Module B
EC-type examination
1. EC-type examination is the part of a conformity assessment procedure in which a notified body examines the technical
design of a product and verifies and attests that the technical design of the product meets the requirements of the
legislative instrument that apply to it.
2. EC-type examination may be carried out in either of the following manners:
— examination of a specimen, representative of the production envisaged, of the complete product (production
type),
— assessment of the adequacy of the technical design of the product through examination of the technical
documentation and supporting evidence referred to in point 3, plus examination of specimens, representative of
the production envisaged, of one or more critical parts of the product (combination of production type and
design type),
— assessment of the adequacy of the technical design of the product through examination of the technical
documentation and supporting evidence referred to in point 3, without examination of a specimen (design
type).
3. The manufacturer shall lodge an application for EC-type examination with a single notified body of his choice.
The application shall include:
— the name and address of the manufacturer and, if the application is lodged by the authorised representative, his
name and address as well,
— a written declaration that the same application has not been lodged with any other notified body,
— the technical documentation. The technical documentation shall make it possible to assess the product's
conformity with the applicable requirements of the legislative instrument 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 contain, wherever applicable, 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 specimens representative of the production envisaged. The notified body may request further specimens if
needed for carrying out the test programme,
— the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall
mention any documents that have been used, in particular where the relevant harmonised standards and/or
technical specifications have not been applied in full. The supporting evidence shall include, where necessary,
the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing
laboratory on his behalf and under his responsibility.
4. The notified body shall:
For the product:
4.1. examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the
product;
For the specimen(s):
4.2. verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the
elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards
and/or technical specifications, as well as the elements which have been designed without applying the relevant
provisions of those standards;
4.3. carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has
chosen to apply the solutions in the relevant harmonised standards and/or technical specifications, these have been
applied correctly;
4.4. carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the
relevant harmonised standards and/or technical specifications have not been applied, the solutions adopted by the
manufacturer meet the corresponding essential requirements of the legislative instrument;
4.5. agree with the manufacturer on a location where the examinations and tests will be carried out.
5. The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4
and their outcomes. Without prejudice to its obligations vis-à vis the notifying authorities, the notified body shall
release the content of that report, in full or in part, only with the agreement of the manufacturer.
6. Where the type meets the requirements of the specific legislative instrument that apply to the product concerned, the
notified body shall issue an EC-type examination certificate to the manufacturer. The certificate shall contain the name
and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the
necessary data for identification of the approved type. The certificate may have one or more annexes attached.
The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured products
with the examined type to be evaluated and to allow for in-service control.
Where the type does not satisfy the applicable requirements of the legislative instrument, the notified body shall refuse
to issue an EC-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its
refusal.
7. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which
indicate that the approved type may no longer comply with the applicable requirements of the legislative instrument,
and shall determine whether such changes require further investigation. If so, the notified body shall inform the
manufacturer accordingly.
The manufacturer shall inform the notified body that holds the technical documentation relating to the EC-type
examination certificate of all modifications to the approved type that may affect the conformity of the product with
the essential requirements of the legislative instrument or the conditions for validity of the certificate. Such
modifications shall require additional approval in the form of an addition to the original EC-type examination
certificate.
8. Each notified body shall inform its notifying authorities concerning the EC-type examination certificates and/or any
additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its
notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.
Each notified body shall inform the other notified bodies concerning the EC-type examination certificates and/or any
additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning
the certificates and/or additions thereto which it has issued.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC-type
examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a
copy of the technical documentation and the results of the examinations carried out by the notified body. The notified
body shall keep a copy of the EC-type examination certificate, its annexes and additions, as well as the technical file
including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.
L 218/102 EN Official Journal of the European Union 13.8.2008
9. The manufacturer shall keep a copy of the EC-type examination certificate, its annexes and additions together with the
technical documentation at the disposal of the national authorities for 10 years after the product has been placed on
the market.
10. The manufacturer's authorised representative may lodge the application referred to in point 3 and fulfil the obligations
set out in points 7 and 9, provided that they are specified in the mandate.
