MHRA Opens Consultation on Indefinite CE Mark Recognition
•February 16, 2026
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Why It Matters
Indefinite CE recognition offers manufacturers regulatory certainty and cost savings, while maintaining patient safety through enhanced post‑market oversight. The shift also signals the UK’s strategic focus on MedTech innovation and market stability.
Key Takeaways
- •90% of GB devices currently CE‑marked.
- •Indefinite CE recognition reduces dual‑regulatory costs.
- •UKCA mark shifts to innovative, AI‑driven devices.
- •Higher‑risk CE devices face international reliance oversight.
- •Consultation closes 10 April 2026.
Pulse Analysis
Post‑Brexit, the United Kingdom has operated two parallel medical‑device regimes: the legacy CE system and the newer UKCA mark. The split has created compliance complexity for manufacturers seeking access to both EU and GB markets, prompting industry calls for clearer guidance. By proposing indefinite recognition of EU‑MDR and IVDR‑compliant devices, the MHRA aims to harmonise regulatory expectations, reduce duplicated testing, and prevent supply disruptions that could arise from divergent timelines. This approach mirrors broader government efforts to streamline trade‑related standards across sectors.
For MedTech firms, the proposal translates into tangible financial and operational benefits. Eliminating a fixed expiry for CE marks means manufacturers can avoid the costly process of re‑certifying products under UKCA, especially for legacy devices that dominate the market. The dual‑track model preserves the UKCA pathway for breakthrough innovations—particularly AI‑driven diagnostics—allowing companies to showcase cutting‑edge solutions without sacrificing the stability of established product lines. The targeted international reliance route for higher‑risk devices adds a layer of scrutiny while still facilitating market entry, balancing safety with commercial agility.
Patient safety remains central to the MHRA’s agenda. Strengthening post‑market surveillance and fostering information‑sharing with EU regulators ensures that indefinite CE recognition does not dilute oversight. Aligning the initiative with the Life Sciences Sector Plan underscores the UK’s ambition to become a global MedTech hub by 2030. As stakeholders submit feedback ahead of the April 2026 deadline, the outcome will shape the regulatory landscape, influencing investment decisions, supply‑chain resilience, and the pace of innovation across the British healthcare system.
MHRA Opens Consultation on Indefinite CE Mark Recognition
Chris Whitehouse, political consultant and expert on medical‑technology policy and regulation at Whitehouse Communications
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on proposals that could allow CE‑marked medical devices to be recognised indefinitely in Great Britain – a move poised to reshape regulatory planning for MedTech suppliers across the UK and Europe.
The consultation responds directly to long‑standing industry calls for clarity on the future of CE recognition. With an estimated 90 % of devices currently used in Great Britain carrying a CE mark, the MHRA’s proposals aim to secure long‑term supply continuity, reduce regulatory friction, and support patient access to safe and effective technologies.
Three Pillars of the Proposal
The consultation outlines three core measures that would form the basis of a new, more predictable regulatory environment:
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Extended transitional arrangements for MDD‑certified devices
The MHRA proposes aligning Great Britain’s transition timelines with the EU’s shift from the Medical Device Directive (MDD) to the Medical Device Regulation (EU MDR). This alignment is intended to minimise supply disruption and avoid divergence that could burden manufacturers with dual regulatory deadlines.
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Indefinite recognition of EU MDR and IVDR‑compliant devices
Under the plan, devices meeting the requirements of the EU MDR and In Vitro Diagnostic Regulation (IVDR) would continue to be accepted in Great Britain without a defined end date. For suppliers, this could significantly reduce the cost and complexity of maintaining access to the GB market.
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A targeted international reliance route for higher‑risk devices
A small subset of CE‑marked devices that would fall into a higher‑risk class under Great‑Britain‑wide rules may require additional oversight. The MHRA proposes an international reliance mechanism to ensure appropriate scrutiny while maintaining access for patients and providers.
A Dual‑Track Future: CE Recognition and a Repositioned UKCA
Alongside indefinite CE recognition, the MHRA plans to reposition the UKCA mark as a specialist route for innovative, first‑in‑market technologies – including AI‑driven medical devices. This approach is intended to complement, rather than replace, CE recognition, creating a dual‑track system that supports both stability and innovation.
The agency notes that this strategy aligns with the government’s Life Sciences Sector Plan and the ambition for the UK to become a global leader in MedTech access by 2030. It also mirrors wider government policy across other manufactured‑goods sectors, where continued CE recognition has already been agreed.
MHRA Chief Executive Lawrence Tallon emphasized that industry feedback played a decisive role in shaping the proposals. “The number one request that the med‑tech industry made of us was to provide long‑term certainty over CE recognition,” he said, adding that the approach serves both patient interests and the sector’s need to reduce friction and cost.
Strengthened Post‑Market Surveillance
While the proposals ease market entry, the MHRA stresses that patient safety remains central. The agency plans to continue strengthening post‑market surveillance and enhancing information‑sharing with EU partners – an important signal for suppliers concerned about regulatory robustness.
Consultation Now Open
The MHRA is inviting responses from manufacturers, Approved Bodies, UK Responsible Persons, clinicians, patient groups and the wider public. The consultation runs until 10 April 2026; details can be found here.
The author used AI in preparing this article. Comments or questions about this article can be addressed to [email protected].
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