Version in force , Modified +58 −120§
Amended by Digital Omnibus on AI 32026R1744 on EUR-Lex (external, EUR-Lex)
Explanation, written by a model and checked against the cited text
The scope of paragraph 1 changes from microenterprises, defined by reference to Recommendation 2003/361/EC and excluding those with partner or linked enterprises, to SMEs including start-ups.
The reference to that Recommendation is retained but now used only to define partner or linked enterprises, and the guidance the Commission is to develop is described as considering the needs of SMEs rather than microenterprises.
Cited: Art. 63, v1 (external, EUR-Lex) · Art. 63, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, before and after
Previous version 32024R1689 → this version, in force 27 July 2026 02024R1689-20260727
Article 63
Derogations for specific operators
1. Microenterprises within the meaning of Recommendation 2003/361/EC SMEs, including start-ups, may comply with certain elements of the quality management system required by Article 17 of this Regulation in a simplified manner, provided that they do not have partner enterprises or linked enterprises within the meaning of that Recommendation. 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 microenterprises, 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.