Map of the AI Act
Article 63: derogations for SMEs in the quality management system
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obligation
Article 63: derogations for SMEs in the quality management system
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. Until 27 July 2026 this read microenterprises; Article 1, point (26), of Regulation (EU) 2026/1744 replaced paragraph 1 and widened the circle to SMEs. Which elements those are is for the Commission to set out in guidelines, considering the needs of SMEs and without affecting the level of protection or the need for compliance with the requirements in respect of high-risk AI systems. Paragraph 2 rules out any wider reading: the provision 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.
based on
- Article 63 on EUR-Lexguidance
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Read at 2 Aug 2026. What did not yet apply on that date is not shown here. The transparency duties of article 50 apply, and the Commission can enforce against GPAI providers.