EU Declaration of Conformity: Content and Requirements

Article 22 specifies the minimum information that must appear in the EU Declaration of Conformity. The declaration must include:

1. Product identification: The product name, type, batch, serial number, or other element allowing unambiguous identification
2. Manufacturer details: Name and address of the manufacturer; if applicable, the authorised representative's name and address
3. Declaration statement: A statement that the manufacturer takes sole responsibility for the declaration of conformity
4. Regulatory basis: Identification of the CRA as the legislation to which the declaration relates, with specific references to Article 5 and Annex I
5. Standards or specifications: References to relevant harmonised standards applied, or to common specifications or other technical specifications used
6. Conformity assessment procedure: Identification of the conformity assessment procedure used (the relevant Module from Annex VI)
7. Notified body details: Where a notified body was involved, its name, identification number, and the certificate reference
8. Additional certifications: References to any other EU legislation under which CE marking is affixed
9. Signature information: Place and date of issue, name and function of the signatory

The EU Declaration of Conformity must be drawn up in one of the official languages of the EU member states where the product is placed on the market. Where a product is sold across multiple EU member states, the declaration may need to be available in multiple languages, or member states may accept an English version for imported products — national rules vary.

The DoC must be kept available and must be accessible to market surveillance authorities throughout the product's active market life and for 10 years afterwards. Manufacturers should have systems for archiving declarations against product identifiers so that the correct version can be retrieved for any product unit.

For products sold in digital formats, the DoC may be made available electronically — for example, as a downloadable PDF on the manufacturer's website — rather than as a physical document accompanying the product. However, Article 22 requires that the DoC is available on request, so digital-only distribution must ensure reliable long-term accessibility.

Where a product is too small for a full EU Declaration of Conformity to accompany it (for example, a microchip or small embedded component), or where including the full DoC would be disproportionate, Article 22 allows the use of a simplified declaration format.

The simplified declaration, set out in Annex IX, contains a short statement that the full DoC is available at a specified URL. This is particularly relevant for embedded components, IoT devices in miniaturised form factors, and products where packaging space is severely constrained.

Manufacturers using the simplified declaration must ensure that the full DoC is genuinely available at the referenced URL throughout the relevant period and that the URL remains stable. Linking to a corporate homepage that might change structure is not adequate — the URL must resolve directly to the declaration document.

Many products are subject to multiple EU regulations simultaneously — for example, a Wi-Fi router may be subject to both the CRA and the Radio Equipment Directive (RED). Article 22 permits manufacturers to draw up a single EU Declaration of Conformity that addresses all applicable EU legislation, rather than separate declarations for each regulation.

A combined declaration must clearly identify each regulation to which it applies and the specific essential requirements and conformity assessment procedures relevant to each. Manufacturers taking this approach should ensure the declaration template is comprehensive and that no regulatory reference is overlooked.

The advantage of a combined declaration is administrative simplicity — a single document covers all CE marking obligations. The potential risk is that errors or omissions in the declaration may affect compliance under multiple regulations simultaneously.

The EU Declaration of Conformity is not a static document — it must be updated when product changes occur that affect the product's compliance. If a significant software update changes the product's security properties, or if a new conformity assessment is required due to a material product modification, the DoC must be revised to reflect the updated compliance basis.

Manufacturers should establish version control for their DoCs and maintain a record of which version of the declaration applies to which product versions or production batches. When a declaration is revised, the previous version should be archived but should not be destroyed — authorities may need to review the declaration applicable to a specific historical product batch.

Minor product updates that do not affect compliance — such as software updates that fix bugs without changing security-relevant functionality — generally do not require DoC revision. The threshold for requiring a new declaration should be assessed against the materiality of the change to the product's compliance position.