MHRA consultation on indefinite recognition of CE-marked medical devices: Legal comment

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is consulting on whether it should indefinitely recognise CE-marked medical devices in Britain.

The regulator said 90% of medical devices used in the UK are CE marked – which indicates compliance with EU health and safety standards.

Since leaving the EU, Britain launched its own UKCA marking regime and general medical devices with CE marking are only recognised in the UK until 30 June 2028. Other products, including in vitro diagnostic medical devices, can be placed on the British market until 30 June 2030.

The consultation, launched today and forming part of the MHRA’s wider programme of regulatory reform of medical devices, runs until 10 April 2026. It seeks views on three key proposals:

1. Extending current transitional arrangements for devices certified under the EU Medical Device Directive, aligning UK timelines with the EU’s transition to the EU Medical Device Regulation (EU MDR) to minimise the risk of supply disruption.
2. Indefinite recognition of EU MDR and EU IVDR-compliant devices, to reduce the risk of interruption to the supply of medical devices for patients in Britain. 
3. Introducing an international reliance route for a small proportion of CE-marked devices that would fall into a higher risk class under GB rules, to ensure appropriate oversight while maintaining access. 

Gerard Hanratty, Head of Health and Life Sciences at UK and Ireland law firm Browne Jacobson, said: “If the UK healthcare system is to benefit from the innovation that medical device manufacturers can deliver, it makes sense for Britain to form a closer regulatory relationship with the EU.

“The size of the EU market means the UK could risk falling behind European countries in adopting the latest MedTech innovations by running two separate regulatory regimes.

“Enhanced regulatory agility is one of the key recommendations in our white paper, Advancing inward investment into the UK health sector.

“Since leaving the EU, a combination of post-Brexit bureaucracy and regulatory complexities has resulted in fragmented investment efforts, a decline in SME engagement and may ultimately reduce Britain’s attractiveness as a strategic gateway to Europe. Many of our clients say regulatory uncertainty has affected business planning and funding opportunities.

“Alongside an indefinite recognition of CE marking in Britain, we would like to see the UK health and life sciences sectors leverage their post-Brexit regulatory freedoms to streamline approval pathways for low-risk MedTech and digital health innovations.

“This includes creating AI regulations that enable a flexible approach and agreement with Europe, as well as other jurisdictions, on reciprocity of authorisation approvals. This would support the government’s ambition to become a central player in life sciences globally.

“Adequately funding and empowering the MHRA will be critical to this effort, enabling faster approvals, fostering international collaboration, and ensuring the UK remains competitive in attracting cutting-edge solutions.”