Which documents are required for CE marking?
The New Approach Directives require that the manufacturer compiles technical documentation with information that demonstrates compliance with the applicable requirements. Together, these documents make up a product’s technical file.
The contents of the technical file vary per directive, depending on the nature of the product and the information that is necessary to demonstrate that the product meets the essential requirements of the relevant Directive(s). In general, the design, manufacture and operation (user manual) of the product are described.
The most important document that is required for CE marking is the EU Declaration of Conformity. The Declaration of Conformity declares that the responsible party (a manufacturer or their authorised representative) warrants that the product meets the essential requirements of the applicable Directives.