Conformity Assessment – Art. 43
Overview
High-risk AI systems must undergo a conformity assessment before being placed on the market. The AI Act provides two paths:
Path 1: Internal Control (Annex VI) — Self-Assessment
For most high-risk AI systems, a self-assessment by the provider is sufficient. This comprises:
- Review of the QMS (Art. 17)
- Review of the technical documentation
- Confirmation of conformity with Art. 8–15
Path 2: Third-Party Assessment (Annex VII)
Only required for certain Annex III systems, in particular:
- Remote biometric identification (Annex III No. 1)
- Critical infrastructure (Annex III No. 2) — under certain conditions
- Certain law enforcement systems (Annex III No. 6–7)
BAUER GROUP Strategy
BAUER GROUP will only place AI systems on the EU market for which self-assessment (Annex VI) is sufficient. Systems requiring third-party conformity assessment are subject to an automatic No-Go due to disproportionate effort.
Procedure for Products under EU Harmonisation Legislation
Where the AI system is a safety component of an already regulated product (Annex I), the AI Act conformity assessment is integrated into the existing product conformity assessment.