Direct answer
What does Article 63 of the AI Act say about derogations for SMEs in the quality management system?
Your question is about Article 63: derogations for SMEs in the quality management system. That obligation applies today. Whether your system actually falls under it depends on conditions you assess yourself.
You determine this yourself
- Two cumulative conditions. The organisation is an SME, including a start-up, within the meaning of Recommendation 2003/361/EC, and it does not have partner enterprises or linked enterprises within the meaning of that Recommendation. A standalone small enterprise that is not a microenterprise is therefore covered since 27 July 2026. The thresholds and the notions of partner enterprise and linked enterprise sit in that Recommendation and not in this Regulation; anyone relying on this article tests against that text. The benefit touches only the quality management system required by Article 17, and only those elements of it that the Commission designates in its guidelines. Article 63 sits in Chapter VI, which is named in none of the three exceptions in the third paragraph of Article 113; the general date of application in the second paragraph therefore governs, 2 August 2026.
- Paragraph 2 expressly provides that paragraph 1 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. The risk management system, data and data governance, technical documentation, record-keeping, transparency, human oversight, accuracy, robustness and cybersecurity, post-market monitoring and the reporting of serious incidents therefore continue to apply in full.
First step: Determine and bound the simplification of your quality management system.
Article 63 of the AI Act covers 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. This provision concerns the provider of an AI system. This provision applies today.
This applies now
Your first actions
- Determine and bound the simplification of your quality management system. Test whether you are a microenterprise with no partner or linked enterprises, build the Article 17 system, mark which elements you would want to simplify once the Commission guidelines exist, and keep the nine articles of Article 63(2) expressly outside that simplification.
Record this
General interpretation, not legal advice. Checked against Regulation (EU) 2024/1689 and the Digital Omnibus (EU) 2026/1744; the official source remains authoritative.
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