CE Marking - Declaration of conformity

General
Products which are to be provided with the CE marking shall be designed to comply with relevant requirements.

Products with the CE marking shall be produced in accordance with the design that was found to comply with relevant requirements.

This leaflet provides information about the "Declaration of Conformity", which is an official statement that a product is in conformance with an approved design.

The "Technical Construction File" is the basis of the conformity assessment of the design. A separate information leaflet on this file is available here.

The Declaration
Essentially the declaration concerns an individual product. It shall state that the product is in accordance with "Essential Requirements" of applicable EU-directives. Several directives require that the declaration is actually kept with individual products.

The declaration shall identify the individual product and the requirements. The declaration may refer to an "EC Type-examination Certificate" issued by a Notified Body in the design-stage.

Administration of the declaration
In principle, a declaration shall be available for each individual product. In case of series-production and production of (large) numbers of identical products, the declaration may apply to lots or batches of products. The marking of the products (by serial-numbers, date-codes, etc.) and the registration-indications of the declarations shall clearly refer to each other.

Governmental authorities and Notified Bodies will require insight in the administration system of the manufacturer. Upon their request, the declaration concerning a certain product, shall be made available on short notice.

Notified Body
All modules (except Module A) of the conformity assessment scheme require the involvement of a Notified Body in the production-stage. It is the obligation of the Notified Body to verify the declarations and to repeat evaluations and tests if considered necessary.