Module F1
Conformity based on product verification
1. Conformity based on product verification is the conformity assessment procedure whereby the manufacturer fulfils
the obligations laid down in points 2, 3, 6.1 and 7 and ensures and declares on his sole responsibility that the
products concerned, which have been subject to the provisions of point 4, are in conformity with the requirements of
the legislative instrument that apply to them.
2. Technical documentation
The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the
product's conformity with the relevant requirements, and shall include an adequate analysis and assessment of the
risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the
assessment, the design, manufacture and operation of the product. The technical documentation shall, wherever
applicable, contain at least the following elements:
— a general description of the product,
— conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
— descriptions and explanations necessary for the understanding of those drawings and schemes and the operation
of the product,
— a list of the harmonised standards and/or other relevant technical specifications the references of which have
been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the
solutions adopted to meet the essential requirements of the legislative instrument where those harmonised
standards have not been applied. In the event of partly applied harmonised standards, the technical
documentation shall specify the parts which have been applied,
— results of design calculations made, examinations carried out, etc., and
— test reports.
The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for
10 years after the product has been placed on the market.
3. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure
conformity of the manufactured products with the applicable requirements of the legislative instrument.
4. Verification
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests to check the
conformity of the products with the applicable requirements of the legislative instrument.
The examinations and tests to check the conformity with those requirements shall be carried out, at the choice of the
manufacturer, either by examination and testing of every product as specified in point 5, or by examination and
testing of the products on a statistical basis as specified in point 6.
5. Verification of conformity by examination and testing of every product
5.1. All products shall be individually examined and appropriate tests, set out in the relevant harmonised standards and/or
technical specifications, or equivalent tests, shall be carried out to verify conformity with the requirements that apply
to them. In the absence of such a harmonised standard and/or technical specification the notified body concerned
shall decide on the appropriate tests to be carried out.
5.2. 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 at the disposal of the national authorities for 10 years after
the product has been placed on the market.
6. Statistical verification of conformity
6.1. The manufacturer shall take all measures necessary so that the manufacturing process ensures the homogeneity of
each lot produced, and shall present his products for verification in the form of homogeneous lots.
6.2. A random sample shall be taken from each lot according to the requirements of the legislative instrument. All
products in the sample shall be individually examined and appropriate tests set out in the relevant harmonised
standards and/or technical specifications, or equivalent tests, to establish conformity with the requirements that apply
to them, shall be carried out to determine whether the lot is accepted or rejected. In the absence of such a harmonised
standard and/or technical specification the notified body concerned shall decide on the appropriate tests to be carried
out.
6.3. 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 10 years after
the product has been placed on the market.
If a lot is rejected, the notified body 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.
7. Conformity marking and declaration of conformity
7.1. The manufacturer shall affix the conformity marking set out in the legislative instrument, and, under the responsibility
of the notified body referred to in point 4, the latter's identification number to each individual product that satisfies
the applicable requirements of the legislative instrument.
7.2. 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 5 agrees and under its responsibility, the manufacturer may also affix the
notified body's identification number to the products.
8. 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.
9. 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 3 and 6.1.
