MDDI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Proposal to Postpone EU Medical Device Regulation Underway--Update

A delay of one year could allow authorities and industry to focus instead on urgent responses needed to address the COVID-19 pandemic.

Image by Rob Grant from Pixabay 

Update: On March 25, MD+DI reported that the European Commission was working on a proposal to postpone “the entry into force of the new medical device regulations for one year,” Stefan De Keersmaecker, a spokesperson for European Commission, explained at the time. (See the article below.)

The proposal has now been submitted. De Keersmaecker told MD+DI on April 4 that “the proposal to postpone the EU MDR has been adopted at Commission level. Our proposal will now go to the co-legislators, Parliament, and Council, who have the competence to adopt our proposal (at that moment our proposal becomes « law » ). We hope they will do so, in the context of an accelerated procedure.”

 

Original article published on March 25:

The European Commission is working on a proposal to postpone “the entry into force of the new medical device regulations for one year,” Stefan De Keersmaecker, a spokesperson for European Commission, explained during this video shared by the commission. The proposal is expected to be submitted in early April.

“We call on parliament and on council to adopt it quickly, as the deadline for entry into force is at the end of May,” De Keersmaecker said.

This delay would relieve pressure "from national authorities and industry and allow them to focus on urgent priorities related to the coronavirus crisis,” he explained.

Earlier this year at the MD&M West 2020 conference, experts had discussed preparing for the regulations during the Feb. 11 panel discussion, “Strategies for Implementing the New EU MDR Requirements.”

The European Commission also sought to help industry address urgent medical supply needs during the pandemic in another way. The commission requested that the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) make available a number of European standards for certain medical devices and personal protective equipment, and they agreed. "This action will help both EU and third-country companies willing to manufacture these items to swiftly start production and place products on the internal market more easily while ensuring a high degree of safety," the commission reported in a news release.

500 characters remaining