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MDR delay Regulation published

  • Posted by: inetika
  • Category: GLOBAL NEWS

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:

  • MDR DoA deferred until 26th May 2021.
  • Correspondingly, the Medical Device Directive (MDD, 93/42/EEC) and Active Implantable Medical Device Directive (AIMDD, 90/385/EEC) will continue as the legislative framework until the revised DoA, and will not be repealed on 26th May 2020.
  • The end of the ‘grace period’ included within the MDR, which allows devices to be placed on the market according to the MDD and AIMDD remains as 27th May 2024.
  • The ‘Humanitarian Device Exemption’ rules will be pan-EU to ensure a consistent EU approach during the current Covid-19 pandemic.
    Other transitional arrangements are deferred accordingly.

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.