What is assessed by whom?

As clinical investigations with medical devices must be assessed by an authorised review committee (accredited METC or CCMO), the review committee is required to include an expert on medical devices.

A limited number of review committees are authorised for clinical investigation with high-risk medical devices in the context of conformity purposes (see table below).

Clinical investigation framework* Class of medical device Review committee**

Clinical investigation for conformity purposes
(MDR article 62/74.2)

Class I and non-invasive Class II (a & b) accredited MREC or CCMO
Class III and invasive Class II (a & b) CMO Arnhem-Nijmegen, MEC-U, MREC AMC, MREC AZM/UM, MREC Erasmus MC, MREC LDD, MREC UMCG, MREC Utrecht, MREC VUmc or CCMO

Clinical investigation for PMCF with invasive and burdensome procedures
(MDR article 74.1)

All classes accredited MREC or CCMO

Clinical investigation with a different purpose
(MDR article 82)

All classes accredited MREC or CCMO

* For the framework for clinical investigations see Clinical investigations: definition and framework.

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

To select an authorised MREC you may use the online tool Committee Finder.

For clinical research that may only be assessed by CCMO see Review by CCMO.