Before drawing up the EC declaration of conformity, the manufacturer, or his authorised representative in the Community, shall have ensured and be able to guarantee that the documentation listed below is and will remain available on his premises for any inspection purposes:
This is what is required to demonstrate conformity with the provisions of the Directive.
For the purposes of this Annex, ‘machinery’ means either ‘machinery’ or ‘safety component’ as defined in
1. The EC declaration of conformity is the procedure by which the manufacturer, or his authorised representative established in the Community declares that the machinery being placed on the market complies with all the essential health and safety requirements applying to it.
2. Signature of the EC declaration of conformity authorises the manufacturer, or his authorised representative in the Community, to affix the CE marking to the machinery.
3. Before drawing up the EC declaration of conformity, the manufacturer, or his authorised representative in the Community, shall have ensured and be able to guarantee that the documentation listed below is and will remain available on his premises for any inspection purposes:
(a) a technical construction file comprising:
— an overall drawing of the machinery together with drawings of the control circuits,
— full detailed drawings, accompanied by any calculation notes, test results, etc., required to check the conformity of the machinery with the essential health and safety requirements,
— a list of:
— the essential requirements of this Directive,
— standards, and
— other technical specifications, which were used when the machinery was designed,
— a description of methods adopted to eliminate hazards presented by the machinery,
— if he so desires, any technical report or certificate obtained from a competent body or laboratory (1),
— if he declares conformity with a harmonised standard which provides therefor, any technical report giving the results of tests carried out at his choice either by himself or by a competent body or laboratory (1),
— a copy of the instructions for the machinery;
(b) for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive.
The manufacturer must carry out necessary research or tests on components, fittings or the completed machine to determine whether by its design or construction, the machine is capable of being erected and put into service safely.
Failure to present the documentation in response to a duly substantiated request by the competent national authorities may constitute sufficient grounds for doubting the presumption of conformity with the requirements of the Directive.
4. (a) The documentation referred to in 3 above need not permanently exist in a material manner but it must be possible to assemble it and make it available within a period of time commensurate with its importance.
It 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 basic safety requirements.
(1) A body or laboratory is presumed competent if it meets the assessment criteria laid down in the relevant harmonised standards.
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