Article 63: Derogations for Specific Operators

Summary of Article 63

  • Simplified Compliance for Microenterprises: Microenterprises without partner or linked enterprises may adhere to simplified quality management system requirements, guided by Commission-issued guidelines, while remaining fully obligated to meet all other regulatory requirements.

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 910111213141572 and 73.

All you need to know about the EU AI Act
in one Cheat Sheet

Get Free PDF Now
About the author
Philip Mohr

Philip Mohr

Philip Mohr, a certified AIGP, is an AI governance consultant with over a decade of expertise in product management, data governance and privacy, leading initiatives at Addtrust (addtrust.com).

#1 Resource on EU AI ACT Compliance

Sign up to get access to free resources and checklists

#1 Resource on EU AI ACT Compliance

Great! You’ve successfully signed up.

Welcome back! You've successfully signed in.

You've successfully subscribed to #1 Resource on EU AI ACT Compliance.

Success! Check your email for magic link to sign-in.

Success! Your billing info has been updated.

Your billing was not updated.