Article 63
Derogations for Specific Operators
Regulation (EU) 2026/1744, the Digital Omnibus on AI
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.
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.
Where Article 63 sits in the EU AI Act
Article 63 is provision 7 of 7 in Chapter VI: Measures in Support of Innovation, which covers Articles 57–63 of Regulation (EU) 2024/1689.
Provisions referenced in Article 63
The text of Article 63 cites the following provisions. Read them alongside it: cross-references carry binding requirements.
Source and verification
This is Article 63 of Regulation (EU) 2024/1689 as amended by Regulation (EU) 2026/1744. The wording differs from the text as originally adopted in 2024. It has been checked against the consolidated text on EUR-Lex. Where this page and EUR-Lex disagree, EUR-Lex governs.