The MHRA, FDA and Health Canada have today published five guiding principles for PCCP development for MLMD manufacturers. These guiding principles are intended to support MLMD manufacturers by reducing the regulatory burden of re-evaluation following certain changes and updates to their devices.
Building on it Ten Guiding Principles for Good Machine Learning PracticesThe five guiding principles for MLMD manufacturers describe that a PCCP should be:
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Focused and Delimited: Describe specific changes that a manufacturer intends to implement.
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Risk-based: The intent, design and implementation of a PCCP is driven by a risk-based approach that adheres to risk management principles.
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Evidence-based: Demonstrate that benefits outweigh risks throughout the product life cycle.
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Transparent: Provide clear and appropriate information and detailed plans for continued transparency to all stakeholders, from patients to healthcare professionals.
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Total Product Life Cycle 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 updates or major changes to their medical device, they must notify their conformity assessment body and their device may be re-assessed to ensure that these changes have not had a negative impact on the product. performance and safety.
Medical devices that use artificial intelligence and machine learning may require frequent updates and therefore potentially lengthy re-evaluations every time a change is made. This could create a significant regulatory burden for both developers and testers.
PCCPs allow MLMD manufacturers to demonstrate what 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 areas in which the MHRA, FDA, and Health Canada are aligned in their expectations of an acceptable PCCP to reduce or eliminate the need for re-evaluation.
While these guiding principles will support PCCP development in the UK, US and Canada, each regulator will have specific national guidelines that manufacturers will need to follow. The MHRA will publish its guidance in 2024.
Dr Paul Campbell, MHRA director of software and artificial intelligence, said:
โAI and MLMDs are becoming more prevalent and regulators must adapt their processes to support innovations for patients while still ensuring their safety.
โBy collaborating with the FDA and Health Canada on these guiding principles, we can clearly outline where we align with 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
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK ensuring that they work and are acceptably safe. All of our work is backed by strong, fact-based judgment to ensure the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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For media inquiries, please contact newscenter@mhra.gov.uk or call 020 3080 7651.
