Government confirms indefinite recognition of CE marked medical devices

Patients across Great Britain will have continued access to medical devices and in vitro diagnostic devices (IVDs) already approved for the EU market.

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.

In parallel, the UKCA route remains the current domestic approval route for medical devices placed on the market in Great Britain. This is being modernised through the pre-market statutory instrument, which will update the requirements devices must meet to be UKCA marked. Alongside this, we will continue to seek enabling powers through primary legislation to develop a future licencing approach for medical devices, intended to support a more modern and adaptable framework that is better able to respond to advancing medical technologies, including software and AI medical devices, reflecting recommendations from the National Commission into the Regulation of AI in Healthcare.

Our approach will secure supply of medical devices for UK patients while also supporting safe, rapid access to innovation so that patients can benefit from the best new technologies. By providing a clear and predictable regulatory framework. The approach supports the development and availability of new health technologies for patients, in line with the ambitions of the Government’s Life Sciences Sector Plan and 10 Year Health Plan.

Continued recognition of CE-marked devices also reflects the wider ambition 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.

Lawrence Tallon, Chief Executive of the MHRA, said:

“This decision gives patients, the NHS and industry the long-term certainty they need on access to medical devices. By continuing to recognise CE marked devices, we’re ensuring that patients across Great Britain maintain uninterrupted access to the medical technologies they depend on, from life-saving diagnostics to everyday treatments, while our wider device reforms will ensure our regulatory framework is ready for the innovative technologies of tomorrow, including AI-powered medical devices. The MHRA will continue to oversee the safety of every device on the UK market, and we remain committed to working closely with international partners to identify and act on safety concerns quickly.”

Steve Lee, Executive Director, Regulation, ABHI, said:

“Regulatory predictability and avoiding unnecessary duplication are fundamental to industry investment decisions, which ultimately determine how quickly patients can access new technologies. Long-term recognition of CE marking is therefore a significant and welcome decision, providing much-needed certainty for manufacturers, safeguarding patient access and strengthening the UK’s position as an attractive and competitive market for HealthTech.

“We look forward to its implementation, with this practical and proportionate approach supporting continuity of supply and ensuring friction-free access to the medical devices, IVDs and digital health technologies on which UK patients, citizens and the NHS rely.”

The government will continue to engage with patients, clinicians and industry as these arrangements are implemented, including a programme of engagement sessions with patient groups to explain the response and address questions on safety and oversight.

Notes to Editors

The consultation on the future regulation of medical devices sought views on the indefinite recognition of CE marked devices in Great Britain.

The MHRA will continue to oversee all devices on the UK market and has strengthened its post-market surveillance activity.

Further information on the government’s response, including the full consultation outcome, is available at Medical devices regulations: targeted consultation on the indefinite recognition of CE marked devices - GOV.UK

The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. The MHRA is an executive agency of the Department of Health and Social Care.

For media enquiries, please contact newscentre@mhra.gov.uk or call 020 3080 7651.