NREC-MD

The remit of the National Research Ethics Committee for Clinical Investigations of Medical Devices and Performance Studies of In Vitro Diagnostic Medical Devices (NREC-MD) is to review the submission of ethics applications regulated by the Medical Devices Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Devices (EU) 2017/746.

Studies of medical devices which require ethical review under MDR include:

  • Clinical investigations conducted to demonstrate conformity of devices outlined in Article 62 of the Medical Devices Regulation (EU) 2017/745
  • Post-market clinical follow up (PMCF) investigations regarding devices bearing the CE marking outlined in Article 74 of the Medical Devices Regulation (EU) 2017/745
  • Substantial modifications to clinical investigations outlined in Article 75 of the Medical Devices Regulation (EU) 2017/745
  • Other clinical investigations outlined in Article 82 of the Medical Devices Regulation (EU) 2017/745

Studies of in vitro diagnostic medical devices which require ethical review under IVDR include:

  • Performance studies outlined in Article 58 of In Vitro Diagnostic Medical Devices (EU) 2017/746
  • Performance studies regarding devices bearing the CE marking outlined in Article 70 of In Vitro Diagnostic Medical Devices (EU) 2017/746
  • Substantial modifications to performance studies outlined in Article 71 of In Vitro Diagnostic Medical Devices (EU) 2017/746

NREC-MD is recognised by the Department of Health under the S.I. No. 260/2021 -European Union (National Research Ethics Committee for Clinical Investigations of Medical Devices) Regulations 2021 and is authorised to carry out the ethics review of clinical investigations of medical devices.

The NREC-MD is fully compliant with the regulations as they relate to ethics committees and endorses the conditions and principles of good clinical practice.

The NREC-MD meets once monthly.

For further information related to the NREC-MD, please contact the National Office – devices@nrec.ie

If you plan to submit an application for ethics review of a clinical investigation of a medical device or performance studies of in vitro diagnostic medical device, please visit Apply NREC-MD.

If you are interested in the underlying processes and management of the NREC-MD, please download our Operational Framework.

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