Updated on 31 July 2024 based on the version published in the Official Journal of the EU dated 12 July 2024 and entered into force on 1 August 2024.

In order to ensure legal certainty, ensure an appropriate adaptation period for operators and avoid disruption to themarket, 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 there of, 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 pursuant to this Regulation. On an exceptional basis 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 an annex to this Regulation and operators of high-risk AI systems that are intended to be used by public authorities should, respectively, take the necessary steps to comply with the requirements of this Regulation by end of 2030 and by 2 August 2030.