ELECTROMAGNETIC COMPATIBILITY

(EMC) DIRECTIVE (2014/30/EU)

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 02014L0030 — EN — 11.09.2018 — 001.001 — 1

This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability
for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official
Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links
embedded in this document

►B DIRECTIVE 2014/30/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 26 February 2014
on the harmonisation of the laws of the Member States relating to electromagnetic compatibility
(recast)
(Text with EEA relevance)
(OJ L 96, 29.3.2014, p. 79)

Amended by:

Official Journal

No page date
►M1 Regulation (EU) 2018/1139 of the European Parliament and of the L 212 1 22.8.2018
Council of 4 July 2018
 02014L0030 — EN — 11.09.2018 — 001.001 — 2

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DIRECTIVE 2014/30/EU OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
of 26 February 2014
on the harmonisation of the laws of the Member States relating to
electromagnetic compatibility (recast)
(Text with EEA relevance)

CHAPTER 1

GENERAL PROVISIONS

Article 1
Subject matter

This Directive regulates the electromagnetic compatibility of equipment.

It aims to ensure the functioning of the internal market by requiring
equipment to comply with an adequate level of electromagnetic
compatibility.

Article 2
Scope

1. This Directive shall apply to equipment as defined in Article 3.

2. This Directive shall not apply to:

(a) equipment covered by Directive 1999/5/EC;

▼M1
(b) the following aviation equipment, where that equipment falls within
the scope of Regulation (EU) 2018/1139 of the European
Parliament and of the Council (1) and is intended exclusively for
airborne use:

(i) aircraft, other than unmanned aircraft, as well as associated

engines, propellers, parts and non-installed equipment;

(ii) unmanned aircraft, as well as associated engines, propellers,

parts and non-installed equipment, the design of which is
certified in accordance with Article 56(1) of that Regulation
which are intended to operate only on frequencies allocated
by the Radio Regulations of the International Telecommuni­
cations Union for protected aeronautical use;

(1) Regulation (EU) 2018/1139 of the European Parliament and of the Council of
4 July 2018 on common rules in the field of civil aviation and establishing a
European Union Aviation Safety Agency, and amending Regulations (EC)
No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014
and Directives 2014/30/EU and 2014/53/EU of the European Parliament and
of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No
216/2008 of the European Parliament and of the Council and Council Regu­
lation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1).
 02014L0030 — EN — 11.09.2018 — 001.001 — 3

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(c) radio equipment used by radio amateurs within the meaning of the
Radio Regulations adopted in the framework of the Constitution of
the International Telecommunication Union and the Convention of
the International Telecommunication Union (1), unless the
equipment is made available on the market;

(d) equipment the inherent nature of the physical characteristics of

which is such that:

(i) it is incapable of generating or contributing to electromagnetic

emissions which exceed a level allowing radio and telecom­
munication equipment and other equipment to operate as
intended; and

(ii) it operates without unacceptable degradation in the presence of

the electromagnetic disturbance normally consequent upon its
intended use;

(e) custom built evaluation kits destined for professionals to be used

solely at research and development facilities for such purposes.

For the purposes of point (c) of the first subparagraph, kits of

components to be assembled by radio amateurs and equipment made
available on the market and modified by and for the use of radio
amateurs are not regarded as equipment made available on the market.

3. Where, for the equipment referred to in paragraph 1, the essential

requirements set out in Annex I are wholly or partly laid down more
specifically by other Union legislation, this Directive shall not apply, or
shall cease to apply, to that equipment in respect of such requirements
from the date of implementation of that Union legislation.

4. This Directive shall not affect the application of Union or national

legislation regulating the safety of equipment.

Article 3
Definitions

1. For the purposes of this Directive, the following definitions shall

apply:

(1) ‘equipment’ means any apparatus or fixed installation;

(2) ‘apparatus’ means any finished appliance or combination thereof

made available on the market as a single functional unit, intended
for the end-user and liable to generate electromagnetic disturbance,
or the performance of which is liable to be affected by such
disturbance;

(3) ‘fixed installation’ means a particular combination of several types

of apparatus and, where applicable, other devices, which are
assembled, installed and intended to be used permanently at a
predefined location;

(4) ‘electromagnetic compatibility’ means the ability of equipment to

function satisfactorily in its electromagnetic environment without
introducing intolerable electromagnetic disturbances to other
equipment in that environment;

(1) Constitution and Convention of the International Telecommunication Union

adopted by the Additional Plenipotentiary Conference (Geneva, 1992) as
amended by the Plenipotentiary Conference (Kyoto, 1994).
 02014L0030 — EN — 11.09.2018 — 001.001 — 4

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(5) ‘electromagnetic disturbance’ means any electromagnetic
phenomenon which may degrade the performance of equipment;
an electromagnetic disturbance may be electromagnetic noise, an
unwanted signal or a change in the propagation medium itself;

(6) ‘immunity’ means the ability of equipment to perform as intended

without degradation in the presence of an electromagnetic
disturbance;

(7) ‘safety purposes’ means the purposes of safeguarding human life

or property;

(8) ‘electromagnetic environment’ means all electromagnetic

phenomena observable in a given location;

(9) ‘making available on the market’ means any supply of apparatus

for distribution, consumption or use on the Union market in the
course of a commercial activity, whether in return for payment or
free of charge;

