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---
title: "Article 63 — Derogations for specific operators"
type: regulation
legal_status: in_force
source: "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02024R1689-20260727"
source_retrieved: 2026-09-28
shortTitle: "Article 63 — Derogations for specific operators"
instrument_type: level1_regulation
authority: Commission
binding: true
binding_character: binding
mica_level2: false
legal_basis: "Regulation (EU) 2024/1689"
instrument: aiact
celex: "32024R1689"
regulation: AI Act
regulation-full: "Regulation (EU) 2024/1689"
article: 63
status: in_force
object_id: eu.aiact.legal_text.article.63
text_version: "Consolidated version of 27 July 2026"
source_url: "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02024R1689-20260727"
check_status: matched
verified: true
last_checked: 2026-10-26
---

*In force · Consolidated version of 27 July 2026 · Checked against EUR-Lex on 26 Oct 2026 · [Official source](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02024R1689-20260727)*

1. <a id="p-1"></a>SMEs, including start-ups, may comply with certain elements of the quality management system required by [Article 17](17.md) 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. <a id="p-2"></a>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](9.md), [10](10.md), [11](11.md), [12](12.md), [13](13.md), [14](14.md), [15](15.md), [72](72.md) and [73](73.md).

***

[Chapter VI — Measures in support of innovation](../chapters/vi.md) · [← Article 62](62.md) · [Article 64 →](64.md)
