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, meaning products already approved for the European market will not need a separate British approval.
The decision covers devices that patients and the NHS rely on, from insulin pumps and replacement joints to diagnostic tests and surgical equipment. The government said continued recognition of CE marking would help maintain safe, uninterrupted access to those treatments and technologies.
Consultation and the size of the CE-marked register
The confirmation 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 others. The government described the outcome as widely anticipated.
According to the announcement, 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 and that approval has been recognised as providing access to the British market. Because no additional approval route will be required for those devices, manufacturers avoid duplicated assessment, which the government links to stable supply and patient access.
CE recognition sits alongside the UKCA marking route, which continues to operate as the domestic approval pathway for devices placed on the market in Great Britain. The two therefore run in parallel: CE marking keeps European-approved devices on the British market, while UKCA marking remains available for domestic approvals. The government pointed to existing guidance on placing UKCA or CE-marked products on the market in Great Britain.
The announcement sets no end date for CE recognition and describes the arrangement as long-term rather than transitional.