What should be the contents of the Technical File?

Whether for the UK or EU, whether for legislative CE, UKCA, UKNI or private IC Mark, the Technical File for product shall consist of:  

  • Overall and detailed plans of the product accompanied, if appropriate, by calculation notes and the results of prototype tests in so far as is necessary for the verification of compliance with the Legislative Requirements.  
  • An exhaustive list of the safety requirements for the product and of the standards or other technical specifications used to demonstrate compliance with the Legislative Requirements.
  • A copy of the User Information or Instructions for Use supplied with the product.
  • A description of the control and test facilities to be used in the manufacturer's plant to check compliance of production with the standards or other technical specification.
 Each conformity scheme will have different requirements.  For more guidance, please ask us for information.
 

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