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

 

ANNEX V

MODULE F: CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION

1.           Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5 and ensures and declares on his sole responsibility that the products concerned, which have been subject to the provisions of point 3, are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.

§ 197  Conformity to type based on product verification

Module F “Conformity to type based on product verification” as Annex V to the ATEX Directive 2014/34/EU (indicated as “Product verification” 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, examination and tests of every product are carried out by a notified body to check the conformity of the equipment, protective system or device with the requirements of Directive 2014/34/EU, and draws up a certificate of conformity.

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 approved type described in the EU-type examination certificate and with the requirements of this Directive that apply to them.

§ 198  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.           Verification

              A notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the products with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Directive.

              The examinations and tests to check the conformity of the products with the appropriate requirements shall be carried out by examination and testing of every product as specified in point 4.

4.           Verification of conformity by examination and testing of every product

4.1.        All products shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify conformity with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Directive.

              In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out.

4.2.        The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved product or have it affixed under its responsibility.

              The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the product has been placed on the market.

§ 199  Verification

The notified body has to carry out appropriate examinations and tests (testing of every product or statistical checks).

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 issues a certificate of conformity and:

- affixes its identification number or delegates to the manufacturer the affixing of its identification number,

- keeps a record of its decisions and other relevant information, and

- informs its notifying authorities and the other bodies about the examinations performed.

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

5.1.        The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3, the latter's identification number to each individual product other than a component that is in conformity with the approved type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.

5.2.        The manufacturer shall draw up a written EU declaration of conformity for each 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.

              If the notified body referred to in point 3 agrees and under its responsibility, the manufacturer may also affix the notified body's identification number to the products other than components.

5.3.        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.

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

As in this conformity assessment module (F) 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.

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.

6.           If the notified body agrees and under its responsibility, the manufacturer may affix the notified body's identification number to the products during the manufacturing process.

§ 201  The notified body’s identification number

This is a matter of contractual or informal agreement between the manufacturer and the notified body.

7.           Authorised representative

              The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer's obligations set out in point 2.

§ 202  Authorised representative

According to the mandate contractually agreed with the manufacturer, the authorised representative can be entitled to fulfil the manufacturer’s obligations, with the exception of those related to the conformity of the manufactured products with the approved type.