Governance

Conformity Assessment

Definition

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.

Verwandte Begriffe

High-Risk AI System

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.

AI Notified Body

An independent third-party organisation designated by an EU Member State to conduct conformity assessments of high-risk AI systems. Not all high-risk AI requires a notified body—many categories allow self-assessment—but systems used in critical infrastructure or law enforcement typically do not.

CE Marking (AI)

The European conformity mark that high-risk AI systems must bear before entering the EU market, indicating compliance with applicable EU regulations including the AI Act. The CE mark serves as a declaration that the system meets safety, health, and environmental protection standards.

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