Directive 2014/34/EU of the European Parliament and of the CouncilShow full title

3. The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice.

The application shall include:

(a)

the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

(b)

a written declaration that the same application has not been lodged with any other notified body,

(c)

the technical documentation. The technical documentation shall make it possible to assess the product’s conformity with the applicable requirements of this Directive 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 product. The technical documentation shall contain at least the following elements:

(i)

a general description of the product,

(ii)

conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,

(iii)

descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product,

(iv)

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 health and safety 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,

(v)

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

(vi)

test reports,

(d)

the specimens representative of the production envisaged. The notified body may request further specimens if needed for carrying out the test programme.