The UK government has confirmed that CE-marked medical devices and in vitro diagnostic devices (IVDs) will be recognised in Great Britain on an indefinite, long-term basis. The decision means patients will continue to have access to devices ranging from insulin pumps and replacement joints to diagnostic tests and surgical equipment.
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 other stakeholders. The decision had been widely anticipated.
No separate approval route
Under the confirmed approach, the UK will not require an additional approval route for devices already approved for the EU market. The government said this avoids duplication for manufacturers and helps maintain stable supply and patient access to medical technologies, while preserving the existing domestic route.
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. That approval has been recognised as providing access to the Great British market. Continuing to recognise these devices is intended to help maintain safe, uninterrupted access to treatments and technologies relied on by patients and the NHS. The government said the approach would preserve access without creating a parallel approval requirement for products that have already undergone EU assessment.
UKCA marking remains in place
The UKCA marking route continues to operate as the domestic approval pathway for devices placed on the market in Great Britain. The long-term recognition of CE marking therefore sits alongside UKCA marking rather than replacing it, leaving two routes available for products sold in Great Britain.
Guidance on placing UKCA- or CE-marked products on the market in Great Britain remains available. The government's announcement focused on continuing CE recognition for devices already approved in the EU, while retaining the UKCA route for the domestic market. The guidance covers products bearing either marking.
For manufacturers, the outcome removes the need for a separate approval process for devices that already hold EU approval, according to the announcement. For patients and the NHS, the stated aim is continuity of access to a broad range of medical technologies, from diagnostic tests to implantable devices and surgical equipment.
The consultation captured views from patients, healthcare organisations, industry and others. The government said the long-term acceptance of CE-marked devices would help avoid duplication and support stable supply, while the UKCA pathway remains available for devices placed on the British market.