Predetermined change control plans for machine learning-enabled medical devices: Guiding principles
Guidance establishing principles for predetermined change control plans in machine learning-enabled medical devices. Provides framework for managing modifications to AI/ML algorithms in regulated devices.
📅 Effective / published: 2023-10-24
Manufacturers and sponsors placing medical devices on the Canada market should review their current compliance documentation against this change. Assess whether your device class, labelling, registration status, or technical documentation is affected. Where gaps are identified, update your files and notify your local representative or importer. Refer to the official source below for the full regulatory text and any transitional arrangements.
View official source ↗