Notified body
An independent expert organisation approved by an EU government to inspect and certify that high-risk AI systems meet legal requirements.
The Simple Version
An independent expert organisation approved by an EU government to inspect and certify that high-risk AI systems meet legal requirements.
Detailed Explanation
Under the EU AI Act, most high-risk AI systems (excluding those listed in Annex III points 1–8 that are safety components of regulated products) may conduct internal conformity assessments. However, some categories, such as biometric identification, require third-party assessment by a notified body. Notified bodies must be accredited for AI by national accreditation authorities and listed in the NANDO database. They issue certificates of conformity that enable CE marking and must report suspicious non-compliance to national authorities.
Key Characteristics
- Designated by national authorities and listed in NANDO
- Conducts third-party conformity assessments where mandated
- Issues EU certificates of conformity enabling CE marking
- Subject to ongoing competence monitoring by national accreditation bodies
Why It Matters
Providers of biometric identification and other high-risk AI categories that require third-party certification must budget time and cost for notified-body engagement early in product development, as certification timelines can be lengthy.
Real-World Analogy
MOT test centres are designated by the government to assess vehicle roadworthiness on behalf of regulators, notified bodies play an equivalent certification role for high-risk AI systems.
Common Misconceptions
- All high-risk AI requires notified-body certification, most Annex III categories allow internal (provider self) conformity assessment; third-party review is mandated only for specific categories.
- Any ISO-accredited body can act as a notified body, specific AI Act designation and NANDO listing are required.