The European Commission is putting together a proposal to ask the European Parliament and Council to delay enforcement of the new Medical Device Regulation (EU MDR) by one year in light of the coronavirus pandemic.
Medical device companies have been scrambling to meet the implementation of the new MDR, scheduled for May 26. (The in vitro device regulation (IVDR) goes into effect on May 26, 2022.)
“We’re working hard to submit this proposal in early April and call on Parliament and Council to adopt it quickly as the deadline to force is in May,” EU spokesman Stefan de Keersmaecker said today. “This will relieve pressure from national authorities and industry and allow them to focus fully on urgent priorities related to the coronavirus crisis.”
Pressure to postpone implementation of MDR has been mounting. On Monday, the trade association MedTech Europe called on EU institutions to postpone the implementation of the new MDR and IVDR because of the pandemic. Members of the European Parliament have been doing the same.
“Fewer resources are available to ensure the implementation of the regulation, for example, the approval of clinical studies, the designation and auditing of notified bodies and in manufacturing,” six parliament members wrote in a letter to European Commission president Ursula von der Leyen and commissioner Stella Kyriakides on Monday. “We propose to maintain the current system and postpone the implementation deadline of 26 May 2020 to allow the industry focus on the essential and urgent work of tackling COVID19.”
A 1-year delay in implementing MDR would be a major change in strategy for the EU, according to Tracy Eberly, president and CEO of medtech regulatory firm Fang Consulting (Roseville, Minn.).
“I have some midsize to small clients that are overjoyed,” Eberly told DeviceTalks editorial director Tom Salemi in a podcast due out Friday. “I have some very large giants, while they’re very happy, they’re now looking at the money they spent to get this done and they’re wondering if they could have saved a little money. Or the competitive advantage they thought they might have had over a competitor that didn’t get MDR might evaporate. It’s going to be a mixed bag for our larger clients who spent the time and money to get prepared. And it’s going to be great for smaller to mid-sized companies that have been avoiding dealing with MDR.”
The coming implementation of MDR has already faced a slew of obstacles, with reports in September 2019 suggesting that only about a fourth of medical device companies plan to be fully compliant with the new regulations come May. In November 2019, MedTech Europe accused government authorities of dragging their feet on the process, claiming the industry was held back by the slow implementation of the new framework.
This article has been modified with comments from Tracy Eberly, CEO of Fang Consulting.