Technical File

A technical file is required by the primary directives to document the conformity assessment and the product's design. The technical file shall be compiled by the manufacturer or authorized representative and contain design documentation, manufacturing, test reports and operation information to show conformity as required by the directives.

File Components:

• Declaration of Conformity (and/or certificate for regulated products)
• The name and address of the manufacturer and identification of the products
• European agent's name and address, if applicable
• List of harmonized standards followed and/or the solutions adopted to satisfy the ERs
• Description of the product (model, name, etc...)
• Operating instructions
• Test report(s)
• Design details, description of operation, components list, test rationale, circuits and diagrams - including items necessary to understand the solutions adopted to satisfy the ERs

Technical Construction File (TCF) - This is a special technical file for regulated products, high-risk machines (Annex IV machinery), and occasionally for EMC (large equipment, etc.), where the use of a Notified or Competent Body is mandatory.

TÜV Rheinland, headquartered in Cologne, Germany, has earned an excellent reputation with more than a century of testing and certification experience. TÜV Rheinland has offices in more than 30 countries, including many in the U.S.