(Council of the European Union: Brussels) -- In a press release today the Council of the European Union announced that it has adopted a regulation which extends the deadline for the certification of medical devices. This measure aims to prevent that medical devices which cannot be certified by the initial cut-off date become unavailable for European patients.

“Today we have agreed on measures that will allow the industry to continue bringing essential medical devices to the market and ensure that patients have safe access to medical devices,” says Acko Ankarberg Johansson, Swedish minister for health care.

A staggered and conditional extension

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.

The extension of the transition period will be granted under certain conditions. These ensure that only devices that are safe and for which manufacturers have already started the certification procedure will benefit from the additional time.

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