Module F
Conformity to type based on product verification
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 his 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 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 approved type described in the EC-type examination certificate and
with the requirements of the legislative instrument 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 legislative instrument.
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 appropriate tests set out in the relevant harmonised standard(s) and/or
technical specifications, or equivalent tests, shall be carried out in order to verify conformity with the approved type
described in the EC-type examination certificate and with the appropriate requirements of the legislative instrument.
In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be
carried out.
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
10 years after the product has been placed on the market.
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 his products for verification in the form of homogeneous lots.
5.2. A random sample shall be taken from each lot according to the requirements of the legislative instrument. All
products in a sample shall be individually examined and appropriate tests set out in the relevant harmonised standard(
s) and/or technical specifications, or equivalent tests, shall be carried out in order to ensure their conformity with
the applicable requirements of the legislative instrument and to determine whether the lot is accepted or rejected. In
the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be
carried out.
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 to 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 10 years after
the product has been placed on the market.
5.4. If a lot is rejected, the notified body or the competent authority shall take appropriate measures to prevent that lot's
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 required conformity marking set out in the legislative instrument, 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 satisfies the
applicable requirements of the legislative instrument.
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 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.
If the notified body referred to in point 3 agrees and under its responsibility, the manufacturer may also affix the
notified body's identification number to the products.
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 his authorised representative, on his behalf and under his
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.
