UK: MHRA publishes ‘roadmap’ for AI and software as medical devices

in a nutshell

The UK government recently published a roadmap for regulating AI as a medical device (AIaMD) and software as a medical device (SaMD). This will form part of the foundation for the UK medical device regulatory reform scheduled for 2024.

Given the operational challenges faced by the NHS, AIaMD and SaMD are attractive solutions to reduce pressure on the UK health system. However, these products are complex and require a high degree of regulatory scrutiny to ensure efficacy and protect patient safety.

MHRA has designed a series of work packages that identify the issues and deliverables needed to address these issues. The main objective of the work package is to align the UK MDR with the practical day-to-day needs of AIaMDs and SaMDs that cannot be met by current regulations and to provide clarity to manufacturers. Rather than looking at each work package in isolation, we must work together to ensure the safety of AIaMD and SaMD for use in the UK.

Here are the main points of each work package:

Samdo

1. Qualification: Clarify to manufacturers what is considered SaMD.
2. classification: Classify software in proportion to the risk it may pose to patient and public safety.
   • airlock process: MHRA also understands that some manufacturers are unable to produce the required level of evidence in the premarket stage. As a result, the government may consider an “airlock process” to address this issue for SaMD products.
3. Premarket requirements: Intended to clarify premarket requirements for SaMD. There are also best practice guides to highlight areas where current “best practices” may not meet the regulatory definition of “state of the art.”
4. Post-market requirements: The MHRA has developed guidance to clarify what constitutes an adverse incident and has clearly set out reporting requirements when such an incident occurs or is at risk of occurring. increase. In addition, guidance is provided on processes for change control that do not compromise patient safety.
5. cyber security: The future UK MDR aims to better address and better consider cybersecurity risks and the MHRA will issue guidance on cybersecurity incident reporting requirements.

AIaMD

1. AI RIG: AI RIG seeks to address lack of clarity around the use of AI in medical devices. This includes creating guidance on good machine learning practices and limiting bias in AI to ensure AIaMD is appropriate for all sections of the population.
2. Project Glass Box (AI interpretability): Project Glass Box ensures that due consideration is given to human interpretability and consequences for the safety and efficacy of AIaMD products.
3. Theseus’ Project Ship (AI Adaptability): This includes updating our change notification and management requirements and processes to align with AIaMD.

This roadmap is a first step towards greater clarity on how the UK MDR can keep up with the pace of SaMD and AIaMD development. However, the manufacturer is particularly eager to draft how the roadmap will be implemented and whether he considers how his SaMD and AIaMD work in practice to foster innovation while protecting patients. you will see

The full text of the UK Government press release is available here.

For more information and what this development means for you, please contact your regular Baker McKenzie representative.