Declaration of Conformity
The CE marking directives impose an obligation for the manufacturer, or his authorized representative established in Europe, to draw up a Declaration of Conformity (or ‘EU Declaration of Conformity’) as a part of the conformity assessment procedure. The Declaration must be issued before the product is placed on the market in Europe. (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 is the document in which the manufacturer states that the product satisfies the essential requirements of the applicable legislation.
By drawing up and signing the EU Declaration of Conformity, the manufacturer assumes responsibility for the compliance of the product.
The Declaration of Conformity must contain all relevant information to identify the EU legislation according to which it is issued. The documents also must contain the contact details of the manufacturer, the authorised representative, and the notified body if applicable, as well as the product details, and where appropriate a reference to harmonised standards or other technical specifications.
When a product is covered by several CE directives requiring an EU Declaration of Conformity, only a single one needs to be drawn up.
The Declaration of Conformity must be kept for ten years from the date of placing the product on the market, unless the applicable CE directives provides for any other duration. This is the responsibility of the manufacturer or the authorised representative. For imported products, the importer must take on this responsibility for the Declaration of Conformity.
The 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 Declaration of Conformity. That means that for these products you need to send the Declaration together with the product.
Language of the Declaration of Conformity
The 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 EU declaration of conformity is translated into their official language or languages. The CE 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.
Content of the Declaration of Conformity
The contents of the Declaration of Conformity are laid down in the concerned CE directive (or CE directives). So please refer to the applicable directive(s).
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
Where several pieces of EU legislation apply to a product, the manufacturer or the authorised representative has to provide a single Declaration of Conformity in respect of all such acts.
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