Recital 177 Already placed on the market

In order to ensure legal certainty, ensure an appropriate adaptation period for operatorsmeans a provider, product manufacturer, deployer, authorised representative, importer or distributor; and avoid disruption to the market, including by ensuring continuity of the use of AI systemsmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments;, it is appropriate that this Regulation applies to the high-risk AI systemsmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; 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, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions; to significant changes in their design or intended purposemeans the use for which an AI system is intended by the provider, including the specific context and conditions of use, as specified in the information supplied by the provider in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation;. 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 modificationmeans 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;, which is used with regard only to high-risk AI systemsmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; pursuant to this Regulation. On an exceptional basis and in light of public accountability, operatorsmeans a provider, product manufacturer, deployer, authorised representative, importer or distributor; of AI systemsmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; which are components of the large-scale IT systems established by the legal acts listed in an annex to this Regulation and operatorsmeans a provider, product manufacturer, deployer, authorised representative, importer or distributor; of high-risk AI systemsmeans a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; 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.