{"id":4020,"date":"2021-11-04T10:24:05","date_gmt":"2021-11-04T09:24:05","guid":{"rendered":"https:\/\/www.universalmedica.com\/?p=4020"},"modified":"2021-11-04T10:35:16","modified_gmt":"2021-11-04T09:35:16","slug":"new-incoming-regulation-update-in-vitro-diagnostic-regulation-ivdr-2022","status":"publish","type":"post","link":"https:\/\/www.universalmedica.com\/en\/new-incoming-regulation-update-in-vitro-diagnostic-regulation-ivdr-2022\/","title":{"rendered":"New incoming regulation update: In Vitro Diagnostic Regulation (IVDR) 2022"},"content":{"rendered":"<p>After a five year-long transition period, <strong>the IVDD <\/strong>(In Vitro Diagnostic Directive)<strong> will be replaced by the IVDR <\/strong>(In Vitro Diagnostic Regulation) on 26<sup>th<\/sup> May 2022<strong> and will apply to all in vitro diagnostic devices marketed in EU Member States.\u00a0 <\/strong><\/p>\n<p>The IVDR has the same basic requirements as the IVDD, but with some important improvements to modernise the current system. Compared to the IVDD, the IVDR is more rigorous, particularly with regard to risk classes and monitoring by Notified Bodies.<\/p>\n<p>The new In Vitro Diagnostic Regulation aimed to ensure consistent and high level of patient safety throughout the EU member states.<\/p>\n<p><img fetchpriority=\"high\" decoding=\"async\" class=\" wp-image-4021 aligncenter\" src=\"https:\/\/www.universalmedica.com\/wp-content\/uploads\/2021\/11\/Post-LinkedIn-UMUMG-19-300x157.jpg\" alt=\"\" width=\"929\" height=\"486\" srcset=\"https:\/\/www.universalmedica.com\/wp-content\/uploads\/2021\/11\/Post-LinkedIn-UMUMG-19-300x157.jpg 300w, https:\/\/www.universalmedica.com\/wp-content\/uploads\/2021\/11\/Post-LinkedIn-UMUMG-19-1024x536.jpg 1024w, https:\/\/www.universalmedica.com\/wp-content\/uploads\/2021\/11\/Post-LinkedIn-UMUMG-19-768x402.jpg 768w, https:\/\/www.universalmedica.com\/wp-content\/uploads\/2021\/11\/Post-LinkedIn-UMUMG-19.jpg 1200w\" sizes=\"(max-width: 929px) 100vw, 929px\" \/><\/p>\n<p>As we are near to the end of IVDR transition period, it is important to be in compliance with the IVDR.\u00a0 <a href=\"https:\/\/www.universalmedica.com\/en\/contact\/\">Contact<\/a> our expert today to find out more about IVDR and how you can implement it in your company.<\/p>\n<p><strong>Latest update &#8211;<\/strong> The European Union recently proposed to delay\u00a0the deadline of IVDR transition period for certain activities due to COVID backlog. The proposal will now go to the European Parliament and Council for approval.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>After a five year-long transition period, the IVDD (In Vitro Diagnostic Directive) will be replaced by the IVDR (In Vitro Diagnostic Regulation) on 26th May 2022 and will apply to all in vitro diagnostic devices marketed in EU Member States.\u00a0 The IVDR has the same basic requirements as the IVDD, but with some important improvements [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":4016,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[143,142,137],"tags":[],"class_list":["post-4020","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-compliance","category-materiovigilance-en","category-pharmacovigilance-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - 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