The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a call for evidence on the regulation of AI in healthcare, asking members of the public, clinicians, industry, and healthcare providers to share their views on the modernisation of AI rules, keeping patients safe as AI evolves, and the distribution of responsibilities between regulators, companies, healthcare organisations, and individuals.
Insights from respondents will be heard by the National Commission into the Regulation of AI in Healthcare, established to consider what the regulatory rules should be around AI as a medical device. The Commission and its four working groups include health professionals, regulators, AI specialists, and experts from across the UK.
In particular, views are sought on the UK’s current framework for regulating AI in healthcare and how it may need to be improved to “ensure fast access to safe and effective AI medical devices”, as well as on approaches to check safety once AI medical devices are in use, and how responsibility and liability are split between different parties involved in their deployment.
The questionnaire also provides individuals or organisations responding to comment on how regulation could be improved, how post-market surveillance might be managed, and what approach should be taken to sharing out responsibility. Along with written evidence, respondents can upload documents to be considered as part of their submission.
Alastair Denniston, head of the UK’s Centre of Excellence in Regulatory Science in AI and Digital Health, noted that although the potential benefits of AI health technologies for patients are beginning to be seen, a “rethink” is required for safeguards, to ensure they take into account how the technology works in the real world. “It is about how AI is used by health professionals or directly by patients, and how it is regulated and used safely by a complex healthcare system such as the NHS,” he said. “This is everyone’s opportunity to help shape what a future AI-supported healthcare service will look like, and how safety is ensured across the system.”
The deadline for the questionnaire is 23:59pm on 2 February 2026.
Key developments in MHRA regulation across health and care
The Medical Devices (Post-Market Surveillance Requirements) Regulations 2024 entered into law on 16 December 2024, taking effect from 16 June 2025 following a six-month implementation period. The regulations apply to all UKCA- and CE-marked devices placed on the GB market after 16 June 2025, including in vitro diagnostic devices, and active implantable medical devices such as pacemakers and hearing implants. Key requirements for manufacturers include the collection of real-world data on device performance in everyday use, expanded scope for incident reporting, shorter timelines for reporting serious incidents, new data analysis reporting to support earlier detection of trends, and stronger duties toward assessing, managing, and notifying users of risks.
The MHRA has opened an offering to provide regulatory advice meetings on medical devices and in vitro diagnostic devices for manufacturers, at a cost of £987 for one hour. During the one hour meeting, the person or organisation requesting support is to begin with a short presentation outlining their questions and the “issues and controversies” surrounding them. The service aims to provide regulatory advice relating to medical devices, particularly if the application of existing regulatory guidance is not straightforward.
Late last year, the Medical and Healthcare products Regulatory Agency selected five new technologies as part of the AI Airlock scheme, “to better understand how we can regulate artificial intelligence powered medical devices”. This includes medical devices for cancer, chronic respiratory disease and radiology diagnostic services.
