Which documents are in the Technical File?

Content of a Technical File

The contents of the Technical File can vary depending on the type of product and the relevant EU directives or regulations that apply, but it generally includes the following documents and information:

• A general description of the product, including technical specifications
• Design and production drawings
• Detailed technical drawings about the essential aspects of the product
• Risk assessment to determine which safety and health requirements apply to the product
• A list of relevant EU standards and harmonised standards, including the essential health and safety requirements that were met
• Report of performed calculations and tests
• Certificates and inspection reports
• Declaration of Conformity
• User’s Information
  • User Manual and Instructions for Use
  • Labeling and Marking Information
  • Packaging Information
• For series production, the internal stipulations that were complied with to guarantee conformity with the directive(s) and/or regulations

The specific contents of the Technical File can vary based on the product category and applicable directives and regulations.

Responsibility Manufacturer

Manufacturers are responsible for maintaining this file and making it available for inspection by relevant authorities as required. It is crucial to consult the specific directives and standards applicable to your product to ensure that all necessary documents are included in the Technical File. Feel free to contact us for assistance in guiding, compiling, or assembling your Technical File. Our experts are here to help.