In a ‘letter to industry‘ dated 22 October 2022, the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), advised that it was implementing a 12-month extension to the current ‘standstill period’, mainly because additional time is needed to introduce the new medical device regulation that was initially planned to take effect from 1 July 2023.
The new regulation is now slated for introduction on 1 July 2024, which brings into effect a welcome one-year extension to the current requirement to include a UKCA mark with devices from 1 July 2023.
In the letter, MHRA acknowledges that concerns have been raised about the very limited capacity available from those UK Approved Bodies (UKABs) so far designated, there being only four currently available, with two more expected to be designated before the end of 2022.
In line with the government’s response to the recent public consultation on the future of UK device regulation, extended transition times will be allowed for CE marked devices and devices holding UKCA marks under the current legislation. In this context, it is anticipated that separate legislation will be introduced to codify these updated transition periods early in 2023.