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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)
  • MREC Oost-Nederland,
  • Medical Research Ethics Committees United (MEC-U),
  • MREC Amsterdam UMC,
  • MREC Academic Hospital Maastricht / University Maastricht (MREC AZM/UM),
  • MREC Erasmus Medical Center Rotterdam (MREC Erasmus),
  • MREC Leiden The Hague Delft (LDD),
  • MREC University Medical Center Groningen (MREC UMCG),
  • MREC NedMec,
  • Central Committee on Research Involving Human Subjects (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.