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Risk level: high Title III — High-Risk AI Systems Notifying Authorities

Article 34 — Harmonised Standards and Standardisation Deliverables

Operational obligations of notified bodies 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...

Article 34
Operational obligations of notified bodies
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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