Article 43
Conformity assessment
High riskApplicable from August 2, 2026
Applies to: Provider
Before a high-risk AI system is placed on the market, the provider must complete the applicable conformity assessment procedure.
Key points
- Internal control under Annex VI or notified-body assessment under Annex VII
- Route depends on the use case and on the application of harmonised standards
- Substantial modification requires a new assessment
- Certificates issued by notified bodies are time-limited and renewable
- Documentation must be retained and made available to authorities
Related terms
Related articles
This page is a plain-language summary for orientation only. It is not legal advice — the binding text is Regulation (EU) 2024/1689.