Regulatory clarification
It is the sponsor’s responsibility to determine whether the performance study is covered by the IVDR; whether it requires an application to REK KULMU or regional REK; and whether it requires an application or notification to NOMA. The sponsor must therefore familiarise itself with the relevant information available on NOMA’s website.
Before submitting an application through the REK-portal, it must be established whether the performance study requires an application to REK KULMU or regional REK.
Please contact NOMA if further regulatory guidance is required.
Applications for performance studies to REK KULMU – IVDR Article 58 (1), 58 (2) or 70
Applications for prior approval must be submitted through the Medical devices (MDR/IVDR) application form (Medisinsk utstyr (MDR/IVDR)) in the REK-portal for assessment by REK KULMU.
Applications are processed on an ongoing basis by REK KULMU, which endeavours to comply with the deadlines set out in the Regulation.
The following documents must be enclosed with an application to REK KULMU:
- 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 Performance Study Plan (CPSP) 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.
Performance studies covered by IVDR Article 58 (2)
Where the device is intended for companion diagnostics (CDx), and only leftover biological material is to be used, the performance study requires an application to REK KULMU. This is conditional upon the biological material still being located and/or collected in Norway or there are related research activities taking place in Norway.
An exemption from the application requirement may apply if the leftover biological material has already been sent abroad for analyses before it is decided that the material will be used for further research. In such cases, the assessment of the performance study falls outside REK KULMU’s mandate. Please note that any use of biological material is limited to the purposes for which the participants have provided consent.
Applications for performance studies to regional REK – IVDR Article 57
For performance studies not covered by Article 58 (1), 58 (2) or 70 of the IVDR, the general requirements in Article 57 of the IVDR apply. Performance studies covered only by Article 57 must be assessed by regional REK under the Health Research Act. Please note the applicable application deadlines for regional REK.
For these applications, the Project application form in the REK-portal must be used. In sections 1.11 and 1.11.1 of the application form, indicate that the study concerns testing of a medical device under the IVDR. In addition, the application should clearly state that the study is covered by Article 57 of the IVDR.
Updated 23.09.2026
