Responsible AI Platform

Annex V AI Act

class="oj-doc-ti" id="d1e38-132-1">BILAG V

Official text

id="anx_V"> BILAG V EU-overensstemmelseserklæring EU-overensstemmelseserklæringen, der er omhandlet i artikel 47, skal indeholde følgende oplysninger:

1. AI-systemets navn, type og enhver yderligere entydig reference, der gør det muligt at identificere og spore AI-systemet

2. udbyderens navn og adresse eller, hvis det er relevant, den bemyndigede repræsentants navn og adresse

3. en erklæring om, at den i artikel 47 omhandlede EU-overensstemmelseserklæring udstedes på udbyderens ansvar

4. en erklæring om, at AI-systemet er i overensstemmelse med denne forordning og eventuelt med al anden relevant EU-ret, der fastsætter bestemmelser om udstedelse af den i artikel 47 omhandlede EU-overensstemmelseserklæring

5. hvis et AI-system indbefatter behandling af personoplysninger, en erklæring om, at AI-systemet overholder forordning (EU) 2016/679 og (EU) 2018/1725 samt direktiv (EU) 2016/680

6. referencer til de relevante anvendte harmoniserede standarder eller referencer til anden fælles specifikation, som der erklæres overensstemmelse med

7. hvis det er relevant, navnet og identifikationsnummeret på det bemyndigede organ, en beskrivelse af den gennemførte overensstemmelsesvurderingsprocedure og identifikation af den udstedte attest

8. udstedelsessted og -dato for erklæringen, navn og stilling på den person, der har underskrevet den, samt en angivelse af, for hvem eller på hvis vegne vedkommende har underskrevet, og underskrift.

Source: EUR-Lex, Regulation (EU) 2024/1689 — text reproduced verbatim.

📬 AI Act Weekly

Get the most important AI Act developments in your inbox every week.

Subscribe

Frequently asked questions

What must be included in the EU declaration of conformity under Annex V?

Annex V requires eight elements: (1) AI system name and type, (2) provider name and address, (3) statement of sole responsibility, (4) conformity statement with the AI Act, (5) statement on personal data (GDPR/LED), (6) references to standards, (7) notified body details if applicable, and (8) date, place and signature.

How do I fill in the EU declaration of conformity?

Follow the eight points of Annex V: identify the AI system, state your company details, declare your responsibility as provider, confirm conformity with the AI Act and any other legislation, reference applied standards, and have an authorised person sign with date and place.

Do I need to state GDPR compliance in the declaration of conformity?

Yes, point 5 of Annex V explicitly requires that if the AI system processes personal data, a statement must be included confirming compliance with GDPR (2016/679), Regulation (EU) 2018/1725, and the Law Enforcement Directive (2016/680).

Who must sign the declaration of conformity?

Point 8 of Annex V requires the declaration to be signed by a person with their name and function stated, indicating for or on behalf of whom they sign, plus the date and place of issue.

Do I need to mention a notified body on the declaration of conformity?

Only where applicable. Point 7 requires you to state the name and identification number of the notified body, a description of the conformity assessment procedure performed, and identification of the certificate issued.

Is the declaration of conformity per AI system or per product line?

The declaration is per AI system. Point 1 requires the name, type and any additional unambiguous reference allowing identification and traceability of the specific AI system.

Which standards must I reference in the declaration of conformity?

Point 6 requires references to any relevant harmonised standards or other common specifications in relation to which conformity is declared. These are the same standards referenced in the technical documentation (Annex IV, point 7).

Where do I store the EU declaration of conformity?

Under Article 47(2), the declaration must be available for 10 years after market placement. A copy must also be included in the technical documentation (Annex IV, point 8) and submitted for EU database registration (Annex VIII).