EUMDR DEADLINE EXTENSION - LIFEBUOY FOR MEDICAL DEVICES

Magic carpet to Aladdin is the same as the Extended Deadlines to the EUMDR awaiting manufacturers.

The revised proposal intends to extend the transition period deadline from 26 May 2024 to either 31 December 2027 or 31 December 2028, depending on the risk class of the device. High-risk devices will have a shorter transition period ending in 2027, while low- and medium-risk devices will have until the end of 2028 to complete a conformity assessment.

For class III custom-made implantable devices, a new transition period until 26 May 2026 is proposed. This extension will only apply to manufacturers who apply to a notified body by 26 May 2024 and sign a certification contract by 26 September 2024.

The medical device industry will be grateful to the European Commission and notified bodies for recognizing the challenges faced during the transition and proposing these revised timelines. The proposal is now awaiting approval from the European Parliament and Council under an accelerated co-decision procedure.

In light of these developments, it is crucial for member states, notified bodies, and the industry to work together to ensure a smooth and timely transition to the new rules established by the Medical Devices Regulation. This collaboration will help safeguard access to essential medical devices for patients most in need.

The exact verbiage of the proposal can be found here.

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