Notified Body
Independent organization designated to assess conformity of certain high-risk AI systems.
Definitions (7)
A body designated under national procedures and notified to the Commission to carry out conformity assessment activities for high-risk AI systems, including auditing technical documentation and issuing certificates where required; notified bodies operate under oversight of notifying authorities.
An organisation formally designated under the national framework to carry out conformity‑assessment procedures (including ex ante checks) for high‑risk AI systems and to issue conformity certifications in accordance with the AI Act and national implementing measures.
An entity authorized to carry out conformity assessment of high‑risk AI systems, whose involvement may be coordinated by the competent authority and which aligns assessment practices with EU delegated and implementing acts to support market access.
A conformity assessment body (public, private or academic) that has been assessed, designated, and notified by the national notifying authority (Innovation Agency) to carry out conformity assessments of high-risk AI systems in accordance with harmonised procedures and public registry requirements.
An organisation authorised by the national notifying authority (the Innovation Agency) to perform conformity assessment and certification activities for high‑risk AI systems in accordance with EU AI Act procedures. Notified bodies are evaluated under national technical procedures and may be proposed for notification into the EU conformity assessment network.
An accredited third‑party conformity assessment organisation authorised by the notifying authority to perform conformity assessments and issue attestations for high‑risk AI systems in accordance with the AI Act and national implementing rules. Notified bodies are supervised by the notifying authority and must meet accreditation, procedural and confidentiality standards set out in the implementing framework.
A Notified Body is an independent third-party organization designated by a Member State to carry out conformity assessment tasks, such as testing, inspection, and certification, for products falling under specific EU legislation. For certain high-risk machinery under the EU Machinery Regulation, third-party assessment by a Notified Body is mandatory.
Related Terms
Conformity Assessment
Process to verify that high-risk AI systems meet regulatory requirements before market placement....
High-Risk AI System
AI systems that pose significant risks to health, safety, or fundamental rights....
CE Marking
Conformity mark indicating AI system compliance with EU requirements....