Amendment EU 2023/607 was published 20 March 2023 but what does it actually mean in practice for the industry?

The purpose of the amendment is to allow more time to transition and meet requirements of the MDR.

Key points
– amendment 2023/607 allows an extension of MDD/AIMDD certificates ‘done automatically by law’ so long as the manufacturer complies with Article 120 (3c) of the MDR (has lodged an application for MDR with a notified body before 26 May 2024)
– only applies to legacy devices. New devices or legacy devices with significant changes must comply to MDR.
– Sell off date: provided that the device was compliant with article 120 of the MDR and the expiry of the device is still valid, the sell-off deadline does not exist.

Our thoughts: make the best use of the additional time. As we have seen, there is so much work to do to become MDR compliant.

For any help understanding the requirements for your device or to help transition, contact Russell Regulatory Consultants
[email protected]