Hurry Up and Wait: 7 Takeaways From New EU MDR Flex Plans

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ARTICLE SUMMARY:

Years of hand-wringing about a May 2024 regulatory bottleneck that could result in massive medical device shortages in Europe have finally translated into specific plans to prevent that outcome, including a legislative proposal and short-term “bridge” plan. Here are 7 takeaways.

EU policymakers are accelerating efforts to give companies and notified bodies more time to fully transition to the EU Medical Device Regulation, citing growing fears of serious device shortages.

On May 26, 2024, all CE mark certificates granted under the legacy EU directives will have expired and they must all have earned an MDR certificate to stay on the market. But there are upwards of 23,000 certificates pending MDR decisions and the likelihood of resolution on a large chunk of those before May 24 is rapidly diminishing.

That date would be pushed back by three to four years, depending on device risk class, as the result of a proposal that the European Commission presented to the Council of the EU December 9 to update the MDR legislation. On the same day, the Commission published a shorter-term plan to address CE marks that expire before the legislative change goes forward.

“The transition to the new rules has been slower than anticipated,” Stella Kyriakides, the EU Commissioner for Health and Food Safety, acknowledged during the Council hearing, citing the pandemic, raw material shortages stemming from Russia’s invasion of Ukraine, and low notified body capacity as the main challenges.

“We are facing a risk of shortage of life-saving medical devices for patients,” she said. “This is a risk that we cannot take.” EU national health ministers unanimously spoke in support of the Commission’s plan during the hearing, signaling a sense of urgency to act.

Here are seven takeaways about the post-December 9 state of play.

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