Guide to application of the ATEX 2014/34/UE directive - ANNEX VIII MODULE A: INTERNAL PRODUCTION CONTROL

ANNEX VIII

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 and 4, and ensures and declares on his sole responsibility that the products concerned satisfy the requirements of this Directive that apply to them.

§ 216  Internal production control

Annex VIII to the ATEX Directive 2014/34/EU includes module A “Internal production control” as (indicated as “Internal control of production” in the previous Directive 94/9/EC). In this conformity assessment procedure, the product and quality system assessment procedure is carried out by the manufacturer.

In the cases of Article 13(1)(b)(ii) (equipment-group I and II, category M2 and 2, neither internal combustion engines nor electrical equipment), communication/deposit of the technical documentation to a notified body, and retention of such documentation by the notified body, are required.

2.           Technical documentation

              The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the product's 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 product. The technical documentation shall contain at least the following elements:

              (a)     a general description of the product,

              (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 product,

              (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 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,

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

              (f)     test reports.

§ 217  Technical documentation

In this module there is no involvement of a notified body in the conformity assessment activities. The required tests may be done by manufacturer itself or in any independent laboratory the manufacturer considers adequate.

The need to carry out tests may arise from the technical solution adopted and/or by the use of standards (harmonised or other).

In case of equipment-group I and II, category M2 and 2, technical documentation identifying product should be communicated to a notified body, which retains it in its facilities located in the European Union.

The notified body does not examine the conformity of such documentation file; in some cases it can be requested that the documentation file is sealed. Documentation file is stored in notified body’s archives upon the request of manufacturer (or its authorised representative).

For received and stored documentation, the notified body issues a “Confirmation of product documentation file retention/deposit” typically identified by codification numbers and/or letters.

3.           Manufacturing

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

§ 218  Manufacturing

The manufacturer has to draw up the technical documentation and to ensure compliance of the manufactured products to the legislative requirements.

For the general obligations of manufacturers, see section § 75.

4.           CE marking, EU declaration of conformity and attestation of conformity

4.1.        The manufacturer shall affix the CE marking to each individual product other than a component that satisfies the applicable requirements of this Directive.

4.2.        The manufacturer shall draw up a written EU declaration of conformity for a product model other than a component and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product, other than a component, has been placed on the market. The EU declaration of conformity shall identify such product model for which it has been drawn up.

              A copy of the EU declaration of conformity shall accompany every product other than a component.

4.3.        The manufacturer shall draw up a written attestation of conformity for each component model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.

§ 219  CE marking, EU declaration of conformity and attestation of conformity

As in this conformity assessment module (A) no notified body is involved in the production phase, the CE marking must not be followed by any notified body’s identification number.

CE marking should not be affixed to a component.

A written declaration of conformity should be issued by the manufacturer (or its authorised representative) except for components. For components a written attestation of conformity must be issued.

5.           Authorised representative

              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.

§ 220  Authorised representative

According to the mandate contractually agreed with the manufacturer, the authorised representative can be entitled to fulfil the manufacturer’s obligations related to CE marking, EU declaration of conformity and attestation of conformity.

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