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 is intended to preserve patient access to technologies such as insulin pumps, replacement joints, diagnostic tests and surgical equipment.
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.
Under the decision, devices already approved for the EU market will not need an additional UK approval route. The government said this avoids duplication for manufacturers and helps maintain stable supply and patient access. 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 for access to the Great British market.
Continuing to recognise these devices is expected to help maintain safe, uninterrupted access to the treatments and technologies that patients and the NHS rely on. 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.