(10) ‘placing on the market’ means the first making available of

apparatus on the Union market;

(11) ‘manufacturer’ means any natural or legal person who manu­

factures apparatus or has apparatus designed or manufactured,
and markets that apparatus under his name or trade mark;

(12) ‘authorised representative’ means any natural or legal person estab­

lished within the Union who has received a written mandate from
a manufacturer to act on his behalf in relation to specified tasks;

(13) ‘importer’ means any natural or legal person established within the
Union who places apparatus from a third country on the Union
market;

(14) ‘distributor’ means any natural or legal person in the supply chain,
other than the manufacturer or the importer, who makes apparatus
available on the market;

(15) ‘economic operators’ means the manufacturer, the authorised

representative, the importer and the distributor;

(16) ‘technical specification’ means a document that prescribes

technical requirements to be fulfilled by the equipment;

(17) ‘harmonised standard’ means harmonised standard as defined in

point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012;

(18) ‘accreditation’ means accreditation as defined in point 10 of

Article 2 of Regulation (EC) No 765/2008;

(19) ‘national accreditation body’ means national accreditation body as

defined in point 11 of Article 2 of Regulation (EC) No 765/2008;

(20) ‘conformity assessment’ means the process demonstrating whether

the essential requirements of this Directive relating to an apparatus
have been fulfilled;

(21) ‘conformity assessment body’ means a body that performs

conformity assessment activities including calibration, testing,
certification and inspection;
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(22) ‘recall’ means any measure aimed at achieving the return of
apparatus that has already been made available to the end-user;

(23) ‘withdrawal’ means any measure aimed at preventing apparatus in

the supply chain from being made available on the market;

(24) ‘Union harmonisation legislation’ means any Union legislation

harmonising the conditions for the marketing of products;

(25) ‘CE marking’ means a marking by which the manufacturer

indicates that the apparatus is in conformity with the applicable
requirements set out in Union harmonisation legislation providing
for its affixing.

2. For the purposes of this Directive, the following shall be

considered as apparatus:

(1) ‘components’ or ‘sub-assemblies’ intended for incorporation into an

apparatus by the end-user, which are liable to generate electrom­
agnetic disturbance, or the performance of which is liable to be
affected by such disturbance;

(2) ‘mobile installations’ defined as a combination of apparatus and,

where applicable, other devices, intended to be moved and
operated in a range of locations.

Article 4
Making available on the market and/or putting into service

Member States shall take all appropriate measures to ensure that

equipment is made available on the market and/or put into service
only if it complies with this Directive when properly installed, main­
tained and used for its intended purpose.

Article 5
Free movement of equipment

1. Member States shall not impede, for reasons relating to electrom­

agnetic compatibility, the making available on the market and/or the
putting into service in their territory of equipment which complies
with this Directive.

2. The requirements of this Directive shall not prevent the application

in any Member State of the following special measures concerning the
putting into service or use of equipment:

(a) measures to overcome an existing or predicted electromagnetic com­

patibility problem at a specific site;

(b) measures taken for safety reasons to protect public telecommuni­

cations networks or receiving or transmitting stations when used for
safety purposes in well-defined spectrum situations.

Without prejudice to Directive 98/34/EC of the European Parliament

and of the Council of 22 June 1998 laying down a procedure for the
provision of information in the field of technical standards and regu­
lations (1), Member States shall notify those special measures to the
Commission and to the other Member States.

(1) OJ L 204, 21.7.1998, p. 37.

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The special measures which have been accepted shall be published by
the Commission in the Official Journal of the European Union.

3. Member States shall not create any obstacles to the display and/or
demonstration at trade fairs, exhibitions or similar events of equipment
which does not comply with this Directive, provided that a visible sign
clearly indicates that such equipment may not be made available on the
market and/or put into service until it has been brought into conformity
with this Directive. Demonstration may only take place provided that
adequate measures have been taken to avoid electromagnetic disturb­
ances.

Article 6
Essential requirements

The equipment shall meet the essential requirements set out in Annex I.

CHAPTER 2

OBLIGATIONS OF ECONOMIC OPERATORS

Article 7
Obligations of manufacturers

1. When placing their apparatus on the market, manufacturers shall

ensure that they have been designed and manufactured in accordance
with the essential requirements set out in Annex I.

2. Manufacturers shall draw up the technical documentation referred

to in Annex II or Annex III and carry out the relevant conformity
assessment procedure referred to in Article 14 or have it carried out.

Where compliance of apparatus with the applicable requirements has

been demonstrated by that procedure, manufacturers shall draw up an
EU declaration of conformity and affix the CE marking.

3. Manufacturers shall keep the technical documentation and the EU

declaration of conformity for 10 years after the apparatus has been
placed on the market.

4. Manufacturers shall ensure that procedures are in place for series

production to remain in conformity with this Directive. Changes in
apparatus design or characteristics and changes in the harmonised
standards or in other technical specifications by reference to which
conformity of apparatus is declared shall be adequately taken into
account.

5. Manufacturers shall ensure that apparatus which they have placed

on the market bear a type, batch or serial number or other element
allowing their identification, or, where the size or nature of the
apparatus does not allow it, that the required information is provided
on the packaging or in a document accompanying the apparatus.

