UK Launches Consultation on Indefinite Recognition of CE-Marked Medical Devices

The United Kingdom is continuing to refine its post-Brexit regulatory framework for medical technologies. In February 2026, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched a public consultation exploring the long-term recognition of CE-marked medical devices in Great Britain.

The proposal represents an important development in the UK’s evolving medical device regulatory landscape and may significantly influence market access strategies for manufacturers operating in Europe and the UK.

Background: CE Mark vs UKCA Marking

Following the UK’s exit from the European Union, the government introduced the UK Conformity Assessed (UKCA) mark as the new product safety marking for medical devices placed on the Great Britain market.

Initially, the UKCA mark was expected to gradually replace the CE mark, which demonstrates compliance with European regulatory requirements under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

However, due to concerns about supply continuity and industry readiness, the UK government introduced transitional arrangements allowing CE-marked devices to remain on the market. These transitional provisions currently permit CE-marked devices to be placed on the Great Britain market until 2028 or 2030, depending on device type and certification pathway.

The new consultation signals that the UK may now be considering a more permanent approach.

Key Proposal: Indefinite Recognition of CE-Marked Devices

One of the central proposals under consultation is the indefinite recognition of medical devices that comply with the EU MDR and IVDR frameworks in Great Britain.

Under this approach, manufacturers with CE-marked devices could continue placing them on the Great Britain market without needing to obtain separate UKCA certification, provided that the devices are registered with the MHRA.

The consultation also explores whether this recognition should apply to:

• All devices are compliant with EU MDR and IVDR

• Only devices with the same or lower risk classification under UK regulations

• Or a combination of approaches, depending on product risk and regulatory pathways.

This proposal aims to maintain strong regulatory oversight while reducing unnecessary duplication of regulatory requirements.

Ensuring Continuity of Medical Device Supply

A major factor behind the consultation is the need to protect the continuity of medical device supply in the UK healthcare system.

Approximately 90% of medical devices currently used in Great Britain carry a CE mark, highlighting the importance of continued recognition of EU-approved technologies.

By considering indefinite recognition, the MHRA aims to minimise regulatory barriers that could potentially disrupt the availability of essential medical technologies for healthcare providers and patients.

At the same time, the regulator intends to maintain robust oversight to ensure that devices placed on the UK market continue to meet high standards for safety, quality, and performance.

Additional Regulatory Considerations

The consultation also proposes the introduction of an international reliance route for certain devices that may fall into a higher risk classification under UK rules compared to EU classifications.

This approach would allow the UK regulator to rely on existing international regulatory assessments when appropriate, while still maintaining the ability to conduct additional reviews when required.

The consultation, which opened on 16 February 2026, will remain open for stakeholder feedback until 10 April 2026, allowing manufacturers, healthcare professionals, and other stakeholders to contribute to shaping the future regulatory framework.

Implications for Manufacturers

For global medical device manufacturers, the outcome of this consultation could significantly influence regulatory strategy for entering or expanding within the UK market.

If implemented, indefinite recognition of CE-marked devices could:

• Reduce regulatory duplication between the EU and UK markets

• Simplify market access pathways for manufacturers

• Support continued availability of innovative medical technologies in the UK

• Provide greater regulatory certainty for industry stakeholders

At the same time, manufacturers will still need to ensure compliance with UK registration requirements and ongoing post-market obligations under the UK regulatory framework.

ARQon Perspective

The MHRA’s consultation reflects a pragmatic regulatory approach aimed at balancing patient safety, market access, and regulatory efficiency.

As regulatory authorities worldwide seek to modernise frameworks for emerging medical technologies, regulatory cooperation and reliance mechanisms are becoming increasingly important in supporting both innovation and global healthcare supply chains.

For manufacturers operating internationally, staying informed about these evolving regulatory policies will remain critical for effective market access planning.

At ARQon, we continue to monitor regulatory developments across global markets to support organisations navigating complex compliance environments and bringing safe, innovative healthcare technologies to patients worldwide.