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This article was co-authored by Hannah Green, Litigation Assistant.
The Medicines and Healthcare products Regulatory Agency (MHRA) recently announced its intention to consult later this year on the indefinite recognition of CE marked medical devices in Great Britain (GB). This proposal addresses a critical regulatory issue that has been a priority for manufacturers, healthcare providers, and patient groups since the UK’s departure from the European Union (EU).
What is the indefinite recognition of CE marking?
CE marking is the conformity mark indicating that a medical device meets EU safety, health, and environmental protection requirements. Prior to Brexit, CE marking was the standard regulatory approval required for marketing medical devices across the European Economic Area, including the UK.
Following Brexit, GB introduced its own regulatory mark — the UK Conformity Assessed (UKCA) marking — aimed at replacing the CE mark for products placed on the GB market. However, a transitional period was initially set to allow continued acceptance of CE marked devices until 30 June 2028 for most devices, with extended deadlines for certain device classes until 30 June 2030.
The MHRA’s new proposal would remove these sunset dates and enable CE marked medical devices to be recognized indefinitely in GB, allowing devices meeting EU standards to remain on the GB market without requiring immediate re-certification under UKCA requirements.
Why this proposal matters
The indefinite recognition of CE marking is a practical, proportionate regulatory step that responds directly to longstanding industry concerns. Since the introduction of UKCA marking, manufacturers, distributors, and healthcare providers have faced uncertainty about the regulatory status of CE marked devices and the timelines for transitioning to UKCA.
By allowing CE marked devices to continue to be accepted indefinitely, the MHRA aims to:
- Ensure patient access: Patients and clinicians in GB will maintain uninterrupted access to a broad range of established and innovative medical devices without supply chain disruptions.
- Provide regulatory certainty: Manufacturers gain clarity on regulatory expectations, reducing the risk of costly delays and compliance challenges.
- Support innovation and competitiveness: The move reduces duplication of regulatory work and positions the GB as a globally competitive market that aligns with international standards whist promoting innovation.
The Association of British HealthTech Industries (ABHI), a key industry body, has been a vocal advocate for indefinite CE recognition, identifying this as a major regulatory priority that supports both patient safety and economic growth.
Broader regulatory context
The MHRA’s proposal is part of a wider effort to modernise and streamline medical device regulation in GB. Alongside indefinite CE mark recognition, the MHRA plans reforms such as expanding reliance on trusted international regulators (including the US Food and Drug Administration – FDA, and Australia’s Therapeutic Goods Administration - TGA), promoting innovation via the UKCA route for first-to-market devices, and adopting a risk-based approach to in vitro diagnostics.
This balanced regulatory strategy aims to maintain high safety standards while reducing burdens on manufacturers and accelerating patient access to new technologies.
Impact on stakeholders of proposed indefinite CE mark recognition
- Manufacturers
The indefinite CE mark recognition reduces pressure to transition products rapidly to UKCA marking, allowing companies to focus on innovation and market expansion rather than navigating complex dual regulatory systems. It also decreases regulatory costs and resource duplication, enabling more investment in research and development.
- Healthcare providers and patients
Clinicians can be confident that devices already in use and trusted for safety and effectiveness will remain available. This continuity helps prevent disruptions in clinical care and maintains high standards of treatment.
- Regulators
The MHRA can allocate resources more efficiently by prioritising innovative products entering the market via UKCA while leveraging established regulatory approvals through CE marking. This enables a sharper focus on safety monitoring and support for cutting-edge medical technologies.
Next steps: the consultation and beyond
The MHRA plans to launch a formal consultation later this year to seek detailed feedback from manufacturers, healthcare providers, patient groups, and other stakeholders on the proposal for indefinite CE mark recognition. The consultation will explore practical implementation details, including any safeguards or conditions necessary to maintain patient safety.
The MHRA has committed to transparency and collaboration, recognising that regulatory certainty is key to supporting the domestic MedTech sector.
The MHRA will also notify the World Trade Organization of any changes to its medical device regulations as part of its international obligations, maintaining alignment and communication with global trading partners.
Comment
The MHRA’s intention to consult on the indefinite recognition of CE marked medical devices marks a significant milestone in GB’s evolving medical device regulatory landscape. By providing long-term certainty around CE mark recognition, the UK is poised to enhance patient access, support industry innovation, and strengthen its position as a global leader in medical technology.
Life sciences
United Kingdom