MHRA to set up Centre for AI and Digital Health under 2030 strategy

The Medicines and Healthcare products Regulatory Agency (MHRA) will establish a Centre for AI and Digital Health and aims to deliver what it calls a globally leading approach to regulating AI as a medical device by 2030, under MHRA Strategy 2030, published on 14 October 2026. The five-year strategy covers the UK regulator’s work on medicines and medical devices; this report covers its commitments on AI, software and digital services.

The strategy’s explainer for the medtech sector says the centre is intended “to strengthen expertise and support developers.” It lists continuous monitoring of real-world performance, staged authorisation and expanded Predetermined Change Control Plans as parts of the AI as a medical device approach, along with “exploration of foundation model Master Files” and a “whole-system approach to safe deployment”.

HTN, reporting on the strategy on 15 October, said the expansion of Predetermined Change Control Plans is meant to allow pre-agreed model updates to be made without unnecessary delay, and that master files could let developers of foundation models share essential safety and performance information for AI-enabled devices.

Devices, sandboxes and safety reporting

The medtech explainer says unique device identifiers, or an equivalent system, will be required for most medical devices, subject to Parliamentary approval, and that upgraded registration and reporting systems will improve transparency and help identify safety issues faster. It also points to regulatory sandboxes, the Innovation Accelerator and the Early Access Service for Devices, which it says will help companies bring promising technologies to patients more quickly. The MHRA will chair the International Medical Device Regulators Forum in 2029, the document says.

The explainer for innovators and academics says the MHRA will further develop its AI Airlock programme, which focuses on AI as a medical device, continue to develop regional AI sandboxes and introduce a sandbox on the use of AI in pre-clinical testing. It says the agency will publish an AI Medicines Development Action Plan in 2027, publish guidance on digital twins and enable hybrid trials using digital twins and synthetic data.

The explainer for patients and the public says that “From 2027, we will begin introducing a more conversational Yellow Card reporting service” and that the MHRA will “explore integration with the NHS App and other health-system technology.” It aims to make all product information available as structured digital content by 2030, while keeping alternative formats for those who need them.

The executive summary says the agency will use “data, analytics and AI to identify safety risks earlier”. HTN reported that the strategy also commits the MHRA to using AI routinely to automate tasks such as application triage and evidence pre-screening, and said an AI-enabled checker for clinical trial protocols is reportedly in development. The documents read by The Healthcare Daily give no budget for the AI commitments and no dates for the device framework beyond the 2030 horizon.

Our reading

• The Healthcare Daily’s reading: for companies selling AI software into the NHS, expanded change control plans and staged authorisation go to a recurring commercial cost of regulated AI, which is seeking approval again when a model is updated. Until the MHRA publishes detail and dates, suppliers cannot plan release cycles around them.
• Foundation model master files remain at the exploration stage. If adopted, they would change how device makers that build on third-party models document safety, and how model providers share information with them.
• Mandatory unique device identifiers, subject to Parliament, would add registration work for device and software manufacturers, and trusts would gain a way to trace products. Because the requirement is subject to Parliamentary approval, its timing depends on legislation rather than MHRA guidance alone.
• A conversational Yellow Card service linked to the NHS App could increase the volume of patient safety reports reaching manufacturers’ vigilance teams; the strategy frames NHS App integration as something to explore, not a commitment.