The government have set out their response to the recommendations made by the Regulatory Horizons Council (RHC) on the regulation of AI as a medical device.
In a letter from Baroness Merron, the government has broadly welcomed the Regulatory Horizons Council (RHC) report on the regulation of Artificial Intelligence as a Medical Device (AIaMD) and provided a detailed response outlining its aim to ensure safe and effective regulation while fostering innovation.
The response highlights the growing potential of AI in healthcare, with AIaMD representing a rapidly advancing subset of software as a medical device (SaMD). The government is actively reforming the Medical Devices Regulations 2002 (UK MDR 2002) to better accommodate these developments, ensuring patient safety without stifling innovation.
Key reforms include the creation of a regulatory framework that addresses the specific challenges of AI technologies. This includes guidance on mitigating risks such as AI bias and generalisability. This initiative aims to deliver real-world insights into the challenges of regulating AIaMD, with a focus on safety, effectiveness, and innovation.
Key takeaways are:
- Regulatory Capacity and Capability: The MHRA has been allocated funding to enhance its regulatory capabilities, including £1 million from the NHS AI Lab to pilot an AI-focused regulatory sandbox. The government is also working on expanding the MHRA’s expertise through training and guidance for both regulators and manufacturers.
- Whole Product Lifecycle: Recommendations about ensuring AIaMD are safely managed from development to post-market phases have been embraced. The government supports a “legislatively light” approach, leveraging existing regulations while addressing the unique challenges of AI technologies. Guidance is being developed on AI-specific issues like model bias and the interpretability of AI outputs.
- Transparency and Patient Involvement: The MHRA aims to improve transparency in the regulatory process, making guidelines and information accessible to innovators and the public. The government also supports enhanced patient and public involvement throughout the product lifecycle, ensuring the design and evaluation of AIaMD are aligned with patient needs.
- International Leadership and Collaboration: The UK is positioning itself as a leader in the global regulation of AIaMD. Through its membership in international forums like the International Medical Device Regulators Forum (IMDRF) and partnerships with regulators such as the FDA and Health Canada, the UK is advocating for international regulatory harmonisation.
BIVDA’s Regulatory working group have a sub-group dedicated to AIaMD, which is meeting next virtually on 27th March.
