{"id":6856,"date":"2025-04-04T14:23:17","date_gmt":"2025-04-04T12:23:17","guid":{"rendered":"https:\/\/darkgreen-crane-601020.hostingersite.com\/rek-kulmu\/clinical-investigations-of-medical-devices-mdr\/combination-trials\/"},"modified":"2026-09-17T15:33:52","modified_gmt":"2026-09-17T13:33:52","slug":"combination-trials","status":"publish","type":"page","link":"https:\/\/rekportalen.no\/en\/rek-kulmu\/clinical-investigations-of-medical-devices-mdr\/combination-trials\/","title":{"rendered":"Combination studies"},"content":{"rendered":"<h3><strong>Combination studies involving clinical trials of medicinal products and clinical investigations of medical devices<\/strong><\/h3>\n<p>If a clinical investigation includes a clinical trial of a medicinal product under the Clinical Trials Regulation (CTR), in parallel with a clinical investigation of a medical device, two separate applications must be submitted to REK KULMU.<\/p>\n<p>The clinical trial of the medicinal product must be submitted under the CTR through the Clinical Trials Information System (<a href=\"https:\/\/euclinicaltrials.eu\/ctis-for-sponsors\/\">CTIS<\/a>) and will be assessed by NOMA (DMP) and REK KULMU.<\/p>\n<p>The application for the clinical investigation of the medical device under the MDR must be submitted to the REK-portal, using the <em>Medical devices (MDR\/IVDR) <\/em>application form (Medisinsk utstyr (MDR\/IVDR)). The clinical investigation may also require an application or notification to NOMA; please see NOMA\u2019s website for further information.<\/p>\n<p>Both studies may be described in one combined informed consent form, or two separate informed consent forms may be prepared. In both cases, it must be clearly stated what participation in each study entails. Please consult REK KULMU\u2019s templates for informed consent forms for further guidance or contact REK KULMU.<\/p>\n<p>&nbsp;<\/p>\n<p><em>Updated 17.09.2026<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Combination studies involving clinical trials of medicinal products and clinical investigations of medical devices If a clinical investigation includes a clinical trial of a medicinal product under the Clinical Trials Regulation (CTR), in parallel with a clinical investigation of a medical device, two separate applications must be submitted to REK KULMU. The clinical trial of [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"parent":6845,"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-6856","page","type-page","status-publish","hentry","category-rek-kulmu-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Combination studies - 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-medical-devices-mdr\/combination-trials\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Combination studies - Rekportalen\" \/>\n<meta property=\"og:description\" content=\"Combination studies involving clinical trials of medicinal products and clinical investigations of medical devices If a clinical investigation includes a clinical trial of a medicinal product under the Clinical Trials Regulation (CTR), in parallel with a clinical investigation of a medical device, two separate applications must be submitted to REK KULMU. 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