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 the medicinal product must be submitted under the CTR through the Clinical Trials Information System (CTIS) and will be assessed by NOMA (DMP) and REK KULMU.
The application for the clinical investigation of the medical device under the MDR must be submitted to the REK-portal, using the Medical devices (MDR/IVDR) application form (Medisinsk utstyr (MDR/IVDR)). The clinical investigation may also require an application or notification to NOMA; please see NOMA’s website for further information.
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’s templates for informed consent forms for further guidance or contact REK KULMU.
Updated 17.09.2026
