The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a wide‑ranging call for evidence on how artificial intelligence used in healthcare should be regulated, as part of work to develop a new national framework for AI‑enabled medical devices.
The exercise is intended to inform the recommendations of the National Commission into the Regulation of AI in Healthcare, a body bringing together clinicians, regulators, patient advocates and global AI specialists, which was launched in September 2025.
According to the MHRA, the government intends to create a healthcare system “fit for the future”, with AI expected to play a central role in improving safety, personalisation and efficiency of care. The call for evidence seeks views on how the regulatory system should evolve to support this ambition while addressing the novel risks posed by AI‑driven technologies.
The Commission’s work sits alongside commitments in the 10‑Year Health Plan for England and the Life Sciences Sector Plan, both of which aim to make the NHS the world’s most AI‑enabled healthcare system.
Key issues under review
The MHRA highlights that AI has the potential to transform patient care but also presents “new regulatory challenges” that must be addressed to ensure safe deployment and public confidence.
The call for evidence invites input on:
- How AI‑enabled medical devices should be assessed and monitored.
- Approaches to transparency, explainability and accountability.
- Managing risks associated with adaptive or continuously learning systems.
- Ensuring patient safety while supporting innovation and sector growth.
The agency is seeking responses from clinicians, industry, healthcare providers, patients and members of the public. The call for evidence closes at 11:59pm on 2 February 2026.
The MHRA described the initiative as a “pivotal moment” for healthcare regulation, emphasising the need for a framework that can keep pace with rapid technological change while supporting the UK’s ambition to lead globally in health AI.
