{"id":6851,"date":"2025-01-26T12:16:25","date_gmt":"2025-01-26T11:16:25","guid":{"rendered":"https:\/\/darkgreen-crane-601020.hostingersite.com\/rek-kulmu\/clinical-investigations-of-in-vitro-diagnostic-medical-devices-ivdr\/"},"modified":"2025-07-01T13:38:53","modified_gmt":"2025-07-01T11:38:53","slug":"clinical-investigations-of-in-vitro-diagnostic-medical-devices-ivdr","status":"publish","type":"page","link":"https:\/\/rekportalen.no\/en\/rek-kulmu\/clinical-investigations-of-in-vitro-diagnostic-medical-devices-ivdr\/","title":{"rendered":"Clinical investigations of in vitro diagnostic medical devices (IVDR)"},"content":{"rendered":"<h2>Reserach ethics assessment of clinical investigations of in vitro diagnostic medical devices (IVDR)<\/h2>\n<p>The EU regulations for in vitro-diagnostic medical devices (<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32017R0746&amp;from=EN\">In Vitro Diagnostic Medical Device Regulation 2017\/746<\/a>), IVDR entered into force on 26 May 2022.<\/p>\n<p>Applications for performance studies that fall within the scope of IVDR are now processed according to IVDR and associated regulations.<\/p>\n<p>On behalf of the ethics authorities, REK KULMU carries out a research ethics assessment of applications that fall within the scope of IVDR.<\/p>\n<p><span data-contrast=\"auto\">Until<\/span><span data-contrast=\"auto\"> further clarifications from the EU, all performance studies <\/span><span data-contrast=\"auto\">regulated by<\/span><span data-contrast=\"auto\"> IVDR <\/span><span data-contrast=\"auto\">a<\/span><span data-contrast=\"auto\">rticle 58(1), 58(2), or 70 <\/span><span data-contrast=\"auto\">must apply for approval by<\/span><span data-contrast=\"auto\"> REK KULMU. This includes studies of <\/span><span data-contrast=\"auto\">IVD<\/span><span data-contrast=\"auto\"> for companion diagnostics (<\/span><span data-contrast=\"auto\">CDx<\/span><span data-contrast=\"auto\"> performance studies) where only leftover samples of biological material are to be used.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">For performance studies not <\/span><span data-contrast=\"auto\">regulated<\/span><span data-contrast=\"auto\"> by IVDR <\/span><span data-contrast=\"auto\">a<\/span><span data-contrast=\"auto\">rticle 58(1), 58(2), or 70, the general requirements of IVDR <\/span><span data-contrast=\"auto\">a<\/span><span data-contrast=\"auto\">rticle 57 apply. <\/span><span data-contrast=\"auto\">The assessment of performance studies under <\/span><span data-contrast=\"auto\">a<\/span><span data-contrast=\"auto\">rticle 57 will be carried out by the regional RECs according to the Health Research Act. <\/span><span data-contrast=\"auto\">Please be<\/span><span data-contrast=\"auto\"> aware that <\/span><span data-contrast=\"auto\">a<\/span><span data-contrast=\"auto\">rticle 57 studies should be submitted in accordance with the application deadlines of the regional <\/span><span data-contrast=\"auto\">RECs.<\/span><span data-contrast=\"auto\"> The checkbox for medical devices in the REK application form (section 1.10) should not be selected, but <\/span><span data-contrast=\"auto\">make sure to<\/span><span data-contrast=\"auto\"> clearly describe in the application if IVDR <\/span><span data-contrast=\"auto\">a<\/span><span data-contrast=\"auto\">rticle 57<\/span><span data-contrast=\"auto\"> applies<\/span><span data-contrast=\"auto\">.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Resource pages IVDR:<\/strong><\/p>\n<ul>\n<li><a href=\"https:\/\/www.dmp.no\/medisinsk-utstyr\">NoMA&#8217;s website<\/a><\/li>\n<li><a href=\"https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations\/guidance-mdcg-endorsed-documents-and-other-guidance_en\">Guidance documents<\/a> from MDCG; medical device coordination group<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Reserach ethics assessment of clinical investigations of in vitro diagnostic medical devices (IVDR) The EU regulations for in vitro-diagnostic medical devices (In Vitro Diagnostic Medical Device Regulation 2017\/746), IVDR entered into force on 26 May 2022. Applications for performance studies that fall within the scope of IVDR are now processed according to IVDR and associated [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"parent":5868,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_cn_metabox_post_checkbox_dont_send_once":false,"_cn_metabox_post_checkbox_dont_send_ever":false,"inline_featured_image":false,"footnotes":""},"categories":[62],"tags":[],"class_list":["post-6851","page","type-page","status-publish","hentry","category-rek-kulmu-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Clinical investigations of in vitro diagnostic medical devices (IVDR) - Rekportalen<\/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:\/\/rekportalen.no\/en\/rek-kulmu\/clinical-investigations-of-in-vitro-diagnostic-medical-devices-ivdr\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Clinical investigations of in vitro diagnostic medical devices (IVDR) - Rekportalen\" \/>\n<meta property=\"og:description\" content=\"Reserach ethics assessment of clinical investigations of in vitro diagnostic medical devices (IVDR) The EU regulations for in vitro-diagnostic medical devices (In Vitro Diagnostic Medical Device Regulation 2017\/746), IVDR entered into force on 26 May 2022. 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