Module C2
Conformity to type based on internal production control plus supervised product checks at random
intervals
1. Conformity to type based on internal production control plus supervised product checks at random intervals is the
part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3
and 4, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type
described in the EC-type examination certificate and satisfy the requirements of the legislative instrument 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 type described in the EC-type examination certificate and with the
requirements of the specific legislative instrument that apply to them.
3. Product checks
At the choice of the manufacturer, either an accredited in-house body or a notified body, chosen by the manufacturer,
shall carry out product checks or have them carried out at random intervals determined by the body, in order to verify
the quality of the internal checks on the product, taking into account, inter alia, the technological complexity of the
products and the quantity of production. An adequate sample of the final products, taken on site by the notified body
before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the
harmonised standards and/or technical specifications, or equivalent tests, shall be carried out to check the conformity
of the product with the relevant requirements of the legislative instrument. Where a sample does not conform to the
acceptable quality level, the body shall take appropriate measures.
The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the
product performs within acceptable limits, with a view to ensuring conformity of the product.
Where the tests are carried out by notified body, the manufacturer shall, under the responsibility of the notified body,
affix the notified body's identification number during the manufacturing process.
4. Conformity marking and declaration of conformity
4.1. The manufacturer shall affix the required conformity marking set out in the legislative instrument to each individual
product that is in conformity with the type described in the EC-type examination certificate and satisfies the applicable
requirements of the legislative instrument.
4.2. The manufacturer shall draw up a written declaration of conformity for a product model and keep it at the disposal of
the national authorities for 10 years after the product has been placed on the market. The declaration of conformity
shall identify the product 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.
5. Authorised representative
The manufacturer's obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and
under his responsibility, provided that they are specified in the mandate.
