UK, 19 DEC 2025 — Understanding MHRA’s Role in AI Regulation for Healthcare the Medicines and Healthcare products Regulatory Agency (MHRA) has formally launched a “Call for Evidence” regarding the regulation of Artificial Intelligence (AI) in healthcare. This initiative supports the work of the newly formed National Commission into the Regulation of AI in Healthcare, which advises the MHRA on the future of health AI regulation. The goal is to shape a new set of standards and safeguards for how AI is used in the NHS and wider healthcare system, ensuring regulations remain “risk-proportionate” while fostering innovation.
ADAPTIVE AI AND POST-MARKET SAFETY: WHAT MANUFACTURERS NEED TO KNOW
The consultation seeks specific input on three critical areas that will directly impact medical device development and compliance:
- Modernising the Rules: The MHRA is determining if current regulations are working or if they require updates to keep pace with new technology.
- Adaptive AI & Post-Market Safety: As AI systems evolve and “learn” post-deployment, the Commission is seeking methods to spot and address problems quickly. This suggests potential new requirements for monitoring algorithms that change over time.
- Clarifying Responsibility: The inquiry aims to define the distribution of liability between regulators, companies (manufacturers), and healthcare organizations. This could redefine accountability when AI tools are used in clinical settings.
KEY DEADLINES AND HOW TO SUBMIT YOUR EVIDENCE ON AI REGULATION
The publication of this call for evidence triggers the following timeline for manufacturers and stakeholders:
- OPEN NOW (18 DECEMBER 2025) : The submission window is live. Manufacturers, clinicians, and the public are invited to share their views.
- CLOSING DATE (02 FEBRUARY 2026) : All evidence and submissions must be received by this date.
- RECOMMENDATIONS (2026) : The information gathered will inform the Commission’s formal recommendations to the MHRA later in 2026.
RESOURCES
To help stakeholders participate, the following official resources are available:
- Call for Evidence Submission Link: Regulation of AI in Healthcare – GOV.UK
- MHRA Press Release: MHRA seeks input on AI regulation at ‘pivotal moment’ for healthcare