The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a public consultation on proposals that could allow medical devices with CE marks to be recognised indefinitely in Great Britain. This initiative is expected to have significant implications for medical technology suppliers in both the UK and Europe.
Currently, about 90% of medical devices used in Great Britain carry a CE mark. The MHRA’s proposed changes aim to ensure continued supply, reduce regulatory complexity, and maintain patient access to safe technologies.
The consultation focuses on three main measures. First, it suggests extending transitional arrangements for devices certified under the Medical Device Directive (MDD), aligning British timelines with the European Union’s move from MDD to the Medical Device Regulation (EU MDR). This is intended to minimise disruption and prevent manufacturers from facing overlapping regulatory deadlines.
Second, the plan would allow indefinite recognition of devices compliant with EU MDR and In Vitro Diagnostic Regulation (IVDR), removing any set end date for their acceptance in Great Britain. This change could lower costs and simplify market access for suppliers.
Third, for higher-risk CE-marked devices that fall into stricter categories under British rules, an international reliance mechanism is proposed. This would provide additional oversight while ensuring patients and providers retain access to necessary products.
Alongside these changes, the MHRA intends to reposition the UKCA mark as a specialised route for innovative technologies such as AI-driven medical devices. The dual-track system would support both ongoing stability through CE recognition and encourage innovation via UKCA marking.
According to the agency, this approach aligns with government strategies aimed at making the UK a global leader in MedTech by 2030. It also reflects broader policy decisions already made in other manufacturing sectors regarding continued CE recognition.
MHRA Chief Executive Lawrence Tallon said industry input was central: “The number one request that the med tech industry made of us was to provide long term certainty over CE recognition,” he stated. He added that this approach addresses both patient interests and reduces burdens on businesses.
While these proposals are designed to ease market entry, the MHRA emphasised its commitment to patient safety by continuing efforts to strengthen post-market surveillance and improve information sharing with EU partners—a key point for those concerned about regulatory standards.
The consultation is open until April 10th, 2026, inviting feedback from manufacturers, clinicians, patient groups, Approved Bodies, UK Responsible Persons, and members of the public.
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