Review of a clinical investigation with a medical device – guidance document for MRECs

As of 26 May 2021, the EU Medical Device Regulation (MDR) will be applicable. This guidance sets out the implications for the review of medical device research by the accredited Medical Research Ethics Committees (MRECs).

The guidance has been drawn up by a working group of experts from the field and is specifically intended for MREC members and secretaries. The guidance focuses on the quality and safety of medical devices used in clinical investigation. In addition, the guidance describes the new procedures for submission, assessment and conduct of such studies. CCMO and the NVMETC Board have adopted the guidance.