The UK government has confirmed that CE-marked medical devices and in vitro diagnostic devices (IVDs) will continue to be accepted in Great Britain on a long-term basis, settling the question of whether products already approved for the European market would need a separate national approval.
The decision covers the kinds of technology patients and the NHS rely on, from insulin pumps and replacement joints to diagnostic tests and surgical equipment. Devices holding a CE mark will remain eligible for the Great British market without an additional approval step.
Consultation drew more than 1,000 responses
The confirmation follows a public consultation that ran from 16 February 2026 to 10 April 2026 and received more than 1,000 responses from patients, healthcare organisations, industry and others. The government described the outcome as widely anticipated.
Because CE-marked devices will not require an additional approval route, manufacturers avoid duplicated assessment for products already cleared for the European market. The government presented the decision as a way to help maintain stable supply and patient access to medical technologies.
Both medical devices and in vitro diagnostic devices fall within the scope of the arrangement, so the recognition applies across the device types named in the announcement rather than to a single product group.
More than 90% of registered devices carry a CE mark
According to the announcement, more than 90% of medical devices currently registered for use in Great Britain carry a CE mark, meaning they have been assessed and approved for the European market and that approval has been recognised as providing access to the Great British market. Continuing to recognise these products is intended to support safe, uninterrupted access to the treatments and technologies patients and the NHS depend on.
UKCA marking continues as the domestic route
Long-term recognition of CE marking sits alongside UKCA marking, which continues to operate as the domestic approval pathway for devices placed on the market in Great Britain. The government said guidance on placing UKCA or CE-marked products on the market in Great Britain is available.
Two routes therefore stand as accepted means of reaching the Great British market: CE marking, recognised on a long-term basis, and UKCA marking, the domestic pathway. For devices already assessed in Europe, the CE route removes the need to repeat that assessment for the British market.
In practical terms, the announcement preserves market access for the large majority of registered devices while leaving the UKCA route in place for domestic approvals. The recognition is described as indefinite rather than time-limited, and no new device category or additional assessment step is introduced.