Directive 2014/30/EU of the European Parliament and of the CouncilShow full title

ANNEX II MODULE A: INTERNAL PRODUCTION CONTROL

1. Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 4 and 5 of this Annex, and ensures and declares on his sole responsibility that the apparatus concerned satisfy the requirements of this Directive that apply to it.

2. Electromagnetic compatibility assessment

The manufacturer shall perform an electromagnetic compatibility assessment of the apparatus, on the basis of the relevant phenomena, with a view to meeting the essential requirements set out in point 1 of Annex I.

The electromagnetic compatibility assessment shall take into account all normal intended operating conditions. Where the apparatus is capable of taking different configurations, the electromagnetic compatibility assessment shall confirm whether the apparatus meets the essential requirements set out in point 1 of Annex I in all the possible configurations identified by the manufacturer as representative of its intended use.

3. Technical documentation

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the apparatus 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 apparatus. The technical documentation shall, wherever applicable, contain at least the following elements:

(a)

a general description of the apparatus;

(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 apparatus;

(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 and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;

(e)

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

(f)

test reports.

4. Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured apparatus with the technical documentation referred to in point 3 of this Annex and with the essential requirements set out in point 1 of Annex I.

5. CE marking and EU declaration of conformity

5.1. The manufacturer shall affix the CE marking to each individual apparatus that satisfies the applicable requirements of this Directive.

5.2. The manufacturer shall draw up a written EU declaration of conformity for an apparatus model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the apparatus has been placed on the market. The EU declaration of conformity shall identify the apparatus for which it has been drawn up.

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

6. Authorised representative

The manufacturer’s obligations set out in point 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.