MHRA proposes indefinite recognition of CE-marked medical devices in UK

The UK’s medicines regulator has launched a consultation on allowing CE-marked medical devices to be recognised indefinitely in Great Britain. The move aims to safeguard access to critical health technologies while reducing regulatory barriers for manufacturers and supporting innovation across the UK care sector.

MHRA proposes indefinite recognition of CE-marked medical devices in UK

The UK’s medical device regulator has opened a consultation on plans that could reshape how health technologies enter the British market.

Medicines and Healthcare products Regulatory Agency (MHRA) is seeking feedback on proposals to allow CE-marked medical devices to be recognised indefinitely in Great Britain. The move is designed to ensure patients continue to have access to essential technologies while reducing regulatory friction for manufacturers supplying the UK health and care system.

The consultation, which runs from 16 February to 10 April 2026, forms part of the MHRA’s broader programme of regulatory reform aimed at making the UK an attractive destination for health technology innovation.

With around 90% of medical devices currently used in Great Britain carrying the European CE mark, the decision could have wide-ranging implications for manufacturers, NHS organisations and care providers.

A post-Brexit regulatory challenge

Since leaving the EU, the UK has been developing its own regulatory framework for medical devices. The government introduced the UKCA mark as the domestic certification system intended to replace the European CE mark.

In practice, however, the transition has been slower than originally planned. To avoid disruption to supply chains, the government has repeatedly extended the period during which CE-marked devices can still be used in Great Britain.

Many of those devices are certified under European frameworks such as the EU Medical Device Regulation and the EU In Vitro Diagnostic Medical Device Regulation.

These rules cover a broad range of technologies, including digital diagnostics, remote monitoring equipment and AI-enabled medical software that are increasingly used across community health services and home care settings.

What the consultation proposes

At the centre of the consultation is a proposal to recognise devices approved under EU regulations indefinitely in Great Britain. In practice, this would mean CE-marked devices compliant with EU MDR or IVDR could continue to be placed on the UK market without needing additional certification from a UK approved body, although they would still need to be registered with the MHRA.

The regulator is also considering an “international reliance” route for devices that would fall into a higher risk category under UK rules. In those cases, a UK approved body would carry out a targeted review that takes account of the EU assessment before allowing the product onto the market.

Finally, the MHRA has proposed a six-month extension to existing transitional arrangements for some older devices certified under the previous EU Medical Device Directive. This would align UK timelines with the EU’s transition to newer regulatory rules and help avoid disruption to supply.

Industry push for regulatory certainty

Medical technology companies have long called for greater clarity on the UK’s regulatory direction following Brexit.

Lawrence Tallon, chief executive of the MHRA, said the consultation reflects direct feedback from industry.

“The number one request that the med tech industry made of us was to provide long-term certainty over CE recognition,” he said.

“It is in the best interests of British patients to ensure continued access to the latest medical devices approved in Europe. It is also in the best interests of the med tech sector to reduce friction and costs of doing business.”

Tallon added that the UK’s own certification route would increasingly focus on innovative products entering the market for the first time, including artificial intelligence systems used as medical devices.

Growth in digital health innovation

The consultation comes at a time of growing activity in digital health and medical technology development in the UK.

The MHRA reported a 17% increase in approved clinical investigations in 2025 compared with the previous year. The regulator has also seen a rise in studies involving emerging technologies such as neurotechnology and AI-powered diagnostics.

Many of these innovations are aimed at improving early diagnosis, supporting remote care and enabling more personalised treatment. For NHS community services and care providers delivering support at home, these technologies are becoming an increasingly important part of care delivery.

Ensuring the UK remains an accessible market for these products is therefore a key concern for both regulators and industry.

What it means for the UK care sector

For organisations across the UK care sector, from NHS community services to home care providers, access to medical technology is closely linked to the ability to deliver more care outside hospital settings.

Digital monitoring devices, connected diagnostic tools and assistive technologies are playing a growing role in supporting people with long-term conditions at home. Many of these products are developed and approved for international markets, particularly in Europe.

Allowing CE-marked devices to remain available in Great Britain could help ensure care providers continue to access the same technologies used across the EU while avoiding delays caused by duplicate regulatory processes.

At the same time, the MHRA says it will continue strengthening post-market surveillance and collaboration with European regulators to ensure patient safety remains central to the system.