Notified Body
Articles 31 et seq. — external conformity assessment body
Practitioner's note: This article is practice-oriented compliance documentation, not legal advice. We are a compliance specialist, not a law firm. For legally binding information please consult a licensed lawyer.
TL;DR
Notified Bodies (NBs) carry out conformity assessments under Article 43(1) EU AI Act where the provider so elects or where it is legally required (in particular for Annex II products).
What is a Notified Body?
When is a Notified Body mandatory?
- Annex II products (machinery, medical devices, etc.) — usually with NB involvement
- Annex III high-risk AI: the provider may choose between internal assessment and an NB
- For major systemic risks (expected BVerwG case law): NB is recommended
DACH NBs as of 04/2026:
- TÜV Süd AI Conformity
- TÜV Rheinland AI Quality Assurance
- DEKRA
- VDE Testing and Certification Institute
Practical example
Manufacturer of an AI medical diagnostic tool: subject to dual regulation under the MDR + EU AI Act. The notified body BSI/TÜV is notified for both legal acts. Assessment period 6-9 months, costs EUR 30,000-300,000.
Frequently asked questions
Is one NB sufficient for several countries?
Yes, NB notification applies EU-wide.
Who can become an NB?
Accredited conformity assessment bodies notified under Articles 31-39 EU AI Act.
Cost thresholds?
EUR 30,000-300,000 per assessment — borne by the provider.