Article 63: Derogations for specific operators
The article allows microenterprises to comply with certain quality management system requirements in a simplified manner, as long as they do not have partner or linked enterprises within the meaning of Recommendation 2003/361/EC. The Commission will develop guidelines for this simplified compliance, ensuring it does not compromise protection levels or other regulatory requirements for high-risk AI systems.
1. Microenterprises within the meaning of Recommendation 2003/361/EC may comply with certain elements of the quality management system required by Article 17 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.