EU Declaration of Conformity

The EU Declaration of Conformity is a document, in which the manufacturer declares that the product conforms to the requirements. The EU Declaration of Conformity is a part of the conformity assessment procedure in accordance with the EU product legislation.
 

The manufacturer draws up and signs the declaration and states that the product fulfils all relevant requirements. The manufacturer's declaration of conformity lists all of the directives and regulations with requirements that the product fulfils.
 

The manufacturer can appoint an authorised representative to take these measures on the manufacturer’s behalf.

Specific requirements in the EU legislation that applies to the product

Information about the requirements can be found in the product group-specific legislation as well as on the product-specific web pages.
 

An EU Declaration of Conformity is not required for all product groups. For example, instead of the an EU Declaration of Conformity, a Declaration of Performance is drawn up for CE marked construction products.

Drawn up by the manufacturer or its authorised representative

Manufacturer or authorised representative, take the following into account when drawing up an EU Declaration of Conformity:

  • Draw up an EU Declaration of Conformity for CE marked products sold or otherwise distributed in EU countries.
  • Before drawing up a manufacturer's declaration of conformity, make sure that the product fulfils all applicable requirements, draw up the necessary technical documentation, and make sure that the required conformity assessment is carried out.
  • Store the EU Declaration of Conformity and keep the document available for 10 years after placing the product on the market.
  • Some products must be accompanied by an EU Declaration of Conformity.

The manufacturer, authorised representative, importer and distributor must provide the authorities with an EU Declaration of Conformity upon request.

All statutory requirements in one EU Declaration of Conformity

The manufacturer or authorised representative draws up one EU Declaration of Conformity for the product, and the information listed below is recorded in it. Based on the information, the market surveillance authority can check which regulations and standards have been followed in the design and manufacture of the product. If several EU regulations that require an EU Declaration of Conformity apply to the product, one single EU Declaration of Conformity can be drawn up for all regulations. The EU Declaration of Conformity can also be a document that consists of all of the individual manufacturer's declarations of conformity that apply to the product.

Information in the EU Declaration of Conformity

The EU Declaration of Conformity must include at least the following information:

  • Product identification number; the number can refer to the product batch, type or serial number
  • The name and address of the manufacturer
  • If necessary, the name and address of the authorised representative established within the EU
  • A clause stating that the EU Declaration of Conformity has been prepared under the sole responsibility of the manufacturer
  • Description and identifying information of the product; a photograph may be attached
  • Reference to all applicable EU legislation
  • A specific reference to all relevant harmonised standards that have been used, or a reference to the specifications, based on which the EU Declaration of Conformity has been issued
  • If necessary, the name and number of the notified body and a reference to the certificate or decision issued by the notified body
  • The date when the EU Declaration of Conformity was issued
  • The identifying information and signature of the person authorised to represent the manufacturer or his authorised representative

Language requirements on the manufacturer's declaration of conformity

The EU Declaration of Conformity must be translated into the language or languages required by the EU country, in which the product is intended to be sold or otherwise distributed.
 

The EU Declaration of Conformity of a product on the Finnish market must be available in Finnish, Swedish, or another language approved by the market surveillance authority. If the legislation requires that the product must be accompanied with the EU Declaration of Conformity, or that the information in the EU Declaration of Conformity must be provided in the operating instructions, the EU Declaration of Conformity must always be translated into both Finnish and Swedish.
 

If the translation of the EU Declaration of Conformity has not been signed by the manufacturer or an authorised representative, a copy of the original EU Declaration of Conformity signed by the manufacturer must be attached to the translation.

 

Product groups that require an EU Declaration of Conformity:

Personal protective equipment
Lifts
Machines
Toys
Measuring instruments
Pressure equipment
Rescue service equipment
Explosives and fireworks
Electrical equipment

Related content