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The Technical File is a collection of documents that a manufacturer is obliged to prepare in order to demonstrate the conformity of its products to the Essential Safety and Health Protection Requirements (EHSRs) laid down in various product directives requiring CE marking.

Specifically, this is a dossier of documents covering the design, manufacture and operation of a product.


The Machinery Directive 2006/42/EC (like other directives) also requires the production of this technical dossier to demonstrate to the control authorities (upon justified request) that the machine/device complies with the Essential Safety Requirements laid down by law.

It is the manufacturer's responsibility to conduct the necessary research and tests on components and accessories or on the whole machine in order to determine whether it can be installed and put into service safely as a result of its design or construction. It is the manufacturer's responsibility to ensure that the technical file is available before this stage, or before placing it on the market.


the Technical File is the dossier in which the relevant reports and results are included to demonstrate that the certification process has been properly completed.
Please be assured that our technical files are compliant with all applicable laws.


The documents contained in the Technical File describe fully and in detail the design and construction choices inherent to machinery safety:

  • diagrams
  • technical drawings
  • structural calculations
  • laboratory tests
  • characteristics of marketing materials
  • certifications and subcontractor manuals
  • choice justifications
  • risk assessment

In particular, the risk assessmentis detailed, explaining the method of analysis and the procedure carried out for the evaluation.


Something more about a Technical file

  • it is the construction file of a machine or device
  • it must contain the construction drawings of the machine or device
  • it must be drawn up in one of the official languages of the European Community
  • it must be made available to the member states' competent authorities for at least 10 years from the date of manufacture of the machine/device or of the last unit produced in the case of series manufacture
  • there is no requirement that it be physically available and kept on the territory of the European Community, but it must be so where requested
  • failure to produce it following a duly justified request by the relevant national authorities may constitute sufficient grounds to question the machinery's compliance with essential health and safety requirements.


Entrusting the production of the Technical File to us for your machines means that you can enjoy the following advantages:


Documentation compliant and up-to-date with current regulations

As standards and directives change, machines can also change over time, resulting in the need to update their Technical Files. By entrusting us with the Technical File, you can rest assured that everything is taken care of.

Immediate availability of documents

Possibility of immediately demonstrating the certification process to requesting competent authorities. In fact, by submitting the Technical File at the time the competent body requests it, it is possible to demonstrate clearly that the process has been carried out.

Transferring our know-how to your personnel

Through our consultancy, you acquire the opportunity to transfer our expertise to your in-house technicians, who are generally more concerned with quality than safety when it comes to performance planning.

Safety-related product improvement ideas

It is possible for us to provide solutions so that your machine will perform much better from a safety standpoint, and hence be considered to be of a superior quality as a result.

Business competitiveness in relation to customer audits

If the machine is well designed in terms of both performance and safety, the end customer (especially the more advanced one) is likely to perceive that they are dealing with a professional, high-quality manufacturer

Costs are subject to change and will be charged to the specific order

By entrusting the drafting of the Technical File to us, you can allocate a specific cost centre by charging the consultancy/editing to the individual job number, and not charging the cost for the design as would be the case if you produced the technical documentation in-house