United Kingdom Will Continue to Recognize European CE Mark for Medical Devices

October 26, 2026—The United Kingdom’s Medicines and Healthcare Agency (MHRA) announced that the government confirmed it will continue to accept CE Mark-approved medical devices on a long-term basis.

According to MHRA, the United Kingdom will not require an additional approval route for devices already approved for the European market, avoiding duplication for manufacturers and helping to maintain stable supply and patient access to medical technologies. Patients in Great Britain will have continued access to medical devices and in vitro diagnostic devices already approved for the European Union market.

The agency stated that more than 90% of medical devices registered for use in Great Britain currently carry a CE Mark. The UK Conformity Assessed (UKCA) marking route continues to operate as the domestic approval pathway for devices placed on the market in Great Britain.

The MHRA advised it will continue to oversee all devices on the United Kingdom market, monitor safety through mechanisms including the Yellow Card scheme, and work closely with international partners to share safety information enabling the MHRA to take action to protect patients where needed. Additionally, the UKCA route is being modernized through the premarket statutory instrument, which will update the requirements devices must meet to be UKCA marked.

Continued recognition of CE Mark devices reflects the intention of the MHRA’s 2030 Strategy to expand reliance and recognition routes with trusted regulators, reducing regulatory burden, strengthen supply resilience, and supporting timely patient access, stated the agency.

MHRA noted that the decision follows a public consultation on the future regulation of medical devices that sought views on the indefinite recognition of CE Mark-approved devices in Great Britain. The consultation was conducted from February 16 to April 10, 2026, and received more than 1,000 responses from patients, healthcare organizations, industry and others.

The complete MRHA announcement and the full consultation outcomes are available online.