Application for the authorisation for performance studies of in vitro diagnostic medical devices

03 February 2023

Overview of forms used in connection with application for the authorisation for performance studies of in vitro diagnostic medical devices

Application form for the authorisation for performance studies of in vitro diagnostic medical devices

Application for modifications to a performance study

Application form for the authorisation to make substantial modifications to the performance study of in vitro diagnostic medical devices

In the case of performance studies authorised by the Danish Medicines Agency, the modification must be applied for simultaneously to the Danish Medicines Agency and the Medical Research Ethics Committees.

If a sponsor wants to introduce modifications to a performance study that might substantially impact the safety, health or rights of research participants or the robustness or reliability of the clinical data generated in connection with the study, the Danish Medicines Agency must authorise the modifications prior to their implementation.

The Danish Medicines Agency has 38 days to review the application for a modification, and the Medical Research Ethics Committees must have finished their review of the modification before the Danish Medicines Agency can make a decision. The sponsor must submit updated versions of the relevant documentation in which the modifications must be clearly identifiable.

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