Division B Relevant technical documentation for partly completed machinery

This part describes the procedure for compiling relevant technical documentation. The documentation must show which requirements of this Directive are applied and fulfilled. It must cover the design, manufacture and operation of the partly completed machinery to the extent necessary for the assessment of conformity with the essential health and safety requirements applied. The documentation must be compiled in one or more official Community languages.

It shall comprise the following:

1. (a)

   a construction file including:

   • the overall drawing of the partly completed machinery and drawings of the control circuits,

   • full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the partly completed machinery with the applied essential health and safety requirements,

   • the risk assessment documentation showing the procedure followed, including:

     1. (i)

        a list of the essential health and safety requirements applied and fulfilled,

     2. (ii)

        the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, where appropriate, the indication of the residual risks,

     3. (iii)

        the standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards,

     4. (iv)

        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,

     5. (v)

        a copy of the assembly instructions for the partly completed machinery;

2. (b)

   for series manufacture, the internal measures that will be implemented to ensure that the partly completed machinery remains in conformity with the essential health and safety requirements applied.

The manufacturer must carry out necessary research and tests on components, fittings or the partly completed machinery to determine whether by its design or construction it is capable of being assembled and used safely. The relevant reports and results shall be included in the technical file.

The relevant technical documentation must be available for at least 10 years following the date of manufacture of the partly completed machinery or, in the case of series manufacture, of the last unit produced, and on request presented to the competent authorities of the Member States. It does not have to be located in the territory of the Community, nor does it have to be permanently available in material form. It must be capable of being assembled and presented to the relevant authority by the person designated in the declaration for incorporation.

Failure to present the relevant technical documentation in response to a duly reasoned request by the competent national authorities may constitute sufficient grounds for doubting the conformity of the partly completed machinery with the essential health and safety requirements applied and attested.