During a Q&A section of a European Commission (EC) college meeting on 25 March, EC spokesperson Stefan de Keersmaecker stated that the commission were looking to delay the “entry into force” of the new European medical device regulations (MDR) because of the global coronavirus pandemic.
de Keersmaecker, who spoke via video, said: “The EC is working on a proposal to postpone the entry into force of the new MDR for one year. We are working hard to submit this proposal by early April.” He added that he and his colleagues were calling on the European council and parliament to adopt the proposal (once complete) “quickly” given that the new MDR is due to come into force on 26 May this year. The delay, de Keersmaecker noted, “will relieve pressure from national authorities and industry and it will allow them to focus fully on urgent priorities related to the coronavirus”.
However, even before pandemic, there were calls to delay or revise the new MDR. In a commentary written last year (October 2019), Jeffrey Jump (chairman and CEO of MedAlliance), said: “My belief—one that is shared with others in the industry—is that the MDR could become the most disruptive factor to hit the European healthcare market since the start of the Second World War. For a start, around a half of the estimated 500,000 products currently available in Europe simply will not be re-approved, due to the time, cost and administrative input required.”
He added: “I believe that—even at this relatively late stage—the MDR can still be changed to make it more workable, and some of these changes are very simple. The first and most fundamental is to extend the deadline for the implementation of MDR until at least 20 notified bodies have been accredited.”