Regulators develop five principles for machine learning-enabled medical devices  

The new principles will remove the regulatory burden for MLMD manufacturers

The Medicines and Healthcare products Regulatory Agency (MHRA), the US Food and Drug Administration (FDA) and Health Canada have collaboratively developed five guiding principles for machine learning-enabled medical devices (MLMDs).

The new principles aim to remove the regulatory burden for MLMD manufacturers by enabling the reallocation of resources to improve products.

Artificial intelligence (AI) and machine learning technology have been on the rise in health care, deriving new and important insights from large amounts of data generated from every-day health care delivery.

The regulators identified guiding principles for the development of predetermined change control plans (PCCPs), which build on the ten guiding principles for Good Machine Learning Practice, published in 2021.

The five guidelines outline that a PCCP must be focused and bounded, risk-based, evidence-based, transparent and have a total product lifecycle perspective.

Currently, in the UK, manufacturers must notify their conformity assessment body for the reassessment of the safety and performance of MLMDs, following any updates or changes to them.

Medical devices that comprise AI and machine learning usually require frequent updates, which ultimately leads to reoccurring reassessments, creating a significant burden for developers and assessors.

PCCPs will allow MLMD manufacturers to demonstrate which changes and updates would be made to ensure safety and effectiveness are maintained without regulatory intervention across the UK, US and Canada.

Each regulator will have specific national guidance for manufacturers to follow.

Dr Paul Campbell, head of software and AI at the MHRA, said: “AI and MLMDs are becoming more prevalent, and regulators must adapt their processes to support innovations for patients while continuing to ensure their safety.

“By collaborating with the FDA and Health Canada on these guiding principles, we can clearly outline where we align on our expectations for a successful change control plan and help reduce the regulatory burden for manufacturers.

The MHRA will publish its guidance in 2024.