CHAPTER VI
AI Act Article 63: Derogations for specific operators
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 amended. The text below is its consolidated wording from 27 July 2026.
1. SMEs, including start-ups, may comply with certain elements of the quality management system required by Article 17 in a simplified manner, provided that they do not have partner enterprises or linked enterprises within the meaning of Recommendation 2003/361/EC. For that purpose, the Commission shall develop guidelines on the elements of the quality management system which may be complied with in a simplified manner considering the needs of SMEs, without affecting the level of protection or the need for compliance with the requirements in respect of high-risk AI systems.
2. Paragraph 1 of this Article shall not be interpreted as exempting those operators from fulfilling any other requirements or obligations laid down in this Regulation, including those established in Articles 9, 10, 11, 12, 13, 14, 15, 72 and 73.
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.