FAQs Technical File Documentation and Compilation

All EU and UK product legislation using the CE, UKCA and related conformity markings requires technical documentation to show that products comply. Some legislation calls it a technical file.

The manufacturer must compile and keep it to show how the product complies with the legislation. Their authorised representative may deliver it to the authorities, especially if the manufacturer is outside the jurisdiction where the product is supplied.

Technical documentation is required to demonstrate to the authorities and conformity assessment bodies that the products comply with the requirements of the applicable product legislation.

No. Only market surveillance authorities and conformity assessment bodies have the right to see technical documentation.

Market surveillance authorities are consumer protection, trading standards and health and safety authorities. Conformity Assessment Bodies approve and certify higher-risk products. They include EU Notified Bodies and UK (Market) Conformity Assessment Bodies (UKMCAB or UKCAB) also known as Approved or Appointed Bodies.

A technical file must include the following information on the products:

• identity and description;
• legal and technical requirements;
• how the design, manufacture and quality control measures meet the requirements;
• user information;
• third party certification;
• traceability and product safety incident plans.

You can purchase checklists for product technical documentation on our sister site at Product Compliance Support

A technical file must include the following information on the products:

• Identification of the products covered:
• Description of the products;
• Overall drawings, datasheets, specifications
• The legal and technical requirements –
  • Usually summarised on the Declaration of Conformity;
• Show how all the requirements have been met:
  • reports of tests on the technical requirements. These may be from the manufacturer or from an outside test laboratory. Certificates are not usually enough on their own.
  • checklists of the requirements of legislation and standards
  • risk assessments
  • declarations, certificates, datasheets, etc. for components and raw materials
• •All user information supplied:
  • o Markings, labels on the product itself
  • o Packaging artwork, labels
  • o Instruction manuals, other documents supplied to the user.
• Conformity assessment body reports and certificates
  • (only if required by the legislation)
• Control measures to ensure conformity of production:
  • Quality control procedures relevant to compliance.
  • checks and tests carried out on during or after manufacture
  • Raw material and component checks
• Traceability plan with sufficient detail on products, components, materials, and their supply chains:
• Product safety incident plan
• Declarations of conformity