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Annex V

EU Declaration of Conformity

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

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 Article 47 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 the EU declaration of conformity referred to in Article 47;

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.

[Previous version]

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

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 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.

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

The EU declaration of conformity referred to in Article 48, shall contain all of the following information:

1. AI system name and type and any additional unambiguous reference allowing identification and traceability of the AI system;

2. Name and address of the provider or, where applicable, their authorised representative;

3. A statement that the EU declaration of conformity is issued under the sole responsibility of the provider;

4. A statement that the AI system in question is in conformity with this Regulation and, if applicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of conformity;

4a. 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;

5. References to any relevant harmonised standards used or any other common specification in relation to which conformity is declared;

6. 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;

7. Place and date of issue of the declaration, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature.

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