Governance

High-Risk AI System

Definition

An AI system classified under the EU AI Act as posing significant risks to health, safety, or fundamental rights. High-risk systems must undergo conformity assessment, maintain technical documentation, enable human oversight, and be registered in an EU database before market deployment.

Verwandte Begriffe

EU AI Act

The world's first comprehensive AI regulation, adopted by the European Union in 2024 and phasing in through 2027–2028 (prohibitions from February 2025, GPAI obligations from August 2025, stand-alone high-risk systems from 2 December 2027, and high-risk AI embedded in regulated products from 2 August 2028). It classifies AI systems by risk level—unacceptable, high, limited, and minimal—and imposes obligations proportionate to risk, from outright bans to conformity assessments and transparency requirements.

Conformity Assessment

The formal process by which a high-risk AI system is evaluated against the requirements of the EU AI Act before being placed on the market. Depending on the risk category, assessment may be self-conducted or require a third-party notified body.

AI Act Annex III

The list of high-risk AI application areas appended to the EU AI Act, including biometric systems, critical infrastructure management, education, employment, essential private/public services, law enforcement, migration, and administration of justice. Companies operating in these areas face the most stringent obligations.

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