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conceptUpdated Apr 18, 2026

High-Risk AI Systems

ai-systemsrisk-classificationregulatory-requirements
Jurisdiction
EU
Effective
2024-08-01

High-risk AI systems under the eu-ai-act-regulation-2024-1689 are AI systems that pose significant risks to health, safety, or fundamental rights and are subject to strict regulatory requirements.

Classification Rules (Article 6)

AI systems are classified as high-risk if:

  1. Product-related systems: AI systems that are safety components of products covered by EU harmonization legislation (Annex I) and require third-party conformity assessment

  2. Stand-alone systems: AI systems listed in Annex III across eight areas:

    • Biometrics (remote identification, categorization, emotion recognition)
    • Critical infrastructure (digital infrastructure, road traffic, utilities)
    • Education and vocational training
    • Employment and worker management
    • Access to essential services and benefits
    • Law enforcement
    • Migration, asylum and border control
    • Administration of justice and democratic processes

Derogation (Article 6(3))

Systems in Annex III are not high-risk if they don't pose significant risk because they:

  • Perform narrow procedural tasks
  • Improve previously completed human activities
  • Detect decision-making patterns without replacing human assessment
  • Perform preparatory tasks for assessments

Exception: Systems involving profiling are always high-risk.

Requirements for High-Risk Systems

Chapter III, Section 2 establishes mandatory requirements:

  • Risk management system (Article 9)
  • Data and data governance (Article 10)
  • Technical documentation (Article 11)
  • Record-keeping (Article 12)
  • Transparency and information provision (Article 13)
  • Human oversight (Article 14)
  • Accuracy, robustness and cybersecurity (Article 15)

Operator Obligations

  • Providers: Ensure compliance, quality management, conformity assessment, CE marking, registration
  • Deployers: Use according to instructions, human oversight, monitoring, fundamental rights impact assessment
  • Importers/Distributors: Verify compliance, cooperation with authorities

Conformity Assessment

High-risk systems must undergo conformity assessment before market placement, with procedures varying by system type and risk level.

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