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, the manufacturer is responsible for identifying all possible risks that his product may pose and for determining the applicable essential requirements. This analysis should be included in the technical documentation. In addition, the manufacturer should explain how it has addressed all identified risks, to ensure that its product meets the applicable requirements, for example by applying harmonized standards.
  • As we have seen, the declaration of conformity is part of the technical documentation that must accompany every product that enters the EU. Therefore, it is part of the set of processes involved in the CE marking of a product, and it is a document that states that the product is marketed in accordance with the legislation applicable to said product, in the corresponding country.

Although the process for generating a Declaration of Conformity and its purpose is the same, there may be slight variations in the requirements of the different Directives, referring to different products. 

Therefore, it is always important to refer to the relevant legislation and pay attention to details. For example, the Toy Safety Directive requires that a color image of the toy be included in the Declaration, while other Directives allow it to be a voluntary option or simply do not refer to it.

Obviously, the procedure to obtain the CE Marking for Medical Devices of a medical device is completely different from that of obtaining the CE Marking of an electronic device. Similarly, there are products to which the directives of various products apply. 

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