EU Declaration of Conformity (EU DoC)
A formal document drawn up by the manufacturer before placing a product with digital elements on the market, in which the manufacturer declares that the product meets the essential cybersecurity requirements of Annex I and any other applicable Union harmonisation legislation. The EU DoC must follow the model structure in Annex V and contain all eight elements specified in Article 28.
Source citations
Regulation text
Article 28(1) of Regulation (EU) 2024/2847:
"The EU declaration of conformity shall state that it has been demonstrated that the essential cybersecurity requirements set out in Annex I are fulfilled."
Article 28(2) specifies the eight required elements:
- Product name, type, and version/batch number
- Manufacturer's name and address
- A statement that the EU DoC is issued under the manufacturer's sole responsibility
- Object of the declaration (identification of the product)
- Reference to the relevant harmonised standards or technical specifications relied upon, or reference to the common specifications
- Name and number of the notified body (if involved) and the certificate number
- Additional information (where applicable)
- Signed declaration: place, date, signature, name, and title of signatory
Simplified EU DoC (Annex VI)
Where multiple Union acts require an EU DoC, a single simplified EU DoC may be drawn up containing all the required information — the document must contain a reference pointing to each individual EU DoC, and both forms must be made available to users and market surveillance.
How long must it be kept?
The EU DoC must be kept for a minimum of 10 years after the product is placed on the market, or for the duration of the support period if longer (Art. 13(12)).
Where must it be available?
- Kept on file by the manufacturer (or authorised representative)
- Available to market surveillance authorities on request
- Available to users on request; provided with the product or via a website link
Language requirement
The EU DoC must be drawn up in a language or languages required by the Member State in which the product is placed on the market (Art. 28(4)).