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.