MHRA publishes guidelines for machine-learning-enabled medical devices

The UK Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada have joined together to identify five guiding principles for the development of predetermined change control plans (PCCPs).

The principles aim to remove the regulatory burden for developers of machine-learning-enabled medical devices (MLMDs), enabling reallocation of resources to improve product performance for patients.

The five guiding principles for MLMD manufacturers outline that a PCCP must be: Focused and Bounded, describing specific changes that a manufacturer intends to implement; Risk-based, the intent, design, and implementation of a PCCP are driven by a risk-based approach that adheres to the principles of risk management; and Evidence-based, demonstrating that benefits outweigh the risks throughout the product lifecycle.

The guidelines also state that a PCCP must be transparent, provide clear and appropriate information and detailed plans for ongoing transparency to all stakeholders, from patients to healthcare professionals and Total Product Lifecycle Perspective, improve the quality and integrity of a PCCP by continually considering the perspectives of all stakeholders.

Dr Paul Campbell, MHRA head of software and AI, 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.  

“Collaboration between regulators on these guiding principles demonstrates how working with international partners can help the development of agile regulatory processes that support innovative manufacturers and patients globally.”

Image by Gerd Altmann from Pixabay