In Spring 2024, the Medicines and Healthcare Products Regulatory Agency (MHRA) unveiled its strategic approach to artificial intelligence (AI) of medical product. This approach has its roots in the Government’s 2023 White Paper, ‘A pro-innovation approach to AI regulation’. Since its release, the MHRA has made substantial progress in implementing their recommendations.
AI principles and objectives
The principles beaconing the MHRA’s work in the AI realm are safety, transparency, fairness, accountability, and contestability. In its Policy Paper detailing the organisation’s steps to align with the white paper’s objectives, the MHRA explicates its aim to position the UK as a global leader in science and technology by 2030, focusing on the opportunities and risks presented by Artificial Intelligence (AI).
The latter are evaluated from three perspectives:
- Regulator of AI products: With a focus on ensuring that AI used for medical purposes complies with UK regulations, the MHRA aims to balance risk and innovation.
- Public service organisation: The MHRA plans to enhance regulatory efficiency through AI, facilitating faster access to medical products and allowing resources to focus on high-priority tasks.
- Evidence-based decision-making: The MHRA is committed to effectively overseeing AI used by regulated entities to maintain public and patient safety.
Regulatory Reform to evolve alongside AI technologies
Regulatory decisions hinge on solid evidence, which forms the backbone of the MHRA’s evaluation procedures encompassing submissions, premises inspections, and data analysis. As a regulatory authority, the MHRA must ensure these processes and protocols evolve alongside emerging AI technologies. Accordingly, the agency is implementing a regulatory reform program focused on AI-driven medical devices (AIaMD).
Key aspects of the regulatory framework for AIaMD may entail:
- Pre-market Assessment: AI-based medical devices will undergo rigorous evaluation before they can be marketed or used in clinical practice. This evaluation will assess the performance, safety, and reliability of the AI algorithms.
- Clinical Evidence: Manufacturers will need to provide clinical evidence demonstrating the effectiveness and safety of their AI algorithms in real-world healthcare settings.
- Quality Management System: Manufacturers will be required to establish robust quality management systems to ensure the consistency and reliability of AI algorithms throughout their lifecycle.
- Post-market Surveillance: There will be mechanisms in place for ongoing monitoring and surveillance of AI-based medical devices once they are on the market, to detect and address any potential safety issues or performance concerns.
- Transparency and Accountability: There may be requirements for transparency regarding the functioning of AI algorithms, including how they make decisions, handle uncertainties, and mitigate biases. Additionally, mechanisms for accountability in case of errors or adverse outcomes may be established.
Specific challenges posed by Artificial Intelligence Medical Devices include addressing bias, ensuring transparency, and managing post-market changes to AI models.
AI-Airlock regulatory sandbox
Among the strategies devised by the agency, it is relevant to mention the Predetermined Change Control Plans (PCCP) to enhance accountability and governance throughout the product lifecycle and the launch of the AI-Airlock, a regulatory sandbox aimed at confronting novel challenges. Scheduled to kick off its pilot phase in the spring of 2024, this initiative will bring together key stakeholders, including UK Approved Bodies, the NHS, and other regulators, in a collaborative effort to navigate the complexities of regulating AI in healthcare.
By fully leveraging its potential and minimizing its risks, the UK is capitalising on the significant opportunities presented by AIaMD regulation: it promises to foster innovation and attract investment.
Chiara Lai
Regulatory Department
04/06/2024
References
Medicines and Healthcare products Regulatory Agency. The regulation of AI as a Medical Device report. Retrieved on 04/06/2024.
Medicines and Healthcare products Regulatory Agency. Impact of AI on the regulation of medical products. Retrieved on 04/06/2024.
Department for Science, Innovation and Technology. A pro-innovation approach to AI regulation. Retrieved on 04/06/2024.
Medicines and Healthcare products Regulatory Agency. Impact of AI on the regulation of medical products. Retrieved on 04/06/2024.
Was this article helpful?
Check Obelis UK News page to keep up to date with the latest Medical Devices and Cosmetics market in the UK.
Any questions? Contact us and we will guide you through the process!
The information contained on Obelis UK is presented for general information purposes only, without obligation and it has been compiled with the utmost care to ensure it remains up to date. Nevertheless, Obelis Group cannot be held liable for the accuracy and completeness of the information published. Any reliance placed on such information is therefore strictly at the User’s risk.