The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published its ambitious software and AI as a medical device change programme in September 2021. It is envisioned that these proposals will cement the UK as “the home of responsible innovation for medical device software”. The MHRA plans to deliver key elements of each work package between Autumn 2021 and Summer 2023.

In conjunction with these reforms, the MHRA launched a consultation on the future regulation of medical devices in the UK, which runs until 25 November 2021. The consultation sets out the upcoming legislative changes and a new legislative framework for medical devices. In particular, Chapter 10 of the consultation proposal provides the possible changes that would be specific to, or have implications for, Software as a Medical Device (SaMD).

These changes include, for example, (1) defining software, (2) modifying the definition of ‘placing on the market’ to clarify when SaMD is deployed on websites, app stores and via other electronic means, and, (3) defining specific requirements for AI as a Medical Device (AIaMD).

The intention of the MHRA’s work programme is that it will set a benchmark for the development of regulation for medical device software in the UK. The work packages aim to ensure that:

  1. The requirements for software and AI as a medical device provide a high degree of assurance that they are acceptably safe and function as intended, thereby protecting patients and the public

  2. The requirements are clear, supported by both clarificatory guidance and streamlined processes that work for software, as well as bolstered with the tools to show compliance, for instance, via the designation of standards, and

  3. Friction is taken out of the market by working with key partners like the National Institute for Health and Care Excellence and NHSX to align, de-duplicate, and combine requirements, ultimately providing a joined-up offer for digital health within the UK. The NHSX is a joint unit bringing together the Department of Health and Social Care, NHS England and NHS Improvement to drive digital transformation of care.

Any changes to legislation proposed by the work programme will build upon the wider reforms to medical device regulation being considered as part of the consultation.

Key Elements of the Work Packages

The MHRA’s work programme includes eleven work packages across two workstreams:

  1. Key reforms across the SaMD lifecycle, and

  2. Further challenges that AI can pose to medical device regulation.

It is anticipated that much of the reform required to meet the objectives in the work packages will be in the form of clarificatory guidance, standards, or processes rather than secondary legislation. The key elements of the eleven work packages are:

  • Qualification - Ensure that medical device regulations are broad enough to capture relevant software and protect patients and the public.

  • Classification - Ensure that classification rules can closely track the risk that SaMD poses, but also impose proportionate safety and performance requirements and incorporate enough flexibility to address novel devices.

  • Pre-market – Ensure that SaMD is safe, effective and of requisite quality before being placed on the market, that any premarket requirements are sufficiently clear and appropriate for SaMD, and that there are appropriate registration requirements for robust post market surveillance system.

  • Post-market – Ensure: (1) a robust post market surveillance system with a clear safety signal to efficiently deal with, and thoroughly capture, adverse SaMD incidents is in place; and (2) ensure SaMD functions as intended via use of real-world evidence, maintains performance and clearly outlines change management requirements and processes.

  • Cyber Secure Medical Devices - Articulate how cybersecurity issues can translate to SaMD safety issues and ensure this is adequately reflected in both SaMD pre-and post-market surveillance requirements. Cooperate with other relevant bodies, for example, the Connected Medical Devices Security Steering Group for consistency of approach.

  • Innovative Access - Collaborate with MHRA and National Institute for Health and Care Excellence (NICE) on the potential need for a novel pathway to market for medical devices, like Innovative Licensing and Access Pathway (ILAP) based on critical need, innovation, and compelling benefit.

  • SaMD Airlock – Explore, if there is a need for, an “airlock classification rule” to enable interim market access for novel innovative SaMD whose risk profile needs further study. If there is need, articulate the criteria to be eligible for this rule, how the rule might function, and when the rule would cease to apply.

  • Mobile Health, and Apps - Collaborate across government via other work packages to ensure that the SaMD market provides further safety, effectiveness, and quality assurance for patients and the public.

  • Project AI RIG (AI Rigour) - Utilise existing and broadly accepted frameworks to ensure AIaMD placed on the market is safe and effective.

  • Project Glass Box (AI Interpretability) - Develop frameworks regarding interpretability of AIaMD to ensure that AI models are sufficiently transparent to be robust and testable, or are otherwise properly validated, and articulate how opacity in AIaMD can translate into safety or effectiveness issues.

  • Project Ship of Theseus (AI Adaptivity) - Articulate problems of fit with medical device regulation for adaptive AIaMD, and clarify how adaptive AIaMD of each type might fit within existing change management processes required by medical device regulations, and where appropriate, craft new rules and guidance that allows for adaptive AIaMD that does not fit within existing change management processes.

Conclusion

It is clear that the MHRA is seeking to position the UK as a leader in AI regulation and establish a robust regulatory framework. The MHRA explicitly states that it is working with opposite numbers in key jurisdictions and international bodies on many of the issues contained in the work packages, and that further updates on this will be revealed soon. Once these changes are enacted, it will be interesting to see how, or if, the future regime on the regulation of AI in the UK differs to that which is suggested in the EU.