The UK government has announced that the implementation of the future UK Medical Device Regulations will be pushed back from 1 July 2023 to 1 July 2024.
The MHRA’s announcement means that CE-marked products will continue to be accepted in Great Britain and manufacturers will only be required to obtain a UK Conformity Assessed (UKCA) mark from July 2024. As a result, this extension will provide manufacturers an extra year to ensure that their products are compliant with the new UK regime.
The extension is unsurprising in light of concerns over the lack of regulatory certainty post-Brexit, and the limited number of approved bodies to carry out UKCA conformity assessments.
While the decision was welcomed, there are legitimate concerns that regulatory certainty is slow to come from industry bodies such as the ABHI. Steve Lee, the Director of Diagnostics Regulation at the ABHI commented, “Though of course welcome…progress over the coming months must be rapid and decisive if we are to avert a similar cliff edge scenario one year from now”. In the meantime, manufacturers will be able to take advantage of the extension as it provides a longer transition period for products with a CE marking to be placed in the UK market.
It remains unclear how the new regulations will look however, and the industry is hoping that the new UK regime will be closely aligned with the EU Medical Regulations 2017/745. The government intends to introduce legislation by Spring 2023 which will outline transitional arrangements and post-market surveillance requirements.
The UK government press release is available in full here.
For further information and to discuss what this development might mean for you, please get in touch with your usual Baker McKenzie contact.