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 deviceReview 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 classesaccredited MREC or CCMO

Clinical investigation with a different purpose
(MDR article 82)

All classesaccredited 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.

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