Guidance for MRECs

The guidance document describes the consequences of the MDR for the assessment of clinical investigations with medical devices by the accredited Medical Research Ethics Committees (MRECs) in the Netherlands.

The guidance has been compiled by a working group of experts from the field and is specifically intended for MRECs. The focus of the guideline is on the quality and safety of medical devices used in clinical investigations. In addition, the new procedures for submission, assessment and implementation of such investigations are described in the guidance document. CCMO and the board of the NVMETC have jointly adopted the guidance.

Appendix F of the guidance contains an overview of the assessment criteria and relevant articles from the MDR and WMO that apply to the substantive assessment of clinical investigations with medical devices.