An EC declaration of conformity (DofC) is a document through which a product is declared compliant with an EC Directive. It can be used for declaring compliance with more than one EC Directive. There are 21 CE marking Directives in total and each has to be considered for the product in question but typically no more than a two or three EC Directives would apply to any one product.

The DofC is the sole responsibility of the manufacturer or his appointed authorised representative. And it has to be signed by someone who is personally and legally responsible for the product (usually a Technical Director). It forms an essential part of product compliance and it is the most important document you have in your compliance technical file.

The requirements for what go into a DofC vary slightly between the EC Directives.

It is important to realise that the DofC is not about compliance with tests or test standards. It is solely about compliance with the requirements of the EC Directives, sometimes called the "essential requirements". Test standards are typically a route to meeting the requirements of an EC Directive.

If the manufacturer, or his authorised representative, declares compliance with the applicable test standards as listed in the Official Journal then he has a "presumption of conformity" with the requirements of the EC Directive. A "preseumption of conformity" is the best legal position to be in. If the latest standards have not been used as the route to compliance, then the "presumption of conformity" is lost and further technical justification would be required in the technical documentation.

Remember that the Official Journal for each EC Directive changes typically once a year so it is important to keep up to date with those changes to maintain the "presumption of conformity".