CCMO validation of IVD performance studies

IVDR stipulates that IVD performance studies (IVDR article 58 and 70(2)) must be validated before they can be assessed by a review committee.

Validation of IVD performance studies (IVDR article 58/70(2)) is carried out by CCMO. CCMO checks whether the performance study falls within the scope of IVDR and whether the research file is complete. The check for completeness only concerns the presence of all documents; it is not a substantive assessment.

If the performance study falls within the scope of IVDR and the research file is complete, CCMO sends the file to the review committee of your choice, after which the assessment of the investigation commences. The date of a positive validation notification is the validation date.

Maximum legal deadlines apply to both the sponsor and CCMO. CCMO can extend a deadline by itself or at the request of the sponsor. If the sponsor has exceeded the deadline, the submission is cancelled and the file must be resubmitted for validation. The application is tacitly validated if CCMO exceeds the maximum deadline.

In the case of a negative validation, it is possible to file an objection to CCMO. The figure below shows the procedure and the deadlines (number of calendar days and possible extension in calendar days).

Image: ©CCMO