Government confirms indefinite recognition of CE medical devices

The UK Government has confirmed that patients across the UK 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. On 21 October 2026, the government confirmed that it will continue to accept CE marked medical devices on a long-term basis.

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 which means they have been assessed and approved for the European market and this approval has been recognised to provide access in the 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. 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. They will also work closely with international partners to share safety information so they can take action to protect patients where needed.

At the same time, the UKCA route remains the current domestic approval route for medical devices placed on the market in Great Britain. This is being modernised to update the requirements devices must meet to be UKCA marked, alongside seeking powers through primary legislation to develop a future licencing approach for medical devices intended to support a more modern and adaptable framework.

Importantly, this decision gives patients the long-term assurance they need on access to medical devices, as well as the NHS and industry. The continuation of recognition of CE marked devices patients across the UK can maintain uninterrupted access to the medical technologies they depend on, from life-saving diagnostics to everyday treatments. The MHRA will continue to oversee the safety of every device on the UK market.