Please see NOMA (DMP)’s website for information on modifications to clinical investigations under the MDR. In addition, Annex II to the European Commission’s guidance on clinical investigations provides information on what may be regarded as a substantial modification. It is the sponsor’s responsibility to assess whether a modification is substantial or non-substantial pursuant to Article 75 of the MDR.
Both substantial and non-substantial modifications must be submitted to REK KULMU through the REK-portal, using the Modification and/or inquiry form (Endring og/eller henvendelse). The application must state whether the modification(s) has been assessed as substantial or non-substantial.
A modification application that must 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 NOMA and REK KULMU have access to updated and identical documents at all times.
REK KULMU will assess the modification application within 38 days of receiving the application.
The modification application must be approved by REK KULMU, and any necessary approvals from NOMA, must be in place before any modifications can be implemented.
Combination studies previously approved by regional REK where the clinical trial of the medicinal product is transferred to CTIS
Please contact REK KULMU if a modification related to the medical device in a combination study requires submission of a modification application via the REK-portal.
Updated 17.09.2026
