The following is important information for Sponsors / Principal Investigators of clinical investigations of medical devices that were approved under the Council Directives 93/42/EEC and 90/385/EEC (and their transposing legislation SI 252/1994 and SI 253/1994 as amended) and were still ongoing on the date of effect (26th May 2021) of the EU Medical Device Regulation (MDR; EU No. 2017/745). This information is informed by guidance from the Department of Health.
The MDR came into effect on 26th May 2021 and is now implemented by corresponding national law, Statutory Instruments 260 and 261. SI 260/261 enable the NREC-MD only to issue an ethics opinion on clinical investigations of medical devices for Ireland in line with the MDR from this date.
Clinical investigations of medical devices that were started under the Directives (‘old legislation’) and ongoing on 26th May 2021, can continue, but after this date, they must be in conformity with the MDR. It is the responsibility of the Sponsor / Principal Investigator to ensure that their studies are compliant with prevailing law, including the MDR.
To ensure compliance with the MDR, Sponsors / Principal Investigators must as of the 26th May 2021 notify the NREC-MD on all aspects of:
- reporting, including annual and safety reports and device deficiencies;
- any other matter that requires an ethical decision, such as substantial amendments; or
- any other matter that requires notification, such as non-substantial amendments.
In practice, all clinical investigations of medical devices must report to the NREC-MD for research ethics purposes, with immediate effect. The requirement for a decision by, or report or notification to, the NREC-MD will be the ‘trigger’ for transfer of the relevant historical documentation on studies approved by the local REC system, to the National Office for the records of the NREC-MD; this will require coordination by the research team with the National Office.
The National Office website will be updated shortly with operational guidance to support this transition. In the meantime, please feel free to consult Frequently Asked Questions on the NREC-MD. For timely notifications, you may wish to consider subscribing for updates at www.nrecoffice.ie. For any additional queries, please contact firstname.lastname@example.org