The UK government confirmed on 21 October 2026 that CE-marked medical devices and in vitro diagnostic devices (IVDs) will continue to be accepted in Great Britain on a long-term basis, according to the Medicines and Healthcare products Regulatory Agency (MHRA). The decision followed 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 others.

The MHRA said more than 90% of medical devices registered for use in Great Britain currently carry a CE mark. Under the confirmed approach, the UK will not require an additional approval route for devices already approved for the EU market. The UKCA marking route continues as the domestic approval pathway for devices placed on the market in Great Britain, and the MHRA said that route is being modernised through a pre-market statutory instrument.

MHRA Chief Executive Lawrence Tallon said the decision gives patients, the NHS and industry long-term certainty. Steve Lee, Executive Director, Regulation, at ABHI, welcomed the long-term recognition of CE marking. The MHRA said it will continue to oversee all devices on the UK market, monitor safety through mechanisms including the Yellow Card scheme, and engage with patient groups as the arrangements are implemented.