What is assessed by whom?

An IVD performance study that needs to be reviewed (i.e. falling within the scope of IVDR articles 58 or 70) may be assessed by a review committee of your choice (accredited MREC or CCMO).

If the study also falls within the scope of CTR (clinical trials with into a medicinal product) or MDR (clinical investigations with medical devices), a more limited number of review committees is authorised to assess the study concerned.

For IVD performance studies that may only be assessed by CCMO,  see Review by CCMO.