MHRA Publishes Revised Roadmap of Future Regulatory Framework for Medical Devices

By Karen Hill

The UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), published a revised roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices.  

In January 2024,  the MHRA shared a roadmap for 2024 detailing how it planned to implement future medical device regulations. Now, in December 2024, the MHRA has published a revised roadmap, providing a further update on the intended timelines to implement the future medical device regulations. This new revision provides updates in four key areas, along with associated milestones and expected timelines for each.   

Post-market Surveillance (PMS) Statutory Instrument (SI) Progresses in Legislature

The draft PMS statutory instrument (PMS SI) was laid before parliament on October 21. It was debated in Parliament on November 28 and given that there were no comments, the motion was agreed, and it is anticipated that the first iteration of the PMS Guidance will be published in the first quarter of 2025. The Regulation will then come into force 6 months later, with the final publication expected by mid-2025. As Emergo has previously reported, this PMS SI introduces new PMS requirements and gives greater clarity to manufacturers on the surveillance, vigilance and reporting requirements to ensure devices on the UK market continue to be safe and perform as expected.

New Pre-Market Requirements Are Currently Under Consultation

As announced in November, the MHRA launched a public consultation on proposed changes to the medical device regulatory framework in the UK, which included the introduction of an international reliance scheme, the removal of the requirement for UKCA marking, a new classification system for IVDs and the removal of the revocation dates for four pieces of assimilated EU law. This consultation is due to close on January 5, 2025, and the responses are due to be published in the first half of 2025. It is then anticipated that the draft regulations will be published on the World Trade Organization (WTO) website mid-2025 and the SI will be introduced into parliament and debated late in 2025, with the new pre-market SI coming into force in 2026.

In addition, responses to the Coronavirus Test Device Approvals (CTDA) and Common Specifications for high-risk IVDs consultation, which closed in June 2024,  will be published in the first half of 2025.

Finally, throughout the year priority standards for designation will be identified.

Policy Development in Four Areas Proposed

Four new guidance/policy documents are anticipated during 2025:

• New Exceptional Use Authorization (EUA) Guidance to be developed and published in the first quarter of 2025
• A Policy for early access and innovation is currently in development, with a planned publication in the first half of 2025
• The policy and guidance on health institution exemption (HIE) will be refined to align with government strategy and published by mid-2025
• A Roadmap for IVDs is expected to be published in the second half of 2025

Software Guidance Documents Expected

Four guidance documents related to software, including artificial intelligence (AI) and digital mental health products, are also anticipated during 2025:

• A draft guidance for digital mental health tech is currently in development and anticipated to be published in the first quarter of 2025;
• Guidance on Good Machine Learning Practice (GMLP) Mapping is expected to be published for comment in the first quarter of 2025;
• Guidance on AI development and deployment is expected to be published for comment in the second quarter of 2025; and,
• Guidance on cybersecurity for Software as a Medical Device (SaMD) is planned for publication in the second quarter of 2025.

Concluding remarks

As 2024 draws to a close, it is exciting to discover what lies ahead in terms of future UK medical device legislation, and when these changes can be expected to be implemented. It is also good to see that the experience from the European regulations has impacted the legislation in the UK, with one example being how to manage innovation.

We at Emergo by UL will continue to monitor these developments and look forward to what these changes will bring to the medical device community in the UK.