SCHEDULE 5 Module: EC type-examination
Regulation 10(3)(a) and (b)(i) (Annex III to the ATEX Directive)
1 This module describes that part of the procedure by which a notified body ascertains and attests that a specimen representative of the production envisaged meets the relevant applicable provisions of the ATEX Directive.
2 The application for the EC type-examination shall be lodged by the manufacturer or his authorised representative established in the Community with a notified body of his choice.
The application shall include:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address in addition;
a written declaration that the same application has not been lodged with any other notified body;
the technical documentation, as described in paragraph 3.
The applicant shall place at the disposal of the notified body a specimen representative of the production envisaged and hereinafter called ‘type'. The notified body may request further specimens if needed for carrying out the test programme.
3 The technical documentation shall enable the conformity of the product with the requirements of the ATEX Directive to be assessed. It shall, to the extent necessary for such assessment, cover the design, manufacture and operation of the product and shall to that extent contain:
a general type-description;
design and manufacturing drawings and layouts of components, sub-assemblies, circuits, etc.;
descriptions and explanations necessary for the understanding of said drawings and layouts and the operation of the product;
a list of the standards referred to in Article 5 of the ATEX Directive, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the ATEX Directive where the standards referred to in that Article have not been applied;
results of design calculations made, examinations carried out, etc.;
test reports.
4 The notified body shall:
4.1 examine the technical documentation, verify that the type has been manufactured in conformity with the technical documentation and identify the elements which have been designed in accordance with the relevant provisions of the standards referred to in Article 5 of the ATEX Directive, as well as the components which have been designed without applying the relevant provisions of those standards;
4.2 perform or have performed the appropriate examinations and necessary tests to check whether the solutions adopted by the manufacturer meet the essential requirements of the ATEX Directive where the standards referred to in Article 5 of the ATEX Directive have not been applied;
4.3 perform or have performed the appropriate examinations and necessary tests to check whether these have actually been applied, where the manufacturer has chosen to apply the relevant standards;
4.4 agree with the applicant the location where the examinations and necessary tests shall be carried out.
5 Where the type meets the provisions of the ATEX Directive, the notified body shall issue an EC type-examination certificate to the applicant. The certificate shall contain the name and address of the manufacturer, conclusions of the examination and the necessary data for identification of the approved type.
A list of the relevant parts of the technical documentation shall be annexed to the certificate and a copy kept by the notified body.
If the manufacturer or his authorised representative established in the Community is denied a type certificate, the notified body shall provide detailed reasons for such denial.
Provision shall be made for an appeals procedure.
6 The applicant shall inform the notified body which holds the technical documentation concerning the EC type-examination certificate of all modifications to the approved equipment or protective system which must receive further approval where such changes may effect conformity with the essential requirements or with the prescribed conditions for use of the product. This further approval is given in the form of an addition to the original EC type-examination certificate.
7 Each notified body shall communicate to the other notified bodies the relevant information concerning the EC type-examination certificates and additions issued and withdrawn.
8 The other notified bodies may receive copies of the EC type-examination certificates and/or their additions. The annexes to the certificates shall be kept at the disposal of the other notified bodies.
9 The manufacturer or his authorised representative established in the Community shall keep with the technical documentation copies of EC type-examination certificates and their additions for a period ending at least 10 years after the last equipment or protective system was manufactured.
Where neither the manufacturer nor his authorised representative is established in the Community, the obligation to keep the technical documentation available shall be the responsibility of the person who places the product on the market in the Community.