EU Declaration of Conformity

Official/legal definition: The EU declaration of conformity is a written (machine‑readable, physical or electronically signed) declaration that a specific high‑risk AI system meets the requirements laid down in Section 2 of Chapter III of the EU Artificial Intelligence Act. It must identify the AI system, be kept available to national competent authorities for 10 years after the system is placed on the market or put into service, and contain the elements listed in Annex V to the Regulation. ([eur-lex.europa.eu](https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng?utm_source=openai))

Context and scope: The obligation to draw up an EU declaration of conformity applies to providers of high‑risk AI systems as defined and classified by the Regulation (i.e., systems listed in Annex III and subject to the high‑risk regime). By issuing the declaration the provider assumes responsibility for compliance with the Regulation’s requirements; where the same AI system is also subject to other Union harmonisation legislation that requires a declaration of conformity, a single combined EU declaration may be drawn up that identifies all applicable Union law. The declaration must be translated into a language easily understood by the national competent authorities of Member States where the AI system is placed on the market or made available. Providers must keep the declaration available and submit a copy to national authorities on request. ([eur-lex.europa.eu](https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng?utm_source=openai))

Practical implications for businesses: For any AI system classified as high‑risk, the provider must prepare and maintain a formal EU declaration of conformity before—or as part of—placing the system on the EU market or putting it into service. The declaration is a central element of post‑market supervision and enforcement: it documents the provider’s legal claim that the system complies with the Act and functions as an auditable record that enforcement authorities and notified bodies may require. Providers should integrate the declaration into their compliance workflows (conformity assessment, technical documentation, quality management, post‑market monitoring), ensure it is kept up to date after substantive changes, and retain copies for the statutory retention period. Where third‑party conformity assessment or a notified body is involved, information about the certificate and notified body must be included in the declaration. ([eur-lex.europa.eu](https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng?utm_source=openai))

Key contents and requirements (Annex V): The EU declaration of conformity must contain the following information (non‑exhaustive list drawn from Annex V):

• AI system name, type and any unambiguous identifier enabling identification and traceability;
• the name and address of the provider or, where applicable, their authorised representative;
• a statement that the declaration is issued under the sole responsibility of the provider;
• a statement that the AI system is in conformity with the EU AI Act and, where applicable, any other relevant Union law;
• where personal data are processed, an explicit statement of compliance with relevant EU data protection instruments (e.g., Regulation (EU) 2016/679 and Regulation (EU) 2018/1725);
• references to harmonised standards or other common specifications relied upon;
• where applicable, identification of the notified body, the conformity assessment procedure performed and the certificate issued;
• place and date of issue, name and function of the signatory, indication of on whose behalf the signatory acts, and signature (or equivalent electronic attestation).

These content items are mandatory elements identified by the Regulation and may be updated by delegated acts of the Commission. Providers must ensure the declaration’s contents reflect the conformity assessment route chosen (internal control vs. notified‑body procedure) and any cross‑references to certificates, technical documentation or CE marking. ([ai-act-service-desk.ec.europa.eu](https://ai-act-service-desk.ec.europa.eu/en/ai-act/annex-5?utm_source=openai))

Related compliance links and examples: The EU declaration of conformity is tightly linked to the chosen conformity assessment procedure (e.g., internal control under Annex VI or notified‑body assessment under Annex VII), the technical documentation that substantiates compliance, and the rules on CE marking for high‑risk AI systems. For example, if a notified body issues a certificate after assessing a provider’s quality management and technical documentation, the declaration must identify that notified body and the certificate in accordance with Annex V; where CE marking applies, the declaration underpins the provider’s right to affix the CE mark. Practically, businesses should map the declaration to their product identity, conformity evidence, quality management records and retention policies so the declaration can be produced on request during market surveillance or audit. ([ai-act-service-desk.ec.europa.eu](https://ai-act-service-desk.ec.europa.eu/en/ai-act/article-43?utm_source=openai))