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.
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.
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.
The content of the Declaration of Conformity
- 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.
If you are a product supplier you should pass Declaration of Conformity down the supply chain to the end user as in most cases the final purchaser is entitled to receive a copy of the Declaration of Conformity for the particular product. If you are aware of products (other than those for which a Declaration of Conformity doesn’t have to be provided, such as electrical equipment under the Low Voltage Directive) that do not have a Declaration of Conformity, you should obtain the correct one before supplying the product onward.
Purchasers should retain Declarations of Conformity as they provide documentary evidence that a product complied with the safety requirements applying to that product when first placed the market, or brought into use.
Hirers may also need to copy the Declaration of Conformity onto to users.
Declaration of Conformity should be taken into account seriously as this can be reason that the product is banned in market from market from side of surveillance agencies. If product is imported in EU customs will at first will verify Declaration of Conformity, applied standards and applied directives. If some of stated standards or directives are out of date, products will not be let in EU market and will be sent back to manufacturer.
Take close look at EMC MARKET SURVEILANCE CAMPAIGN (2011) //The administrative compliance was shockingly low– only 28.8%, mainly the CE marking and the Declaration of Conformity (DoC) was missing.//