EU declaration of conformity
The EU declaration of conformity is a special form of declaration of conformity in the area regulated by law to prove that the requirements of European directives or European regulations have been met.
With the EU declaration of conformity, the "responsible manufacturer" or his authorized representative (based in the EU) confirms, under sole responsibility and legally binding , that a product he has placed on the market complies with the basic health and safety requirements of all relevant European directives, i.e. with them is compliant . The EU declaration of conformity is a mandatory requirement for CE marking and the placing on the market of the corresponding product in the European Economic Area .
"Responsible manufacturer" is either ...
- the physical manufacturer, or
- the legal person who claims to be the manufacturer (e.g. by adding his company name): "designated manufacturer",
or, if the above two fail to meet their obligations ...
- the importer or the distributor : "de facto manufacturer".
For the sake of simplicity, all of these characteristics are subsumed as “manufacturers”.
Since every (even complex) product must have one and only one manufacturer, several parties involved in the development or manufacturing process, who can all have an impact on product safety, may have to agree on a "responsible manufacturer" who at least formally assumes overall responsibility . This also applies to consortia without their own legal form.
The required content of the EU declaration of conformity is specified in the individual EU directives . On the other hand, there are no requirements for the shape and appearance. General requirements for the content of declarations of conformity and design suggestions are contained in the standards EN ISO / IEC 17050-1: 2004 and EN ISO / IEC 17050-2: 2004 as well as in the Blue Guide of the European Commission.
An EU declaration of conformity must be drawn up in one of the official languages of the European Union . As a rule, the declaration remains with the manufacturer as part of the technical documentation. At the request of the supervisory authorities, it must be submitted to them “in a reasonable time”. The supervisory authority can request a translation into "one of its preferred languages".
Some EU directives (e.g. the Machinery Directive , Pressure Equipment Directive , ATEX Product Directive ) stipulate that the EU declaration of conformity must be enclosed with every product delivered. In this case, the declaration must be attached in the languages of the respective country of use or in the language specified by the respective country of use.
If a product is affected by several EU directives, all of which require the CE marking, all directives for this product must be summarized in an EU declaration of conformity. A dossier made up of several individual declarations is also permitted.
With the implementation of the Lisbon Treaty , the European Community (EC ) was further developed into the European Union (EU) in 2011 . This changes the designation from the EC Declaration of Conformity to the EU Declaration of Conformity for all declarations of conformity that are drawn up in accordance with guidelines published from 2011. The new name was first used in the RoHS directive 2011/65 / EU of June 8, 2011. Declarations of conformity that are drawn up in accordance with applicable directives that were published before 2011 (e.g. Machinery Directive) must still be referred to as EC declarations of conformity and are still valid.
- , accessed on November 22, 2016 (RoHS Directive)
- , accessed on March 30, 2017 (Machinery )
- New Legislative Framework (accessed: 2020-03-06)
- 'Blue Guide' on the implementation of EU product rules (accessed: 2020-03-06)