Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (recast) (Text with EEA relevance) (c. 68)

ANNEX III U.K. CONFORMITY ASSESSMENT PROCEDURES

1. MODULE A: (INTERNAL PRODUCTION CONTROL) U.K.

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 pressure equipment concerned satisfy the requirements of this Directive. U.K.

2. Technical documentation U.K.

The manufacturer shall establish the technical documentation.

The technical documentation shall make it possible to assess the conformity of the pressure equipment 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 pressure equipment. The technical documentation shall, wherever applicable, contain at least the following elements:

• a general description of the pressure equipment,

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

• descriptions and explanations necessary for an understanding of those drawings and diagrams and the operation of the pressure equipment,

• a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and a description of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

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

• test reports.

3. Manufacturing U.K.

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured pressure equipment with the technical documentation referred to in point 2 and with the requirements of this Directive.

4. CE marking and EU declaration of conformity U.K.

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

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

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

5. Authorised representative U.K.

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.