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Annex VII: Conformity Based on an Assessment of the Quality Management System and an Assessment of the Technical Documentation

1. Introduction
Conformity based on an assessment of the quality management system and an assessment of the technical documentation is the conformity assessmentconformity assessmentmeans the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI systemAI systemmeans 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 environmentsArticle 3(1) have been fulfilledArticle 3(20) procedure based on points 2 to 5.
2. Overview
The approved quality management system for the design, development and testing of AI systems pursuant to Article 17 shall be examined in accordance with point 3 and shall be subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58) to surveillance as specified in point 5. The technical documentation of the AI systemAI systemmeans 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 environmentsArticle 3(1) shall be examined in accordance with point 4.
3. Quality management system
1. The application of the providerprovidermeans 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 chargeArticle 3(3) shall include:
(a) the name and address of the providerprovidermeans 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 chargeArticle 3(3) and, if the application is lodged by an authorised representativeauthorised representativemeans a natural or legal person located or established in the Union who has received and accepted a written mandate from a providerprovidermeans 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 chargeArticle 3(3) of an AI systemAI systemmeans 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 environmentsArticle 3(1) or a general-purpose AI modelgeneral-purpose AI modelmeans an AI model, including where such an AI model is trained with a large amount of data using self-supervision at scale, that displays significant generality and is capable of competently performing a wide range of distinct tasks regardless of the way the model is placed on the market and that can be integrated into a variety of downstream systems or applications, except AI models that are used for research, development or prototyping activities before they are placed on the marketArticle 3(63) to, respectively, perform and carry out on its behalf the obligations and procedures established by this RegulationArticle 3(5), also their name and address;
(b) the list of AI systems covered under the same quality management system;
(c) the technical documentation for each AI systemAI systemmeans 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 environmentsArticle 3(1) covered under the same quality management system;
(d) the documentation concerning the quality management system which shall cover all the aspects listed under Article 17;
(e) a description of the procedures in place to ensure that the quality management system remains adequate and effective;
(f) a written declaration that the same application has not been lodged with any other notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22).
2. The quality management system shall be assessed by the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22), which shall determine whether it satisfies the requirements referred to in Article 17.
The decision shall be notified to the providerprovidermeans 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 chargeArticle 3(3) or its authorised representativeauthorised representativemeans a natural or legal person located or established in the Union who has received and accepted a written mandate from a providerprovidermeans 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 chargeArticle 3(3) of an AI systemAI systemmeans 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 environmentsArticle 3(1) or a general-purpose AI modelgeneral-purpose AI modelmeans an AI model, including where such an AI model is trained with a large amount of data using self-supervision at scale, that displays significant generality and is capable of competently performing a wide range of distinct tasks regardless of the way the model is placed on the market and that can be integrated into a variety of downstream systems or applications, except AI models that are used for research, development or prototyping activities before they are placed on the marketArticle 3(63) to, respectively, perform and carry out on its behalf the obligations and procedures established by this RegulationArticle 3(5).
The notification shall contain the conclusions of the assessment of the quality management system and the reasoned assessment decision.
3. The quality management system as approved shall continue to be implemented and maintained by the providerprovidermeans 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 chargeArticle 3(3) so that it remains adequate and efficient.
4. Any intended change to the approved quality management system or the list of AI systems covered by the latter shall be brought to the attention of the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) by the providerprovidermeans 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 chargeArticle 3(3).
The proposed changes shall be examined by the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22), which shall decide whether the modified quality management system continues to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.
The notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) shall notify the providerprovidermeans 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 chargeArticle 3(3) of its decision. The notification shall contain the conclusions of the examination of the changes and the reasoned assessment decision.
4. Control of the technical documentation.
1. In addition to the application referred to in point 3, an application with a notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) of their choice shall be lodged by the providerprovidermeans 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 chargeArticle 3(3) for the assessment of the technical documentation relating to the AI systemAI systemmeans 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 environmentsArticle 3(1) which the providerprovidermeans 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 chargeArticle 3(3) intends to place on the market or put into service and which is covered by the quality management system referred to under point 3.
2. The application shall include:
(a) the name and address of the providerprovidermeans 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 chargeArticle 3(3);
(b) a written declaration that the same application has not been lodged with any other notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22);
(c) the technical documentation referred to in Annex IV.
3. The technical documentation shall be examined by the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22). Where relevant, and limited to what is necessary to fulfil its tasks, the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) shall be granted full access to the training, validation, and testing datatesting datameans data used for providing an independent evaluation of the AI systemAI systemmeans 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 environmentsArticle 3(1) in order to confirm the expected performance of that system before its placing on the market or putting into serviceArticle 3(32) sets used, including, where appropriate and subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58) to security safeguards, through API or other relevant technical means and tools enabling remote access.
4. In examining the technical documentation, the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) may require that the providerprovidermeans 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 chargeArticle 3(3) supply further evidence or carry out further tests so as to enable a proper assessment of the conformity of the AI systemAI systemmeans 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 environmentsArticle 3(1) with the requirements set out in Chapter III, Section 2. Where the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) is not satisfied with the tests carried out by the providerprovidermeans 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 chargeArticle 3(3), the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) shall itself directly carry out adequate tests, as appropriate.
