Directive 2014/35/EU of the European Parliament and of the CouncilShow full title

Internal production control

1. Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the electrical equipment concerned satisfy the requirements of this Directive that apply to it.

2. Technical documentation

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the electrical equipment’s conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the electrical equipment. The technical documentation shall, 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 of which have been published in the Official Journal of the European Union or international or national standards referred to in Articles 13 and 14 and, where those harmonised standards or international or national standards have not been applied, descriptions of the solutions adopted to meet the safety objectives of this Directive, 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 Articles 13 and 14, the technical documentation shall specify the parts which have been applied;

(e)

results of design calculations made, examinations carried out, etc.; and

(f)

test reports.

3. Manufacturing

The manufacturer shall 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 point 2 and with the requirements of this Directive that apply to it.

4. CE marking and EU declaration of conformity

4.1. The manufacturer shall affix the CE marking to each individual electrical equipment that satisfies the applicable requirements of this Directive.

4.2. The manufacturer shall 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 national market surveillance authorities for 10 years after the electrical equipment has been placed on the market. The EU declaration of conformity shall identify the electrical equipment for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant market surveillance authorities upon request.

5. Authorised representative

The manufacturer’s obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.