Substantial modification is a change to an AI system after market placement or service deployment that affects compliance or changes the system’s intended purpose. In regulatory contexts, such a change can create new assessment or responsibility obligations.
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 results in a modification to the intended purpose for which the AI system has been assessed.