The sector has welcomed the news that patients will have continued access to medical devices and in vitro diagnostic devices already approved for the EU market.

Patients will continue to have access to the medical devices and in vitro diagnostic devices (IVDs) after 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. More than 90% of medical devices registered for use in the UK 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 in Britain. 

In a statement, the government said that 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. 

“This decision gives patients, the NHS and industry the long-term certainty they need on access to medical devices,” said Lawrence Tallon, chief executive of the MHRA. 

“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,” he continued. 

Significant and welcome

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, strengthening supply resilience and supporting timely patient access.

What was immediately dubbed “hugely significant” news by regulatory specialist Elaine Gemmell of InnoScot Health was widely characterised as a pragmatic decision by the government. 

“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,” said Gerard Hanratty, partner and head of health and life sciences at UK and Ireland law firm Browne Jacobson. 

“Regulatory predictability and avoiding unnecessary duplication are fundamental to industry investment decisions, which ultimately determine how quickly patients can access new technologies,” added Steve Lee, executive director of regulation at ABHI, who also called it a “significant and welcome” decision. 

The government decision follows a public consultation, which ran from February to April this year and received more than 1,000 responses from patients, healthcare organisations, industry and others.