Health Canada’s Pre-market Guidance for Machine Learning-enabled Medical Devices: What Manufacturers Need to Know

Health Canada’s Pre-market Guidance for Machine Learning-enabled Medical Devices¹, published in February 2025, provides essential direction for manufacturers seeking approval for medical devices that incorporate machine learning (ML). As artificial intelligence (AI) continues to revolutionize healthcare, this guidance ensures that ML-enabled medical devices (MLMD) meet stringent safety, effectiveness, and transparency standards. 

Understanding ML-enabled Medical Devices 

MLMDs are medical devices that use ML algorithms to achieve their intended purpose. Unlike traditional software-based devices, MLMDs evolve through data-driven learning rather than explicit programming. This adaptability introduces unique regulatory challenges, particularly in ensuring ongoing safety and effectiveness. 

Key Regulatory Considerations 

Health Canada’s guidance outlines several critical areas for manufacturers: 

• Good Machine Learning Practice (GMLP): Emphasizes best practices in ML model development, including data selection, training, and validation. 
• Risk Management: Identifies potential risks associated with MLMDs and strategies to mitigate them. 
• Transparency: Ensures that stakeholders—including patients, healthcare providers, and regulators—have access to clear information about the device’s functionality, limitations, and performance. 
• Clinical Validation: Requires robust testing to confirm the device’s effectiveness in real-world medical settings. 

Predetermined Change Control Plan (PCCP) 

One of the most significant aspects of the guidance is the Predetermined Change Control Plan (PCCP). This mechanism allows manufacturers to pre-authorize planned modifications to ML systems, addressing known risks proactively. Given the dynamic nature of ML models, PCCPs help maintain regulatory oversight while enabling innovation. 

Implications for Manufacturers 

Manufacturers submitting applications for Class II, III, and IV MLMDs must adhere to these guidelines. Compliance ensures that devices not only meet regulatory requirements but also uphold patient safety and trust. The guidance encourages manufacturers to integrate terms and conditions (T&Cs) on medical device licenses, reinforcing accountability. 

Looking Ahead 

As AI-driven healthcare technology advances, regulatory frameworks like Health Canada’s MLMD guidance will play a crucial role in balancing innovation with safety. By following these principles, manufacturers can navigate the approval process effectively while contributing to the future of medical technology. 

For more details, you can explore the full guidance document below. For help with regulatory affairs and quality assurance requirements for medical devices in Canada, Europe and the U.S.A. please contact Dell Tech to discuss how our medical device specialists can support your business. 

¹Pre-market guidance for machine learning-enabled medical devices. 

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