Conformity Assessment (Article 43 EU AI Act)
Mandatory assessment for providers of high-risk AI — the Annex III obligations in Chapter III Sections 1–3 apply from 2 December 2027 (Regulation (EU) 2026/1744, in force since 27 July 2026)
TL;DR
Conformity assessment under Art. 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 (Art. 43(2)). In special cases (Annex III no. 1 biometrics plus certain sub-categories): external assessment by a notified body.
What is conformity assessment (Article 43 EU AI Act)?
Two procedures are possible:
- Internal assessment (Art. 43(2)): for Annex III nos. 2-8 — the provider carries out the check itself, documents it and draws up the EU declaration of conformity
- External assessment (Art. 43(1)): only for biometrics plus sub-categories — by a notified body (designated nationally)
For Annex III systems, the high-risk obligations in Chapter III Sections 1–3 apply from 2 December 2027, and for Annex I systems from 2 August 2028 (Regulation (EU) 2026/1744, in force since 27 July 2026); the general date of application of 2 August 2026 remains unchanged. Result where successful: CE marking plus entry in the EU database (Art. 49).
Practical example
An HR recruiting tool, from the provider's perspective:
- Draw up the technical documentation under Annex IV
- Implement a risk management system (Art. 9)
- QMS manual (Art. 17)
- Document the internal assessment
- EU declaration of conformity (Art. 47)
- EU database entry (Art. 49)
- Affix the CE marking