EveryAILaw.comDoes EU AI Act require Conformity Assessment?
European Union • phased enforcement
Yes — 1 provision
Requirements at a glance
This regulation imposes 6 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); implementation must be proportionate to the size of the provider's organisation, in particular for SMEs, start-ups, and small mid-cap enterprises, without lowering the rigour needed for compliance (Article 17(2), as replaced by Regulation (EU) 2026/1744)
- Documentation — Maintain technical documentation throughout lifecycle (Article 18); SMEs, start-ups, and SMCs may supply the Annex IV elements in simplified form using a Commission-issued simplified form (Article 11(1), as amended)
- No forced third-party assessment — Where Annex I Section A legislation lets a manufacturer self-assess against harmonised standards, classification of the product as high-risk under Article 6(1) does not by itself force a third-party conformity assessment (Article 43(3), as replaced)
- Annex III phasing — Annex III high-risk systems: 2027-12-02 (deferred from 2026-08-02 by Regulation (EU) 2026/1744). Annex I high-risk (safety components covered by other EU product laws, e.g., medical devices): 2028-08-02 (deferred from 2027-08-02). Notified bodies already notified under Annex I Section A legislation must apply for designation under the AI Act by 2028-01-28
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); implementation must be proportionate to the size of the provider's organisation, in particular for SMEs, start-ups, and small mid-cap enterprises, without lowering the rigour needed for compliance (Article 17(2), as replaced by Regulation (EU) 2026/1744) |
| Documentation | Maintain technical documentation throughout lifecycle (Article 18); SMEs, start-ups, and SMCs may supply the Annex IV elements in simplified form using a Commission-issued simplified form (Article 11(1), as amended) |
| No forced third-party assessment | Where Annex I Section A legislation lets a manufacturer self-assess against harmonised standards, classification of the product as high-risk under Article 6(1) does not by itself force a third-party conformity assessment (Article 43(3), as replaced) |
| Annex III phasing | Annex III high-risk systems: 2027-12-02 (deferred from 2026-08-02 by Regulation (EU) 2026/1744). Annex I high-risk (safety components covered by other EU product laws, e.g., medical devices): 2028-08-02 (deferred from 2027-08-02). Notified bodies already notified under Annex I Section A legislation must apply for designation under the AI Act by 2028-01-28 |
Penalties
| Violation | Fine |
|---|---|
| High-risk non-compliance | Up to EUR 15M or 3% global turnover |