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The manufacturer must draw up the technical documentation in conformity with the particular requirements set by the Directives/Regulations applicable to your 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 compliance of the product with the essential requirements of the relevant Union harmonisation legislation or with harmonised standards, if these 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 content type is the technical documentation must related?
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 compliance of the product is demonstrated, with regards to the relevant standards applicable
- The address of the manufacturer and possible storage locations
- Design and manufacture of the products
- Which Directives apply to the product and evidence of compliance with their requirements
- Certificates of the type examinations performed, if applicable
