The UK government will continue recognising CE marked medical devices on a long-term basis, allowing products approved for the EU market to remain available to patients across the country. The Medicines and Healthcare products Regulatory Agency (MHRA) announced the decision on 21 October after a public consultation received more than 1,000 responses.
The consultation ran from 16 February to 10 April 2026 and drew responses from patients, healthcare organisations and industry. The government says the decision covers medical devices and in vitro diagnostic devices (IVDs), including insulin pumps, replacement joints, diagnostic tests and surgical equipment.
CE Marked Medical Devices Keep Their Existing Route
Under the decision, the UK will not require an additional approval route for devices already approved for the EU market. The government says avoiding a duplicate route will reduce repeated work for manufacturers and help 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 remain in operation alongside CE recognition as the domestic approval pathway for devices placed on the UK market.
The government is modernising UKCA through a pre-market statutory instrument that will update its requirements. The two routes will continue side by side under the announced arrangement.
UKCA Updates and Future Licensing Plans
The government also intends to seek enabling powers through primary legislation to develop a future licensing approach for medical devices. It says this is intended to create a more adaptable framework as technologies advance, including software and artificial intelligence (AI) medical devices.
The plans reflect recommendations from the National Commission into the Regulation of AI in Healthcare, according to the government. The source gives no timetable for the future licensing approach or its final requirements.
The MHRA will continue overseeing every device on the UK market and monitoring safety through mechanisms that include the Yellow Card scheme. It will also share safety information with international partners. These measures sit alongside strengthened post-market surveillance and reporting requirements already in place.
Readers can review the MHRA’s 2030 strategy. Meditech Today has also covered how regulators assess digital tools, including AI scribes with possible regulated functions.
Implementation Will Include Patient Engagement
MHRA chief executive Lawrence Tallon said the decision gives patients, the NHS and industry long-term certainty about access to medical devices. He said continued CE recognition is intended to maintain uninterrupted access across Great Britain, from life-saving diagnostics to everyday treatments.
Tallon said the regulator would continue overseeing device safety and working with international partners to act on concerns. He linked the decision with wider reforms for innovative technologies, including AI-powered medical devices.
Steve Lee, executive director for regulation at the Association of British HealthTech Industries (ABHI), said predictable rules and avoiding unnecessary duplication matter to industry investment decisions. He said those decisions ultimately affect how quickly patients can access new technologies.
Lee welcomed long-term CE recognition as a source of certainty for manufacturers and said it would support patient access and the UK’s position as a HealthTech market. He also said the approach could support continuity of supply and access to medical devices, IVDs and digital health technologies used by UK patients, citizens and the NHS.
The government says it will continue engaging with patients, clinicians and industry as the arrangements are implemented. It plans sessions with patient groups to explain its response and address questions about safety and oversight. A separate report examines medical device certification activity.
The next stated step is that engagement programme, alongside continued CE recognition and the UKCA route. The source does not give dates for the sessions or a timetable for the planned legislative work.
