A change to an AI system after its placing on the market or putting into service which is not foreseen or planned in the initial conformity assessment carried out by the provider and as a result of which the compliance of the AI system with the requirements set out in Chapter III, Section 2 is affected or modification of the intended purpose for which the AI system has been assessed
Defined in / by
Also defined different in / by
- Substantial modification defined in / by CRA (32024R2847)
Last updated: 22 August 2026.