The UK government has confirmed that CE-marked medical devices will continue to be accepted in Great Britain on an indefinite, long-term basis, removing the prospect of an additional national approval step for products already certified for the European market.
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 others. The government said the outcome means patients across Great Britain will keep access to the medical devices and in vitro diagnostics they rely on, from insulin pumps and replacement joints to diagnostic tests and surgical equipment.
Manufacturers will not need an additional approval route for devices already approved in the EU, which the government says avoids duplication and helps maintain stable supply and patient access. A CE mark indicates that a device has been assessed and approved for the European market, and that approval has been recognised as giving access to the Great British market. According to the announcement, more than 90% of medical devices currently registered for use in Great Britain carry a CE mark.
The CE route will sit alongside UKCA marking, which 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 British market remains in place.