Recital 66 Coverage of mandatory requirements

Requirements should apply to high-risk AI systems means 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; as regards risk means the combination of the probability of an occurrence of harm and the severity of that harm; management, the quality and relevance of data sets used, technical documentation and record-keeping, transparency and the provision of information to deployers means a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activity;, human oversight, and robustness, accuracy and cybersecurity. Those requirements are necessary to effectively mitigate the risks means the combination of the probability of an occurrence of harm and the severity of that harm; for health, safety and fundamental rights. As no other less trade restrictive measures are reasonably available those requirements are not unjustified restrictions to trade.