Article 63 — AI Office

Article 63

Derogations for specific operators

1. Microenterprises within the meaning of Recommendation 2003/361/EC 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. 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, 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.

CHAPTER VII

GOVERNANCE

SECTION 1

Governance at Union level