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(128)
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In line with the commonly established notion of substantial modification for
products regulated by Union harmonisation legislation, it is appropriate that whenever
a change occurs which may affect the compliance of a high-risk AI system with this
Regulation (e.g. change of operating system or software architecture), or when the intended
purpose of the system changes, that AI system should be considered to be a new AI system
which should undergo a new conformity assessment. However, changes occurring to the
algorithm and the performance of AI systems which continue to ‘learn’ after being placed on the
market or put into service, namely automatically adapting how functions are carried out, should
not constitute a substantial modification, provided that those changes have been
pre-determined by the provider and assessed at the moment of the conformity assessment.
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