Government confirms indefinite recognition of CE marked medical devices

Patients across Great Britain will continue to have access to the medical devices and in vitro diagnostic devices (IVDs) they rely on, from insulin pumps and replacement joints to diagnostic tests and surgical equipment, after the government has today, 21 October 2026, confirmed it will continue to accept CE marked medical devices on a long-term basis.  

The decision follows a public consultation, which ran from 16 February 2026 to 10 April 2026, that received more than 1,000 responses from patients, healthcare organisations, industry and others. 

The decision means the UK will not require an additional approval route for devices already approved for the EU market, avoiding duplication for manufacturers and helping to maintain stable supply and patient access to medical technologies. 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, and this approval has been recognised to provide access to the Great British market. Continuing to recognise these devices will help maintain safe, uninterrupted access to the treatments and technologies that patients and the NHS rely on. This sits alongside the UKCA marking route, which continues to operate as the domestic approval pathway for devices placed on the market in Great Britain. 

These arrangements sit alongside strengthened post-market surveillance and reporting requirements already in place. The MHRA will continue to oversee all devices on the UK 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.