IMDRF Consultation Feedback - AI/ML WG - Technical Framework for Artificial Intelligence Life Cycle Management

Overview

The International Medical Device Regulators Forum (IMDRF) recognizes the growing role of artificial intelligence (AI) technologies in medical devices and has continued its efforts to establish a harmonized approach for the oversight, evaluation, and use of AI-enabled medical devices. Building on its previous work, including the publication IMDRF/AIML WG (Artificial Intelligence/Machine Learning-enabled Working Group)/N88 FINAL:2025: Good Machine Learning Practice (GMLP) for Medical Device Development: Guiding Principles, IMDRF is introducing this document focused on considerations for AI-enabled medical devices across their total product life cycle.

The GMLP principles describe foundational best practices for the development of AI-enabled medical devices, emphasizing areas such as data quality, model transparency, performance evaluation, and the role of multidisciplinary expertise. These principles underpin each step of the AI life cycle, and this document provides relevant GMLP references to help provide a foundational understanding of applicable principles.

Together with the broader IMDRF mission, this work contributes to the establishment of globally harmonized considerations that, when applied across a device’s total product life cycle, can foster innovation while protecting public health.

Why your views matter

The IMDRF Artificial Intelligence/Machine Learning-enabled Working Group appreciates your feedback which will be considered prior to finalization of the document for publication.