CHAPTER III · SECTION 4

AI Act Article 34: Operational obligations of notified bodies

Amended text. Regulation (EU) 2026/1744, the Digital Omnibus on AI, amended this Regulation with effect from 27 July 2026. The articles it changed, and the six it inserted (4a, 60a, 75a, 75b, 75c and 75d), are shown here in their consolidated wording, taken from the official consolidated text of 27 July 2026. The recitals are those of the original Regulation. Consolidated text on EUR-Lex (CELEX 02024R1689-20260727).

This article was not changed by the amendment.

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.

Source text: EUR-Lex, Official Journal HTML (CELEX 32024R1689), with the articles amended by Regulation (EU) 2026/1744 taken from the consolidated text (CELEX 02024R1689-20260727). The parser was validated against the anchor articles verified in REP-08.