Article 31 Requirements relating to notified bodies

A notified body means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; shall be established under the national law of a Member State and shall have legal personality.

Notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; shall satisfy the organisational, quality management, resources and process requirements that are necessary to fulfil their tasks, as well as suitable cybersecurity requirements.

The organisational structure, allocation of responsibilities, reporting lines and operation of notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; shall ensure confidence in their performance, and in the results 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; activities that the notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; conduct.

Notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; shall be independent of 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; of a 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; in relation to which they perform 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; activities. Notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; shall also be independent of any other operator means a provider, product manufacturer, deployer, authorised representative, importer or distributor; having an economic interest in 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; assessed, as well as of any competitors of 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;. This shall not preclude the use of assessed 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 are necessary for the operations of the conformity assessment body means a body that performs third-party conformity assessment activities, including testing, certification and inspection;, or the use of such 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; for personal purposes.

Neither a conformity assessment body means a body that performs third-party conformity assessment activities, including testing, certification and inspection;, its top-level management nor the personnel responsible for carrying out its 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; tasks shall be directly involved in the design, development, marketing or use of 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;, nor shall they represent the parties engaged in those activities. They shall not engage in any activity that might conflict with their independence of judgement or integrity in relation to 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; activities for which they are notified. This shall, in particular, apply to consultancy services.

Notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; shall be organised and operated so as to safeguard the independence, objectivity and impartiality of their activities. Notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; shall document and implement a structure and procedures to safeguard impartiality and to promote and apply the principles of impartiality throughout their organisation, personnel and assessment activities.

Notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; shall have documented procedures in place ensuring that their personnel, committees, subsidiaries, subcontractors and any associated body or personnel of external bodies maintain, in accordance with Article 78, the confidentiality of the information which comes into their possession during the performance of 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; activities, except when its disclosure is required by law. The staff of notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; shall be bound to observe professional secrecy with regard to all information obtained in carrying out their tasks under this Regulation, except in relation to the notifying authorities means the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring; of the Member State in which their activities are carried out.

Notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; shall have procedures for the performance of activities which take due account of the size of a 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;, the sector in which it operates, its structure, and the degree of complexity of the 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; concerned.

Notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; shall take out appropriate liability insurance for their 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; activities, unless liability is assumed by the Member State in which they are established in accordance with national law or that Member State is itself directly responsible for 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;.

Notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; shall be capable of carrying out all their tasks under this Regulation with the highest degree of professional integrity and the requisite competence in the specific field, whether those tasks are carried out by notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; themselves or on their behalf and under their responsibility.

Notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; shall have sufficient internal competences to be able effectively to evaluate the tasks conducted by external parties on their behalf. The notified body means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; shall have permanent availability of sufficient administrative, technical, legal and scientific personnel who possess experience and knowledge relating to the relevant types of 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;, data and data computing, and relating to the requirements set out in Section 2.

Notified bodies means a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; shall participate in coordination activities as referred to in Article 38. They shall also take part directly, or be represented in, European standardisation organisations, or ensure that they are aware and up to date in respect of relevant standards.