CHAPTER VI

Article 63: Derogations for specific operators

Plain English Summary

What this article does: Provides derogations for micro and small enterprises from certain procedural requirements. Who it applies to: Micro-enterprises and small enterprises. Key requirements: Para 1: Certain elements of the quality management system (Article 17) may be simplified, proportionate to the size of the enterprise. Para 2: The Commission must develop guidelines and templates tailored to the needs of micro and small enterprises.

1. Microenterprises within the meaning of Recommendation 2003/361/EC may comply with certain elements of the quality management system required by of this Regulation in a simplified manner, provided that they do not have partner enterprises or linked enterprises within the meaning of that Recommendation. 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 microenterprises, 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. CHAPTER VII GOVERNANCE SECTION 1 Governance at Union level

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