EU Commission confirms it will propose MDR deadline delay due to coronavirus

By Jillian Deutsch | POLITICO Pro | 3/25/20, 1:16 PM CET

The Commission will propose a one-year delay for the Medical Device Regulation (MDR) transition deadline, Commission spokesperson Stefan De Keersmaecker said today.

The Commission is still working on the proposal, De Keersmaecker said, but it aims to have it go to the Council and the Parliament at the beginning of April. De Keersmaecker urged them to “adopt it quickly.”

“This will relieve pressure on industry and allow them to focus fully on urgent priorities related to the coronavirus crisis,” De Keersmaecker said.

The MDR transition deadline is May 26, 2020. The medtech industry said this week it’s struggling to meet these new rules while also getting protective gear to help health care systems during the coronavirus outbreak.

Citing those pressures, the medtech industry has asked for the deadline to be delayed six months after the coronavirus pandemic is declared over.
MEPs and EU member countries this week had also begun pushing for a delay to the deadline. MEP Peter Liese, of the European People’s Party, called for a one-year delay.

Meanwhile, the transition deadline for the In Vitro Diagnostics Regulation (IVDR), set for May 26, 2022, has not been postponed. The medtech industry also called for a delay to this regulation.

Source: Politico, a global nonpartisan politics and policy news organization

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