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Annex VIII

Information to be Submitted Upon the Registration of High-Risk AI Systems in Accordance with Article 51

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

SECTION A - Information to be submitted by providers of high-risk AI systems in accordance with Article 51(1)

The following information shall be provided and thereafter kept up to date with regard to high-risk AI systems to be registered in accordance with Article 51(1):

1. Name, address and contact details of the provider;

2. Where submission of information is carried out by another person on behalf of the provider, the name, address and contact details of that person;

3. Name, address and contact details of the authorised representative, where applicable;

4. AI system trade name and any additional unambiguous reference allowing identification and traceability of the AI system;

5. Description of the intended purpose of the AI system and of the components and functions supported through this AI system;

5a. A basic and concise description of the information used by the system (data, inputs) and its operating logic;

6. Status of the AI system (on the market, or in service; no longer placed on the market/in service, recalled);

7. Type, number and expiry date of the certificate issued by the notified body and the name or identification number of that notified body, when applicable;

8. A scanned copy of the certificate referred to in point 7, when applicable;

9. Member States in which the AI system is or has been placed on the market, put into service or made available in the Union;

10. A copy of the EU declaration of conformity referred to in Article 48;

11. Electronic instructions for use; this information shall not be provided for high-risk AI systems in the areas of law enforcement and migration, asylum and border control management referred to in Annex III, points 1, 6 and 7.

12. URL for additional information (optional).

SECTION B - Information to be submitted by deployers of high-risk AI systems in accordance with Article 51(1b)

The following information shall be provided and thereafter kept up to date with regard to high-risk AI systems to be registered in accordance with Article 51:

1. The name, address and contact details of the deployer;

2. The name, address and contact details of the person submitting information on behalf of the deployer;

5. A summary of the findings of the fundamental rights impact assessment conducted in accordance with Article 29a;

6. The URL of the entry of the AI system in the EU database by its provider;

7. A summary of the data protection impact assessment carried out in accordance with Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680 as specified in paragraph 6 of Article 29 of this Regulation, where applicable.

SECTION C - Information to be submitted by providers of high-risk AI systems in accordance with Article 51(1a)

The following information shall be provided and thereafter kept up to date with regard to AI systems to be registered in accordance with Article 51(1a).

1. Name, address and contact details of the provider;

1. Where submission of information is carried out by another person on behalf of the provider, the name, address and contact details of that person;

2. Name, address and contact details of the authorised representative, where applicable;

3. AI system trade name and any additional unambiguous reference allowing identification and traceability of the AI system;

4. Description of the intended purpose of the AI system;

5. Based on which criterion or criteria provided in Article 6(2a) the AI system is considered as not high-risk;

6. Short summary of the grounds for considering the AI system as not high-risk in application of the procedure under Article 6(2a);

7. Status of the AI system (on the market, or in service; no longer placed on the market/in service, recalled); Member States in which the AI system is or has been placed on the market, put into service or made available in the Union.

[Previous version]

Providers, authorised representatives and users that are public authorities, agencies or bodies shall submit the information referred to in Part I. Providers or, when applicable, authorised representatives shall ensure that the information on their high-risk AI systems referred to in Part II, 1 to 11 is complete, correct and kept up to date. Information laid down in II.12 shall be automatically generated by the database.

Part I. Information related to operators (upon operators' registration)

-1. Type of operator (provider, authorised representative or user);

1. Name, address and contact details of the provider;

2. Where submission of information is carried out by another person on behalf of the operator, the name, address and contact details of that person;

Part II. Information related to the high-risk AI system

1. Name, address and contact details of the provider

2. Name, address and contact details of the authorised representative, where applicable;

3. AI system trade name and any additional unambiguous reference allowing identification and traceability of the AI system;

4. Description of the intended purpose of the AI system;

5. Status of the AI system (on the market, or in service; no longer placed on the market/in service, recalled);

6. Type, number and expiry date of the certificate issued by the notified body and the name or identification number of that notified body, when applicable;

7. A scanned copy of the certificate referred to in point 6, when applicable;

8. Member States in which the AI system is or has been placed on the market, put into service or made available in the Union;

9. A copy of the EU declaration of conformity referred to in Article 48;

10. Electronic instructions for use;

11. URL for additional information (optional).

12. Name, address and contact details of users.

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