In a nutshell
The UK government recently released its roadmap for managing AI as a medical device (AIaMD) and as a medical device (SaMD) software. This will be part of the basis of the upcoming UK Medical Device Regulatory Reform in 2024.
Recognizing 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 high regulatory scrutiny to ensure the effectiveness and safety of patients.
MHRA has developed a series of work packages that identify issues and distributions needed to address these issues. The core purpose of the work package is to bring UK MDR in line with the day-to-day practical requirements of AIaMD and SaMD, where current regulations do not allow this, and to provide clarity for manufacturers. Each package should not be viewed in isolation, but should work together to ensure the security of AIaMD and SaMD for use in the UK.
The main points taken from each package are:
- Qualifications: Provide clarity to manufacturers regarding what qualifies as SaMD.
- Rating: Classification of programs in proportion to the risks it poses to patients and public safety.
- Run Airlock: MHRA also understands that some manufacturers may not be able to establish the level of proof needed in the pre-market stage. As a result, the government may seek “air locking processes” to address this issue for SaMD products.
- Pre-market demand.: Aims to clarify prior market demand for SamMD. There will also be guidelines on best practices to highlight areas where current “best practices” may not meet the regulatory definition of “art status”.
- Post-market demand: The MHRA will develop guidelines to clarify what constitutes a bad incident and clearly define the need to report when such an incident occurs or where there is a risk of an accident. In addition, there will be guidelines for the process for managing changes that do not affect patient safety.
- Cyber SecurityUK MDR Future aims to mediate and adequately consider cyber security risks, and MHRA will publish guidelines on cyber security reporting requirements.
- AI RIG (AI Rigor): AI RIG seeks to address the lack of clarity on the use of AI for medical devices. This includes developing guidelines for good machine learning practices and setting bias in AI to ensure that AIaMD is appropriate across all segments of the population.
- Project Glass Box (AI Interpretation): The project’s glass box will ensure that sufficient consideration is given to the human interpretation and its consequences for safety and efficacy in AIaMD products.
- Project Ship of Theseus (AI Adaptability): This involves updating requirements and processes around notification and change management to fit AIaMD.
The roadmap is a step towards providing a clearer picture of how the 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 drafts of how the roadmap will be implemented and whether these consider the practical work of SaMD and AIaMD to facilitate innovation while Which also protects the patient.
The full text of the UK Government press release is here.
For more information and to discuss what this development might mean for you, contact your regular Baker McKenzie contact.