Definition · Plain-language
Notified body
A notified body is an accredited, independent organisation designated by an EU member state to carry out conformity assessments of certain high-risk AI systems.
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What a notified body does
A notified body is an independent organisation that carries out conformity assessment on behalf of the regulatory system, rather than the provider assessing itself. Under the EU AI Act, where a high-risk system falls into a category requiring third-party assessment, a notified body examines the system, its technical documentation and the provider’s quality management system to judge whether the Act’s requirements are met. Its independence is the point: by separating the assessor from the provider, third-party conformity assessment adds objectivity and external assurance for systems whose risks justify more than self-declaration.
Designation and oversight
Notified bodies do not self-appoint. Each EU member state has a notifying authority responsible for assessing, designating and monitoring the bodies in its territory, and a notified body must demonstrate competence, independence and impartiality to be designated for the AI Act. Once designated it is listed and given an identification number, and it remains subject to ongoing supervision, with designation able to be restricted, suspended or withdrawn. This structure — designation by national authorities, coordination across the Union — is inherited from the EU’s established approach to regulating products, adapted here to the specific demands of high-risk AI.
How notified bodies fit the regime
Notified bodies occupy one route within the Act’s conformity-assessment framework. Many high-risk systems are assessed by the provider through internal control, but where the regulation specifies third-party assessment, a notified body must be involved. Its evaluation feeds the EU declaration of conformity and CE marking that allow a system onto the market. Notified bodies are part of a wider enforcement architecture that also includes national market-surveillance authorities and, at Union level, the European Commission’s AI Office, which coordinates implementation. Together these actors share responsibility for ensuring that high-risk AI placed on the EU market meets the regulation’s requirements.
Key facts
At a glance
- Definition: an accredited third-party body designated to perform AI Act conformity assessments
- Role: independent evaluation of certain high-risk systems against requirements
- Designation: by national notifying authorities; given an identification number
- Requirements: competence, independence and impartiality
- When used: only where third-party assessment is required, not for all high-risk systems
- Origin: carried over from the EU product-safety framework
Common misconceptions
What people often get wrong
Often heard: A notified body assesses every AI system on the EU market.
Actually: Notified bodies assess only certain high-risk systems where the EU AI Act requires third-party conformity assessment. Most high-risk systems use provider self-assessment, and lower-risk systems are not subject to this procedure at all.
Often heard: A company can simply declare itself a notified body.
Actually: Notified bodies are formally designated and monitored by national notifying authorities and must demonstrate competence, independence and impartiality. Designation can be restricted, suspended or withdrawn; it is not self-conferred.
Often heard: A notified body is the same as a regulator that enforces the AI Act.
Actually: A notified body assesses conformity; enforcement and market surveillance sit with national authorities and, at Union level, the AI Office. The roles are distinct parts of the wider regulatory architecture.
Going deeper
