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). However, the BEBO Foundation’s MREC assesses this type of research only when it is part of a combined study involving a medicinal product.

The review committee is required to include an expert on medical devices.

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.