附属書IV 内部生産管理

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 its sole responsibility that the product satisfies the requirements of the delegated act adopted pursuant to Article 4.

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the product's conformity to the requirements of the delegated act adopted pursuant to Article 4. 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, wherever applicable, contain at least the following elements:

—a general description of the product and of its intended use,

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

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

—a list of the harmonised standards, common specifications or other relevant technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the requirements 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,

—the results of measurements carried out in relation to ecodesign requirements, including details of the conformity of these measurements as compared with the ecodesign requirements set out in the delegated act adopted pursuant to Article 4,

—test reports, and

—a copy of the information provided in accordance with the information requirements pursuant to Article 7.

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the product with the technical documentation referred to in point 2 and with requirements of the delegated act adopted pursuant to Article 4.

The manufacturer shall affix the required conformity marking to each individual product that satisfies requirements of the delegated act adopted pursuant to Article 4.

The manufacturer shall draw up a written declaration of conformity for each product model in accordance with Article 44 and keep it, together with the technical documentation, at the disposal of the competent national authorities for ten years after the product has been placed on the market or put into service. The declaration of conformity shall identify the product for which it has been drawn up.

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

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