Some AI products that currently can be put on the market without conformity assessment will move to a higher risk class, requiring more scrutiny.

Dive Brief:

• A U.K. agency outlined its position on the regulation of artificial intelligence as a medical device in a policy paper published Tuesday.
• The Medicines and Healthcare products Regulatory Agency (MHRA) said many AI products that can be put on the market now without conformity assessment will move to a higher risk category in upcoming reforms.
• The paper explains how MHRA interprets a government AI strategy focused on principles such as safety, security and robustness and aligns it with international standards.

Dive Insight:

The U.K. government committed to five cross-sector principles for the regulation of AI in February. A consultation found “strong support” for the principles, the government said, and established them as the basis for a regulatory framework designed to keep pace with rapidly advancing AI technology. Days later, the government wrote to the MHRA to request details of its approach to AI. 

In response, the MHRA published a policy paper that describes how it is interpreting and applying the five principles. The paper covers AI as a medical device, how the MHRA is using AI internally and how the use of AI by industry may affect the agency.

AI with a medical purpose is very likely to meet the definition of a medical device, the MHRA said. Today, the agency puts many AI products in the lowest risk classification, meaning they can come to market without being assessed by a notified body. The MHRA said many AI products will move up to higher risk classifications as part of the post-Brexit medical device regulatory framework.

The agency made multiple references to the need for international alignment in its discussion of AI as a medical device, citing its use of documents from the International Organization for Standardization and the International Medical Devices Regulators Forum to mitigate the risk of bias in AI. The MHRA is also working on its own machine learning and AI development practices. 

The agency has three people, or full-time equivalents (FTEs), working on AI as a medical device activities. It plans to grow the team to 7.5 FTEs through the 2024 to 2025 financial year. The government is providing funding for two FTEs. 

The other two sections of the paper could also have implications for the medical device industry. In one section, the MHRA discusses ways it may use AI internally, such as the application of machine learning to real world data to understand links between products and clinical outcomes. The final section covers the internal use of AI by companies, which the MHRA said is generally unlikely to affect how it regulates.