Corona crisis: Delay of MDR implementation is likely

The Medical Device Regulation (MDR) is due to take effect as of May 26th, 2020.

After requests of the medical device industry, even Stella Kyriakides, head of the EU health commission, argues for a delay of the MDR.

During the current Corona crisis and increasing infections, manufacturers shall be in charge of their complete capacity and productivity, especially for face masks and protective clothing in these times.

Generally, the MDR implies intensifications of approvals, stricter checks, visits and examinations of medical devices. The regulations of the MDR are accompanied by an extra of bureaucracy which should not prevent the manufacturers from production in the current situation of crisis, as Kyriakides states.

Possibly, the implementation of the MDR is delayed for one year, until May 2021.

The EU commission will decide in April.

Do you have questions on the impacts of the MDR on your company and the correlating Market Access strategy?

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