Application for ethical assessment of clinical investigations under the MDR
An application for prior approval of a clinical investigation covered by the MDR must be submitted through the Medical devices (MDR/IVDR) application form (Medisinsk utstyr (MDR/IVDR)) in the REK-portal. Applications are processed on an ongoing basis by REK KULMU, which endeavours to comply with the deadlines set out in the Regulation.
- CVs for the investigators at all study sites in Norway
- All participating study sites must be registered in the REK-portal as collaborating institutions
- Clinical Investigation Plan (CIP) or study protocol
- Informed consent form in Norwegian. It is recommended to use REK KULMU’s template for informed consent form(s); see rekportalen.no
- Recruitment materials, where relevant
- Questionnaires, where relevant
- Any statement from NOMA (DMP) that may be relevant to REK’s assessment
Applicants will be asked to remove other documents from the REK-portal. However, REK KULMU may request additional documents and information where necessary.
An application that is to be submitted or notified to both NOMA and REK KULMU must be submitted to both authorities on the same day. It is the sponsor’s responsibility to ensure that the DMP and REK KULMU have access to identical versions of all documents that are to be submitted to both authorities.
Regulatory clarification
It is the sponsor’s responsibility to determine whether the clinical investigation is covered by the MDR and whether it requires an application or notification to NOMA. The sponsor must therefore get to know the relevant information published on NOMA’s website.
Before submitting an application through the REK-portal, it must be established that the clinical investigation falls within the scope of the MDR and requires an application to REK KULMU.
Please contact NOMA if regulatory guidance is required.
Applications, software and artificial intelligence may constitute medical devices
Please note that applications and software, including artificial intelligence, may be defined as medical devices pursuant to Article 2(1) of the MDR. Please consult the flowchart and guidance document for further information, and contact NOMA for additional guidance where relevant.
Updated 17.09.2026
