An extension to the EU MDR transition period, approved by the European Council on March 7, is now in force following its publication in the Official Journal of the European Union on March 20.
Producers of medical devices will now have until December 31, 2027, for higher risk devices and until December 31, 2028, for medium and lower risk devices to meet the legal requirements of EU MDR.
The extension will be granted only for devices that are safe and for which manufacturers have already started the certification procedure.
The extension was granted to reduce the risk of medical devices shortages by removing the “sell-off” date rule. The “sell-off” date is the end date after which devices already on the market but not yet with the final user should be withdrawn. Only devices that comply with the previous EU law on medical devices will benefit from the extended transition period.
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