Who this applies to
This obligation applies to
providers (including developers) and
deployers of
high-risk AI systems as defined under
Article 6(1), as well as
importers and
distributors of such systems under
Article 24(1).
Public sector entities using high-risk AI in the public interest (e.g., law enforcement, critical infrastructure) are also subject to conformity assessment per
Article 43(1).
What is required
- Conduct a conformity assessment for high-risk AI systems prior to market placement or deployment, demonstrating compliance with Article 43(1) and Annex VII requirements.
- Prepare and maintain technical documentation as specified in Article 11(1), including:
- Detailed system design and training methodologies (
Annex IV, Section 1).
- Risk management processes (
Article 9).
- Data governance and quality assurance measures (
Article 10).
- Draw up an EU declaration of conformity per Article 48(1), signed by an authorized representative, affirming compliance with Article 5 (prohibited practices) and Article 8 (data quality).
- Affix the CE marking to the AI system in accordance with Article 49(1), indicating conformity with the AI Act.
- Register the high-risk AI system in the EU database (per Article 60) before deployment, including:
- System identification details (
Article 60(2)(a)).
- Conformity assessment results (
Article 60(2)(b)).
- Implement a post-market monitoring system to track performance and compliance post-deployment, as required by Article 61(1) and Article 72(1).
Key deadlines
The primary deadline for this obligation is
August 2, 2026.
Enforcement patterns
AI Act enforcement begins August 2, 2026. No precedent currently exists. This page will be updated as enforcement cases emerge.
Cross-border considerations
Implementation references suggest
Spain (ES) and
Norway (NO) have early engagement with
Article 44 (42 citations, including 5 from ES) and
Article 47 (1 citation from NO), often co-cited with GDPR provisions on data transfers. No jurisdiction-specific deviations from the AI Act’s conformity assessment framework are yet documented.