EveryAILaw.comDoes EU AI Act require Conformity Assessment?
European Union • phased enforcement
Yes — 1 provision
Requirements at a glance
This regulation imposes 5 specific requirements for Conformity Assessment across 1 provision:
- Conformity assessment — Must undergo before placing on market or putting into service (Article 43)
- CE marking — Required for high-risk AI systems once assessment complete (Article 48)
- Quality management — Must establish quality management system (Article 17)
- Documentation — Maintain technical documentation throughout lifecycle (Article 18)
- Annex III phasing — Annex III high-risk systems: 2027-12-02 (deferred from 2026-08-02 by Digital Omnibus, political agreement 2026-05-07, not yet in OJ). Annex I high-risk (safety components covered by other EU product laws, e.g., medical devices): 2028-08-02 (deferred from 2027-08-02)
Conformity Assessment #
Requirements
| Requirement | Details |
|---|---|
| Conformity assessment | Must undergo before placing on market or putting into service (Article 43) |
| CE marking | Required for high-risk AI systems once assessment complete (Article 48) |
| Quality management | Must establish quality management system (Article 17) |
| Documentation | Maintain technical documentation throughout lifecycle (Article 18) |
| Annex III phasing | Annex III high-risk systems: 2027-12-02 (deferred from 2026-08-02 by Digital Omnibus, political agreement 2026-05-07, not yet in OJ). Annex I high-risk (safety components covered by other EU product laws, e.g., medical devices): 2028-08-02 (deferred from 2027-08-02) |
Penalties
| Violation | Fine |
|---|---|
| High-risk non-compliance | Up to EUR 15M or 3% global turnover |