The UK government has confirmed that CE-marked medical devices and in vitro diagnostic devices (IVDs) will continue to be recognised in Great Britain on a long-term basis, removing the prospect of a separate approval step for products already certified for the European market.
The decision covers the technologies patients and the NHS depend on, from insulin pumps and replacement joints to diagnostic tests and surgical equipment, and is intended to keep access to them safe and uninterrupted.
It follows a public consultation held between 16 February and 10 April 2026, which received more than 1,000 responses from patients, healthcare organisations, industry and others.
The widely anticipated outcome means the UK will not require an additional approval route for devices already approved in the EU, avoiding duplication for manufacturers and helping to maintain stable supply. More than 90% of medical devices currently registered for use in Great Britain carry a CE mark, indicating they have been assessed and approved for the European market, with that approval recognised as providing access to the Great British market.
UKCA marking continues alongside CE
The UKCA marking route remains in place as the domestic approval pathway for devices placed on the market in Great Britain. Guidance on placing UKCA or CE-marked products on the British market continues to apply, and the two routes now sit side by side.