The UK government has confirmed that it will continue to accept CE marked medical devices in Great Britain on a long-term basis, and will not require an additional approval route for products already approved for the European market.
The decision covers medical devices and in vitro diagnostic devices (IVDs), a group that ranges from insulin pumps and replacement joints to diagnostic tests and surgical equipment. It follows a public consultation that ran from 16 February 2026 to 10 April 2026 and received more than 1,000 responses from patients, healthcare organisations, industry and others.
What the decision changes
Devices assessed and approved for the European market will keep their route to patients in Great Britain without a separate UK approval step. The government presents the move as a way to avoid duplication for manufacturers and to help maintain stable supply and patient access to medical technologies.
According to the announcement, 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. Continued recognition means that this approval will keep providing access to the Great British market for the large majority of registered products.
UKCA route continues
The UKCA marking route remains in operation as the domestic approval pathway for devices placed on the market in Great Britain, so the two routes sit alongside each other rather than one replacing the other.
The government pointed manufacturers to existing guidance on placing UKCA or CE marked products on the market in Great Britain.