ANNEX VIII
Information to be provided when registering high-risk AI systems in accordance with Article 49
Section A - Information to be submitted by high-risk AI system providers in accordance with Article 49(1)
With regard to high-risk AI systems to be registered in accordance with Article 49(1), the following information shall be provided and kept current thereafter:
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1. |
The provider's name, address and contact information; |
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2. |
if the information is submitted by another person on behalf of the provider, the name, address and contact information of that person; |
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3. |
The name, address and contact information of the authorized representative, if any; |
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4. |
the trade name of the AI System, as well as any additional unambiguous references by which the AI System can be identified and traced; |
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5. |
A description of the intended purpose of the AI system and the components and functions supported by this AI system; |
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6. |
A basic and concise description of the information (data, inputs) used by the system and its operational logic; |
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7. |
The status of the AI system (on the market, in use, no longer on the market/in use, recalled); |
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8. |
the type, number and expiration date of the certificate issued by the notified body and the name or identification number of that notified body, if applicable; |
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9. |
A scanned copy of the certificate referred to in Item 8, if applicable; |
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10. |
Member States in which the AI system has been placed on the market, put into service or made available on the Union market; |
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11. |
a copy of the EU declaration of conformity referred to in Article 47; |
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12. |
an 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; |
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13. |
A URL for additional information (optional). |
Section B - Information to be submitted by high-risk AI system providers in accordance with Article 49(2)
With regard to high-risk AI systems to be registered in accordance with Article 49(2), the following information shall be provided and kept current thereafter:
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1. |
The provider's name, address and contact information; |
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2. |
if the information is submitted by another person on behalf of the provider, the name, address and contact information of that person; |
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3. |
The name, address and contact information of the authorized representative, if any; |
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4. |
the trade name of the AI System, as well as any additional unambiguous references by which the AI System can be identified and traced; |
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5. |
A description of the intended purpose of the AI system; |
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6. |
the condition or conditions under Article 6(3) under which the AI system is not considered a high-risk system; |
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7. |
A brief summary of the reasons why the AI system is not considered a high-risk system when applying the procedure under Article 6(3); |
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8. |
The status of the AI system (on the market, in use, no longer on the market/in use, recalled); |
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9. |
Member States in which the AI system has been placed on the market, put into service or made available on the Union market. |
Section C - Information to be submitted by persons responsible for the use of high-risk AI systems in accordance with Article 49(3)
With regard to high-risk AI systems to be registered in accordance with Article 49(3), the following information shall be provided and kept current thereafter:
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1. |
The name, address and contact information of the person responsible for use; |
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2. |
The name, address, and contact information of the person submitting information on behalf of the use manager; |
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3. |
The URL of the entry of the AI system into the EU database by its provider; |
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4. |
A summary of the findings of the fundamental rights impact assessment conducted pursuant to Article 27; |
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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, if applicable. |
