Directive 2009/23/EC of the European Parliament and of the Council (repealed)Show full title

1. EC type-examination

1.1. EC type-examination is the procedure whereby a notified body verifies and certifies that an instrument, representative of the production envisaged, meets the requirements of this Directive.

1.2. The application for EC type-examination shall be lodged with a single notified body by the manufacturer or his authorised representative established within the Community.

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 application has not been lodged with any other notified body,

• the design documentation, as described in Annex III.

The applicant shall place at the disposal of the notified body an instrument, representative of the production envisaged, hereinafter the ‘type’.

1.3. The notified body shall:

1.3.1. examine the design documentation and verify that the type has been manufactured in accordance with that documentation;

1.3.2. agree with the applicant on the location where the examinations and/or tests shall be carried out;

1.3.3. perform or have performed the appropriate examinations and/or tests to check whether the solutions adopted by the manufacturer meet the essential requirements where the harmonised standards referred to in Article 6(1) have not been applied;

1.3.4. perform or have performed the appropriate examinations and/or tests to check whether, where the manufacturer has chosen to apply the relevant standards, these standards have been applied effectively, thereby assuring conformity with the essential requirements.

1.4. Where the type complies with the provisions of this Directive, the notified body shall issue an EC type-approval certificate to the applicant. The certificate shall contain the conclusions of the examination, conditions (if any) for its validity, the necessary data for identification of the approved instrument and, if relevant, a description of its functioning. All the relevant technical elements such as drawings and layouts shall be annexed to the EC type-approval certificate.

The certificate shall have a validity period of 10 years from the date of its issue, and may be renewed for subsequent periods of 10 years each.

In the event of fundamental changes to the design of the instrument, e.g. as a result of the application of new techniques, the validity of the certificate may be limited to two years and extended by three years.

1.5. Each notified body shall periodically make available to all Member States the list of:

• applications received for EC type-examination,

• EC type-approval certificates issued,

• applications for type-certificates refused,

• additions and amendments relating to documents already issued.

Each notified body shall moreover inform all the Member States forthwith of withdrawals of EC type-approval certificates.

Each Member State shall make this information available to the bodies which it has notified.

1.6. The other notified bodies may receive a copy of the certificates together with the annexes to them.

1.7. The applicant shall keep the notified body that has issued the EC type-approval certificate informed of any modification to the approved type.

Modifications to the approved type must receive additional approval from the notified body that issued the EC type-approval certificate where such changes influence conformity with the essential requirements of this Directive or the prescribed conditions for use of the instrument. This additional approval is given in the form of an addition to the original EC type-approval certificate.