Technical Documentation
Technical documentation refers to the comprehensive set of information prepared by the manufacturer or their authorized representative to demonstrate that a product complies with applicable regulatory requirements. It is a core element of the conformity assessment process and must be provided to market surveillance authorities without delay upon justified request.
Role in Conformity Assessment
In the European Union, technical documentation is required under directives such as:
The documentation supports the Declaration of Conformity (DoC) and must be retained for ten years after the product has been placed on the market.
Typical Contents
Depending on the product and applicable legislation, technical documentation typically includes:
Product description and intended use
Design and manufacturing drawings
Bills of materials and components
Risk assessment and applied standards
Test reports and conformity evaluations
Copies of issued certificates (e.g., EU Type Examination Certificate)
Instructions and safety information provided with the product
Description of the conformity assessment procedure applied (if applicable)
The content must be sufficient to assess the product's conformity with essential requirements. It may need to be translated or made available in the official language(s) of the Member State where the product is marketed.
Related Services
Need support compiling technical documentation for EU compliance? Learn more about conformity documentation and certification support on our
CE Marking services page.