Introduction: MLMDs
The integration of Artificial Intelligence (AI) and Machine Learning (ML) into medical devices is revolutionising healthcare. However, this innovation comes with its own set of regulatory challenges. Recognising this, the Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA), and Health Canada have recently published five guiding principles for the development of predetermined change control plans (PCCPs) for machine learning-enabled medical devices (MLMDs). These principles aim to alleviate the regulatory burden on developers, thereby facilitating the reallocation of resources to improve product performance for patients.
The Evolution of Regulatory Guidelines
In 2021, the FDA, Health Canada, and the MHRA jointly identified 10 guiding principles for Good Machine Learning Practice (GMLP). These principles laid the foundation for the development of safe, effective, and high-quality AI/ML technologies. Building on this, the agencies have now released five guiding principles specifically for PCCPs, which draw upon the overarching GMLP principles, particularly principle 10, which focuses on monitoring deployed models for performance and managing re-training risks.
The Quintessential Five: Guiding Principles for PCCPs
The MHRA, FDA, and Health Canada have collaboratively outlined five guiding principles that serve as the cornerstone for developing a robust PCCP for machine learning-enabled medical devices (MLMDs). These principles are not just regulatory requirements but also best practices that can significantly impact the safety and efficacy of the device. Below, we delve into each principle in detail:
1. Focused and Bounded:
– What It Means: This principle mandates that the PCCP should be explicit about the changes a manufacturer plans to implement.
– Why It’s Important: A vague or overly broad PCCP can lead to regulatory delays and potential safety risks.
– How to Implement: Clearly outline the scope of planned changes, the methodologies for verification and validation, and the anticipated impacts on device performance and safety.
– ISO Standards and Regulations: Adherence to ISO 13485 on quality management systems can help in effectively documenting and controlling planned changes.
2. Risk-based Approach:
– What It Means: The PCCP must be driven by a risk-based approach, incorporating principles of risk management throughout the development process.
– Why It’s Important: A risk-based approach ensures that the most critical safety and performance factors are prioritised.
– How to Implement: Utilise ISO 14971 for risk management to identify, evaluate, and control risks associated with the device.
– ISO Standards and Regulations: ISO 14971 serves as the international standard for risk management in medical devices.
3. Evidence-centric:
– What It Means: The PCCP should be grounded in scientific and clinical evidence, demonstrating that the benefits of the device outweigh the risks.
– Why It’s Important: Regulatory bodies require empirical evidence to validate the safety and efficacy of the device.
– How to Implement: Employ scientifically and clinically justified methods and metrics to measure device performance.
– ISO Standards and Regulations: ISO 14155, which focuses on clinical investigations, can guide the evidence-gathering process.
4. Transparency:
– What It Means: The PCCP must offer clear, detailed plans for ongoing transparency to all stakeholders.
– Why It’s Important: Transparency builds trust and facilitates better decision-making for healthcare providers and patients.
– How to Implement*: Include comprehensive testing protocols for planned changes and establish mechanisms for monitoring deviations in device performance.
– ISO Standards and Regulations: Adherence to ISO 31000, a standard for risk management, can help in creating a transparent risk communication strategy.
5. Lifecycle Perspective:
– What It Means: The PCCP should be a living document, continually updated and improved upon.
– Why It’s Important: Medical devices are not static; they evolve, and so should the plans that govern them.
– How to Implement: Regularly review and update the PCCP to incorporate stakeholder feedback and new risk management practices.
– **ISO Standards and Regulations**: ISO 13485 and ISO 14971 can be used in tandem to manage changes throughout the Total Product Lifecycle (TPLC).
How Deviceology Can Help
Deviceology, a leading consultancy specialising in medical device compliance, can assist manufacturers in incorporating these five guiding principles into their PCCPs. Here’s how:
1. Risk Management: Deviceology can help align your risk management systems with ISO 14971, thereby ensuring that your PCCP is risk-based. This is crucial for meeting the regulatory expectations of agencies like the MHRA, FDA, and Health Canada.
2. Evidence Gathering: Deviceology can guide you through the process of collecting the necessary evidence to demonstrate that the benefits of your device outweigh the risks. This includes advising on scientifically and clinically justified methods and metrics for measuring device performance.
3. Transparency Plans: Deviceology can assist in developing a comprehensive transparency plan that satisfies regulatory requirements. This includes helping you characterise the data used in development and modifications, and setting up mechanisms for monitoring, detection, and response to deviations in device performance.
4. Lifecycle Management: With a focus on total product lifecycle, Deviceology can help you consider the perspectives of all stakeholders, thereby improving the quality and integrity of your PCCP. This includes advising on how to use and support existing regulatory, quality, and risk management measures throughout the TPLC.
5. Regulatory Alignment: Deviceology can serve as your liaison with regulatory bodies like the FDA and MHRA, helping you navigate the complexities of different national guidelines. This is particularly important given that each regulator will have specific national guidance, which manufacturers must follow.
Conclusion
The five guiding principles published by the MHRA, FDA, and Health Canada offer a framework for MLMD manufacturers to develop robust PCCPs. Deviceology can play a pivotal role in helping manufacturers align their PCCPs with these principles, thereby facilitating smoother market entry in the UK, US, and Canada.
For more information on how Deviceology can assist you, visit https://www.deviceology.info
