The EU declaration of conformity is a mandatory document that the manufacturer or his authorised representative must sign in order to declare that their products comply with EU requirements.
What is the Declaration of Conformity?
The Declaration of Conformity involves assessing the degree of compliance with regulations, national or international technical standards and other specifications, requirements or characteristics of a product or service. It covers procedures such as sampling, testing, calibration, certification and inspection/verification. All products, machines, processes, methods, facilities, services or activities must comply with some form of technical standards or regulations.
Machinery manufacturers will have to check whether there are EU standards applying to their machines and ensure that they comply with them before they can be freely marketed in the EU. In many cases, harmonised standards exist and can help demonstrate compliance with EU rules.
By signing the declaration of conformity, the manufacturer assumes full responsibility for the compliance of his product with applicable EU law.
It is important to note that the information required may vary according to the applicable legislation and the type of product. And that this declaration refers exclusively to the machine in the state in which it was placed on the market, and excludes the added components and/or operations performed subsequently by the end user.
Where is this document kept and how should it be?
This document must accompany the equipment physically and must be written in the official language of the Member State in which the product is being marketed. It must also be translated into the language or languages required by the EU country in which the product is sold.
What elements should it include?
In the following list you will find the details of all necessary elements in the declaration of conformity. You can also opt for download our template. In any case, the manufacturer is responsible should include the following information in the Declaration of Conformity:
- business name and full address of the manufacturer and, where applicable, his authorised representative;
- name and address of the person authorised to draw up the technical dossier, which must be established in the Community;
- description and identification of the machine, including generic name, function, model, type, serial number and trade name;
- a phrase expressly declaring that the machinery complies with all the relevant provisions of this directive and, where appropriate, a similar phrase declaring conformity with other directives and/or provisions to which the machinery complies. These references must be those of the texts published in the Official Journal of the European Union;
- where applicable, name, address and identification number of the notified body which carried out the CE type examination referred to in Annex IX and the number of the EC type-examination certificate;
- where applicable, name, address and identification number of the notified body which has approved the fullquality
- where applicable, a reference to the harmonised standards
- where applicable, reference to other standards and technical specifications used;
- the place and date of the declaration;
- the identity and signature of the person authorised to make the declaration on behalf of the manufacturer or his authorised representative.
- aditional information (when necessary)
For imported products, the importer must ensure that the product is accompanied by the declaration of conformity and must keep a copy of it for 10 years from the date of placing on the market.
The EU declaration of conformity must be translated into the language or languages required by the EU country in which the product is sold.