6. Manufacturers shall indicate, on the apparatus, their name,

registered trade name or registered trade mark and the postal address
at which they can be contacted or, where that is not possible, on its
packaging or in a document accompanying the apparatus. The address
shall indicate a single point at which the manufacturer can be contacted.
The contact details shall be in a language easily understood by end-
users and market surveillance authorities.
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7. Manufacturers shall ensure that the apparatus is accompanied by
instructions and the information referred to in Article 18 in a language
which can be easily understood by consumers and other end-users, as
determined by the Member State concerned. Such instructions and
information, as well as any labelling, shall be clear, understandable
and intelligible.

8. Manufacturers who consider or have reason to believe that an

apparatus which they have placed on the market is not in conformity
with this Directive shall immediately take the corrective measures
necessary to bring that apparatus into conformity, to withdraw it or
recall it, if appropriate. Furthermore, where the apparatus presents a
risk, manufacturers shall immediately inform the competent national
authorities of the Member States in which they made the apparatus
available on the market to that effect, giving details, in particular, of
the non-compliance and of any corrective measures taken.

9. Manufacturers shall, further to a reasoned request from a

competent national authority, provide it with all the information and
documentation in paper or electronic form necessary to demonstrate
the conformity of the apparatus with this Directive, in a language
which can be easily understood by that authority. They shall
cooperate with that authority, at its request, on any action taken to
eliminate the risks posed by apparatus which they have placed on the
market.

Article 8
Authorised representatives

1. A manufacturer may, by a written mandate, appoint an authorised

representative.

The obligations laid down in Article 7(1) and the obligation to draw up
technical documentation referred to in Article 7(2) shall not form part of
the authorised representative’s mandate.

2. An authorised representative shall perform the tasks specified in

the mandate received from the manufacturer. The mandate shall allow
the authorised representative to do at least the following:

(a) keep the EU declaration of conformity and the technical documen­

tation at the disposal of national market surveillance authorities for
10 years after the apparatus has been placed on the market;

(b) further to a reasoned request from a competent national authority,

provide that authority with all the information and documentation
necessary to demonstrate the conformity of the apparatus;

(c) cooperate with the competent national authorities, at their request,

on any action taken to eliminate the risks posed by the apparatus
covered by the authorised representative’s mandate.

Article 9
Obligations of importers

1. Importers shall place only compliant apparatus on the market.

2. Before placing apparatus on the market importers shall ensure that

the appropriate conformity assessment procedure referred to in Article 14
has been carried out by the manufacturer. They shall ensure that the
 02014L0030 — EN — 11.09.2018 — 001.001 — 8

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manufacturer has drawn up the technical documentation, that the
apparatus bears the CE marking and is accompanied by the required
documents, and that the manufacturer has complied with the
requirements set out in Article 7(5) and (6).

Where an importer considers or has reason to believe that apparatus is

not in conformity with the essential requirements set out in Annex I, he
shall not place the apparatus on the market until it has been brought into
conformity. Furthermore, where the apparatus presents a risk, the
importer shall inform the manufacturer and the market surveillance
authorities to that effect.

3. Importers shall indicate on the apparatus their name, registered

trade name or registered trade mark and the postal address at which
they can be contacted or, where that is not possible, on its packaging or
in a document accompanying the apparatus. The contact details shall be
in a language easily understood by end-users and market surveillance
authorities.

4. Importers shall ensure that the apparatus is accompanied by

instructions and the information referred to in Article 18 in a
language which can be easily understood by consumers and other
end-users, as determined by the Member State concerned.

5. Importers shall ensure that, while an apparatus is under their

responsibility, its storage or transport conditions do not jeopardise its
compliance with the essential requirements set out in Annex I.

6. Importers who consider or have reason to believe that an apparatus

which they have placed on the market is not in conformity with this
Directive shall immediately take the corrective measures necessary to
bring that apparatus into conformity, to withdraw it or recall it, if
appropriate. Furthermore, where the apparatus presents a risk,
importers shall immediately inform the competent national authorities
of the Member States in which they made the apparatus available on the
market to that effect, giving details, in particular, of the non-compliance
and of any corrective measures taken.

7. Importers shall, for 10 years after the apparatus has been placed on
the market, keep a copy of the EU declaration of conformity at the
disposal of the market surveillance authorities and ensure that the
technical documentation can be made available to those authorities,
upon request.

8. Importers shall, further to a reasoned request from a competent

national authority, provide it with all the information and documentation
in paper or electronic form, necessary to demonstrate the conformity of
apparatus in a language which can be easily understood by that auth­
ority. They shall cooperate with that authority, at its request, on any
action taken to eliminate the risks posed by apparatus which they have
placed on the market.

Article 10
Obligations of distributors

1. When making apparatus available on the market distributors shall

act with due care in relation to the requirements of this Directive.

2. Before making apparatus available on the market distributors shall

verify that the apparatus bears the CE marking, that it is accompanied
by the required documents and by instructions and the information
referred to in Article 18 in a language which can be easily understood
 02014L0030 — EN — 11.09.2018 — 001.001 — 9

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by consumers and other end-users in the Member State in which the
apparatus is to be made available on the market and that the manu­
facturer and the importer have complied with the requirements set out in
Article 7(5) and (6) and Article 9(3) respectively.

