Health Canada Issues Pre-Market Guidance for Machine Learning-Enabled Medical Devices

"Health Canada has released guidance for machine learning-enabled medical devices (MLMDs) to ensure their safety, effectiveness, and regulatory compliance.

Key Highlights:

• Device Design: Covers training algorithms, feature attributions, input parameters, and compatible devices.
• Data Selection & Management: Requires detailed documentation of training, tuning, and testing datasets.
• Risk Management: Addresses erroneous outputs, bias, overfitting, underfitting, and performance degradation.
• Transparency: Ensures stakeholders understand device performance, risks, and regulatory status.
• Post-Market Monitoring: Mandates risk mitigation plans to maintain device safety and effectiveness.
• Regulatory Framework: Introduces the Predetermined Change Control Plan (PCCP) for pre-authorized ML system updates.
• This guidance helps manufacturers navigate regulatory requirements and maintain compliance throughout the MLMD lifecycle.

Region: North America

Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/pre-market-guidance-machine-learning-enabled-medical-devices.html