MHRA Launches Consultation on Indefinite Recognition of CE Marked Medical Devices in Great Britain

The Medicines and Healthcare products Regulatory Agency has launched a significant consultation that could reshape the regulatory landscape for medical devices in Great Britain. Announced on 16 February 2026, the proposal focuses on the indefinite recognition of CE marked medical devices, a move designed to protect patient access, maintain supply chains, and provide long term certainty to the med tech sector.

With around 90 percent of medical devices currently used in Great Britain carrying a CE mark, the consultation signals a pragmatic and patient focused approach to regulation. The proposals aim to reduce disruption, support innovation, and align Great Britain more closely with European regulatory timelines while strengthening domestic oversight.

Why CE Mark Recognition Matters

CE marking indicates that a product meets European Union safety, health, and environmental protection standards. For medical devices, compliance with European regulatory frameworks has long served as a gateway to market access across Europe and, historically, the United Kingdom.

Following regulatory changes in recent years, transitional arrangements were introduced in 2023 to allow CE marked medical devices to continue being placed on the Great Britain market. However, those measures were time limited. The new consultation proposes making recognition indefinite for certain categories of devices, offering much needed stability for manufacturers, healthcare providers, and patients.

Ensuring regulatory continuity is particularly important in a sector where supply chains are complex and product lifecycles can span many years. Any uncertainty risks delays in availability, increased costs, and potential disruption to patient care.

The Three Key Proposals

The consultation outlines three central proposals designed to safeguard access while maintaining appropriate regulatory oversight.

1. Extending Transitional Arrangements

The first proposal seeks to extend current transitional arrangements for devices certified under the EU Medical Device Directive, known as MDD. This would align Great Britain timelines with the European Union transition to the EU Medical Device Regulation, commonly referred to as MDR.

By synchronising timelines, the government aims to minimise the risk of supply disruption. Many manufacturers operate across multiple jurisdictions. Divergent deadlines could force companies to prioritise one market over another, potentially limiting device availability in Great Britain.

2. Indefinite Recognition of EU MDR and EU IVDR Devices

The second proposal introduces indefinite recognition for devices compliant with the EU MDR and the In Vitro Diagnostic Regulation, known as IVDR. This would significantly reduce the risk of interruption in the supply of devices that meet updated European safety standards.

For patients and healthcare professionals, this means continued access to established technologies and innovations already approved under robust European frameworks. For manufacturers, it reduces duplication of regulatory effort and associated costs.

3. International Reliance Route for Higher Risk Devices

The third proposal introduces an international reliance route for a small proportion of CE marked devices that would fall into a higher risk classification under Great Britain rules.

This route would ensure appropriate scrutiny while maintaining patient access. It balances regulatory vigilance with practical flexibility, recognising that certain higher risk devices may require additional oversight within the domestic framework.

Supporting Innovation Through UKCA

Alongside the proposals for indefinite recognition, the MHRA has confirmed plans to reposition the UKCA marking as a specialist route for first in market innovative products. This includes areas such as artificial intelligence based medical devices.

According to the agency, this strategy aims to make the United Kingdom a leading destination for med tech innovation by 2030. By offering a dedicated pathway for breakthrough products, the UKCA route could become an attractive option for developers seeking early market entry.

The approach will be informed by findings from the National Commission into the Regulation of AI in Healthcare, expected to report later this year.

Industry and Patient Impact

Lawrence Tallon, Chief Executive of the MHRA, emphasised that long term certainty over CE recognition was a key request from the med tech industry. Manufacturers have consistently highlighted the importance of predictable regulatory frameworks in planning investment, product development, and distribution strategies.

From a patient perspective, the stakes are equally high. Medical devices range from everyday diagnostic tools to life sustaining implants. Any disruption in availability could have serious consequences for treatment continuity and clinical outcomes.

The proposals also align with broader government ambitions outlined in the Life Sciences Sector Plan and the 10 Year Health Plan. Both strategies aim to position the UK as a global leader in health innovation while ensuring patients benefit from rapid access to safe and effective technologies.

Strengthening Post Market Surveillance

While the consultation focuses on recognition of CE marked devices, the MHRA has confirmed that it will continue strengthening post market surveillance systems. This includes improving information sharing with European partners and enhancing monitoring mechanisms within Great Britain.

Post market surveillance plays a critical role in ensuring ongoing device safety. Even after regulatory approval, real world data can reveal performance issues or emerging risks. By investing in robust surveillance systems, regulators can act swiftly if concerns arise.

Consultation Timeline and Stakeholder Engagement

The consultation opened on 16 February 2026 and will run until 10 April 2026. The MHRA is encouraging feedback from a wide range of stakeholders, including manufacturers, Approved Bodies, UK Responsible Persons, healthcare professionals, patient groups, and members of the public.

Engagement at this stage is crucial. Regulatory frameworks shape the healthcare ecosystem for years to come. Input from those directly affected can help refine proposals and ensure that final policies deliver optimal outcomes for both patients and industry.

Broader Regulatory Reform

This consultation forms part of a wider programme of medical device regulatory reform led by the MHRA. The goal is to create a system that is risk proportionate, innovation friendly, and patient focused.

The recognition of CE marked devices also aligns with government policy in other manufactured goods sectors, where continued recognition has been agreed to reduce trade friction and maintain economic stability.

By combining international recognition with a strengthened domestic innovation pathway, the UK is attempting to strike a balance between global alignment and national ambition.

What Happens Next?

After the consultation closes in April 2026, the MHRA will review responses and determine whether to proceed with the proposals as outlined or make amendments. Any regulatory changes will likely require further guidance and implementation planning.

For businesses operating in the medical device sector, staying informed and participating in the consultation process will be essential. For healthcare providers and patients, the outcome will influence the availability and diversity of medical technologies in the years ahead.

Conclusion

The MHRA consultation on indefinite recognition of CE marked medical devices represents a pivotal moment in the evolution of medical device regulation in Great Britain. By seeking to provide long term certainty, minimise supply disruption, and support innovation, the proposals aim to protect patient access while fostering economic growth.

As the healthcare landscape becomes increasingly technology driven, regulatory agility and clarity will be key. The outcome of this consultation will help determine how effectively Great Britain navigates the complex intersection of patient safety, innovation, and global regulatory alignment.

Source:
Medicines and Healthcare products Regulatory Agency. “MHRA launches a consultation on indefinite recognition of CE-marked medical devices.” Published 16 February 2026 on GOV.UK.

Disclaimer:
This blog is for informational purposes only and does not constitute legal or regulatory advice. For official details, guidance, and updates, please refer directly to the GOV.UK website and the formal consultation documents issued by the MHRA.