The UK government has recently published its roadmap for regulating AI as a medical device (AIaMD) and software as a medical device (SaMD). This will form part of the basis of the upcoming UK Medical Device Regulation reforms in 2024.
In light of the operational difficulties faced by the NHS, AIaMD and SaMD are attractive solutions to alleviate pressures on the UK health system. Yet these products are complex and require a high level of regulatory scrutiny to ensure effectiveness and protect the safety of patients.
The MHRA has designed a series of work packages which identify the issues and deliverables required to address these issues. The core aims of the work packages are to bring the UK MDR in line with the practical day-to-day needs of AIaMD and SaMD where the current regulations fail to do so, and to provide clarity for manufacturers. Each work package should not be viewed in isolation but rather work together to ensure the safety of AIaMD and SaMD for use in Great Britain.
The key takeaways from each work package are:
- Qualification: Providing clarity to manufacturers regarding what qualifies as a SaMD.
- Classification: Classifying software proportionate to the risk that it might pose to the patient and public safety.
- Airlock process: The MHRA also understands that some manufacturers are unable to generate the level of evidence required in the pre-market phase. As a result, the government may explore an “airlock process” to address this issue for SaMD products.
- Pre-market requirements: Aims to clarify the pre-market requirements for SaMD. There will also be a best practices guide to highlight areas where current “best practice” may not meet the regulatory definition of the “state of the art”.
- Post-market requirements: The MHRA will produce guidance to clarify what constitutes as an adverse incident and clearly set out the reporting requirements when such incidents occur or where there is a risk of incidents occurring. In addition, there will be guidance for processes in place for change management which does not compromise patient safety.
- Cyber security: The future UK MDR aims to better accommodate and adequately consider cyber security risks and the MHRA will publish guidance on the reporting requirements of cyber security issues.
- AI RIG (AI Rigour): AI RIG seeks to address the lack of clarity on the use of AI for medical devices. This includes developing guidance on good practices in machine learning and limiting bias in AI to ensure AIaMD is suitable across all sections of the population.
- Project Glass Box (AI Interpretability): Project Glass Box will ensure that adequate consideration is taken of human interpretability and its consequences for safety and effectiveness in AIaMD products.
- Project Ship of Theseus (AI Adaptability): This involves updating the requirements and processes around the notification and management of change to fit AIaMD.
The roadmap is a step towards providing greater clarity on how UK MDR will seek to keep up to date with the pace of SaMD and AIaMD development. However, manufacturers will be particularly eager to see the drafts of how the roadmap will be implemented and whether these consider the practical workings of SaMD and AIaMD to facilitate innovation while also protecting patients.
The UK government press release is available in full here.
For further information and to discuss what this development might mean for you, please get in touch with your usual Baker McKenzie contact.