The UK Government has announced that patients across Great Britain will have continued access to medical devices and in vitro diagnostic devices (IVDs) already approved for the EU market.

The Medicines and Healthcare products Regulatory Agency (MHRA) will continue to accept CE-marked medical devices on a long-term basis, it was confirmed today after a public consultation that closed in April this year. 

It 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. 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.

Gerard Hanratty, Partner and 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 would 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 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.”