The remit of the NREC-MD is to review the submission of ethics applications related to Clinical Investigations of Medical Devices as defined in MDR: “any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.” This includes:
- Non-CE marked medical devices being used in a clinical investigation for one or more of the purposes outlined in Article 62 of the Medical Devices Regulation (EU) 2017/745
- CE-marked medical devices being used in a clinical investigation outside the scope of its intended purpose
- CE-marked devices being further assessed in a clinical investigation (PMCF) within the scope of its intended purpose, which involves submitting participants to additional procedures deemed invasive and/or burdensome
- Clinical investigations of medical devices which do not fall under Article 62 of Medical Devices Regulation (EU) 2017/745
The National Research Ethics Committee for Medical Devices (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 will meet once monthly.
The NREC-MD and Health Products Regulatory Authority (HPRA) will facilitate parallel review of applications within the scope of the Medical Device Regulation. This approach refers to reviews that are conducted concurrently by both NREC-MD and the HPRA, enabling delivery of decisions within efficient timeframes.
Alternatively, applications for new clinical investigations of medical devices, or post-market clinical follow-up investigations that include an additional procedure (which is invasive or burdensome to participants), can be submitted to the NREC-MD for review in advance of submission to the HPRA.
For further information related to the NREC-MD, please contact the National Office – firstname.lastname@example.org
If you plan to submit an application for ethics review of a clinical investigation of a 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.