Summary of Article 34
- Conformity Verification and Proportionality: Notified bodies must verify the conformity of high-risk AI systems under Article 43 while minimizing burdens for providers, particularly small and micro enterprises, without compromising compliance standards.
- Documentation and Reporting: Notified bodies must submit all relevant documentation, including providers’ documentation, to the notifying authority to support assessment, designation, notification, and monitoring processes.
Conformity Verification and Proportionality
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.
Documentation and Reporting
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.
