Regulation 5
SCHEDULE 2Conformity Assessment Procedure
Module A Internal production control
1. Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 3 and 4, and ensures and declares on the manufacturer’s sole responsibility that the electrical equipment concerned satisfies the principal elements of the safety objectives.
Technical documentation
2.—(1) The manufacturer must establish the technical documentation.
(2) The documentation must make it possible to assess the electrical equipment’s conformity to the relevant requirements, and must include an adequate analysis and assessment of the risk(s).
(3) The technical documentation must specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the electrical equipment.
(4) The technical documentation must, where applicable, contain at least the following elements—
(a)a general description of the electrical equipment;
(b)conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
(c)descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the electrical equipment;
(d)a list of the harmonised standards applied in full or in part the references to which have been published in the Official Journal or international or national standards referred to in regulation 37 and, where those harmonised standards or international or national standards have not been applied, descriptions of the solutions adopted to meet the principal elements of the safety objectives, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards or international or national standards referred to in regulation 37, the technical documentation must specify the parts which have been applied;
(e)results of design calculations made, examinations carried out, etc.; and
(f)test reports.
Manufacturing
3. The manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured electrical equipment with the technical documentation referred to in paragraph 2 and with the principal elements of the safety objectives.
CE marking and EU declaration of conformity
4.—(1) The manufacturer must affix the CE marking to each individual item of electrical equipment that satisfies the principal elements of the safety objectives.
(2) The manufacturer must draw up a written EU declaration of conformity for a product model and keep it together with the technical documentation at the disposal of the enforcing authorities for 10 years after the electrical equipment has been placed on the market. The EU declaration of conformity must identify the electrical equipment for which it has been drawn up.
(3) A copy of the EU declaration of conformity must be made available to the relevant market surveillance authorities upon request.
Authorised representative
5. The manufacturer’s obligations set out in paragraph 4 may be fulfilled by the manufacturer’s authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.