Guide to application of the ATEX 2014/34/UE directive - ANNEX VI MODULE C1: CONFORMITY TO TYPE

ANNEX VI

MODULE C1: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT TESTING

1.           Conformity to type based on internal production control plus supervised product testing is the part of a 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 are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.

§ 203  Conformity to type based on internal production control plus supervised product testing

Module C1 “Conformity to type based on internal production control plus supervised product testing” as Annex VI to the ATEX Directive 2014/34/EU (indicated as “Conformity to type” in the previous Directive 94/9/EC) is one of modules that may be applied after the Module B (EU-type examination certificate, Annex III).

In this conformity assessment procedure, tests are carried out by a manufacturer on each piece of equipment manufactured, to check the explosion protection aspects of the design. Such tests are carried out under the responsibility of a notified body.

2.           Manufacturing

              The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the type described in the EU-type examination certificate and with the requirements of this Directive that apply to them.

§ 204  Manufacturing

The manufacturer has to ensure compliance of the manufactured products to the approved EU-type (under module B) and the legislative requirements.

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

3.           Product checks

              For each individual product manufactured one or more tests on one or more specific aspects of the product shall be carried out by the manufacturer or on his behalf, in order to verify conformity with the type described in the EU-type examination certificate and with the corresponding requirements of this Directive. The tests shall be carried out under the responsibility of a notified body, chosen by the manufacturer.

              The manufacturer shall, under the responsibility of the notified body, affix the notified body's identification number during the manufacturing process.

§ 205  Product checks

The manufacturer has (directly or on his behalf) to carry out tests on one or more specific aspects of the product. He has to choose a notified body which assume the responsibility of such tests, and to affix the notified body’s identification number during the manufacturing process.

The notified body takes into account the technical documentation but does not examine it, as it has been already examined under module B.

The notified body has to keep record of its decisions and other relevant information, and informs authorities and the other bodies about the examinations performed.

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 is in conformity with the type described in the EU-type examination certificate and 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 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 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 model for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.

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

As in this conformity assessment module (C1) the notified body is involved in the production phase, the CE marking must be followed by the identification number of the notified body.

CE marking should not be affixed to a component, but only the identification number of the notified body involved in the production phase.

The written EU 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.

§ 207  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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