EU

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 al…

EU Commissioner for Health and Food Safety Stella Kyriakides [Photo courtesy of the European Commission]

An MDR transition delay is one step closer to reality following concerns that the current timeline could lead to medical device shortages.

The European Commission on Jan. 6 officially endorsed a proposal to give medical device manufacturers more time to certify their devices under new Medical Devices Regulation (MDR) rules. The proposed MDR transition delay will not become official without approval by the European Parliament and Council.

The proposal would not change any of MDR’s current safety and performance requirements. Instead, it would give manufacturers more time to move from the old rules to the new requirements. It would remove the “sell-off” date and extend transition periods.

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