Artículo 43
Conformity assessment
Alto riesgoAplicable desde 2 de agosto de 2026
Se aplica a: Proveedor
Before a high-risk AI system is placed on the market, the provider must complete the applicable conformity assessment procedure.
Puntos clave
- 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
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Esta página es un resumen orientativo en lenguaje claro. No es asesoramiento jurídico — el texto vinculante es el Reglamento (UE) 2024/1689.