Following its 25 March announcement that it would make a proposal for delaying the Medical Device Regulation (MDR, 2017/745) by 12 months, the European Commission has (ironically) wasted no time in publishing its “Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions” (2020/0060 (COD)).
The eight-page proposal states:
“The COVID-19 outbreak and the associated public health crisis presents an unprecedented challenge to the Member States and is a high burden for national authorities, health institutions, EU citizens and economic operators. The COVID-19 crisis has created extraordinary circumstances that demand substantial additional resources, as well as an increased availability of vitally important medical devices, that could not reasonably have been anticipated at the time of adoption of Regulation (EU) 2017/745 [MDR].
Those extraordinary circumstances have a significant impact on various areas covered by Regulation (EU) 2017/745 and therefore it is very likely that Member States, health institutions, economic operators and other relevant parties will not be in a position to ensure the proper implementation and application of that Regulation from 26 May 2020 as it provides for.”
The proposal also addresses concerns that individual member states may independently adopt different measures to help avoid device shortages during transition to the MDR, explaining that a regional rather than national approach is preferred.
The proposal does not include any reference to the In Vitro Diagnostics Regulation (IVDR, 2017/746), although industry groups have requested a similar delay, to avoid overburdening notified bodies in the run-up to both regulations, as there is now only one year between the respective dates of application, and with only three notified bodies so far designated under the IVDR.
Update as at 9 April 2020: The Commission, recognising it had made errors in drafting the proposal for a 12-month delay in the date of application of the MDR, has corrected these in its now published ‘Mandate for negotiations with the European Parliament‘. This mandate now includes a complete copy of the wording of the proposal, but also includes strike-throughs and new wording intended to correct the initial errors. This is the version that manufacturers should refer to when establishing any revised timelines for transition.