See DMP’s website regarding modifications to a performance study under the IVDR.
It is the responsibility of the sponsor to assess whether a modification is to be regarded as substantial or non-substantial under IVDR Article 71.
Both substantial and non-substantial modifications must be submitted to REK via the REK portal, using the form “Endring og/eller henvendelse”. Please state in the form whether the modification is considered to be substantial or non-substantial.
A modification application that is submitted to both DMP and REK must be submitted to both bodies on the same day. It is the sponsor’s responsibility to ensure that DMP and REK have access to updated and identical documents.
REK KULMU will assess the modification application within 38 days of receiving the application.
The modification must be approved by REK, and any required approvals from DMP must be in place before the modification can be implemented in the performance study.
