Please see NOMA’s website for information on modifications to performance studies under the IVDR. In addition, Annex II to the European Commission’s guidance on performance studies 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 71 of the IVDR.
Both substantial and non-substantial modifications must be submitted to REK KULMU/REK 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.
The modification(s) must be approved by REK KULMU/REK, and any necessary approvals from NOMA (DMP) must be in place before any modifications can be implemented.
Performance studies approved by REK KULMU – IVDR Article 58 (1), 58 (2) or 70
A modification 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.
Combination studies previously approved by regional REK and 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