Where a distributor considers or has reason to believe that apparatus is

not in conformity with the essential requirements set out in Annex I, he
shall not make the apparatus available on the market until it has been
brought into conformity. Furthermore, where the apparatus presents a
risk, the distributor shall inform the manufacturer or the importer to that
effect as well as the market surveillance authorities.

3. Distributors shall ensure that, while apparatus is under their

responsibility, its storage or transport conditions do not jeopardise its
compliance with the essential requirements set out in Annex I.

4. Distributors who consider or have reason to believe that apparatus

which they have made available on the market is not in conformity with
this Directive shall make sure that the corrective measures necessary to
bring that apparatus into conformity, to withdraw it or recall it, if
appropriate, are taken. Furthermore, where the apparatus presents a
risk, distributors shall immediately inform the competent national auth­
orities of the Member States in which they made the apparatus available
on the market to that effect, giving details, in particular, of the non-
compliance and of any corrective measures taken.

5. Distributors shall, further to a reasoned request from a competent

national authority, provide it with all the information and documentation
in paper or electronic form, necessary to demonstrate the conformity of
the apparatus. They shall cooperate with that authority, at its request, on
any action taken to eliminate the risks posed by apparatus which they
have made available on the market.

Article 11
Cases in which obligations of manufacturers apply to importers and
distributors

An importer or distributor shall be considered a manufacturer for the

purposes of this Directive and he shall be subject to the obligations of
the manufacturer under Article 7, where he places apparatus on the
market under his name or trade mark or modifies apparatus already
placed on the market in such a way that compliance with this
Directive may be affected.

Article 12
Identification of economic operators

Economic operators shall, on request, identify the following to the

market surveillance authorities:

(a) any economic operator who has supplied them with apparatus;

(b) any economic operator to whom they have supplied apparatus.

Economic operators shall be able to present the information referred to

in the first paragraph for 10 years after they have been supplied with the
apparatus and for 10 years after they have supplied the apparatus.
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CHAPTER 3

CONFORMITY OF EQUIPMENT

Article 13
Presumption of conformity of equipment

Equipment which is in conformity with harmonised standards or parts

thereof the references of which have been published in the Official
Journal of the European Union shall be presumed to be in conformity
with the essential requirements set out in Annex I covered by those
standards or parts thereof.

Article 14
Conformity assessment procedures for apparatus

Compliance of apparatus with the essential requirements set out in

Annex I shall be demonstrated by means of either of the following
conformity assessment procedures:

(a) internal production control set out in Annex II;

(b) EU type examination that is followed by Conformity to type based

on internal production control set out in Annex III.

The manufacturer may choose to restrict the application of the

procedure referred to in point (b) of the first paragraph to some
aspects of the essential requirements, provided that for the other
aspects of the essential requirements the procedure referred to in point
(a) of the first paragraph is applied.

Article 15
EU declaration of conformity

1. The EU declaration of conformity shall state that the fulfilment of

the essential requirements set out in Annex I has been demonstrated.

2. The EU declaration of conformity shall have the model structure

set out in Annex IV, shall contain the elements specified in the relevant
modules set out in Annexes II and III and shall be continuously
updated. It shall be translated into the language or languages required
by the Member State in which the apparatus is placed or made available
on the market.

3. Where apparatus is subject to more than one Union act requiring

an EU declaration of conformity, a single EU declaration of conformity
shall be drawn up in respect of all such Union acts. That declaration
shall contain the identification of the Union acts concerned including
their publication references.

4. By drawing up the EU declaration of conformity, the manufacturer

shall assume responsibility for the compliance of the apparatus with the
requirements laid down in this Directive.

Article 16
General principles of the CE marking

The CE marking shall be subject to the general principles set out in

Article 30 of Regulation (EC) No 765/2008.
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Article 17
Rules and conditions for affixing the CE marking

1. The CE marking shall be affixed visibly, legibly and indelibly to

the apparatus or to its data plate. Where that is not possible or not
warranted on account of the nature of the apparatus, it shall be
affixed to the packaging and to the accompanying documents.

2. The CE marking shall be affixed before the apparatus is placed on

the market.

3. Member States shall build upon existing mechanisms to ensure

correct application of the regime governing the CE marking and shall
take appropriate action in the event of improper use of that marking.

Article 18
Information concerning the use of apparatus

1. Apparatus shall be accompanied by information on any specific

precautions that must be taken when the apparatus is assembled,
installed, maintained or used, in order to ensure that, when put into
service, the apparatus is in conformity with the essential requirements
set out in point 1 of Annex I.

2. Apparatus for which compliance with the essential requirements

set out in point 1 of Annex I is not ensured in residential areas shall be
accompanied by a clear indication of such restriction of use, where
appropriate also on the packaging.

3. The information required to enable apparatus to be used in

accordance with the intended purpose of the apparatus shall be
included in the instructions accompanying the apparatus.

Article 19
Fixed installations

1. Apparatus which has been made available on the market and

which may be incorporated into a fixed installation shall be subject to
all relevant provisions for apparatus set out in this Directive.

However, the requirements of Articles 6 to 12 and Articles 14 to 18

shall not be compulsory in the case of apparatus which is intended for
incorporation into a particular fixed installation and is otherwise not
made available on the market.

