During and after IVD performance studies

During and after completion of the IVD performance study, you are required to submit information to the review committee, and in some instances to the competent authority medical devices.

The information you need to supply depends on the following points:

  • performance study type
  • whether approval took place before implementation of IVDR
  • whether approval took place after implementation of IVDR

Digital submission

  • Submissions to the review committee can be made to the MREC concerned.
  • Submissions to CCMO as review committee can be mailed to tc@ccmo.nl.
  • Submissions to CCMO as competent authority can be made to devices@ccmo.nl.
  • Submissions at ToetsingOnline continue to proceed in the same manner.