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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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’s 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 Europe due to MDR’s complexity and uncertainty.
New MDR transition dates proposed
Under the MDR transition delay proposal, Class III devices would have their transition period extended to December 2027. Class III medical devices are the ones with high risk and significant importance. Think pacemakers and hip implants.
Class I and Class II devices will have a longer transition extension to December 2028. Those are medium- and low-risk devices like syringes and reusable surgical instruments.
The proposal also extends the transition period for Class III implantable, custom-made devices to May 2026.
What’s next?
Commissioner for Health and Food Safety Stella Kyriakides floated the delay in December. Last week, she asked the European Parliament and the Council to quickly adopt the official proposal through an accelerated co-decision procedure.
“Our rules on medical devices will always prioritize patient safety and support for innovation,” she said in a news release. “A combination of factors has left healthcare systems across the EU facing a risk of shortages of life-saving medical devices for patients. Today, we propose a revised regulatory timeline to provide certainty to industry in order to continue producing essential medical devices, reducing any short-term risk of shortages and safeguarding access for patients most in need.”
She also asked member states and notified bodies to work with the medtech industry to ensure an MDR transition “without further delay.”
The European Commission offered more information on the latest proposal in a Q&A at its website.
