By clicking “Accept”, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. View our Privacy Policy for more information.

Article 55a


Removed on May 8th 2024 based on the version and article numbering in the EU Parliament's 'Corrigendum' version dated April 19th 2024.

[Previous version]

Removed on April 10th 2024 based on the version and article numbering approved by the EU Parliament on March 13th 2024.

Updated on Feb 6th 2024 based on the version endorsed by the Coreper I on Feb 2nd

Derogations for Specific Operators

2b. Microenterprises as defined in Article 2(3) of the Annex to the Commission Recommendation 2003/361/EC concerning the definition of micro, small and medium- sized enterprises, provided those enterprises do not have partner enterprises or linked enterprises as defined in Article 3 of the same Annex may fulfil certain elements of the quality management system required by Article 17 of this Regulation in a simplified manner. For this purpose, the Commission shall develop guidelines on the elements of the quality management system which may be fulfilled in a simplified manner considering the needs of micro enterprises without affecting the level of protection and the need for compliance with the requirements for high-risk AI systems.

2c. Paragraph 1 shall not be interpreted as exempting those operators from fulfilling any other requirements and obligations laid down in this Regulation, including those established in Articles 9, 10, 11, 12, 13, 14, 15, 61 and 62.

Suitable Recitals
Report error

Report error

Please keep in mind that this form is only for feedback and suggestions for improvement.

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.