On 21 October 2026, the UK Government announced that it will continue to accept CE marked medical devices and in vitro diagnostic medical devices (IVDs) approved under EU MDR and EU IVDR on the Great Britain market indefinitely. The announcement follows a recent public consultation by the UK medicines and medical devices regulator, the MHRA (see our previous blog post here).
This decision, while not unexpected, means that manufacturers of medical devices or IVDs holding an appropriate CE mark will not have to also obtain domestic UKCA certification before placing them on the Great Britain market. This is particularly significant given that, according to the announcement, more than 90% of medical devices registered for use in Great Britain are currently CE marked. Post-market surveillance of all devices on the UK market will remain within the oversight of the MHRA.
The UKCA route will nevertheless remain available as the domestic conformity assessment route. This is due to be developed further through the forthcoming pre-market statutory instrument, which will update the requirements which medical devices must obtain to be UKCA marked.
The original proposal to continue recognition of CE marking was widely supported by industry, and has been positively received.
In the announcement, Steve Lee, executive director of regulation at the Association of British HealthTech Industries (the trade association for the UK’s medtech sector) gave strong support to the change, highlighting benefits to patients and industry, and underlining the positive impact on the UK healthtech sector.
The British Healthcare Trades Association, a not-for-profit representing healthcare and assistive technology companies, has also voiced support for the change, reiterating the position set out in its response to the consultation.
Looking ahead, the UK Government intends to develop the UKCA framework and will seek enabling powers for a future licensing approach for medical devices, intended to support a more modern and flexible framework which can better respond to advancements in medtech, including software and AI medical devices.
Learn more about our Life Sciences practice.
Our content explained
Every piece of content we create is correct on the date it’s published but please don’t rely on it as legal advice. If you’d like to speak to us about your own legal requirements, please contact one of our expert lawyers.