EU Commissioner for Health and Food Safety Stella Kyriakides [Photo courtesy of the European Commission]
The European Parliament and Council today voted to approve a Medical Devices Regulation (MDR) transition delay in an effort to avoid shortages.
The move gives medical device manufacturers more time to certify their devices under the new MDR rules.
“I welcome today’s [European Parliament] vote to extend the transition period to new rules under the Medical Devices Regulation,” Commissioner for Health and Food Safety Stella Kyriakides said. “This will help give clarity to manufacturers and ensure that patients can access the essential medical devices they need. This is our top priority.”
The delay does not modify MDR’s current safety and performance requirements. Instead, it gives manufacturers more time to move from the old rules to the new requirements.
It also removes the “sell-off” date that would have prevented the sale of products already on the market but still in the supply chain and not yet received by the user before the transition period ends.
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MDR went into effect in May 2021 with a transition period that runs through May 26, 2024. The new regulations require medical device manufacturers to clear higher safety bars and submit existing products for new certification.
That led some device manufacturers to let product certifications lapse or to withdraw from the market. And device developers say they are more likely to launch novel products in the U.S. rather than in Europe due to MDR’s complexity and uncertainty.
New MDR transition dates
The MDR transition delay extends the transition period for Class III devices and Class IIb implantable devices to December 2027.
The transition period for Class I, Class II and Class IIb non-implantable devices is now extended to December 2028. (However, many Class I devices already transitions as of May 2021.)
The proposal also extends the transition period for Class III implantable, custom-made devices to May 2026.
The European Commission offered more information in a Q&A at its website.
The Munich, Germany–based notified body TÜV SÜD welcomed the change. Royth von Hahn, its global SVP of Medical & Health Services, said in a news release: “The new deadlines will ensure that patients and healthcare professionals will continue to have safe medical devices.”