EU MDR| Postponing of the date of application

On 3 April the European Commission published a proposal to postpone the date of application of the Medical Devices Regulation (MDR) for one year. The Commission calls on the European Parliament and the Council to adopt it quickly, as the original deadline for the application of the MDR is 26 May 2020. The new proposed deadline is 26 May 2021.

This measure was taken to relieve pressure from national authorities, notified bodies, manufacturers, and others, to enable focus on the current crisis. In their communication, the European Commission calls on all actors to “ensure that this additional year is used appropriately”, and call for completion of all work currently incomplete. This suggests that by the end of the postponed date of application, the European Commission will be less likely to further postpone it or to accept incomplete works.

It is interesting to note that on 24 March, the day before the Commission’s communicated the intent to submit this proposal, Members of the European Parliament (MEPs) Mairead McGuinness, Peter Liese, Nils Torvalds, Jytte Guteland, Biljana Borzan, and Claudia Gamon submitted a letter to the European Commission calling for greater flexibility regarding the implementation of the MDR, and possibly even postponement of the implementation deadline.   

You can find the proposal here.

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