TECHNICAL DOCUMENTATION

The manufacturer must prepare the technical documentation in conformity with the particular requirements set by the Directives/regulations applicable to the product. The content of the technical documentation is, therefore, established in each act of harmonisation of the Union, in accordance with the products concerned.

The elements included in the documentation depend on the nature of the product and what is considered necessary, from a technical point of view, to demonstrate the product’s compliance with the essential requirements of the relevant Union harmonisation legislation or harmonised standards, if they have been applied, indicating the essential requirements covered by the standards.

This documentation may also be part of the quality system documentation, if the legislation provides for a conformity assessment procedure based on a quality system (modules D, E, H and their variants).

For some Directives/regulations, the technical documentation must be drafted in the language of the Member State where the product conformity assessment will be carried out, or in a language accepted by the notified body.

What is the typical content that the technical documentation must include?

As a general rule, documentation must include records/information on:
  • The description of the product and its intended use
  • How the product is manufactured
  • How the product’s compliance with the relevant applicable standards is demonstrated
  • The address of manufacture and possible storage locations
  • Design and manufacture of the products
  • What Directives apply to the product and evidence of compliance with their requirements
  • Certificates of the type-examinations performed, if applicable