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Generally, the technical file contains the following information:

  • General description of the product.
  • Information about how to operate the product.
  • Design and manufacturing drawings, including schemes of parts and subassemblies.
  • A list of the applicable harmonized standards such as those specified by the British Standards Institution in the UK.
  • A description of the methods used to meet the essential requirements for each product.
  • Directives that applies to the product.
  • The result of any design calculations.
  • Test reports from the supplier or those you commissioned by an independent testing body.

The regulations require you to keep technical files for 10 years after the production has ceased. At any time, an agency from the UK or any of the EU member states that have the responsibility to monitor product compliance could audit the product file. You can also use the files to demonstrate to potential customers that your product complies with the law.

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© 2024 GTG Group | Global Testing Group. All rights reserved.