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European Commission Proposes Extending IVDR Compliance Under Certain Conditions

NEW YORK – The European Commission on Tuesday proposed giving companies more time to apply the In Vitro Diagnostic Medical Devices Regulation under some conditions.

In a statement, the EC said that data indicates a "considerable number" of IVDs on the EU market don't meet the IVDR rules, which began rolling out in 2022, or new devices that do comply with the new rules have not replaced old ones.

"The situation is especially critical for high-risk IVDs, which are devices used, for example, to test for infections in blood and organ donations," the EC said in a statement. "To improve the availability of such essential devices, today's proposal gives more time for manufacturers to apply the new rules, under certain conditions, without compromising safety requirements."

The current deadlines to comply with the IVDR is May 26, 2025, for high-risk IVDs, and May 26, 2027, for lower-risk IVDs. The EC is proposing a new deadline of December 2027 for high individual and public health risk devices, December 2028 for high individual and moderate public health risk devices, and December 2029 for lower-risk devices.

Device manufacturers would also be required to give prior notice if they expect an interruption in the supply of IVDs or medical devices, under the EC proposal.

The EC also proposed accelerating the launch of the Eudamed database of medical devices that have already been finalized to move up the date when use of the database would be mandatory to late 2025, it said.

As a key feature of IVDR, test and device manufacturers will need to upload data about their devices to Eudamed. Formerly, the EU had targeted 2026 for when it would be mandatory for manufacturers to enter unified device identification data as well as notified body certificate data into Eudamed.

The EC will present its proposal to the European Parliament and Council for adoption, it said.