Article 6: Classification Rules for High-Risk AI Systems
Article 6 establishes the two primary legal pathways through which an artificial intelligence system is classified as High-Risk, triggering mandatory pre-market conformity assessments.
Binding European Union legislative enactment across all 27 Member States.
Calculated on consolidated global group turnover under Article 71 formulas.
Requires specialized corporate tech E&O riders for regulatory defense.
Codified Statutory Requirements & Clauses
Detailed clause-by-clause legal and engineering specifications under Article 6.
AI systems intended to be used as safety components of products covered by EU harmonization legislation (medical devices, machinery, civil aviation, toys, elevators, motor vehicles).
AI systems deployed across 8 critical domains: biometrics, critical infrastructure, education, employment/HR, access to essential services (credit/insurance), law enforcement, migration, and justice.
An Annex III system is NOT high-risk if it does not pose a significant risk of harm to health, safety, or fundamental rights (e.g. narrow procedural tasks, improving previous human activity, preparatory tasks).
Article 6 Technical Compliance Protocol
Complete this operational verification protocol to ensure engineering and organizational alignment with Article 6.