Resource > Hold Technical Files for non-EU manufacturers

Hold Tech Files Ltd. hold Technical Files in Ireland for non-EU manufacturers. The Machinery Directive 2006/42/EC requires companies from outside the European Economic Area to have a company or person established in the EU, appointed by the manufacturer to provide the technical file to a market surveillance authority on request. 

Hold Technical Files

Hold Technical Files

Hold Tech Files Ltd. will act for non-EU manufacturers and will hold technical files on their behalf. We will make this information available to safety authorities as required.

We do not have to assemble the technical file. We liaise with the Machinery Safety Authorities and the manufacturer. Hold Tech Files Ltd. ensure the relevant information is provided. We hold technical files on behalf of manufacturers.

Our details can be added to Declarations of Conformity or Incorporation. EU Health and Safety Authorities can contact Hold Tech Files for information relating to the Technical File. See White Paper.

Contents of a Technical File

1. The technical file shall comprise the following:
(a) a construction file including:
— a general description of the machinery.
— the overall drawing of the machinery and drawings of the control circuits, as well as the pertinent descriptions and explanations necessary for understanding the operation of the machinery.
— full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the machinery with the essential health and safety requirements.
— documentation on risk assessment demonstrating the procedure followed, including:
(i) a list of the essential health and safety requirements which apply to the machinery.
(ii) a description of the protective measures implemented to eliminate identified hazards or to reduce risks and, when appropriate, the indication of the residual risks associated with the machinery.
— the standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards.
— any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer or his authorised representative.
— a copy of the instructions for the machinery.
— where appropriate, the declaration of incorporation for included partly completed machinery and the relevant assembly instructions for such machinery.
— where appropriate, copies of the EC declaration of conformity of machinery or other products incorporated into the machinery.
— a copy of the EC declaration of conformity;
(b) for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of this Directive.
The manufacturer must carry out necessary research and tests on components, fittings or the completed machinery to determine whether by its design or construction it is capable of being assembled and put into service safely. The relevant reports and results shall be included in the technical file.
2. The technical file referred to in point 1 must be made available to the competent authorities of the Member States 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.
It does not have to be located in the territory of the Community, nor does it have to be permanently available in material form. However, it must be capable of being assembled and made available within a period of time commensurate with its complexity by the person designated in the EC declaration of conformity.
The technical file does not have to include detailed plans or any other specific information as regards the sub-assemblies used for the manufacture of the machinery unless a knowledge of them is essential for verification of conformity with the essential health and safety requirements.
3. Failure to present the technical file in response to a duly reasoned request by the competent national authorities may constitute sufficient grounds for doubting the conformity of the machinery in question with the Essential Health and Safety Requirements.

The UK Health and Safety Executive have information on Technical Files.

To ask us to hold technical files on your behalf, please contact derek@holdtechfiles.eu.


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