The UK government has confirmed that CE-marked medical devices and in vitro diagnostic devices will continue to be accepted in Great Britain on a long-term basis.
The decision means patients will retain access to devices ranging from insulin pumps and replacement joints to diagnostic tests and surgical equipment. Devices already approved for the EU market will not need an additional UK approval route, a step intended to avoid duplication for manufacturers and help maintain stable supply and patient access.
The confirmation follows a public consultation held from 16 February to 10 April 2026, which received more than 1,000 responses from patients, healthcare organisations, industry and other stakeholders. The decision had been widely anticipated by industry.
According to the government, more than 90% of medical devices currently registered for use in Great Britain carry a CE mark. Recognition of that approval provides access to the Great British market. Continuing to recognise CE-marked devices is intended to support safe, uninterrupted access to treatments and technologies used by patients and the NHS.
The UKCA marking route continues to operate as the domestic approval pathway for devices placed on the market in Great Britain. Guidance on placing UKCA or CE-marked products on the market in Great Britain remains available.