The Declaration of Conformity is a legal Document which needs to be completed for all CE Marked products sold in the European Union with few exceptions. Almost all new products must be covered by 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.
- Manufacturer or a representative 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 the 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's a legal document 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.
It must be issued by the “manufacturer”; however, this is not necessarily the person or company who actually assembled the product. According to Commission Decision 768/2008/EC (Recital 26) "Any economic operator that either places a product on the market under his own name or trademark or modifies a product in such a way that compliance with applicable requirements may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.” Effectively, if you re-brand a product or modify it such that safety might be affected, you become the manufacturer and should sign a Declaration for the ‘new’ product. You also become the “manufacturer” if you import a product from outside the EU that was not CE marked by its original manufacturer.
A properly issued Declaration of Conformity is always issued by the product's manufacturer (or their representative, if this has been specifically agreed), but never by a test house or Notified Body. The manufacturer does not need to be based in the EU, but certain Directives require an EU-based contact point (e.g. the Machinery Directive; see below).
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:
- 2000/14/EC: Noise Emissions of Outdoor Equipment Directive
- 2014/34/EU: ATEX Directive
- 2009/48/EC: Toy Safety Directive
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 Directive, ATEX Directive, RED (Radio Equipment Directive)) 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. Manufacturers outside Europe may find our DocEUpoint service to be useful in helping them to fulfill this requirement.
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.