In such cases, the accompanying documentation shall identify the fixed

installation and its electromagnetic compatibility characteristics and
shall indicate the precautions to be taken for the incorporation of the
apparatus into the fixed installation in order not to compromise the
conformity of that installation. It shall also include the information
referred to in Article 7(5) and (6) and Article 9(3).

The good engineering practices referred to in point 2 of Annex I shall

be documented and the documentation shall be held by the person or
persons responsible at the disposal of the relevant national authorities
for inspection for as long as the fixed installation is in operation.
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2. Where there are indications of non-compliance of the fixed instal­
lation, in particular, where there are complaints about disturbances being
generated by the installation, the competent authorities of the Member
State concerned may request evidence of compliance of the fixed instal­
lation, and, when appropriate, initiate an evaluation.

Where non-compliance is established, the competent authorities shall

impose appropriate measures to bring the fixed installation into
compliance with the essential requirements set out in Annex I.

3. Member States shall set out the necessary provisions for iden­
tifying the person or persons responsible for the establishment of
compliance of a fixed installation with the relevant essential require­
ments.

CHAPTER 4

NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

Article 20
Notification

Member States shall notify the Commission and the other Member
States of bodies authorised to carry out third-party conformity
assessment tasks under this Directive.

Article 21
Notifying authorities

1. Member States shall designate a notifying authority that shall be

responsible for setting up and carrying out the necessary procedures for
the assessment and notification of conformity assessment bodies and the
monitoring of notified bodies, including compliance with Article 26.

2. Member States may decide that the assessment and monitoring

referred to in paragraph 1 shall be carried out by a national accreditation
body within the meaning of and in accordance with Regulation (EC)
No 765/2008.

3. Where the notifying authority delegates or otherwise entrusts the

assessment, notification or monitoring referred to in paragraph 1 to a
body which is not a governmental entity, that body shall be a legal
entity and shall comply mutatis mutandis with the requirements laid
down in Article 22. In addition it shall have arrangements to cover
liabilities arising out of its activities.

4. The notifying authority shall take full responsibility for the tasks
performed by the body referred to in paragraph 3.

Article 22
Requirements relating to notifying authorities

1. A notifying authority shall be established in such a way that no

conflict of interest with conformity assessment bodies occurs.
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2. A notifying authority shall be organised and operated so as to
safeguard the objectivity and impartiality of its activities.

3. A notifying authority shall be organised in such a way that each

decision relating to notification of a conformity assessment body is
taken by competent persons different from those who carried out the
assessment.

4. A notifying authority shall not offer or provide any activities that

conformity assessment bodies perform or consultancy services on a
commercial or competitive basis.

5. A notifying authority shall safeguard the confidentiality of the

information it obtains.

6. A notifying authority shall have a sufficient number of competent

personnel at its disposal for the proper performance of its tasks.

Article 23
Information obligation on notifying authorities

Member States shall inform the Commission of their procedures for the
assessment and notification of conformity assessment bodies and the
monitoring of notified bodies, and of any changes thereto.

The Commission shall make that information publicly available.

Article 24
Requirements relating to notified bodies

1. For the purposes of notification, a conformity assessment body

shall meet the requirements laid down in paragraphs 2 to 11.

2. A conformity assessment body shall be established under national

law of a Member State and have legal personality.

3. A conformity assessment body shall be a third-party body inde­

pendent of the organisation or the apparatus it assesses.

A body belonging to a business association or professional federation

representing undertakings involved in the design, manufacturing,
provision, assembly, use or maintenance of apparatus which it
assesses, may, on condition that its independence and the absence of
any conflict of interest are demonstrated, be considered such a body.

4. A conformity assessment body, its top level management and the

personnel responsible for carrying out the conformity assessment tasks
shall not be the designer, manufacturer, supplier, installer, purchaser,
owner, user or maintainer of the apparatus which they assess, nor the
representative of any of those parties. This shall not preclude the use of
assessed apparatus that are necessary for the operations of the
conformity assessment body or the use of such apparatus for personal
purposes.

A conformity assessment body, its top level management and the

personnel responsible for carrying out the conformity assessment tasks
shall not be directly involved in the design, manufacture or construction,
the marketing, installation, use or maintenance of those apparatus, or
represent the parties engaged in those activities. They shall not engage
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in any activity that may conflict with their independence of judgement
or integrity in relation to conformity assessment activities for which
they are notified. This shall in particular apply to consultancy services.

Conformity assessment bodies shall ensure that the activities of their

subsidiaries or subcontractors do not affect the confidentiality, objec­
tivity or impartiality of their conformity assessment activities.

5. Conformity assessment bodies and their personnel shall carry out

the conformity assessment activities with the highest degree of profes­
sional integrity and the requisite technical competence in the specific
field and shall be free from all pressures and inducements, particularly
financial, which might influence their judgement or the results of their
conformity assessment activities, especially as regards persons or groups
of persons with an interest in the results of those activities.

6. A conformity assessment body shall be capable of carrying out all

the conformity assessment tasks assigned to it by Annex III and in
relation to which it has been notified, whether those tasks are carried
out by the conformity assessment body itself or on its behalf and under
its responsibility.

