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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.

Frequently Asked Questions

Under Article 34 of the AI Act, notified bodies are responsible for checking high-risk AI systems to make sure they meet required standards, following the conformity assessment guidelines specified in Article 43. This careful verification helps protect people by ensuring reliable, safe, and ethically sound AI use, especially when the AI could significantly affect individuals or society.
Yes, notified bodies are required to consider the size, complexity, and specific industry of the company developing the AI system. They particularly aim to avoid unnecessary administrative work and costs for small and micro-sized enterprises, striking a balance between thorough assessment and the need not to impose unfair financial or administrative strain on smaller businesses.
No, notified bodies must always maintain the required level of thoroughness and protection when assessing AI systems. While they try to minimize unnecessary administrative efforts, the essential standards for safety, compliance, and protection must be fully upheld, even for small companies, to ensure public confidence and safety.
Notified bodies must provide all relevant paperwork, including documents received from AI system providers, to the notifying authority upon request. This requirement ensures the notifying authority can effectively oversee the body’s activities, verify compliance, and carry out responsibilities related to designation, monitoring, and quality control of the notified body itself.

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