Directive 2007/23/EC of the European Parliament and of the Council (repealed)Show full title

1. MODULE B: EC type-examination

1. This module describes that part of the procedure by which a notified body ascertains and attests that a sample, representative of the production envisaged, meets the relevant provisions of Directive 2007/23/EC (hereinafter referred to as this Directive).

2. The application for EC type-examination must be lodged by the manufacturer with the notified body of his choice.

The application must include:

(a)

the name and address of the manufacturer,

(b)

a written declaration that the same application has not been lodged with any other notified body,

(c)

the technical documents, as described in point 3.

The applicant must place at the disposal of the notified body a sample representative of the production envisaged, hereinafter called ‘type’. The notified body may request further samples if needed for carrying out the test programme.

3. The technical documents must enable the conformity of the article with the requirements of this Directive to be assessed. They must, as far as is relevant for such assessment, cover the design, manufacture and operation of the article and contain where relevant for the assessment:

(a)

a general type-description,

(b)

conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

(c)

descriptions and explanations necessary for the understanding of the drawings and diagrams and the operation of the article,

(d)

a list of the harmonised standards referred to in Article 8 of this Directive, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where the harmonised standards referred to in Article 8 of this Directive have not been applied,

(e)

results of design calculations made, examinations carried out, etc.,

(f)

test reports.

4. The notified body must:

(a)

examine the technical documents, verify that the type has been manufactured in conformity with those documents and identify the elements which have been designed in accordance with the relevant provisions of the harmonised standards referred to in Article 8 of this Directive as well as the components which have been designed without applying the relevant provisions of those harmonised standards,

(b)

perform or have performed the appropriate examinations and necessary tests to check whether, where the harmonised standards referred to in Article 8 of this Directive have not been applied, the solutions adopted by the manufacturer meet the essential safety requirements of this Directive,

(c)

perform or have performed the appropriate examinations and necessary tests to check whether, where the manufacturer has chosen to apply the relevant harmonised standards, these have been applied,

(d)

agree with the applicant the location where the examinations and necessary tests are to be carried out.

5. Where the type meets the relevant provisions of this Directive, the notified body must issue an EC type-examination certificate to the applicant. The certificate must contain the name and address of the manufacturer, the results of the examination and the data necessary for the identification of the approved type.

A list of the relevant parts of the technical documents must be annexed to the certificate and a copy thereof kept by the notified body.

Where the manufacturer is refused a type certificate, the notified body 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 documents concerning the EC type-examination certificate of all modifications to the approved article which must receive additional approval where such changes may affect the conformity with the essential requirements or the prescribed conditions for use of the article. This additional approval must be 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 EC type-examination certificates and additions issued or withdrawn.

8. The other notified bodies may receive copies of the EC type-examination certificates and/or any additions thereto. The annexes to the certificates must be kept at the disposal of the other notified bodies.

9. The manufacturer must keep with the technical documents copies of EC type-examination certificates and any additions thereto for a period of at least 10 years after the last date of manufacture of the article concerned.

Where the manufacturer is not established within the Community, the obligation to keep the technical documents available is the responsibility of the person who places the product on the market.