MHRA and international partners publish five guiding principles for machine learning-enabled medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada have collaborated to identify five guiding principles for the development of predetermined change control plans (PCCPs). These guiding principles for PCCPs 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 MHRA, FDA and Health Canada have today published five guiding principles for the development of PCCPs for MLMD manufacturers. These guiding principles aim to support manufacturers of MLMDs by reducing the regulatory burden of reassessment following certain changes and updates to their devices.

Building on the 10 guiding principles for Good Machine Learning Practice, the five guiding principles for MLMD manufacturers outline that a PCCP must be:

1. Focused and Bounded: Describing specific changes that a manufacturer intends to implement.

2. 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.

3. Evidence-based: Demonstrating that benefits outweigh the risks throughout the product lifecycle.

4. Transparent: Provide clear and appropriate information and detailed plans for ongoing transparency to all stakeholders, from patients to healthcare professionals.

5. Total Product Lifecycle Perspective: Improve the quality and integrity of a PCCP by continually considering the perspectives of all stakeholders.

Currently, in the UK, when a manufacturer makes any significant updates or changes to their medical device, they must notify their conformity assessment body and their device may be reassessed to ensure these changes have not had a negative impact on performance and safety.

Medical devices using AI and machine-learning can require frequent updates and therefore potentially lengthy reassessment every time a change is made. This could create significant regulatory burden for both developers and assessors.

PCCPs allow manufacturers of MLMDs to demonstrate which changes and updates would be made, and how they would ensure safety and effectiveness are maintained, without the need for regulatory intervention.

These guidelines outline the areas where the MHRA, FDA and Health Canada are aligned in their expectations of an acceptable PCCP to reduce or remove the need for reassessment.  

While these guiding principles will support PCCP development across the UK, US and Canada, each regulator will have specific national guidance which manufacturers must follow. The MHRA will be publishing its guidance in 2024.

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.”

Notes to editors

1. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.  All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.

2. The MHRA is an executive agency of the Department of Health and Social Care.