Module C2

1.

Conformity to type based on internal production control plus supervised product checks at random intervals is the part of the conformity assessment procedure whereby the manufacturer fulfills the obligations laid down in points 2, 3, and 4, and, under his sole responsibility, guarantees and declares that the products in question are in conformity with the type described in the EC-type examination certificate and meet the requirements of the legislative instrument applicable to them.

2.

The manufacturer shall take all necessary measures to ensure that the manufacturing process and its control ensure the conformity of the manufactured products with the type described in the EC-type examination certificate and with the requirements of the specific legal instrument applicable to them.

3.

At the manufacturer’s discretion, either an accredited in-house body or a notified body selected by the manufacturer shall carry out or have carried out product inspections at random intervals determined by the manufacturer to verify the quality of the internal product inspections, taking into account, among other things, the technological complexity of the products and the quantity produced. Prior to placing the product on the market, the notified body shall take an appropriate sample of the finished products directly on site, which must be examined and subjected to the appropriate tests set out in the relevant parts of the harmonized standards or technical specifications, or equivalent tests, to verify the product’s conformity with the relevant requirements of the legal instrument. If the sample does not meet an acceptable level of quality, the body shall take appropriate measures.

The procedure for determining the acceptability of samples to be used shall be designed to verify that the manufacturing process for the product in question is operating within acceptable limits to ensure product conformity.

Where the notified body carries out the tests, the manufacturer shall, during the manufacturing process, affix the notified body’s identification number to the products under the responsibility of the notified body.

4.

5.

The manufacturer’s obligations set forth in Section 4 may be fulfilled on the manufacturer’s behalf and under the manufacturer’s responsibility by an authorized representative, provided that they are specified in the mandate.