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# MHRA Opens Consultation on Indefinite CE Mark Recognition
- URL: https://med-techinsights.com/mhra-opens-consultation-on-indefinite-ce-mark-recognition/
- Published: 2026-02-16T12:14:07.000Z
- Updated: 2026-10-22T08:36:45.000Z
- Description: Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, identifies a new consultation launched by the UK’s MedTech regulator. The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on pro
- Author: Oliver Johnson
- Tags: Insights, Medical Device Manufacturing, Policy & Regulation

###### [***Chris Whitehouse***](https://med-techinsights.com/tag/chris-whitehouse/)***, a political consultant and expert on medical technology policy and regulation at*** [***Whitehouse Communications***](http://www.whitehousecomms.com/?ref=med-techinsights.com)***, identifies a new consultation launched by the UK’s MedTech regulator.***

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The [Medicines and Healthcare products Regulatory Agency](https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency?ref=med-techinsights.com) (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:

- **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.
- **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.
- **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](https://www.gov.uk/government/publications/life-sciences-sector-plan?ref=med-techinsights.com) 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 emphasised 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 **10th April 2026**; and [details can be found here](https://www.gov.uk/government/consultations/medical-devices-regulations-targeted-consultation-on-the-indefinite-recognition-of-ce-marked-devices?ref=med-techinsights.com).

*The author used AI in preparing this article. Comments upon or questions about this article can be addressed to* [*chris.whitehouse@whitehousecomms.com*](mailto:chris.whitehouse@whitehousecomms.com)*.*