What is a EU Declaration of Conformity?

A EU Declaration of Conformity (sometimes referred to as a CE Certificate, EC Declaration of Conformity, or CE Declaration of Conformity) is a legally required document that confirms a product meets all applicable EU legislation related to CE marking. By issuing and signing this declaration, the manufacturer—or their Authorised Representative within the EU—formally takes full responsibility for the product’s compliance with relevant directives or regulations.

The Declaration of Conformity serves several purposes. It acts as written proof that the product has undergone the necessary conformity assessment procedures and meets essential requirements for health, safety, environmental protection, and performance. It is also a mandatory part of the CE marking process and must be kept available for inspection by market surveillance authorities.

This document is crucial for enabling a product to be placed on the EU market. Without a valid Declaration of Conformity, products subject to CE marking requirements cannot legally be sold in the EU or EEA. Failing to produce or maintain a compliant declaration can lead to enforcement actions, including fines, product recalls, or a ban on sales.

In short, the EU Declaration of Conformity is not just paperwork—it’s a key legal and technical assurance that the product is fit for the European market and aligns with the Union’s strict regulatory standards.

Responsibilities

Just like the Technical Documentation, the EU Declaration of Conformity must be kept for ten years from the date the product was placed on the market. It is the responsibility of the manufacturer or the Authorised Representative established in the EU to maintain the Declaration of Conformity. If the products are imported, the importer must take responsibility for the CE Declaration of Conformity.

Content of the EU Declaration of Confomity

The Declaration of Conformity should be drafted in accordance with the model declaration set out in Annex III of EU Decision No 768/2008/EC or with a model declaration attached directly to the relevant EU harmonization legislation.

The model declaration in Decision No 768/2008/EC includes:

1. An identification number of the product; this number does not have to be unique for each product. It can refer to a product, batch, type, or series;
2. The name and address of the manufacturer or his Authorised Representative who has drawn up the CE Declaration of Conformity;
3. A statement that the CE Declaration of Conformity is issued under the full responsibility of the manufacturer;
4. A description on the basis of which the product can be traced; this mainly includes all other relevant information on top of the information mentioned in point 1, describing the product and allowing it to be traced.
5. All relevant EU harmonisation legislation that has been met and the standards with their references or other technical specifications (such as national technical standards and specifications) in a precise, complete and clear manner;
6. The name and identification number of the Notified Body, if it was involved in the conformity assessment procedure;
7. The date of issue of the CE Declaration of Conformity; the signature and job description or equivalent identification of the authorised person.

Important notes

If several CE certification directives and regulations apply to a product, the manufacturer or the Authorised Representative must issue one unique Declaration of Conformity which will list them all.

Several models of one product can be also covered with one EU Declaration of Conformity, if there is no functional difference within model range, but only visual difference (color, size, etc.). If there is functional difference, several DoCs are required.

The EU Declaration of Conformity must be made immediately available on request to the relevant market surveillance authority.

The EU Declaration of Conformity must be translated into the language or languages required by the EU Member State where the product is placed on the market.