Glossary term
Glossary term
Governance and Compliance
An independent conformity assessment organization designated under EU rules to assess certain regulated products or systems. For AI governance, the concept matters where high-risk AI requires external assessment routes. Organizations building or buying regulated AI should understand when third-party assessment is required and what evidence must be available before assessment begins.
The NANDO database lists designated Notified Bodies under EU regulations; AI Act Notified Body designations were beginning in late 2025.
BSI, TUV SUD, and DEKRA are existing Notified Bodies under MDR and MDD seeking AI Act designation for high-risk AI conformity assessment.
Under EU AI Act Annex VII, third-party conformity assessment by a Notified Body is required for biometric high-risk systems and select cases.