Article 34 Operational obligations of notified bodies

Notified bodiesmeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; shall verify the conformity 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; in accordance with the conformity assessmentmeans the process of demonstrating whether the requirements set out in Chapter III, Section 2 relating to a high-risk AI system have been fulfilled; procedures set out in Article 43.

Notified bodiesmeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; shall avoid unnecessary burdens for providersmeans 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; when performing their activities, and take due account of the size of the providermeans 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 high-risk AI 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 environments; concerned, in particular in view of minimising administrative burdens and compliance costs for micro- and small enterprises within the meaning of Recommendation 2003/361/EC. The notified bodymeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; shall, nevertheless, respect the degree of rigour and the level of protection required for the compliance of the high-risk AI 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 environments; with the requirements of this Regulation.

Notified bodiesmeans a conformity assessment body notified in accordance with this Regulation and other relevant Union harmonisation legislation; shall make available and submit upon request all relevant documentation, including the providersmeans 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;’ documentation, to the notifying authoritymeans 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; referred to in Article 28 to allow that authority to conduct its assessment, designation, notification and monitoring activities, and to facilitate the assessment outlined in this Section.