Declaration of Conformity - Technical File

EPD Engineering Services engineers:

  • provides full support for the handling of the CE marking for all types of mechanical construction and the preparation of the Technical Document for all types of mechanical construction, in accordance with the requirements of European and Greek directives.
  • contributes to successful CE certification at all stages of development (initial design, prototype manufacturing, industrialization) and marketing on the European market of all mechanical engineering.
  • have significant experience in assembling CE Certification Technical Files in the following products:
    • Machinery Directive ( 2006/42 / EC)
    • Pressure Equipment (Directive 2014/68 / EU & 97/23 / EC)

Technical File

The technical file shall consist of all documents spelt out in the list of essential requirements of the specific CE directives. In general, the technical file includes:

  • A general description of your product;
  • Information about your product’s design (e.g. circuit diagrams, design drawings, mechanical drawings, component list, manufacturing documentation, etc.);
  • Description and explanations necessary to understand the above-mentioned drawings;
  • Installation description and user manual for the product. The installation description must clarify how users should install and use your product;
  • A list of the applicable CE directives and essential requirements;
  • An analysis of the steps taken to ensure the safety of your product, including a list of the standards used either wholly or partially, or own standards/methods used to verify compliance with the respective CE directive; the results of any product resting; and, a product safety analysis. The safety analysis is mandatory for compliance of a product with the Machinery Directive, for example. By performing a safety analysis, the manufacturer of record assesses the risks’ probability and severity posed by the product in some areas and consequently documents the measures taken for reducing the specific risks. The most residual risks must be limited by the usage of interlocks, while the minor residual risks can be acknowledged with warnings.
  • Certificates of CE compliance of the product from any required notified body.
  • Other grounds used or that may be of use (such as calculations, simulations, etc.);
  • Test reports.