The Official Journal of the European Communities (OJ) has now published ‘Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices [MDR], as regards the dates of application of certain of its provisions’, confirming a 12-month delay to the Date of Application (DoA).
In addition to the DoA delay, the Regulation introduces other important changes in the way ‘humanitarian devices’ are derogated from the normal MDR rules.
In summary, the Regulation covers:
Note that the Regulation covers only the MDR and does not make any reference to the In-Vitro Diagnostics Regulation (IVDR). Industry will continue to argue for a similar delay to the DoA of the IVDR, however, as the number of notified bodies for the IVDR remains at a pitiful three, pressure is sure to grow.
Update on 27 April 2020: One further notified body, the 13th, has been added to the NANDO list for devices under the MDR, this being MDC Medical Device Certification GmbH, Stuttgart, Germany, NB reference no NB 0483.