A significant stage of the CE marking process is to produce technical documentation for the product to provide evidence of conformity for the relevant legislation. The technical documentation can play a vital role in protecting a company, as it will retain information on how the product was developed and how it has evolved during the production run, along with provide evidence of the efforts undertaken to ensure the product remains compliant. The name of this documentation, as well as its contents, can vary with Directives and Regulations.
‘Technical documentation’, ‘Technical Construction File’, ‘TCF’ and ‘Technical File’ are all references to the same documentation, but regardless to its official title, it is required in one form or another by all of the CE marking legislation to perform the same task.
The specific contents of the Technical File can be found in the relevant annex of the specific legislation. Some of the requirements can be common across the Directives and Regulations, but to give you a good idea of what is required we have used the technical documentation requirements given in Annex VII of the Machinery Directive as an example.
  • A general description of the product
  • An overall drawing of the product, as well as other drawings to cover specific aspects of the product, such as circuits diagrams. Drawings shall, where appropriate, be accompanied with descriptions and explanations to understand the product
  • Full detailed drawings, with any calculations, test results, etc, providing proof of the products conformity with the essential health and safety requirements of the applicable Directive/Regulation
  • Copy of the risk assessment, which has documented the identification and mitigation of applicable risks and hazards
  • A list of standards and other technical documentation that have been applied as part of the conformity process
  • Copies of conformity documentation for critical components of the product
  • Copies of technical reports detailing any assessments carried out
  • A copy of instructions and other information supplied for the safe use of the product
  • A copy of the manufacturer’s Declaration
Obviously the above list is not exhaustive of what can be kept in the technical file, other relevant information may also be added. Such as information deemed to contribute to the proof of the conformity of the product that is not listed in the directive. Some information is also not required under some other Directives such as a risk assessment. It is also worth noting that some requirements are also irrelevant if a notified body is not involved due to the nature of the product.
The file must be made available to the competent authorities of the member states for at least ten years after the date that the product was last manufactured. The file does not have to be located in the European Community but it must be made available to either the manufacturer’s authorised representative or the importer of the product as appropriate upon request
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