The UK government has confirmed that it will continue to accept CE marked medical devices on a long-term basis, meaning devices and in vitro diagnostic devices (IVDs) already approved for the EU market will remain available to patients across the UK.
The decision, announced on 21 October by the Medicines and Healthcare products Regulatory Agency (MHRA), follows a public consultation that ran from 16 February to 10 April 2026 and received more than 1,000 responses from patients, healthcare organisations and industry. The government says the products covered include insulin pumps, replacement joints, diagnostic tests and surgical equipment.
Under the decision, the UK will not require an additional approval route for devices already approved for the EU market. The government says this avoids duplication for manufacturers and helps to maintain stable supply and patient access. More than 90% of medical devices registered for use in the UK currently carry a CE mark.
The UK Conformity Assessed (UKCA) marking route will continue to operate alongside CE recognition as the domestic approval pathway for devices placed on the market in the UK. It is being modernised through a pre-market statutory instrument, which will update the requirements devices must meet to be UKCA marked.
The government also intends to continue seeking enabling powers through primary legislation to develop a future licensing approach for medical devices. This is intended to support a more adaptable framework that can respond to advancing technologies, including software and artificial intelligence (AI) medical devices, reflecting recommendations from the National Commission into the Regulation of AI in Healthcare.
The MHRA will continue to oversee all devices on the UK market and monitor safety through mechanisms including the Yellow Card scheme. It will also work with international partners to share safety information. These arrangements sit alongside strengthened post-market surveillance and reporting requirements already in place.
“This decision gives patients, the NHS and industry the long-term certainty they need on access to medical devices. 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. The MHRA will continue to oversee the safety of every device on the UK market, and we remain committed to working closely with international partners to identify and act on safety concerns quickly,” said Lawrence Tallon, chief executive of the MHRA.
Steve Lee, executive director, regulation, at Association of British HealthTech Industries (ABHI), said: “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.
“We look forward to its implementation, with this practical and proportionate approach supporting continuity of supply and ensuring friction-free access to the medical devices, IVDs and digital health technologies on which UK patients, citizens and the NHS rely.”
The government says it will continue to engage with patients, clinicians and industry as the arrangements are implemented, including a programme of engagement sessions with patient groups to explain the response and address questions on safety and oversight.