5. Where necessary to assess the conformity of the high-risk AI systemAI systemmeans 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 environmentsArticle 3(1) with the requirements set out in Chapter III, Section 2, after all other reasonable means to verify conformity have been exhausted and have proven to be insufficient, and upon a reasoned request, the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) shall also be granted access to the training and trained models of the AI systemAI systemmeans 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 environmentsArticle 3(1), including its relevant parameters. Such access shall be subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58) to existing Union law on the protection of intellectual property and trade secrets.
6. The decision of the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) shall be notified to the providerprovidermeans 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 chargeArticle 3(3) or its authorised representativeauthorised representativemeans a natural or legal person located or established in the Union who has received and accepted a written mandate from a providerprovidermeans 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 chargeArticle 3(3) of an AI systemAI systemmeans 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 environmentsArticle 3(1) or a general-purpose AI modelgeneral-purpose AI modelmeans an AI model, including where such an AI model is trained with a large amount of data using self-supervision at scale, that displays significant generality and is capable of competently performing a wide range of distinct tasks regardless of the way the model is placed on the market and that can be integrated into a variety of downstream systems or applications, except AI models that are used for research, development or prototyping activities before they are placed on the marketArticle 3(63) to, respectively, perform and carry out on its behalf the obligations and procedures established by this RegulationArticle 3(5). The notification shall contain the conclusions of the assessment of the technical documentation and the reasoned assessment decision.
Where the AI systemAI systemmeans 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 environmentsArticle 3(1) is in conformity with the requirements set out in Chapter III, Section 2, the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) shall issue a Union technical documentation assessment certificate. The certificate shall indicate the name and address of the providerprovidermeans 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 chargeArticle 3(3), the conclusions of the examination, the conditions (if any) for its validity and the data necessary for the identification of the AI systemAI systemmeans 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 environmentsArticle 3(1).
The certificate and its annexes shall contain all relevant information to allow the conformity of the AI systemAI systemmeans 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 environmentsArticle 3(1) to be evaluated, and to allow for control of the AI systemAI systemmeans 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 environmentsArticle 3(1) while in use, where applicable.
Where the AI systemAI systemmeans 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 environmentsArticle 3(1) is not in conformity with the requirements set out in Chapter III, Section 2, the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) shall refuse to issue a Union technical documentation assessment certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
Where the AI systemAI systemmeans 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 environmentsArticle 3(1) does not meet the requirement relating to the data used to train it, re-training of the AI systemAI systemmeans 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 environmentsArticle 3(1) will be needed prior to the application for a new conformity assessmentconformity assessmentmeans the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI systemAI systemmeans 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 environmentsArticle 3(1) have been fulfilledArticle 3(20). In this case, the reasoned assessment decision of the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) refusing to issue the Union technical documentation assessment certificate shall contain specific considerations on the quality data used to train the AI systemAI systemmeans 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 environmentsArticle 3(1), in particular on the reasons for non-compliance.
7. Any change to the AI systemAI systemmeans 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 environmentsArticle 3(1) that could affect the compliance of the AI systemAI systemmeans 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 environmentsArticle 3(1) with the requirements or its intended purposeintended purposemeans the use for which an AI systemAI systemmeans 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 environmentsArticle 3(1) is intended by the providerprovidermeans 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 chargeArticle 3(3), including the specific context and conditions of use, as specified in the information supplied by the providerprovidermeans 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 chargeArticle 3(3) in the instructions for use, promotional or sales materials and statements, as well as in the technical documentationArticle 3(12) shall be assessed by the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) which issued the Union technical documentation assessment certificate. The providerprovidermeans 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 chargeArticle 3(3) shall inform such notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) of its intention to introduce any of the abovementioned changes, or if it otherwise becomes aware of the occurrence of such changes. The intended changes shall be assessed by the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22), which shall decide whether those changes require a new conformity assessmentconformity assessmentmeans the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI systemAI systemmeans 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 environmentsArticle 3(1) have been fulfilledArticle 3(20) in accordance with Article 43(4) or whether they could be addressed by means of a supplement to the Union technical documentation assessment certificate. In the latter case, the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) shall assess the changes, notify the providerprovidermeans 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 chargeArticle 3(3) of its decision and, where the changes are approved, issue to the providerprovidermeans 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 chargeArticle 3(3) a supplement to the Union technical documentation assessment certificate.
5. Surveillance of the approved quality management system.
1. The purpose of the surveillance carried out by the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) referred to in Point 3 is to make sure that the providerprovidermeans 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 chargeArticle 3(3) duly complies with the terms and conditions of the approved quality management system.
2. For assessment purposes, the providerprovidermeans 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 chargeArticle 3(3) shall allow the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) to access the premises where the design, development, testing of the AI systems is taking place. The providerprovidermeans 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 chargeArticle 3(3) shall further share with the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) all necessary information.
3. The notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) shall carry out periodic audits to make sure that the providerprovidermeans 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 chargeArticle 3(3) maintains and applies the quality management system and shall provide the providerprovidermeans 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 chargeArticle 3(3) with an audit report. In the context of those audits, the notified bodynotified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislationArticle 3(22) may carry out additional tests of the AI systems for which a Union technical documentation assessment certificate was issued.