{"id":16393,"date":"2020-10-22T11:08:51","date_gmt":"2020-10-22T09:08:51","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=16393"},"modified":"2023-01-24T14:59:05","modified_gmt":"2023-01-24T13:59:05","slug":"eu-companies-ask-postponement-ivdr-2017-746","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2020\/10\/22\/eu-companies-ask-postponement-ivdr-2017-746\/","title":{"rendered":"EU: companies ask the postponement of the IVDR (EU) 2017\/746"},"content":{"rendered":"\n<p>As already happened for the Medical Devices Regulation MDR (EU) 2017\/745, the European companies are mobilizing to request the <strong>postponement of the full application of the In Vitro Diagnostic Medical Devices Regulation IVDR (EU) 2017\/746 <\/strong>(scheduled for May 26, 2022), due to delays caused by the Covid-19 health emergency, also pointing out that <strong>the number of Notified Bodies<\/strong> is too <strong>limited<\/strong> for certifications.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/10\/ue-richieste-rinvio-ivdr-2017-746-1024x536.png\" alt=\"companies ask the postponement of the IVDR (EU) 2017\/746\" class=\"wp-image-16362\"\/><figcaption>Companies ask the postponement of the IVDR (EU) 2017\/746<\/figcaption><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>The reasons for the need to postpone the IVDR<\/strong><\/h2>\n\n\n\n<p><strong>Covid-19<\/strong> blocked progress in the\nimplementation of the Regulation and, in particular, it slowed down the\ncertification processes of the European Commission for the competent Notified\nBodies.<\/p>\n\n\n\n<p>The\noperators of the IVD industry expressed strong concern for times that they\nconsider too tight, as in order to be ready by May 2022, they should initiate <strong>applications for certification and\nauthorization of their products as early as 2021<\/strong>.<\/p>\n\n\n\n<p>For this reason, on July 9, 2020, <strong>MedTech Europe<\/strong>, European trade association representing the medical technology industries, from diagnosis to cure, published a document on which it urges the European Commission, Member States and the European Parliament to enact substantive solutions  as soon as possible for the <strong>postponement of deadlines<\/strong>.<\/p>\n\n\n\n<p>The IVDR (EU) 2017\/746 requires very stringent requirements and, by\npostponing its date of application, the pressure <strong>on manufacturers and suppliers<\/strong> which are currently at the forefront\nof the pandemic, could be alleviated.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Few Notified Bodies for IVDR certifications<\/strong><\/h2>\n\n\n\n<p>Currently, the\nEuropean Commission selected <strong>only four\nNotified Bodies<\/strong> appointed to IVDR certifications and checks are being\ncarried out to designate at least four other companies.<\/p>\n\n\n\n<p>Companies operating in the field of in Vitro Diagnostic Medical Devices stress\nfor the appointment of further Notified Bodies as soon as possible in order to\nbe able to plan the CE marking programme for their devices immediately. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>IVDR (EU) 2017\/746: how to prepare for the best<\/strong><\/h2>\n\n\n\n<p>The path to obtain the CE marking of devices and IVD in accordance with the regulation requires an in-depth analysis and a specific regulatory strategy. <br>Thema experts offer support to <strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/ce-certification-support\/\">obtain CE marking <\/a><\/strong>&nbsp;according to IVDR (EU) 2017\/746.<\/p>\n\n\n\n<p><a href=\"mailto:sales@thema-group.it\"><strong>CONTACT US<\/strong> <\/a>&nbsp;for more information and specialist advice.<\/p>\n\n\n\n<p>Discover all the main news of the <strong><a href=\"https:\/\/www.thema-med.com\/en\/regulation-ivdr-eu-2017-746-main-changes\/\">IVDR (EU) 2017\/746<\/a> <\/strong><\/p>\n\n\n\n<p>Source: <\/p>\n\n\n\n<p><a href=\"https:\/\/bit.ly\/33BhNpv\">MedTech Europe<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>As already happened for the Medical Devices Regulation MDR (EU) 2017\/745, the European companies are mobilizing to request the postponement of  [&#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":[2],"tags":[],"class_list":["post-16393","post","type-post","status-publish","format-standard","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EU: companies ask the postponement of the IVDR 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