Conformity Assessment (Article 43 EU AI Act)
Mandatory assessment for high-risk AI providers from 02 August 2026 (Digital Omnibus proposal 19 November 2025: postponement to 02 December 2027 - not adopted)
TL;DR
Conformity assessment pursuant to Article 43 EU AI Act is the procedure for verifying whether a high-risk AI system meets the requirements of the Regulation. For most Annex III systems: internal conformity assessment (Article 43(2)). In special cases (Annex III No. 1 biometrics + specific subcategories): external assessment by a notified body.
What is Conformity Assessment (Article 43 EU AI Act)?
Two procedures are possible:
- Internal assessment (Article 43(2)): for Annex III Nos. 2-8 - the provider performs the assessment itself, documents it, and issues the EU declaration of conformity
- External assessment (Article 43(1)): only for biometrics + subcategories - by a notified body (designated nationally)
Application date 02 August 2026 legally binding (Digital Omnibus proposal 19 November 2025: postponement to 02 December 2027 - trilogue ongoing, not adopted). Result upon success: CE marking + EU database entry (Article 49).
Practical example
HR recruiting tool as a provider: - Prepare technical documentation per Annex IV - Implement risk management system (Article 9) - QMS manual (Article 17) - Document the internal assessment - EU declaration of conformity (Article 47) - EU database entry (Article 49) - Affix the CE marking