Notified Body
Art. 31 et seq. — external conformity assessment body
TL;DR
Notified Bodies (NBs) carry out conformity assessments under Art. 43(1) EU AI Act (Regulation (EU) 2024/1689) where the provider so elects or where it is legally required (in particular for Annex I products).
What is a Notified Body?
When is a Notified Body mandatory?
- Annex I products (machinery, medical devices, etc. covered by EU harmonisation legislation, Art. 6(1)) — usually with NB involvement
- Annex III no. 1 (biometrics): the provider may choose between internal control (Annex VI) and the involvement of a Notified Body (Annex VII) (Art. 43(1) AI Act)
- Annex III nos. 2–8 (including critical infrastructure, education, employment, law enforcement): internal control under Annex VI only — this does not provide for the involvement of a Notified Body (Art. 43(2) AI Act)
- "Systemic risk" concerns general-purpose AI models only (GPAI, Art. 51 AI Act) and is supervised by the EU AI Office — not by Notified Bodies. Notified Bodies assess the conformity of high-risk AI systems only.
Germany and Austria: Applies equally in Germany and Austria (Regulation (EU) 2024/1689). The AI Act is a directly applicable EU regulation; the rules on Notified Bodies (Art. 31 et seq., Art. 43) apply identically in wording in both jurisdictions, without any national restructuring of provisions.
DACH NBs as at 04/2026:
- TÜV Süd AI conformity
- TÜV Rheinland AI Quality Assurance
- DEKRA
- VDE Testing and Certification Institute
Practical example
Manufacturer of an AI medical diagnosis system: subject to dual regulation under the MDR and the EU AI Act. The NB BSI/TÜV is notified for both legal acts. Assessment takes 6-9 months, costs EUR 30-300k.