Article 34: Operational Obligations of Notified Bodies
This article states that notified bodies (officially recognized organizations) must check that high-risk AI systems meet the standards outlined in Article 43. They should avoid causing unnecessary work for providers and consider factors like the provider's size, sector, structure, and the complexity of the AI system. They should especially try to reduce administrative work and compliance costs for small businesses. However, they must still ensure the AI system meets the necessary safety standards. These bodies must also provide all relevant documents to the notifying authority (the body that oversees them) when asked, to help with assessments and monitoring.
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NOTE: This translation is a machine-generated translation. It is not the official translation provided by the European Parliament. When the AI Act is published in the official journal, the machine-generated translations will be replaced by the official translations.
1. Notified bodies shall verify the conformity of high-risk AI systems in accordance with the conformity assessment procedures set out in Article 43.
2. Notified bodies shall avoid unnecessary burdens for providers when performing their activities, and take due account of the size of the provider, the sector in which it operates, its structure and the degree of complexity of the high-risk AI system 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 body shall, nevertheless, respect the degree of rigour and the level of protection required for the compliance of the high-risk AI system with the requirements of this Regulation.
3. Notified bodies shall make available and submit upon request all relevant documentation, including the providers’ documentation, to the notifying authority 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.
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