Notified body
A notified body is an independent third party designated by a Member State to take part in the conformity assessment of certain high-risk AI systems. For systems falling under points 2–8 of Annex III — HR, education, creditworthiness assessment, essential services — internal control always suffices; a notified body is practically relevant only for biometric systems, and even there it is mandatory only in the absence of a harmonised standard.
The rules are set out in Article 43(1)–(6) and Articles 46–48, with the detailed procedure in Annexes V–VII. The system is structured so that in most high-risk areas — including the most common corporate case, HR-related AI — the provider declares conformity itself, without involving an external party. This significantly reduces the administrative burden of high-risk compliance for an average SME. Involvement of a notified body is practically relevant only for biometric identification and categorisation systems, and even there it is mandatory only where no harmonised standard has been applied, or the provider chooses not to apply one. In Hungary, notified bodies are designated and kept on record by the National Accreditation Authority.
Good news for most SMEs: conformity assessment for HR, education or creditworthiness AI does not require engaging an external notified body — documented internal self-assessment suffices.
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Start freeRelated terms
- Conformity assessmentConformity assessment is the procedure by which a provider demonstrates that a high-risk AI system meets the requirements laid down in Section 2 of Chapter III of the Regulation — risk management, data governance, documentation, human oversight, and the rest. For systems falling under points 2–8 of Annex III, internal control suffices; involvement of a notified body is typically mandatory only for biometric systems.
- Harmonised standardA harmonised standard is a technical standard developed on the basis of a Union standardisation request, whose application creates a presumption of conformity: a provider that follows it is presumed to meet the corresponding requirement. As of mid-2026, harmonised standards covering the AI Act's high-risk requirements had not yet been finalised, so the presumption of conformity is not currently available.