{"id":3064,"date":"2024-01-08T14:55:15","date_gmt":"2024-01-08T14:55:15","guid":{"rendered":"https:\/\/artificialintelligenceact.eu\/annex\/8\/"},"modified":"2024-08-07T14:27:06","modified_gmt":"2024-08-07T14:27:06","slug":"8","status":"publish","type":"annex","link":"https:\/\/artificialintelligenceact.eu\/annex\/8\/","title":{"rendered":"Annex VIII: Information to be Submitted upon the Registration of High-Risk AI Systems in Accordance with Article 49"},"content":{"rendered":"
Section A – Information to be submitted by providers of high-risk AI systems in accordance with Article 49<\/a>(1)<\/h5>\n

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<\/a>(1):<\/p>\n

1. The name, address and contact details of the provider;<\/p>\n

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;<\/p>\n

3. The name, address and contact details of the authorised representative, where applicable;<\/p>\n

4. The AI system trade name and any additional unambiguous reference allowing the identification and traceability of the AI system;<\/p>\n

5. A description of the intended purpose of the AI system and of the components and functions supported through this AI system;<\/p>\n

6. A basic and concise description of the information used by the system (data, inputs) and its operating logic;<\/p>\n

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

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;<\/p>\n

9. A scanned copy of the certificate referred to in point 8, where applicable;<\/p>\n

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

11. A copy of the EU declaration of conformity referred to in Article 47<\/a>;<\/p>\n

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<\/a>, points 1, 6 and 7;<\/p>\n

13. A URL for additional information (optional).<\/p>\n

\n
Section B – Information to be submitted by providers of high-risk AI systems in accordance with Article 49<\/a>(2)<\/h5>\n

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<\/a>(2):<\/p>\n

1. The name, address and contact details of the provider;<\/p>\n

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;<\/p>\n

3. The name, address and contact details of the authorised representative, where applicable;<\/p>\n

4. The AI system trade name and any additional unambiguous reference allowing the identification and traceability of the AI system;<\/p>\n

5. A description of the intended purpose of the AI system;<\/p>\n

6. The condition or conditions under Article 6<\/a>(3) based on which the AI system is considered to be not-high-risk;<\/p>\n

7. A short summary of the grounds on which the AI system is considered to be not-highrisk in application of the procedure under Article 6<\/a>(3);<\/p>\n

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

9. Any Member States in which the AI system has been placed on the market, put into service or made available in the Union.<\/p>\n

\n
Section C – Information to be submitted by deployers of high-risk AI systems in accordance with Article 49<\/a>(3)<\/h5>\n

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<\/a>:<\/p>\n

1. The name, address and contact details of the deployer;<\/p>\n

2. The name, address and contact details of the person submitting information on behalf of the deployer;<\/p>\n

3. The URL of the entry of the AI system in the EU database by its provider;<\/p>\n

4. A summary of the findings of the fundamental rights impact assessment conducted in accordance with Article 27<\/a>;<\/p>\n

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<\/a>(8) of this Regulation, where applicable.<\/p>\n","protected":false},"template":"","class_list":["post-3064","annex","type-annex","status-publish","hentry"],"meta_box":{"date_of_eif":"","eif_according_to":"","eif_inherit_from":"","item_summary":"

Before any high-risk AI system \u2013 or a system that the provider has self-determined is not high-risk \u2013 is launched or used, the provider or their representative must register themselves and their system in the EU database according to Article 49.<\/p>\n

This Annex outlines the information required when registering high-risk AI systems. This includes the provider's contact details, the AI system's name and purpose, a description of the data it uses, its status (e.g., on the market, recalled), and any certification details. If the AI system is considered not high-risk, the provider must explain why. For those deploying high-risk AI systems, they must provide their contact details, a link to the AI system's entry in the EU database, and summaries of any impact assessments conducted. This information must be kept up-to-date.<\/p>\n","item_order":"8","annex-recital_to":[]},"_links":{"self":[{"href":"https:\/\/artificialintelligenceact.eu\/wp-json\/wp\/v2\/annex\/3064","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/artificialintelligenceact.eu\/wp-json\/wp\/v2\/annex"}],"about":[{"href":"https:\/\/artificialintelligenceact.eu\/wp-json\/wp\/v2\/types\/annex"}],"version-history":[{"count":8,"href":"https:\/\/artificialintelligenceact.eu\/wp-json\/wp\/v2\/annex\/3064\/revisions"}],"predecessor-version":[{"id":5197,"href":"https:\/\/artificialintelligenceact.eu\/wp-json\/wp\/v2\/annex\/3064\/revisions\/5197"}],"wp:attachment":[{"href":"https:\/\/artificialintelligenceact.eu\/wp-json\/wp\/v2\/media?parent=3064"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}