The Medicines and Healthcare Products Regulatory Agency adopted all 44 recommendations made by the National Commission into the Regulation of AI in Healthcare, an independent group led by National Health Service physicians.
One of the commission’s key conclusions was that AI-enabled medical devices’ performance should be monitored throughout their working life, rather than through one-time assessments. The decision comes as other entities, including the Food and Drug Administration, are also considering postmarket monitoring as a regulatory approach.

Dive Insight:

The MHRA chose to adopt the independent commission’s recommendations as international regulators grapple with AI in medical devices.

In September, the commission laid out recommendations for how the U.K. should approach AI in healthcare as the technology becomes more complex and difficult to regulate. Current approaches were designed for products that are static and easier to assess at a single point in time, the commission wrote in its comments. AI-enabled devices may change rapidly, and performance can vary depending on the setting, workflows, people and surrounding organizations.

Because of this, the commission recommended continuous monitoring of AI-enabled products once they are deployed, adding that one-off pre-market assessments will not be enough.

Trust must be earned, the commission said in its report. People are both enthusiastic about the potential benefits of AI and worried about the risks, and they “want reassurance that any AI is introduced responsibly and equitably, that accountability remains clear, that concerns are heard and acted upon, and that the benefits of innovation are felt by patients and healthcare staff,” according to the report.

The MHRA plans to issue draft guidance by December on a new approach to managing changes to AI-enabled devices as they adapt over time. At the start of the year, the regulator will also consult on how to qualify and classify AI-enabled devices. The MHRA plans to publish a full implementation roadmap addressing the 44 recommendations by spring 2027.

“This is about making sure patients can benefit from safe, trusted AI more quickly, while never losing sight of the safeguards that maintain public confidence,” MHRA Chief Executive Lawrence Tallon said in a statement.

Separately, the MHRA opened applications for its regulatory sandbox for AI-enabled devices, AI Airlock, with the first selections taking place in November. The latest cohort will focus on post-market surveillance and lifecycle regulation, addressing the themes in the commission’s recommendations.

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