AI system

This is the EU AI Act definition. A medical device software that meets it may fall under both the AI Act and the MDR or IVDR, and MDCG 2025-6 explains how the two sets of requirements work together.

The AI Act (AIA) defines an AI system in Article 3(1) as a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments.

MDCG 2025-6 / AIB 2025-1, Section I, Question 1 (citing Article 3(1) AIA)