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, 5.1 and 6, and ensures and declares on its 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 EC type-examination certificate and that they satisfy the requirements of the international instruments that apply to them.
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 EC type-examination certificate and with the requirements of the international instruments that apply to them.
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 EC type-examination certificate and with the appropriate requirements of the international instruments.
The examinations and tests to check the conformity of the products with the appropriate requirements shall be carried out, at the choice of the manufacturer, either by examination and testing of every product as specified in point 4 or by examination and testing of the products on a statistical basis as specified in point 5.
4. Verification of conformity by examination and testing of every product
4.1. All products shall be individually examined and tested in accordance with this Directive, in order to verify conformity with the approved type described in the EC type-examination certificate and with the appropriate requirements of the international instruments.
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 at least 10 years after the wheel mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned.
5. Statistical verification of conformity
5.1. The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced, and shall present its products for verification in the form of homogeneous lots.
5.2. A random sample shall be taken from each lot. All products in a sample shall be individually examined and tested in accordance with this Directive, in order to ensure their conformity with the applicable requirements of the international instruments and to determine whether the lot is accepted or rejected.
5.3. If a lot is accepted, all products of the lot shall be considered approved, except for those products from the sample that have been found not to satisfy the tests. 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 at the disposal of the national authorities for at least 10 years after the wheel mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned.
5.4. If a lot is rejected, the notified body or the competent authority shall take appropriate measures to prevent that lot being placed on the market. In the event of the frequent rejection of lots, the notified body may suspend the statistical verification and take appropriate measures.
6. Conformity marking and declaration of conformity
6.1. The manufacturer shall affix the wheel mark referred to in Article 9, and, under the responsibility of the notified body referred to in point 3, the latter’s identification number to each individual product that is in conformity with the approved type described in the EC type-examination certificate and that satisfies the applicable requirements of the international instruments.
6.2. The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for at least 10 years after the wheel mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned. The declaration of conformity shall identify the marine equipment model for which it has been drawn up.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
7. 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.
8. Authorised representative
The manufacturer’s obligations may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer’s obligations set out in points 2 and 5.1.