Key Takeaways
- The MHRA has initiated a consultation for the indefinite recognition of CE-marked medical devices in Great Britain.
- Indefinite recognition aims to ensure patient access and a consistent supply of safe medical technologies.
- Feedback is sought from various stakeholders to enhance the regulatory framework for medical devices.
Consultation Launched on CE-Marked Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on proposals to grant indefinite recognition of CE-marked medical devices in Great Britain. This initiative aims to protect patient access and ensure a steady supply of safe and effective medical technologies.
Currently, around 90% of medical devices utilized in Great Britain are CE-marked, and the MHRA argues that such indefinite recognition will facilitate a consistent long-term supply, thereby supporting the healthcare system comprehensively. The consultation seeks feedback on extending arrangements put in place in 2023 designed to recognize CE-marked devices, forming part of the MHRA’s broader regulatory reform of medical devices.
Lawrence Tallon, chief executive of the MHRA, emphasized that providing long-term certainty regarding CE recognition was a primary request from the MedTech industry. “It is in the best interests of British patients to ensure continued access to the latest medical devices approved in Europe,” he stated. Tallon also noted that beneficial changes would minimize both friction and costs for businesses within the sector.
In addition to the indefinite recognition proposals, the MHRA plans to reposition the UK Conformity Assessed (UKCA) route as a specialized channel for innovative products entering the market, particularly those involving artificial intelligence in healthcare. This decision is informed by the findings from the National Commission into the Regulation of AI in Healthcare, expected to report this summer.
The proposed measures include:
– Extending current transitional arrangements for devices certified under the EU Medical Device Directive.
– Implementing indefinite recognition for EU MDR and EU IVDR-compliant devices.
– Establishing an international reliance route for CE-marked devices categorized into higher risk classes in Great Britain.
These proposals aim to complement the domestic route to market, focusing on innovation support and helping the UK meet its ambition of becoming a leading hub for MedTech access by 2030, in alignment with the Life Sciences Sector Plan. Furthermore, the MHRA will continue to bolster post-market surveillance and strive to enhance information sharing with European partners.
The consultation is open from February 16, 2026, until April 10, 2026, with the agency encouraging input from medical device manufacturers, approved bodies, UK Responsible Persons, healthcare professionals, patient groups, and the public at large. Additionally, in August 2025, the MHRA unveiled plans that would allow manufacturers to supply innovative medical devices for unmet clinical needs to the NHS before securing full regulatory approval.
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