Article 63 of 11356%
Article 63: Derogations for specific operators
Article 63 allows SMEs, including start-ups, to comply with certain elements of the quality management system in a simplified manner, provided they do not have partner or linked enterprises. Before the amendment by Regulation (EU) 2026/1744 this applied only to microenterprises.
Zahed Ashkara, AI and privacy legal adviserobligations checked against the source on
Praxikon tracks Article 63 (Derogations for specific operators) under the EU AI Act, citing the source for every statement.
EU Official:
Title VI: Governance
Official text
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Source: EUR-Lex, Regulation (EU) 2024/1689. Text reproduced verbatim.
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Frequently asked questions
What derogations apply to SMEs under Article 63 AI Act?+
Article 63 allows SMEs, including start-ups, to comply with certain elements of the quality management system in a simplified manner, provided they do not have partner or linked enterprises. Before the amendment by Regulation (EU) 2026/1744 this applied only to microenterprises.
What documentation does Article 63 of the AI Act require?+
Article 63 of the AI Act requires that relevant documentation is maintained as part of the compliance process. This may include technical documentation, instructions for use, logs or declarations of conformity, depending on the classification of the AI system.
How do I document compliance with Article 63 of the AI Act?+
You document compliance with Article 63 of the AI Act by establishing a risk management system, maintaining technical documentation, and conducting internal audits. Keep all relevant documents for the period prescribed by the AI Act.