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. The decision covers products ranging from insulin pumps and replacement joints to diagnostic tests and surgical equipment.
It 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 others.
The confirmation means the UK will not require an additional approval route for devices already approved for the European market. The approach avoids duplication for manufacturers and helps maintain stable supply and patient access to medical technologies.
CE marking remains central to supply
More than 90% of medical devices registered for use in Great Britain currently carry a CE mark, meaning they have been assessed and approved for the European market. Recognition of that approval provides access to the Great British market. Continuing to recognise these devices is intended to help maintain safe, uninterrupted access to treatments and technologies relied on by patients and the NHS.
The CE-mark route sits alongside UKCA marking, which 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.