Module G
Conformity based on unit verification
1. Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the
obligations laid down in points 2, 3 and 5, and ensures and declares on his sole responsibility that the product
concerned, which has been subject to the provisions of point 4, is in conformity with the requirements of the
legislative instrument that apply to it.
2. Technical documentation
The manufacturer shall establish the technical documentation and make it available to the notified body referred to in
point 4. 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 product with the applicable requirements of the legislative instrument.
4. Verification
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant
harmonised standards and/or technical specifications, or equivalent tests, to check the conformity of the product with
the applicable requirements of the legislative instrument, or have them carried out. 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.
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 the 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. Conformity marking and declaration of conformity
5.1. 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 4, the latter's identification number to each product that
satisfies the applicable requirements of the legislative instrument.
5.2. The manufacturer shall draw up a written declaration of conformity 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 for which it has been drawn up.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
6. Authorised representative
The manufacturer's obligations set out in points 2 and 5 may be fulfilled by his authorised representative, on his behalf
and under his responsibility, provided that they are specified in the mandate.
