‍Removed on April 10^th 2024 based on the version and article numbering approved by the EU Parliament on March 13^th 2024.

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[Previous version]

Updated on Feb 6^th 2024 based on the version endorsed by the Coreper I on Feb 2^nd

In order to ensure legal certainty, ensure an appropriate adaptation period for operators and avoid disruption to the market, including by ensuring continuity of the use of AI systems, it is appropriate that this Regulation applies to the high-risk AI systems that have been placed on the market or put into service before the general date of application thereof, only if, from that date, those systems are subject to significant changes in their design or intended purpose. It is appropriate to clarify that, in this respect, the concept of significant change should be understood as equivalent in substance to the notion of substantial modification, which is used with regard only to high-risk AI systems as defined in this Regulation. By way of exception and in light of public accountability, operators of AI systems which are components of the large-scale IT systems established by the legal acts listed in Annex IX and operators of high-risk AI systems that are intended to be used by public authorities should take the necessary steps to comply with the requirements of this Regulation by end of 2030 and by four years after the entry into application respectively.

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[Previous version]

Concept of Significant Change

In order to ensure legal certainty, ensure an appropriate adaptation period for operators and avoid disruption to the market, including by ensuring continuity of the use of AI systems, it is appropriate that this Regulation applies to the high-risk AI systems that have been placed on the market or put into service before the general date of application thereof, only if, from that date, those systems are subject to significant changes in their design or intended purpose. It is appropriate to clarify that, in this respect, the concept of significant change should be understood as equivalent in substance to the notion of substantial modification, which is used with regard only to high-risk AI systems as defined in this Regulation.