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RGPD

Article 63

Derogations for specific operators

1.   SMEs, including start-ups, may comply with certain elements of the quality management system required by Article 17 in a simplified manner, provided that they do not have partner enterprises or linked enterprises within the meaning of Recommendation 2003/361/EC. 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 SMEs, 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.

Common Questions

Frequently Asked Questions

What special provisions does the AI Act provide for small businesses?
The AI Act allows SMEs, including start-ups, to comply with certain elements of the quality management system for high-risk AI in a simplified manner, as long as they have no partner or linked enterprises.
Which companies can use the simplified rules?

SMEs, including start-ups, can use the simplified rules if they have no partner or linked enterprises within the meaning of Recommendation 2003/361/EC. Under the AI Act, an SME is a micro, small or medium-sized enterprise as defined in that Recommendation (Article 3(14a)).

Are SMEs exempt from all of the AI Act obligations?
No. SMEs must still fully comply with all other requirements and obligations of the AI Act, including those in Articles 9 to 15, 72 and 73, such as risk management, data governance and reporting serious incidents, even if they meet certain elements of the quality management system in a simplified manner.
Will simplified compliance rules lower the safety standards for AI systems developed by small businesses?
No. Simplification must not affect the level of protection or the need to comply with the requirements for high-risk AI systems. The Commission must develop guidelines on the elements of the quality management system that SMEs may meet in a simplified manner, considering their needs.

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