Great Britain will keep accepting CE-marked medical devices and in vitro diagnostic devices on a long-term basis, after the UK government confirmed the arrangement instead of setting an end date for recognition.
The decision means patients will continue to have access to the devices they depend on, from insulin pumps and replacement joints to diagnostic tests and surgical equipment, without a separate national approval step for products already cleared for the European market.
What the government decided
CE marking will remain a recognised route for placing devices on the Great British market on a continuing basis. Manufacturers whose products have already been assessed and approved for the European market will not need an additional approval route to reach British patients, an approach the government presented as avoiding duplication for industry and helping to maintain stable supply.
The UKCA marking route continues to operate alongside it as the domestic approval pathway for devices placed on the market in Great Britain. Guidance on placing UKCA or CE-marked products on the Great British market continues to apply to both routes.
Consultation and the evidence behind the call
The confirmation follows a public consultation that ran from 16 February to 10 April 2026 and drew more than 1,000 responses from patients, healthcare organisations, industry and other respondents. The government characterised the decision as widely anticipated.
Central to the reasoning is the composition of the register: more than 90% of medical devices registered for use in Great Britain currently carry a CE mark. Those devices have been assessed and approved for the European market, and that approval has been recognised as giving access to the Great British market.
Devices and diagnostics
The scope covers both medical devices and in vitro diagnostic devices, the category that includes diagnostic tests. Because the large majority of registered products rely on the CE route, a break in recognition would have reached across many product categories rather than a narrow segment. Keeping recognition in place is intended to protect continuity of access for patients and the NHS, according to the government's stated rationale.
For manufacturers, the practical consequence described is that a single European assessment continues to serve the British market as well, avoiding duplicated approval work for the same product. UKCA marking remains available for companies using the domestic pathway, so the two routes sit side by side rather than one replacing the other.
What the announcement leaves open
The confirmation does not set out transitional arrangements, conditions attached to long-term recognition, or categories of device for which UKCA marking might still be required. It also does not quantify the number of products affected beyond the 90% share of registrations.