---
id: art-63
lang: en
type: article
number: "63"
amended_by: regulation-2026-1744-omnibus
capture: regulation-2024-1689/en-2026-08-18.html
capture_sha256: 8f0b656302f9864cc87e040c371f209a9d65ae1a6cecc25ca5eb737e872d721a
eli: http://data.europa.eu/eli/reg/2024/1689/oj
authoritative: false
---

> Derived text, not the authentic source. Claims cite the capture and the Official Journal.

# Article 63 — Derogations for specific operators

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.