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CE marking requires that the machinery is accompanied by a technical file, whereas no file is required for the partly completed machinery.
The technical file is a key factor for the product conformity assessment within the framework of the market surveillance which is performed by the member states. Indeed, for the large majority of cases, the conformity assessment is only based on the Declaration of Conformity issued by the manufacturer and no report by a third party or a notified body is required.
It is mandatory that the technical file remains at the disposal of the responsible authorities in the member states for the ten years following the machinery construction date or from the production of the last item in case of serial production
It is not necessary to deliver the file in material form at all times. In practice, the individual or legal person appointed with the task in the CE Declaration of Conformity must make sure that the file can be compiled and made available within a reasonable time from the request.
The following records should be included:
information about: design, construction and operation instructions of the product
a basic general description of the appliance including (this is also applied to the variations):
engineering drawings, design and construction outlines
outcome of risk assessments. It is the most important part of the file and it is absolutely compulsory. Regardless of which methodology is applied, the record intends to detail the mechanical, electrical, hydraulic, environmental and operational requirements of the machinery to point out possible sources of health and safety risk that can arise throughout the machine lifecycle. The assessment will result in a list of real risks which should be eliminated at the engineering stage. In case this does not take place, and the risk is also identified on the product being placed on the market, all countermeasures to be taken by the user must be declared. Such information is called “residual risks” and must be stated in the operation and maintenance manual.
list of regulations and of the adopted alternative measures meeting the basic requirements
requirements of the employed materials
files for the products placed on the market
calculations, tests, controls and operation instructions
The main difference between the technical file and the operation and maintenance manual is confidentiality. Only authorities may demand its delivery. As mentioned above, records must be kept by the manufacturer but it is not mandatory to store them in material form.
The quantity and detail level of the information recorded in the technical file depends:
- on the machine requirement,
- on the technical requirements about the compliance with the EU directives and with the harmonized regulations applying to the machinery, if it is the case.
