The manufacturer must compile a technical file for the machinery. The technical file enables the manufacturer to demonstrate the conformity of the machinery as necessary. On the other hand, failure to present the technical file may constitute sufficient grounds for doubting that the machinery meets its statutory safety requirements.
The machinery’s technical file must contain the following information:
- a general description of the machinery
- the overall drawing of the machinery with the necessary descriptions and explanations
- full detailed drawings, calculation notes, test results, etc.
- the documentation on risk assessment, demonstrating
- the procedure followed
- the essential health and safety requirements which apply to the machinery
- the description of the protective measures implemented to eliminate identified hazards or to reduce risks
- where appropriate, the indication of the residual risks
- the standards and other technical specifications, including the information on the extent they are applied to
- where appropriate, any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer
- a copy of the instructions for the machinery
- a copy of the EC declaration of conformity
- for series manufacture, for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity
The technical file does not have to be permanently in written form, and it does not have to be located in the EU. This means that the term ‘technical file’ refers to a body of information that can be stored on paper on in electronic form in one or several places.
In the EC declaration of conformity, the manufacturer must designate a person who is capable of assembling the file and making it available within a reasonable time in response to a request by a competent surveillance authority. The technical file must be compiled in one or more official languages of an EU Member State. This means that the technical file can be prepared in English, and the file does not need to be translated into Finnish and Swedish like the machine instructions.
The technical file must be kept and made available to any competent authority for at least 10 years following the date of manufacture of the machinery or in the case of series manufacture, of the last unit produced.