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Article 43: Conformity assessment
EU Official:
UpcomingAssessment follows the classification route; Annex III route from 2 Dec 2027
Title III: High-Risk AI Systems
Article 43 describes two routes: internal control based on Annex VI, or assessment by a notified body based on Annex VII, depending on the type of AI system.
Official text
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Source: EUR-Lex, Regulation (EU) 2024/1689. Text reproduced verbatim.
Download AI Act (PDF) →Official guidance on this article
2- NEN webinar slides: European AI standards under the AI Act (JTC 21 work programme and timelines)Links work item prEN 18285 to conformity assessment, so it becomes clear which standard will then fill in the procedural side of Article 43PublishedGuidelinesNEN, Artificial Intelligence and Big Data standards committee
- Commission Implementing Decision C(2025) 3871 of 23.6.2025 on a standardisation request to CEN and CENELEC as regards high-risk AI systems in support of Regulation (EU) 2024/1689 and repealing Implementing Decision C(2023) 3215Requests a standard for conformity assessment that must make the process in Article 43 and the associated annexes practically implementablePublishedImplementing actEuropean Commission23 Jun 2025
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Frequently asked questions
How does conformity assessment for AI work under Article 43?+
Article 43 describes two routes: internal control based on Annex VI, or assessment by a notified body based on Annex VII, depending on the type of AI system.
When is third-party assessment mandatory?+
Third-party assessment is mandatory for biometric AI systems (point 1 of Annex III) where the provider has not applied harmonised standards or common specifications.
What documentation does Article 43 of the AI Act require?+
Article 43 of the AI Act requires that relevant documentation is maintained as part of the compliance process. This may include technical documentation, instructions for use, logs or declarations of conformity, depending on the classification of the AI system.