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, keeping EU-approved products on the market without a separate domestic approval step.
The decision follows a public consultation that ran from 16 February to 10 April 2026 and drew more than 1,000 responses from patients, healthcare organisations, industry and other stakeholders.
Officials said the outcome safeguards access to the devices patients depend on, from insulin pumps and replacement joints to diagnostic tests and surgical equipment.
The government noted that 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 this approval has been recognised as providing access to the Great British market. Continued recognition is intended to avoid duplication for manufacturers and to help maintain stable supply and patient access to the technologies relied on by patients and the NHS.
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 GB market has been published.
The announcement had been widely anticipated ahead of the government's confirmation.