2012.10.31 Role of Authorised Representative in different Directives
EMC Directive 2002/108/EC Article 9
2. Each apparatus shall be accompanied by the name and address of the manufacturer and, if he is not established
within the Community, the name and address of his authorised representative or of the person in the Community
responsible for placing the apparatus on the Community market.
If there is an authorised representative, their name must appear on the DOC.
EMC duties of an authorised representative
Article 8
‘CE’ marking
1. Apparatus whose compliance with this Directive has been established by means of the procedure laid down in
Article 7 shall bear the ‘CE’ marking which attests to that fact. The affixing of the ‘CE’ marking shall be the
responsibility of the manufacturer or his authorised representative in the Community.
The ‘CE’ marking shall be affixed in accordance with Annex V.
4. Without prejudice to Article 10, if a competent authority establishes that the ‘CE’ marking has been unduly
affixed, the manufacturer or his authorised representative in the Community shall bring the apparatus into
conformity with the provisions concerning the ‘CE’ marking under conditions imposed by the Member State
concerned.
Article 11
Decisions to withdraw, prohibit or restrict the free movement
of apparatus
2. In the event of a decision as referred to in paragraph 1,
the manufacturer, his authorised representative, or any other
interested party shall have the opportunity to put forward his
point of view in advance, unless such consultation is not
possible because of the urgency of the measure to be taken as
justified in particular with respect to public interest requirements.
ANNEX II
CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 7
(internal production control)
4. The manufacturer or his authorised representative in the Community shall hold the technical documentation at the
disposal of the competent authorities for at least ten years after the date on which such apparatus was last manufactured.
5. The compliance of apparatus with all relevant essential requirements shall be attested by an EC declaration of conformity
issued by the manufacturer or his authorised representative in the Community.
6. The manufacturer or his authorised representative in the Community shall hold the EC declaration of conformity at
the disposal of the competent authorities for a period of at least ten years after the date on which such apparatus
was last manufactured.
EU EMC Guide Feb 2010
For EMC Directive Notified Body role is optional
Article 7
Conformity assessment procedure for apparatus
Compliance of apparatus with the essential requirements referred to in Annex I shall be demonstrated by means of
the procedure described in Annex II (internal production control). However, at the discretion of the manufacturer or
of his authorised representative in the Community, the procedure described in Annex III may also be followed.
ANNEX III
CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 7
1. This procedure consists of applying Annex II, completed as follows:
2. The manufacturer or his authorised representative in the Community shall present the technical documentation to
the notified body referred to in Article 12 and request the notified body for an assessment thereof. The manufacturer
or his authorised representative in the Community shall specify to the notified body which aspects of the essential
requirements must be assessed by the notified body.
3. The notified body shall review the technical documentation and assess whether the technical documentation properly
demonstrates that the requirements of the Directive that it is to assess have been met. If the compliance of the apparatus
is confirmed, the notified body shall issue a statement to the manufacturer or his authorised representative in
the Community confirming the compliance of the apparatus. That statement shall be limited to those aspects of the
essential requirements which have been assessed by the notified body.
4. The manufacturer shall add the statement of the notified body to the technical documentation.
It has been agreed amongst the UK Association of Notified Bodies for Machinery that it is not appropriate for
Notified Body which certifies or provides a Notified Body report or opinion on conformity for a product, to also act as
the Authorised Representative, because that presents a conflict of interest and would not be in accordance with the
requirements for impartiality in accreditation standards.
A Notified Body could act as authorised representative for a product in which it has no other interest.
It has also been agreed that a Notified Body which has certified a product can also act as the person established
within the EU authorised to compile the Technical File at the request of EU enforcement authorities as defined in
Machinery Directive 2006/42/EC. This does not present a conflict of interest, because the NB has duty to hold a
copy of the technical file on which certification and role does not involve any commercial interest in the product,
merely a duty ot be able to compile the technical file.
Blue Guide
3.2. Authorised representative
_ The
manufacturer may appoint any natural or legal person to
act on his behalf as an authorised representative (55).
_ For the purposes of New Approach directives the authorised
representative must be established inside the Community.
_ The authorised representative is explicitly designated by
the manufacturer, and he may be addressed by the authorities
of the Member States instead of the manufacturer with regard
to the latter’s obligations under the New Approach directive in
question.
_ The manufacturer remains generally responsible for actions
carried out by an authorised representative on his behalf.
The manufacturer may be based in the Community or elsewhere. In either case, the manufacturer may appoint an authorised
representative in the Community to act on his behalf in carrying out certain tasks required in the applicable directives. However,
a manufacturer established outside the Community is not obliged to have an authorised representative, although this may present some
advantages (56).
For the purposes of New Approach directives, to be able to act on behalf of the manufacturer, the authorised representative must be
established inside the Community. Commercial representatives of the manufacturer (such as authorised distributors), whether or not
established inside the Community, are not to be confused with the authorised representative in the meaning of New Approach directives.
The delegation of tasks from the manufacturer to the authorised representative must be explicit and should take place in writing, in
particular to define the contents of the tasks and the limits of the representative’s powers. Depending on the conformity assessment
procedure and the directive in question, the authorised representative can, for instance, be appointed to ensure and declare that the
product complies with the requirements, to affix the CE marking and the notified body’s number to the product, to draw up and sign the
EC declaration of conformity, or to keep the declaration and the technical documentation at the disposal of national surveillance
authorities (57).
The tasks that may be delegated to the authorised representative according to the directives are of an administrative nature. Thus, the
manufacturer may neither delegate the measures necessary to ensure that the manufacturing process assures compliance of the
products nor the setting up of a technical documentation, unless otherwise provided for. Further, an authorised representative cannot
modify the product on his own initiative in order to bring it into line with the applicable directives. The authorised representative can, at
the same time, act as a subcontractor. Accordingly, as a subcontractor he may, for instance, take part in the design and manufacture
of the product, on condition that the manufacturer retains the overall control for the product to fulfil his responsibility regarding its
compliance with the provisions of the applicable directives. The authorised representative can also at the same time act as an importer or
a person responsible for placing on the market in the meaning of New Approach directives. His responsibilities are extended accordingly
(58).
(56) As an exception, according to the Directives on medical devices (as regards certain types of devices) and in vitro diagnostic medical devices the
manufacturer must
designate a person
who is established in
the Community to be
responsible for the
marketing of medical
devices, if he does not
have a registered place
of business in a
Member State and he
places devices on the
Community market
under his own name.