The Declaration of Conformity is a legal Document which must accompany all CE Marked products sold in the European Union. Almost all new products must be supplied to the end user with a Declaration of Conformity. This document needs to include the following:
• Name and address of organisation taking responsibility for the product
• Description of product
• A list of the applicable safety directives the product complies with
• Details of relevant standards may be included.
• The manufacturer or a representation of the organisation placing the product on the market should then sign the Declaration.
Conformance has assisted thousands of companies through the CE marking process and helped them produce a Declaration of Conformity to accompany their products.
Detailed information On Declaration of Conformity
The Declaration of Conformity is a special document, which the manufacturer signs to say that the product meets all of the requirements of the applicable directives. It must be issued by the manufacturer, or by the person placing the product on the EU market if the manufacturer is not based in Europe.
Basically, it’s a piece of paper, which someone has to sign to say that the product meets the requirements of the directive(s) which apply to it. The idea is that making someone put their signature on a piece of paper concentrates their mind on whether or not the product really does comply. It also allows an enforcement authority to identify who is responsible for a product and what that person claims to have done to CE mark it.
A properly issued Declaration of Conformity is always issued by the product’s manufacturer (or representative), importer or distributor; never by a test house or Notified Body.
The Declaration needs to be signed by someone who has the power to make binding commitments on behalf of the manufacturer, but for the Declaration to be truly meaningful the signatory should also be someone who has the authority to commit the resources required to ensure that the CE marking process is properly completed. The effect of the Declaration is to identify an individual in the company who can be held responsible if the CE marking on a product turns out to be invalid.
Each directive has slightly different requirements for the content of its Declaration but some features are common to all:
• Name/address of manufacturer (and of responsible person where applicable)
• Model and/or serial number of equipment
• List of relevant directives
• List of standards used, with dates + amendments
• Declaration statement
• Name and position of person signing
If a Notified Body is required to be involved the CE marking process (e.g. for product type approval or quality system assessment) then their details will also need to appear on the Declaration.
Some directives have special additional requirements, E.g:
• 2014/34/EU: ATEX
Most directives require the Declaration to be translated into the languages of the countries in which the product is placed on the market. In addition, some directives (e.g. machinery, ATEX) require the Declaration to be supplied with the product.
One particular requirement in the new Machinery Directive is worthy of special mention. This is that the Declaration must identify the name and address from where the technical documentation for the product may be obtained and that this must be an address within the European Community.
One important note: ATEX Directive shall not stay alone on DoC, only a machine, electronic device, etc can be Ex certified.
Following a review of the CE marking directives in 2008, the Commission issued a recommendation (768/2008/EC) that the requirements for Declarations of Conformity should be made more consistent, and this is currently being implemented. However, this decision has no effect on the requirements of directives issued before 2010.
One of the recommendations in 768/2008/EC is that products should have only a single Declaration document, which makes reference to all of the applicable directives with which the manufacturer is claiming compliance. With this in mind, we have prepared a series of documents, which will help you to draft declarations for the most common Directives.
Outside of EU does CE have any meaning?
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