Issued2025-01-30

Good Machine Learning Practice for Medical Device Development – Guiding Principles (IMDRF/AIML WG/N88 FINAL:2025)

GuidanceInternational

Summary

International guiding principles for Good Machine Learning Practice across the medical device lifecycle, developed by the International Medical Device Regulators Forum's AIML Working Group.

Healthcare Implications

Device developers and hospital innovators can align development, validation, and change management of AI‑enabled devices with these principles; supports harmonized evidence expectations and post‑market practices.

Impact Level

Medium

Keywords

Transparency & Governance; Clinical Quality & Efficacy

Stakeholders

Providers & Health Systems