Article 63

Derogations for specific operators

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.

Frequently Asked Questions

The AI Act allows very small businesses, called microenterprises, to follow simpler versions of certain quality management rules when dealing with high-risk AI, as long as they don’t have partner or linked companies, making compliance easier and more practical for these small businesses without compromising safety or legal standards.
A microenterprise, as defined by an existing EU recommendation, is a very small company typically employing fewer than ten workers and having a yearly turnover or total balance that doesn’t exceed specific financial limits; these businesses receive simplified rules under the AI Act provided they have no partner or linked companies.
No, microenterprises aren’t exempt from all requirements of the AI Act; they still need to fully comply with other obligations like risk management, ensuring accurate training data, and reporting serious incidents, even though they might adopt simpler approaches for certain elements of the required quality management system.
No, simplified compliance rules provided to small businesses under the AI Act will not reduce the necessary level of safety and protection; the EU Commission will create guidelines explicitly designed to keep these essential standards high while allowing microenterprises to meet certain regulatory elements more easily.

AI literacy

Get Started within 24 hours.

Once you have submitted your details, you’ll be our top priority!