High-risk § II.1

Before a system can be classified as high-risk, it must qualify as an AI system within the meaning of Article 3(1) AI Act. That provision defines an AI system 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.’

Accordingly, not every software application or automated decision-making system falls within the scope of the AI Act. Only systems that meet the aforementioned definition so qualify. More information on how the Commission interprets the definition of an AI system can be found in the Guidelines on the definition of an artificial intelligence system³ , which were adopted pursuant to Article 96(1)(f) AI Act.