MHRA have distributed a letter to industry and the Devolved Administrations in relation to the date of application of the new UKCA regulatory regime.
The letter confirms that the date of application will be extended by 12 months until July 2024. This means that there will continue to be unilateral recognition of the CE mark until this date, and CE marked products can continue to be placed on the Great Britain market under a valid CE declaration of conformity or certificate. The 5-year transition period for IVDs utilising UKCA, IVDD or IVDR declaration of conformity or certification will begin from July 2024, potentially allowing these product to continue on the market in Great Britain without a UKCA mark until July 2029.
It goes on to confirm that MHRA intends to lay legislation in Spring 2023 to bring into force the transitional arrangements and certain post-market surveillance requirements. It does not detail a timeline for when the regulations themselves will be available.
We fully understand that one additional year is less than we would have hoped, but it is a positive step for industry and the needs of British patients. We encourage members to stay engaged on this process and BIVDA will continue to provide updates as soon as possible, including further detail on the post-market surveillance requirements mentioned within the letter.