At all times and for each conformity assessment procedure and each
kind or category of apparatus in relation to which it has been notified, a
conformity assessment body shall have at its disposal the necessary:

(a) personnel with technical knowledge and sufficient and appropriate

experience to perform the conformity assessment tasks;

(b) descriptions of procedures in accordance with which conformity

assessment is carried out, ensuring the transparency and the
ability of reproduction of those procedures. It shall have appropriate
policies and procedures in place that distinguish between tasks it
carries out as a notified body and other activities;

(c) procedures for the performance of activities which take due account
of the size of an undertaking, the sector in which it operates, its
structure, the degree of complexity of the apparatus technology in
question and the mass or serial nature of the production process.

A conformity assessment body shall have the means necessary to

perform the technical and administrative tasks connected with the
conformity assessment activities in an appropriate manner and shall
have access to all necessary equipment or facilities.

7. The personnel responsible for carrying out conformity assessment

tasks shall have the following:

(a) sound technical and vocational training covering all the conformity
assessment activities in relation to which the conformity assessment
body has been notified;

(b) satisfactory knowledge of the requirements of the assessments they

carry out and adequate authority to carry out those assessments;
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(c) appropriate knowledge and understanding of the essential
requirements set out in Annex I, of the applicable harmonised
standards and of the relevant provisions of Union harmonisation
legislation and of national legislation;

(d) the ability to draw up certificates, records and reports demonstrating

that assessments have been carried out.

8. The impartiality of the conformity assessment bodies, their top

level management and of the personnel responsible for carrying out
the conformity assessment tasks shall be guaranteed.

The remuneration of the top level management and personnel

responsible for carrying out the conformity assessment tasks of a
conformity assessment body shall not depend on the number of
assessments carried out or on the results of those assessments.

9. Conformity assessment bodies shall take out liability insurance

unless liability is assumed by the State in accordance with national
law, or the Member State itself is directly responsible for the conformity
assessment.

10. The personnel of a conformity assessment body shall observe

professional secrecy with regard to all information obtained in
carrying out their tasks under Annex III or any provision of national
law giving effect to it, except in relation to the competent authorities of
the Member State in which its activities are carried out. Proprietary
rights shall be protected.

11. Conformity assessment bodies shall participate in, or ensure that

their personnel responsible for carrying out the conformity assessment
tasks are informed of, the relevant standardisation activities and the
activities of the notified body coordination group established under
the relevant Union harmonisation legislation and shall apply as
general guidance the administrative decisions and documents produced
as a result of the work of that group.

Article 25
Presumption of conformity of notified bodies

Where a conformity assessment body demonstrates its conformity with

the criteria laid down in the relevant harmonised standards or parts
thereof the references of which have been published in the Official
Journal of the European Union it shall be presumed to comply with
the requirements set out in Article 24 in so far as the applicable
harmonised standards cover those requirements.

Article 26
Subsidiaries of and subcontracting by notified bodies

1. Where a notified body subcontracts specific tasks connected with

conformity assessment or has recourse to a subsidiary, it shall ensure
that the subcontractor or the subsidiary meets the requirements set out in
Article 24 and shall inform the notifying authority accordingly.

2. Notified bodies shall take full responsibility for the tasks

performed by subcontractors or subsidiaries wherever these are estab­
lished.
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3. Activities may be subcontracted or carried out by a subsidiary
only with the agreement of the client.

4. Notified bodies shall keep at the disposal of the notifying authority

the relevant documents concerning the assessment of the qualifications
of the subcontractor or the subsidiary and the work carried out by them
under Annex III.

Article 27
Application for notification

1. A conformity assessment body shall submit an application for

notification to the notifying authority of the Member State in which it
is established.

2. The application for notification shall be accompanied by a

description of the conformity assessment activities, the conformity
assessment module or modules and the apparatus for which that body
claims to be competent, as well as by an accreditation certificate, where
one exists, issued by a national accreditation body attesting that the
conformity assessment body fulfils the requirements laid down in
Article 24.

3. Where the conformity assessment body concerned cannot provide

an accreditation certificate, it shall provide the notifying authority with
all the documentary evidence necessary for the verification, recognition
and regular monitoring of its compliance with the requirements laid
down in Article 24.

Article 28
Notification procedure

1. Notifying authorities may notify only conformity assessment

bodies which have satisfied the requirements laid down in Article 24.

2. They shall notify the Commission and the other Member States
using the electronic notification tool developed and managed by the
Commission.

3. The notification shall include full details of the conformity

assessment activities, the conformity assessment module or modules
and apparatus concerned and the relevant attestation of competence.

4. Where a notification is not based on an accreditation certificate as

referred to in Article 27(2), the notifying authority shall provide the
Commission and the other Member States with documentary evidence
which attests to the conformity assessment body’s competence and the
arrangements in place to ensure that that body will be monitored
regularly and will continue to satisfy the requirements laid down in
Article 24.

5. The body concerned may perform the activities of a notified body

only where no objections are raised by the Commission or the other
Member States within two weeks of a notification where an accred­
itation certificate is used or within two months of a notification where
accreditation is not used.

Only such a body shall be considered a notified body for the purposes
of this Directive.
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6. The notifying authority shall notify the Commission and the other
Member States of any subsequent relevant changes to the notification.

Article 29
Identification numbers and lists of notified bodies

1. The Commission shall assign an identification number to a

notified body.

