Commission proposing a 12 month delay to MDR

At the same time that the device industry is finalising a paper to send to the European Commission to delay the date of application of the Medical Device Regulation (MDR, 2017/745) until at least six months after the Covid-19 pandemic is over, the Commission itself announced it will be proposing a 12-month delay as a result of the additional pressures being placed on manufacturers, notified bodies and competent authorities by the Covid-19 crisis.

The announcement was made during a meeting of the College of Commissioners on 25 March 2020, available as a video clip from the meeting. The Commission is working towards presenting its proposal to the European Parliament and Council in early April, and it is to be hoped that no obstacles will be placed in the way of this eminently sensible delay by either of these two bodies. The formal announcement of the Commission’s proposal can be accessed here.

If adopted, the proposal means that the MDR will now take effect from 26 May 2021. Full details of what the effect of this delay will have on detailed operations during this extended transition will no doubt become clearer once the proposal is published.

MedTech Europe has issued a press release welcoming the announcement, but commenting that a similar delay should be introduced for the IVDR, explaining:

“By providing the same solution for the in vitro diagnostics and medical devices sectors, the EU would be doing even more to keep health systems up running effectively in times of the COVID-19 pandemic.”

COCIR has also issued a statement welcoming the Commission’s proposal.