{"id":6846,"date":"2025-04-04T12:22:10","date_gmt":"2025-04-04T10:22:10","guid":{"rendered":"https:\/\/darkgreen-crane-601020.hostingersite.com\/rek-kulmu\/clinical-investigations-of-medical-devices-mdr\/application-to-rek-for-mdr-studies\/"},"modified":"2026-06-04T13:15:20","modified_gmt":"2026-06-04T11:15:20","slug":"application-to-rek-for-mdr-studies","status":"publish","type":"page","link":"https:\/\/rekportalen.no\/en\/rek-kulmu\/clinical-investigations-of-medical-devices-mdr\/application-to-rek-for-mdr-studies\/","title":{"rendered":"Application to REK for MDR studies"},"content":{"rendered":"<p>Applications for studies regulated by MDR are submitted as ordinary project applications in the <a href=\"https:\/\/rekportalen.no\/en\/\">REK portal<\/a> and are processed regularly by REK KULMU, outside of REK&#8217;s ordinary committee meetings.<br \/>\nIn the application to REK KULMU, documents relevant for the research ethics assessment must be attached:<\/p>\n<ul>\n<li>CV of the principal investigator at all trial sites in Norway<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li>All participating study centers must be added to the REK-portal as collaborating organizations<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li>A clinical investigation plan (MDR) (indicated as \u201cresearch protocol\u201d in the REK application form)<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li>Informed Consent Form(s) (ICF) in Norwegian, REK\u2019s template for informed consent should be used, see the <a href=\"https:\/\/rekportalen.no\/en\/rek-kulmu\/information-forms-ctr-mdr-ivdr\/templates-rek-kulmu\/\">REK portal<\/a><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li>Recruitment material (if relevant)<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li>Questionnaire(s) (if relevant)<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<ul>\n<li>Any statement from NoMA that may be relevant to REK\u2019s application<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>REK may request additional documents and information.<\/p>\n<p>&nbsp;<\/p>\n<p>Please be aware that the help texts in the REK-application form is not updated in relation to role assignments for MDR applications. The role \u201cProject Manager (prosjektleder)\u201d may be hold by the principal investigator, sponsor\u2019s representant or CRO. Please note that if the project manager is not to be regarded as a sponsor\u2019s representative, a sponsor\u2019s representative should be added as a co-user (Medbruker) to obtain writing- and reading access to the application.<\/p>\n<p>&nbsp;<\/p>\n<p>Please contact the REK secretariat for questions regarding roles in the REK-portal.<\/p>\n<p>&nbsp;<\/p>\n<p><em>Applications, software and artificial intelligence could also be medical devices<\/em><br \/>\nPlease be aware that applications and software, including artificial intelligence, can be defined as medical device, cf. article 2 (1) in the respective MDR. Please see the <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2021-03\/md_mdcg_2021_mdsw_en_0.pdf\">flowchart <\/a>and <a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/37581?locale=en\">guide <\/a>for more information and contact <a href=\"https:\/\/www.dmp.no\/medisinsk-utstyr\">the relevant unit at NoMA<\/a> for any further guidance.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Applications for studies regulated by MDR are submitted as ordinary project applications in the REK portal and are processed regularly by REK KULMU, outside of REK&#8217;s ordinary committee meetings. In the application to REK KULMU, documents relevant for the research ethics assessment must be attached: CV of the principal investigator at all trial sites in [&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-6846","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>Application to REK for MDR 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\/application-to-rek-for-mdr-studies\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Application to REK for MDR studies - Rekportalen\" \/>\n<meta property=\"og:description\" content=\"Applications for studies regulated by MDR are submitted as ordinary project applications in the REK portal and are processed regularly by REK KULMU, outside of REK&#8217;s ordinary committee meetings. 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