The UK government has confirmed that it will continue to recognise CE-marked medical devices and in vitro diagnostic devices (IVDs) on a long-term basis.
The decision means manufacturers will not need to obtain a separate UK approval for medical devices already approved for the European Union market.
According to a release issued by the Medicines and Healthcare products Regulatory Agency (MHRA) on October 21, the decision follows a public consultation held from February 16 to April 10, 2026, which received more than 1,000 responses from patients, healthcare organisations, industry representatives and other stakeholders.
Recognition of CE-markedmedical devices, the agency noted, reduces regulatory duplication for manufacturers while helping maintain supply continuity and patient access to medical technologies.
According to MHRA, over 90% of medical devices registered for use in Great Britain currently carry a CE mark. “Continuing to recognise these devices will help maintain safe, uninterrupted access to the treatments and technologies that patients and the NHS rely on,” the agency said.
The CE-marking arrangement will operate alongside the UK Conformity Assessed (UKCA) marking route, which remains the domestic regulatory pathway for medical devices placed on the Great Britain market.
Meanwhile, the government is modernising the UKCA route through a pre-market statutory instrument that will update the requirements for devices seeking UKCA marking.
Additionally, the UK government plans to establish a future licensing framework for medical devices, designed to be more adaptable to technological advances, including software and artificial intelligence-enabled medical devices. The proposed framework reflects recommendations from the National Commission into the Regulation of AI in Healthcare.
Lawrence Tallon, chief executive of the MHRA, said, “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.”
Tallon said the MHRA would continue to oversee the safety of all devices on the UK market and work closely with international partners to identify and address potential safety concerns promptly.
Steve Lee, executive director, Regulation, Association of British HealthTech Industries (ABHI), welcomed the decision, highlighting the importance of regulatory certainty for investment and patient access.
“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.”
Lee added that ABHI looked forward to the implementation of the decision, saying the approach would support continuity of supply and access to medical devices, IVDs and digital health technologies relied upon by patients, citizens and the NHS.
