AIRiskAware
AI Governance Glossary
Governance Concept

What Is Notified Body?

Notified Body is an independent organisation designated by an EU Member State to assess whether certain high-risk AI systems conform to the EU AI Act.

Definition

Notified Bodyan independent organisation designated by an EU Member State to assess whether certain high-risk AI systems conform to the EU AI Act.

For some categories of high-risk AI, conformity cannot be self-assessed by the provider alone — it must be checked by an accredited third party called a notified body (EU AI Act, Articles 28–39). These bodies play the same role they already do for medical devices and machinery, and their availability and capacity is one of the practical bottlenecks in the Act's rollout.

Source: EU AI Act, Articles 28–39

Plain-language explanation

For some categories of high-risk AI, conformity cannot be self-assessed by the provider alone — it must be checked by an accredited third party called a notified body (EU AI Act, Articles 28–39). These bodies play the same role they already do for medical devices and machinery, and their availability and capacity is one of the practical bottlenecks in the Act's rollout.

Primary source: EU AI Act, Articles 28–39

Related terms

Conformity Assessment CE Marking (AI) High-Risk AI

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