What is an ‘EU Declaration of Conformity’ or ‘EC Declaration of Conformity’?
At the end of the CE marking process the manufacturer confirms the CE marking compliance of the product by drawing up a EU Declaration of Conformity (or ‘Declaration of Conformity’ or ‘DoC’) and affixing the CE marking. The EU Declaration of Conformity previously was called an ‘EC Declaration of Conformity’. Basically, the declaration is a one-page letter or document in which the manufacturer specifies which EU CE marking directives and standards his product complies with. The EU Declaration of Conformity must be issued before the product is placed on the market in Europe. (Please note: In the Construction Products Regulation this document is called the ‘Declaration of Performance’. The Machinery Directive requires a Declaration of Incorporation for uncompleted machinery.)
The EU Declaration of Conformity contains all relevant compliance information. For example, the DoC indicates which EU legislation, harmonised standards and other technical specifications are complied with. The DoC contains the product specifications, the contact details of the manufacturer or his authorised representative in the European Union, and the reference to the certification body, if applicable.
When a product is covered by several CE marking directives requiring an EU Declaration of Conformity, this does not mean that multiple declarations have to signed. Only a single one needs to be drawn up. This single EU Declaration of Conformity will list all the directives the product complies with.
Typically, the EU Declaration of Conformity must be kept for ten years. Some CE directives and regulations specify another term. This period starts from the date of placing on the market of the product. Drawing up the DoC is the responsibility of the manufacturer or the authorised representative. For imported products, the importer must verify that the Declaration of Conformity is available. If not, the importer must draw one up.
The EU Declaration of Conformity must be made available to the market surveillance authority immediately upon their request. And the directives relating to machinery, potentially explosive atmospheres, radio and terminal telecommunication equipment, measuring instruments,recreational craft, lifts, high-speed and conventional rail systems and constituents of the European Air Traffic Management network require that each product is accompanied by the DoC. That means that for these products you need to send the Declaration of Conformity together with the product.
What are the language requirements for the EU Declaration of Conformity?
The EU Declaration of Conformity must be drawn up in one of the official languages of the European Union. The EU Member States may require that the DoC is translated into their official language or languages. The CE marking directives do not necessarily specify who has the obligation to translate. However, logically this should be the manufacturer or another economic operator making the product available.
What is the content of the DoC?
Each CE marking directive specifies the exact contents of the EU Declaration of Conformity. So please refer to the applicable directives for specific details. However, in Decision No 768/2008/EC a model declaration is provided which is based on the EN ISO/IEC 17050-1. The declaration may take the form of a document, a label or equivalent, and must contain sufficient information to enable all products covered by it to be traced back to it.
The model declaration of Decision No 768/2008/EC contains:
- A product identification number. This number does not need to be unique to each product. It could refer to a product, batch, type or a serial number. This is left to the discretion of the manufacturer.
- The name and address of the manufacturer or the authorised representative issuing the Declaration.
- A statement that the Declaration is issued under the sole responsibility of the manufacturer.
- The identification of the product allowing traceability. This is basically any relevant information supplementary to point 1 describing the product and allowing for its traceability. It may where relevant for the identification of the product contain an image, but unless specified as a requirement in the Union harmonisation legislation this is left to the discretion of the manufacturer.
- All relevant EU legislation complied with; the referenced standards or other technical specifications (such as national technical standards and specifications) in a precise, complete and clearly defined way; this implies that the version and/or date of the relevant standard is specified.
- The name and identification number of the Notified Body when it has been involved in the conformity assessment procedure.
- All supplementary information that may be required (for example grade, category), if applicable.
- The date of issue of the Declaration; signature and title or an equivalent marking of authorised person; this could be any date after the completion of the conformity assessment.
Draw up the EU Declaration of Conformity when the Technical File is complete. Keep a copy of the declaration in the Technical File.
- Technical File
- Amazon requirements for uploading a Declaration of Conformity and the ‘Responsible Person for CE Marked Products’
- EU CE Marking Directives
- CE Marking
Do you need help to draw up a EU Declaration of Conformity for your products? Contact us for support!