12-month extension to UKCA Standstill period
Whilst not totally unexpected, it was a major relief to hear the announcement from the MHRA, of a 12-month extension to the current standstill period, with legislation on the future UK Medical Device regime now due to come into force a year later, in July 2024. You can find a letter to industry from the MHRA on this development here: MHRA UKCA Extension of Standstill Period Letter
This essentially means that CE marked products can continue to be placed on the GB market under a valid CE certificate, with the respective transition periods for medical devices and diagnostic devices taking effect from July 2024.
We can now expect legislation in Spring 2023 on the transitional arrangements and on specific post-market surveillance requirements, which could take effect from July 2024.
Medilink are delighted that the views of industry have been listened to, both in respect to allowing time to work on detail, to avoid disruption to supplies, and also the issue of limited capacity within the UK Approved (UKAB) system.
This is clearly a positive step, but much more work will need to be done collaboratively between the MHRA and industry representative bodies to ensure that companies have the clarity that they need in order to implement the new legislation in a timely fashion.
We have welcomed feedback from members on the UK’s new medical device regime and hope that we can continue to count on your support to shape future developments.
If you require information / support with regulation please contact [email protected]
Medilink North of England Ltd