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COMPEL Glossary / high-risk-ai-system

High-risk AI system

Under Regulation (EU) 2024/1689, an AI system falling under Article 6(1) because it is a safety component of, or is itself, a product covered by Annex I Union harmonization legislation, or under Article 6(2) because its use case falls within Annex III — unless exempted by the Article 6(3) derogation.

Synonyms

high-risk AI , EU AI Act high-risk system

See also

  • Annex I — The Regulation (EU) 2024/1689 annex listing the existing Union harmonisation legislation — machinery, medical devices, in-vitro diagnostics, toys, radio equipment, lifts, pressure equipment, recreational craft, civil aviation, motor vehicles, rail systems, agricultural vehicles — under which AI-containing safety components fall into the Article 6(1) high-risk pathway..
  • Annex III — The Regulation (EU) 2024/1689 annex listing eight domains of standalone high-risk AI use cases: biometrics; critical infrastructure; education and vocational training; employment and worker management; essential services; law enforcement; migration, asylum and border control; and administration of justice and democratic processes..
  • Article 6(3) derogation — Under Regulation (EU) 2024/1689, a conditional classification that allows an AI system falling within Annex III to be treated as non-high-risk when it does not pose a significant risk of harm to health, safety, or fundamental rights.
  • Provider — Under Regulation (EU) 2024/1689, a natural or legal person, public authority, agency, or other body that develops an AI system or a general-purpose AI model — or has it developed — and places it on the market or puts it into service under its own name or trademark, whether for payment or free of charge..

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