Article 43 Conformity assessment

1. the internal control referred to in Annex VI; or

2. the assessment of the quality management system and the assessment of the technical documentation, with the involvement of a notified body means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation;, referred to in Annex VII.

1. harmonised standards means a harmonised standard as defined in Article 2(1), point (c), of Regulation (EU) No 1025/2012; referred to in Article 40 do not exist, and common specifications means a set of technical specifications as defined in Article 2, point (4) of Regulation (EU) No 1025/2012, providing means to comply with certain requirements established under this Regulation; referred to in Article 41 are not available;

2. the provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; has not applied, or has applied only part of, the harmonised standard means a harmonised standard as defined in Article 2(1), point (c), of Regulation (EU) No 1025/2012;;

3. the common specifications means a set of technical specifications as defined in Article 2, point (4) of Regulation (EU) No 1025/2012, providing means to comply with certain requirements established under this Regulation; referred to in point (a) exist, but the provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; has not applied them;

4. one or more of the harmonised standards means a harmonised standard as defined in Article 2(1), point (c), of Regulation (EU) No 1025/2012; referred to in point (a) has been published with a restriction, and only on the part of the standard that was restricted.

For the purposes of the conformity assessment means the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled; procedure referred to in Annex VII, the provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; may choose any of the notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation;. However, where the high-risk AI system means 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; is intended to be put into service by law enforcement means activities carried out by law enforcement authorities or on their behalf for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including safeguarding against and preventing threats to public security;, immigration or asylum authorities or by Union institutions, bodies, offices or agencies, the market surveillance authority means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; referred to in Article 74(8) or (9), as applicable, shall act as a notified body means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation;.

For high-risk AI systems means 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; referred to in points 2 to 8 of Annex III, providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; shall follow the conformity assessment means the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled; procedure based on internal control as referred to in Annex VI, which does not provide for the involvement of a notified body means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation;.

For high-risk AI systems means 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; covered by the Union harmonisation legislation listed in Section A of Annex I, the provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; shall follow the relevant conformity assessment means the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled; procedure as required under those legal acts. The requirements set out in Section 2 of this Chapter shall apply to those high-risk AI systems means 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; and shall be part of that assessment. Points 4.3., 4.4., 4.5. and the fifth paragraph of point 4.6 of Annex VII shall also apply.

For the purposes of that assessment, notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; which have been notified under those legal acts shall be entitled to control the conformity of the high-risk AI systems means 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; with the requirements set out in Section 2, provided that the compliance of those notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; with requirements laid down in Article 31(4), (5), (10) and (11) has been assessed in the context of the notification procedure under those legal acts.

Where a legal act listed in Section A of Annex I enables the product manufacturer to opt out from a third-party conformity assessment means the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled;, provided that that manufacturer has applied all harmonised standards means a harmonised standard as defined in Article 2(1), point (c), of Regulation (EU) No 1025/2012; covering all the relevant requirements, that manufacturer may use that option only if it has also applied harmonised standards means a harmonised standard as defined in Article 2(1), point (c), of Regulation (EU) No 1025/2012; or, where applicable, common specifications means a set of technical specifications as defined in Article 2, point (4) of Regulation (EU) No 1025/2012, providing means to comply with certain requirements established under this Regulation; referred to in Article 41, covering all requirements set out in Section 2 of this Chapter.

High-risk AI systems means 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 already been subject, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions; to a conformity assessment means the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled; procedure shall undergo a new conformity assessment means the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled; procedure in the event of a substantial modification means 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;, regardless of whether the modified system is intended to be further distributed or continues to be used by the current deployer means a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activity;.

For high-risk AI systems means 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 continue to learn after being placed on the market or put into service, changes to the high-risk AI system means 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; and its performance that have been pre-determined by the provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; at the moment of the initial conformity assessment means the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled; and are part of the information contained in the technical documentation referred to in point 2(f) of Annex IV, shall not constitute a substantial modification means 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;.

The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annexes VI and VII by updating them in light of technical progress.

The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend paragraphs 1 and 2 of this Article in order to subject, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions; high-risk AI systems means 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; referred to in points 2 to 8 of Annex III to the conformity assessment means the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled; procedure referred to in Annex VII or parts thereof. The Commission shall adopt such delegated acts taking into account the effectiveness of the conformity assessment means the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled; procedure based on internal control referred to in Annex VI in preventing or minimising the risks means the combination of the probability of an occurrence of harm and the severity of that harm; to health and safety and protection of fundamental rights posed by such systems, as well as the availability of adequate capacities and resources among notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation;.