It shall assign a single such number even where the body is notified
under several Union acts.

2. The Commission shall make publicly available the list of the

bodies notified under this Directive, including the identification
numbers that have been assigned to them and the activities for which
they have been notified.

The Commission shall ensure that the list is kept up to date.

Article 30
Changes to notifications

1. Where a notifying authority has ascertained or has been informed

that a notified body no longer meets the requirements laid down in
Article 24, or that it is failing to fulfil its obligations, the notifying
authority shall restrict, suspend or withdraw notification as appropriate,
depending on the seriousness of the failure to meet those requirements
or fulfil those obligations. It shall immediately inform the Commission
and the other Member States accordingly.

2. In the event of restriction, suspension or withdrawal of notifi­

cation, or where the notified body has ceased its activity, the
notifying Member State shall take appropriate steps to ensure that the
files of that body are either processed by another notified body or kept
available for the responsible notifying and market surveillance auth­
orities at their request.

Article 31
Challenge of the competence of notified bodies

1. The Commission shall investigate all cases where it doubts, or

doubt is brought to its attention regarding, the competence of a
notified body or the continued fulfilment by a notified body of the
requirements and responsibilities to which it is subject.

2. The notifying Member State shall provide the Commission, on

request, with all information relating to the basis for the notification
or the maintenance of the competence of the notified body concerned.

3. The Commission shall ensure that all sensitive information

obtained in the course of its investigations is treated confidentially.

4. Where the Commission ascertains that a notified body does not

meet or no longer meets the requirements for its notification, it shall
adopt an implementing act requesting the notifying Member State to
take the necessary corrective measures, including withdrawal of notifi­
cation if necessary.
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That implementing act shall be adopted in accordance with the advisory
procedure referred to in Article 41(2).

Article 32
Operational obligations of notified bodies

1. Notified bodies shall carry out conformity assessments in

accordance with the conformity assessment procedures provided for in
Annex III.

2. Conformity assessments shall be carried out in a proportionate

manner, avoiding unnecessary burdens for economic operators.

Conformity assessment bodies shall perform their activities taking due

account of the size of an undertaking, the sector in which it operates, its
structure, the degree of complexity of the apparatus technology in
question and the mass or serial nature of the production process.

In so doing they shall nevertheless respect the degree of rigour and the
level of protection required for the compliance of the apparatus with this
Directive.

3. Where a notified body finds that the essential requirements set out
in Annex I or corresponding harmonised standards or other technical
specifications have not been met by a manufacturer, it shall require that
manufacturer to take appropriate corrective measures and shall not issue
a certificate.

4. Where, in the course of the monitoring of conformity following

the issue of a certificate, a notified body finds that an apparatus no
longer complies, it shall require the manufacturer to take appropriate
corrective measures and shall suspend or withdraw the certificate if
necessary.

5. Where corrective measures are not taken or do not have the

required effect, the notified body shall restrict, suspend or withdraw
any certificates, as appropriate.

Article 33
Appeal against decisions of notified bodies

Member States shall ensure that an appeal procedure against decisions

of the notified bodies is available.

Article 34
Information obligation on notified bodies

1. Notified bodies shall inform the notifying authority of the

following:

(a) any refusal, restriction, suspension or withdrawal of a certificate;

(b) any circumstances affecting the scope of or conditions for notifi­

cation;

(c) any request for information which they have received from market
surveillance authorities regarding conformity assessment activities;

(d) on request, conformity assessment activities performed within the

scope of their notification and any other activity performed,
including cross-border activities and subcontracting.
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2. Notified bodies shall provide the other bodies notified under this
Directive carrying out similar conformity assessment activities covering
the same apparatus with relevant information on issues relating to
negative and, on request, positive conformity assessment results.

Article 35
Exchange of experience

The Commission shall provide for the organisation of exchange of

experience between the Member States’ national authorities responsible
for notification policy.

Article 36
Coordination of notified bodies

The Commission shall ensure that appropriate coordination and cooper­

ation between bodies notified under this Directive are put in place and
properly operated in the form of a sectoral group of notified bodies.

Member States shall ensure that the bodies notified by them participate
in the work of that group, directly or by means of designated represen­
tatives.

CHAPTER 5

UNION MARKET SURVEILLANCE AND CONTROL OF APPARATUS

ENTERING THE UNION MARKET AND UNION SAFEGUARD
PROCEDURE

Article 37
Union market surveillance and control of apparatus entering the
Union market

Article 15(3) and Articles 16 to 29 of Regulation (EC) No 765/2008

shall apply to apparatus.

Article 38
Procedure for dealing with apparatus presenting a risk at national
level

1. Where the market surveillance authorities of one Member State

have sufficient reason to believe that an apparatus covered by this
Directive presents a risk to aspects of public interest protection
covered by this Directive, they shall carry out an evaluation in
relation to the apparatus concerned covering all relevant requirements
laid down in this Directive. The relevant economic operators shall
cooperate as necessary with the market surveillance authorities for
that purpose.

Where, in the course of the evaluation referred to in the first subpara­

graph, the market surveillance authorities find that the apparatus does
not comply with the requirements laid down in this Directive, they shall
without delay require the relevant economic operator to take all appro­
priate corrective actions to bring the apparatus into compliance with
those requirements, to withdraw the apparatus from the market, or to
recall it within a reasonable period, commensurate with the nature of the
risk, as they may prescribe.
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The market surveillance authorities shall inform the relevant notified
body accordingly.

