CLAIM-2026-08-12-07
AI Act Article 43(4) provides that high-risk AI systems already subject to a conformity assessment procedure shall undergo a new one in the event of a substantial modification, and that for high-risk AI systems which continue to learn after being placed on the market, changes predetermined by the provider at the moment of the initial conformity assessment and contained in the technical documentation shall not constitute a substantial modification.
Why it matters
The only available carve-out, and it is a documentation test rather than a technical one. If the change envelope was not written down before assessment, the carve-out is unavailable regardless of how well the system behaves.
Sources
- euaiactexpl2026conformit