Article 63: Derogations for Specific Operators
This article states that small businesses (microenterprises) can follow a simplified version of the quality management system required by the Act, as long as they don't have partner or linked businesses. The Commission will create guidelines for this. However, this doesn't mean these businesses are exempt from other requirements or obligations in the Act, including those in Articles 9, 10, 11, 12, 13, 14, 15, 72 and 73. This is to ensure that the level of protection and compliance with high-risk AI systems is not compromised.
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NOTE: This translation is a machine-generated translation. It is not the official translation provided by the European Parliament. When the AI Act is published in the official journal, the machine-generated translations will be replaced by the official translations.
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.
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