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 AND THE TECHNICAL FILE
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.
IMPORTANT
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.
YOURADVANTAGES
Entrusting the production of the Technical File to us for your machines means that you can enjoy the following advantages:
