The UK government has confirmed that CE-marked medical devices will continue to be accepted in Great Britain on a long-term basis, settling a question that had been widely anticipated across the sector since it affects products already certified for the European market.
The confirmation covers both medical devices and in vitro diagnostic devices (IVDs). The government framed the decision around continuity of patient access, citing products ranging from insulin pumps and replacement joints to diagnostic tests and surgical equipment.
Consultation drew more than 1,000 responses
The decision 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 other stakeholders.
Under the confirmed approach, the UK will not require an additional approval route for devices already approved for the EU market. The government said this avoids duplication for manufacturers and helps maintain stable supply and patient access to medical technologies.
CE mark covers more than 90% of registered devices
According to the government, more than 90% of medical devices currently registered for use in Great Britain carry a CE mark. That marking indicates a device has been assessed and approved for the European market, and this approval has been recognised as providing access to the Great British market.
Continuing to recognise these devices is intended to help maintain safe, uninterrupted access to the treatments and technologies that patients and the NHS rely on.
UKCA route remains in operation
Long-term CE recognition sits alongside the UKCA marking route, which continues to operate as the domestic approval pathway for devices placed on the market in Great Britain. The two routes will therefore coexist for products supplied in Great Britain.
Guidance on placing UKCA- or CE-marked products on the market in Great Britain continues to apply for manufacturers and distributors preparing devices for the British market.
For patients and the NHS, the stated effect of the decision is continuity: devices already supplied under CE certification can remain available without a separate Great Britain approval process, while the UKCA pathway continues for those who use it.