GovernanceCore
Regulation

High-risk AI system

Working definition

Reviewed 30 July 2026

A high-risk AI system is an AI system that meets the classification rules in Article 6 of the EU AI Act. It may be high-risk because it is a safety component of a regulated product or because its intended use falls within an Annex III area and poses the required level of risk.

Context

Why it matters

Classification activates detailed requirements for risk management, data, documentation, logging, transparency, human oversight, performance, cybersecurity, conformity assessment, and post-market monitoring.

Operating note

What this looks like in practice

  1. 01Classify using intended purpose, product-law status, Annex III use, and applicable exceptions.
  2. 02Document the reasoning and revisit it when purpose, functionality, or law changes.
  3. 03Map provider and deployer duties separately across the system lifecycle.

Sources & further research

Primary authority anchors the definition. Research links add conceptual or operational depth. External sources may update independently; always verify legal duties against the current official text.

  1. Official source

    Regulation (EU) 2024/1689, Article 6 and Annexes I and III

    Contains the binding classification rules and listed high-risk use areas.

    European Union
    2024    Open source ↗
  2. Official source

    Navigating the AI Act

    Official practical explanation of high-risk classification and provider and deployer duties.

    European Commission
    2026    Open source ↗