Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments (recast) (Text with EEA relevance) (c. 31)

ANNEX II U.K. CONFORMITY ASSESSMENT PROCEDURES

5. Module F1: Conformity based on product verification U.K.

5.2. Technical documentation U.K.

5.2.1. The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the instrument’s conformity with 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 instrument. The technical documentation shall, wherever applicable, contain at least the following elements: U.K.

(a)

a general description of the instrument;

(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 instrument;

(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.

5.2.2. The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the instrument has been placed on the market. U.K.