Good Machine Learning Practice for Medical Device Development: Guiding Principles

Artificial intelligence and machine learning technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day. They use software algorithms to learn from real-world use and in some situations may use this information to improve the product’s performance. But they also present unique considerations due to their complexity and the iterative and data-driven nature of their development.

In January 2025, the International Medical Device Regulators Forum (IMDRF) released a final document that identifies 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP). These guiding principles will help promote the development of safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML) and consider the total product life cycle of medical devices. They will also help cultivate future growth in this rapidly progressing field.

The final document from IMDRF builds on the guiding principles released in October 2021 by the U.S. Food and Drug Administration, Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency. 

The 10 guiding principles for GMLP presented in this IMDRF document are a call to action to international standards organizations, international regulators, and other collaborative bodies to further advance GMLP.