MDR - 12-month moratorium emerges

MDR – A 12-month moratorium emerges in the shadow of Covid-19

For some time now, there has been a discussion as to whether the Medical Device Regulation (EU) 2017/745 (MDR) can be sensibly implemented at the planned start of validity on 26 May 2020.

There is still insufficient capacity of notified bodies under the MDR, essential implementing acts of the Commission are missing and already since October 2019 it is certain that the European database for medical devices Eudamed will be postponed to May 2022. However, regulatory driven bottlenecks must not lead to a situation where important and life-saving medical technology may no longer be available in sufficient quantities.

In the shadow of the COVID-19 crisis, even the last optimism of purpose now seems to have given way. After trade associations have already increasingly called for a moratorium on MDR in recent days, the responsible EU Commissioner, Stella Kyriakides, announces on Twitter that the Commission is working on a proposal to postpone the start of MDR by 12 months.

The official announcement of the EU Commission is available at: Commission working on proposal to postpone MDR application date for one year

The EU Commission’s proposal for a moratorium is expected in early April. Finally, the form and scope of such a moratorium must also be approved by the other competent institutions. It remains to be seen whether this proposal provides for a blanket postponement of the start of validity or a differentiated regulation.

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25. March 2020 Dr. Boris Handorn