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, a widely anticipated outcome that removes the prospect of an extra national approval step for products already cleared for the European market.
The confirmation covers devices used across routine and specialist care, from insulin pumps and replacement joints to diagnostic tests and surgical equipment, and is intended to keep them available to patients and the NHS without interruption.
It 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 stakeholders.
No duplicate approval route
Under the decision, manufacturers of devices already approved for the EU market will not be required to go through an additional British approval route. That avoids duplicated assessment work for companies and is intended to help maintain stable supply and patient access to medical technologies.
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 British market. Continuing to recognise those devices is presented as a way of maintaining safe, uninterrupted access to the treatments and technologies relied on by patients and the NHS.
The UKCA marking route continues to operate alongside CE recognition as the domestic approval pathway for devices placed on the market in Great Britain, and guidance on placing UKCA or CE-marked products on the British market remains available.