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Which documents are in the Technical File?

Compliance Expert Soufyan Lamdini explains

Basically, the Technical File comprises:

  • A general description of the product; 
  • Sometimes a risk assessment to determine which safety and health requirements apply to the product; 
  • Design and production drawings; 
  • Detailed technical drawings about the essential aspects of the product;
  • A list with the essential health and safety requirements that were met; 
  • Report of performed calculations and tests; 
  • Certificates and inspection reports; 
  • User’s manual; 
  • For series production, the internal stipulations that were complied with to guarantee conformity   with the Directive(s)

 

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