Declaration of conformity and technical documentation
The Technical File documentation is necessary to demonstrate that the product meets the essential requirements and thus justifies and supports the EU declaration of conformity. This documentation is necessary to affix the CE marking on the product. It should include, at a minimum: the name and address of the manufacturer or its authorized representatives. a brief description of the product. the identification of the product, for example, its serial number. the names and addresses of the facilities involved in the design and manufacture of the product. the name and address of any notified body involved in the conformity assessment of the product. a statement of the conformity assessment procedure followed. the EU declaration of conformity. the label and instructions for use. a statement of the relevant regulations to which the product conforms. the identification of the technical norms whose fulfillment is affirmed. the parts list. the results of the tests. In particular, ...