The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on proposals to allow indefinite recognition of CE-marked medical devices in Great Britain, a move intended to safeguard patient access and maintain the continuity of medical device supply.
Approximately 90% of medical devices currently used in Great Britain carry a CE mark. The MHRA says that indefinite recognition would provide long-term certainty for manufacturers and healthcare providers, building on transitional arrangements introduced in 2023. The proposals form part of the Agency’s broader programme of medical device regulatory reform, aimed at being risk-proportionate, innovation-friendly and patient-centred.
The consultation seeks views on three main proposals:
- Extending existing transitional arrangements for devices certified under the EU Medical Device Directive, aligning Great Britain’s timelines with the European Union’s transition to the EU Medical Device Regulation to reduce the risk of supply disruption
- The indefinite recognition of devices compliant with the EU Medical Device Regulation and the EU In Vitro Diagnostic Regulation
- The introduction of an international reliance route for a limited number of CE-marked devices that would fall into higher risk classes under Great Britain rules, providing additional oversight while maintaining market access
Alongside indefinite CE recognition, the MHRA plans to position the UKCA marking as a specialist route for first-in-market innovative products, including artificial intelligence-based medical devices. The Agency says this approach aligns with wider government policy on manufactured goods and with ambitions set out in the Life Sciences Sector Plan and the 10-Year Health Plan.
If adopted, this could potentially increase the efficiency between CE and UKCA pathways, reduce regulatory cost burden and provide long-term clarity for manufacturers operating in the UK and EU simultaneously.
The downstream potential impact for healthcare systems and patients is positive, seeking to secure continued access to a wide range of safe, innovative medical devices while supporting the UK’s broad regulatory reforms.
The consultation opened on 16 February 2026 and closes on 10 April 2026, with responses invited from industry, healthcare professionals, patient groups and the public. Responses can be made online here.
