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 provisions of this Directive.
2. The application for EC type-examination must be lodged by the manufacturer or by his authorised representative established within the Community with a notified body of his choice.
The application must include:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,
a written declaration that the same application has not been lodged with any other notified body,
the technical documentation, as described in point 3.
The applicant must 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 must enable the conformity of the component with the requirements of this Directive to be assessed. It must, as far as is relevant for such assessment, cover the design, manufacture and operation of the component.
The documentation must contain as far as is relevant to assessment:
a general type-description,
conceptual design and manufacturing drawings and schemes of components, subassemblies, circuits, etc.,
descriptions and explanations necessary for the understanding of the said drawings and schemes and the operation of the product,
the list of the European specifications referred to in Article 2(2) of this Directive, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements where the European specifications referred to in Article 2(2) of this Directive do not exist,
the results of design calculations made, examinations carried out, etc.,
test reports.
It must also indicate the field of use of the component.
4. The notified body:
4.1. must examine the technical documentation, verify that the type has been manufactured in conformity with the technical documentation and identify the components which have been designed in accordance with the relevant provisions of the European specifications referred to in Article 2(2) of this Directive as well as those which have been designed without applying the relevant provisions of those European specifications;
4.2. must perform or have performed the appropriate examinations and necessary tests to check whether, where the European specifications referred to in Article 2(2) of this Directive have not been applied, the solutions adopted by the manufacturer meet the essential requirements of this Directive;
4.3. must perform or have performed the appropriate examinations and necessary tests to check whether, where the manufacturer has chosen to apply the relevant European specifications, these have actually been applied;
4.4. must agree with the applicant the location where the examinations and necessary tests are to be carried out.
5. Where the type meets the provisions of this Directive, the notified body must issue an EC type-examination certificate to the applicant. The certificate must state the name and address of the manufacturer, the conclusions of the examination, the conditions for its validity, the duration thereof and give the necessary data for identification of the approved type.
A list of the relevant parts of the technical documentation must be annexed to the certificate and a copy kept by the notified body. If the notified body refuses to issue an EC-type certificate to the manufacturer, the former must provide detailed reasons for such refusal. Provision must be made for an appeals procedure.
6. The applicant must inform the notified body that holds the technical documentation concerning the EC type-examination certificate of all modifications of the approved component which must receive additional approval where such changes may affect the conformity of the component with the essential requirements for the prescribed conditions for its use. This additional approval is given in the form of an addition to the original EC type-examination certificate.
7. Each notified body must 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 must be kept at the disposal of the other notified bodies.
9. The manufacturer or his authorised representative must keep with the technical documentation copies of EC type-examination certificates and their additions for at least 30 years after the last component has been manufactured.
Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the component on the Community market.