esc to close

Technical Documentation

Technical documentation is the comprehensive set of information for demonstrating that a product complies with the applicable regulatory requirements. The manufacturer is responsible for drawing it up; under RED Article 11(1), this obligation may not form part of an authorised representative’s mandate. 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. Language requirements depend on the applicable procedure. For technical documentation and correspondence relating to an EU-type examination, RED Article 21(3) requires an official language of the Member State in which the Notified Body is established or another language acceptable to that body. Documentation requested by a market-surveillance authority must be supplied in a language that authority can easily understand; the complete technical documentation does not generally have to be translated into every language of every market country.

Related Services

Need support compiling technical documentation for EU compliance? Learn more about conformity documentation and certification support on our
CE Marking services page.

ILAC-MRA DAkkS-01 ILAC-MRA DAkkS-01