Mandatory content of the EU Declaration of Conformity for high-risk AI systems
Overview
Specifies the mandatory content of the EU Declaration of Conformity referenced in Article 47, which is the formal statement by a provider that a high-risk AI system meets regulatory requirements.
The EU declaration of conformity referred to in Article 47 shall contain all of the following information:
1. AI system name and type and any additional unambiguous reference allowing the identification and traceability of the AI system.
2. The name and address of the provider or, where applicable, of their authorised representative.
3. A statement that the EU declaration of conformity referred to in is issued under the sole responsibility of the provider.
4. A statement that the AI system is in conformity with this Regulation and, if applicable, with any other relevant Union law that provides for the issuing of an EU declaration of conformity.
5. Where an AI system involves the processing of personal data, a statement that that AI system complies with Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680.
6. References to any relevant harmonised standards used or any other common specification in relation to which conformity is declared.
7. Where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed, and identification of the certificate issued.
8. The place and date of issue of the declaration, the name and function of the person who signed it, as well as an indication for, or on behalf of whom, that person signed, a signature.
