Summary
Final guidance defining machine learning-enabled medical device scope and expectations for evidence, change management (including predetermined change control plans), and lifecycle oversight in pre‑market submissions. Aligns terminology to IMDRF N67 and encourages robust performance evaluation and real‑world monitoring.
Healthcare Implications
Canadian sponsors and partners should structure submissions and validation to meet ML‑specific requirements; healthcare providers adopting machine learning-enabled medical devices can expect clearer labeling and post‑market commitments.