","date_gmt":"2020-04-24T16:26:49","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=14418"},"modified":"2020-04-24T18:26:49","modified_gmt":"2020-04-24T16:26:49","slug":"mdr-the-postponement-to-2021-is-official-the-proposal-has-been-published-in-the-official-journal-eu","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2020\/04\/24\/mdr-the-postponement-to-2021-is-official-the-proposal-has-been-published-in-the-official-journal-eu\/","title":{"rendered":"MDR (EU) 2017\/745: the postponement to 2021 is official. The proposal has been published in the Official Journal of the EU"},"content":{"rendered":"\n<p>After the vote of the\nEuropean Parliament and the European Council, the <strong>postponement<\/strong> of the\nnew regulation on medical devices <strong>MDR (EU) 2017\/745<\/strong> is <strong>official <\/strong>until\n<strong>May 26, 2021<\/strong>.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/04\/blog-rinvio-ufficiale-mdr-2-1024x535.png\" alt=\"MDR (EU) 2017\/745: the postponement to 2021 is official. The proposal has been published in the Official Journal of the EU\" class=\"wp-image-14414\"\/><figcaption>MDR (EU) 2017\/745: the postponement to 2021 is official. <br>The proposal has been published in the Official Journal of the EU<\/figcaption><\/figure>\n\n\n\n<p>On April 24, 2020,\nthe proposal, which had been submitted by the European Commission, was\npublished in the Official Journal of the European Union.<\/p>\n\n\n\n<p>Stella Kyriakides,\nCommissioner for Health and Food Safety, said: \u201cYesterday&#8217;s adoption will allow\nus all, in this time of crisis, to maintain our focus on the most critical\nissues and to ensure the continued availability of vitally important medical\ndevices. This is clear proof of our ongoing determination to tackle the\npandemic through all possible means, while always maintaining the safety of\npatients as our utmost objective. I thank the Parliament and Council for the\nrecord time approval, cooperation and efficient handling of this urgent\nproposal.\u201d<\/p>\n\n\n\n<p>The health emergency caused by COVID-19 leads to an increase in the demand for some medical devices. For this reason, it\u2019s essential to avoid further difficulties or risks of potential limitations of these devices, or delays in making them available.<br>The adopted amendment therefore postpones the application of MDR (EU) 2017\/745 by one year, until 26 May 2021, to allow authorities and Manufacturers alike to prioritise the fight against the coronavirus pandemic by continuing under current procedures.<\/p>\n\n\n\n<p>The present adoption\nwill not have impact on the date of application of the In Vitro Diagnostics\nMedical Devices Regulation IVDR (UE) 2017\/746 (IVDR), which becomes applicable\nfrom 26 May 2022.<\/p>\n\n\n\n<p>Although the MDR can\nbe postponed by one year, the requirements to be applied are a lot. For this\nreason, Thema experts propose a rapid and effective solution:&nbsp;<strong>MDR\nEmergency Kit<\/strong>, a kind of \u201cS.O.S toolbox\u201d in digital format, to solve a\npossible situation in the most rapid way.<\/p>\n\n\n\n<p><strong>It is already\npossible to book the MDR Emergency Kit. Contact us as soon as&nbsp;possible!<\/strong><\/p>\n\n\n\n<p>Thema Staff: phone.\n0542 643496 \/&nbsp;<a href=\"mailto:sales@thema-group.it\">sales@thema-group.it<\/a><\/p>\n\n\n\n<p><em>Sources:<\/em> <\/p>\n\n\n\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32020R0561&amp;from=IT\">https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32020R0561&amp;from=IT<\/a>   <\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/IP_20_718\">https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/IP_20_718<\/a> <\/p>\n","protected":false},"excerpt":{"rendered":"<p>After the vote of the European Parliament and the European Council, the postponement of the new regulation on medical devices MDR  [&#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-14418","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 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>MDR (EU) 2017\/745: the postponement to 2021 is official. 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