Art. 34 Operational obligations of notified bodies | AI act regulation | AI act

This article sets out the operational obligations of notified bodies when carrying out conformity assessments of high-risk AI systems.

It connects directly to Article 43, which defines the conformity assessment procedures notified bodies must follow.

Beyond simply verifying compliance, the article places a balancing obligation on notified bodies: they must conduct their work with appropriate rigour while avoiding unnecessary burdens on providers, with particular consideration given to smaller enterprises.

Important points:

Notified bodies are required to verify conformity of high-risk AI systems in accordance with the procedures set out in Article 43.
Notified bodies must take into account the size, sector, structure, and complexity of the provider and system, with a specific duty to minimise administrative burdens and compliance costs for micro- and small enterprises.
The duty to reduce burden does not override the requirement to maintain the level of rigour and protection demanded by the regulation.

1. Notified bodies shall verify the conformity of high-risk AI systems in accordance with the conformity assessment procedures set out in Article 43.
1. 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.
1. 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.