Declaration of Conformity

The declaration must unambiguously identify the provider (manufacturer) and, if applicable, their authorized representative established within the Union. This includes the registered trade name, address, and the explicit statement that the declaration is issued under the sole responsibility of the provider. For non-EU entities, the Authorized Representative Mandate must be cited, establishing the legal nexus for enforcement within the jurisdiction.

A precise, unambiguous identification of the AI system is required to link the physical or digital product to its compliance record. This includes:

• The model name and trade name of the system.
• The Unique Registration ID assigned by the EU database upon successful registration.
• Any additional serial numbers or software versioning that allows traceability throughout the product's lifecycle. This block creates an unbreakable chain between the physical CE marking and the digital Technical Documentation File.

This is the core performative clause where the provider explicitly states that the AI system is in conformity with the EU AI Act and any other applicable Union harmonization legislation. It must reference:

• The specific Conformity Assessment procedure followed (e.g., internal control or Notified Body review).
• The Harmonized Standards or common specifications applied to achieve the Presumption of Conformity.
• The identification number of the Notified Body that issued the EU-type examination certificate, if applicable.

The declaration legally binds the system to its Intended Purpose Declaration, defining the exact use case and operational context. It must transparently disclose any Residual Risk Disclosure—risks that could not be fully mitigated through design. This section forms the legal boundary of the registration; any use outside this stated purpose, or a Substantial Modification to the system's logic, immediately voids the declaration and triggers a mandatory re-assessment.

The declaration is not valid until signed. It requires the place and date of issue and the signature, name, and function of the person empowered to bind the provider. This transforms the document from a technical report into a legally binding affidavit. A false declaration triggers the full penalty mechanisms of the Act, including potential Registration Suspension and Market Withdrawal Notification by the National Competent Authority.

To ensure accessibility for end-users and market surveillance authorities, the Declaration of Conformity must be translated into the official language(s) required by the Member State where the product is placed on the market. This is not merely a courtesy; it is a legal prerequisite for valid CE Marking. The translated version carries the same legal weight as the original and must be maintained as part of the Post-Market Monitoring documentation package.