What documents are required for CE-marking?

The New Approach Directives require that the manufacturer compiles technical documentation (Technical File) with information to demonstrate compliance with the applicable requirements. The contents of the TF varies per directive. In general, the design, manufacture and operation of the product (user manual) are described.

What details must be included in the TF depends on the nature of the product and what, from a technical perspective, is considered necessary to demonstrate that the product meets the essential requirements of the relevant Directive.

The manufacturer or his authorized representative established in the commumity is also required for EC Declaration of Conformity program. The EC Declaration of Conformity is a declaration by the responsible party represents and warrants that the product meets the essential requirements of applicable directives