{"id":7279,"date":"2018-05-18T17:10:54","date_gmt":"2018-05-18T15:10:54","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=7279"},"modified":"2018-05-18T17:10:54","modified_gmt":"2018-05-18T15:10:54","slug":"what-does-the-entry-into-force-of-ivdr-2017746-entail-for-manufacturers-of-vitro-diagnostic-medical-devices","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2018\/05\/18\/what-does-the-entry-into-force-of-ivdr-2017746-entail-for-manufacturers-of-vitro-diagnostic-medical-devices\/","title":{"rendered":"What does the entry into force of IVDR 2017\/746 entail for manufacturers of in vitro diagnostic medical devices?"},"content":{"rendered":"<p>The complex process of developing IVDs could become difficult and take a long time for most device manufacturers. IVD manufacturers are invited to act on time in order to be in compliance with the entry into force of the new Regulation.<\/p>\n<p>Among the most important innovations, we can mention: changes to devices classification (many IVDs now in the residual category, therefore under self-declaration, will be subject to control by the Notified Body), obligation to establish a Responsible Person, execution of additional tests for the performance evaluation.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The complex process of developing IVDs could become difficult and take a long time for most device manufacturers. IVD manufacturers are  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","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":[892,1556],"tags":[],"class_list":["post-7279","post","type-post","status-publish","format-standard","hentry","category-faq-en","category-why-is-the-ce-marking-required"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>What does the entry into force of IVDR 2017\/746 entail for manufacturers of in vitro diagnostic medical devices? - Thema Med<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.thema-med.com\/en\/2018\/05\/18\/what-does-the-entry-into-force-of-ivdr-2017746-entail-for-manufacturers-of-vitro-diagnostic-medical-devices\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"What does the entry into force of IVDR 2017\/746 entail for manufacturers of in vitro diagnostic medical devices? - Thema Med\" \/>\n<meta property=\"og:description\" content=\"The complex process of developing IVDs could become difficult and take a long time for most device manufacturers. 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