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Annex VIII: Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49

Annex VIII, Regulation (EU) 2024/1689 as amended by Regulation (EU) 2026/1744

High-risk AI systemsDeployerNotified bodyProvider
Amended by Regulation (EU) 2026/1744

The text below is the consolidated version, with the Digital Omnibus changes applied. Each change is listed under Amendments further down this page.

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 49(1):

1. The 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. The name, address and contact details of the authorised representative, where applicable;

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

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

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

7. The status of the AI system (on the market, or in service; no longer placed on the market/in service, recalled);

8. The type, number and expiry date of the certificate issued by the notified body and the name or identification number of that notified body, where applicable;

9. A scanned copy of the certificate referred to in point 8, where applicable;

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

11. A copy of the EU declaration of conformity referred to in Article 47;

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

13. A URL for additional information (optional).

The following information shall be provided and thereafter kept up to date with regard to AI systems to be registered in accordance with Article 49(2):

1. The 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. The name, address and contact details of the authorised representative, where applicable;

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

5. A description of the intended purpose of the AI system;

6. The condition or conditions under Article 6(3)based on which the AI system is considered to be not-high-risk;

8. The status of the AI system (on the market, or in service; no longer placed on the market/in service, recalled);

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 49(3):

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;

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

4. A summary of the findings of the fundamental rights impact assessment conducted in accordance with Article 27;

5. 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 Article 26(8) of this Regulation, where applicable.

Amendments under Regulation (EU) 2026/1744 (1)

delete

Lightens the registration information to be submitted under Article 49(2) by providers who self-assess their Annex III systems as not-high-risk under Article 6(3): the short summary of the grounds for the not-high-risk conclusion (point 7) and the list of Member States of placement (point 9) are deleted from Annex VIII Section B.

Read the amended text

7.

A short summary of the grounds on which the AI system is considered to be not-high-risk in application of the procedure under Article 6(3);

9.

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

[Deleted text taken verbatim from Annex VIII, Section B, points 7 and 9 of Regulation (EU) 2024/1689 as published; the Omnibus itself only states 'in Annex VIII, section B, points 7 and 9 are deleted']

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Mechanically consolidated from the official OJ texts of Regulations (EU) 2024/1689 and 2026/1744 (the Digital Omnibus, in force 27 July 2026); unofficial pending the official EUR-Lex consolidation. Study aid, not legal advice; the official texts on EUR-Lex are authoritative.