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, and that an additional approval route will not be required for devices already approved for the EU market.
The decision follows a public consultation that ran from 16 February to 10 April 2026 and received more than 1,000 responses from patients, healthcare organisations, industry and other respondents.
The devices affected span insulin pumps, replacement joints, diagnostic tests and surgical equipment. According to the government, 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 as providing access to the Great British market.
What the decision changes
Manufacturers will not face duplication between the EU and UK systems, which the government says will help maintain stable supply and patient access to medical technologies. The UKCA marking route continues to operate as the domestic approval pathway for devices placed on the market in Great Britain, so both routes remain in use.
Continued recognition is intended to preserve safe, uninterrupted access to the treatments and technologies that patients and the NHS rely on. Guidance on placing UKCA or CE-marked products on the market in Great Britain remains available.