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’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 Norway
- All participating study centers must be added to the REK-portal as collaborating organizations
- A clinical investigation plan (MDR) (indicated as “research protocol” in the REK application form)
- Informed consent form(s) (ICF) in Norwegian, REK’s template for informed consent should be used, see the REK portal
- Recruitment material (if relevant)
- Questionnaire(s) (if relevant)
- User manual of the medical device is to be administered by the study participant
- Any statement from NoMA that may be relevant to REK’s application
REK may request additional documents and information.
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 “Project Manager (prosjektleder)” may be hold by the principal investigator, sponsor’s representant or CRO. Please note that if the project manager is not to be regarded as a sponsor’s representative, a sponsor’s representative should be added as a co-user (Medbruker) to obtain writing- and reading access to the application.
Please contact the REK secretariat for questions regarding roles in the REK-portal.
Applications, software and artificial intelligence could also be medical devices
Please 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 flowchart and guide for more information and contact the relevant unit at NoMA for any further guidance.
