NREC-MD expands remit to include review of in vitro medical devices

As the new EU In Vitro Medical Devices Regulation comes into effect on 26 May following a five-year transition period, the National Office for Research Ethics Committees is pleased to announce that the National Research Ethics Committee for Medical Devices (NREC-MD) will now expand its remit to review applications seeking ethical approval for performance studies of in vitro diagnostic medical devices.

The Regulation aims to harmonise standards throughout the EU for the development of in vitro diagnostic medical devices, the procedures for introducing these devices to the market, and the management and surveillance processes that apply across the lifetime of these devices after they have been placed on the market. It marks a key milestone in strengthening safety standards for research participants and patients and is set to support research and innovation in new diagnostic devices.

Ethical approval is an essential part of any performance study. The members of the NREC-MD already work to ensure the highest standards of ethical review are applied to clinical investigations of medical devices more broadly, and as of 26 May researchers seeking ethical approval for studies of in vitro diagnostic devices must submit their application to NREC-MD for review.

Chair of NREC-MD Professor Barry O’Sullivan comments: “The Committee members look forward to taking on this new role: robust ethics review at the national level will support vital research in in vitro diagnostic devices here in Ireland, while helping meet our obligations under the new EU Regulation.”

Click here for more information on the work of the NREC-MD and the application process.

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