Article 21 of Regulation (EC) No 765/2008 shall apply to the measures

referred to in the second subparagraph of this paragraph.

2. Where the market surveillance authorities consider that non-

compliance is not restricted to their national territory, they shall
inform the Commission and the other Member States of the results of
the evaluation, and of the actions which they have required the
economic operator to take.

3. The economic operator shall ensure that all appropriate corrective

action is taken in respect of all the apparatus concerned that it has made
available on the market throughout the Union.

4. Where the relevant economic operator does not take adequate

corrective action within the period referred to in the second subpara­
graph of paragraph 1, the market surveillance authorities shall take all
appropriate provisional measures to prohibit or restrict the apparatus’s
being made available on their national market, to withdraw the
apparatus from that market or to recall it.

The market surveillance authorities shall inform the Commission and

the other Member States, without delay, of those measures.

5. The information referred to in the second subparagraph of

paragraph 4 shall include all available details, in particular the data
necessary for the identification of the non-compliant apparatus, the
origin of the apparatus, the nature of the non-compliance alleged and
the risk involved, the nature and duration of the national measures taken
and the arguments put forward by the relevant economic operator. In
particular, the market surveillance authorities shall indicate whether the
non-compliance is due to either of the following:

(a) failure of the apparatus to meet the requirements relating to aspects

of public interest protection covered by this Directive; or

(b) shortcomings in the harmonised standards referred to in Article 13

conferring a presumption of conformity.

6. Member States other than the Member State initiating the

procedure under this Article shall without delay inform the Commission
and the other Member States of any measures adopted and of any
additional information at their disposal relating to the non-compliance
of the apparatus concerned, and, in the event of disagreement with the
adopted national measure, of their objections.

7. Where, within three months of receipt of the information referred

to in the second subparagraph of paragraph 4, no objection has been
raised by either a Member State or the Commission in respect of a
provisional measure taken by a Member State, that measure shall be
deemed justified.

8. Member States shall ensure that appropriate restrictive measures,

such as withdrawal of the apparatus from the market, are taken in
respect of the apparatus concerned without delay.

Article 39
Union safeguard procedure

1. Where, on completion of the procedure set out in Article 38(3)

and (4), objections are raised against a measure taken by a Member
State, or where the Commission considers a national measure to be
contrary to Union legislation, the Commission shall without delay
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enter into consultation with the Member States and the relevant
economic operator or operators and shall evaluate the national
measure. On the basis of the results of that evaluation, the Commission
shall adopt an implementing act determining whether the national
measure is justified or not.

The Commission shall address its decision to all Member States and
shall immediately communicate it to them and the relevant economic
operator or operators.

2. If the national measure is considered justified, all Member States

shall take the necessary measures to ensure that the non-compliant
apparatus is withdrawn from their market, and shall inform the
Commission accordingly. If the national measure is considered unjus­
tified, the Member State concerned shall withdraw that measure.

3. Where the national measure is considered justified and the non-

compliance of the apparatus is attributed to shortcomings in the
harmonised standards referred to in point (b) of Article 38(5) of this
Directive, the Commission shall apply the procedure provided for in
Article 11 of Regulation (EU) No 1025/2012.

Article 40
Formal non-compliance

1. Without prejudice to Article 38, where a Member State makes one

of the following findings, it shall require the relevant economic operator
to put an end to the non-compliance concerned:

(a) the CE marking has been affixed in violation of Article 30 of

Regulation (EC) No 765/2008 or of Article 17 of this Directive;

(b) the CE marking has not been affixed;

(c) the EU declaration of conformity has not been drawn up;

(d) the EU declaration of conformity has not been drawn up correctly;

(e) technical documentation is either not available or not complete;

(f) the information referred to in Article 7(6) or Article 9(3) is absent,

false or incomplete;

(g) any other administrative requirement provided for in Article 7 or

Article 9 is not fulfilled.

2. Where the non-compliance referred to in paragraph 1 persists, the

Member State concerned shall take all appropriate measures to restrict
or prohibit the apparatus being made available on the market or ensure
that it is recalled or withdrawn from the market.

CHAPTER 6

COMMITTEE, TRANSITIONAL AND FINAL PROVISIONS

Article 41
Committee procedure

1. The Commission shall be assisted by the Committee on Electrom­

agnetic Compatibility. That committee shall be a committee within the
meaning of Regulation (EU) No 182/2011.

2. Where reference is made to this paragraph, Article 4 of Regulation

(EU) No 182/2011 shall apply.
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3. The committee shall be consulted by the Commission on any
matter for which consultation of sectoral experts is required by Regu­
lation (EU) No 1025/2012 or by any other Union legislation.

The committee may furthermore examine any other matter concerning

the application of this Directive raised either by its chair or by a rep­
resentative of a Member State in accordance with its rules of procedure.

Article 42
Penalties

Member States shall lay down rules on penalties applicable to

infringements by economic operators of the provisions of national law
adopted pursuant to this Directive and shall take all measures necessary
to ensure that they are enforced. Such rules may include criminal
penalties for serious infringements.

The penalties provided for shall be effective, proportionate and

dissuasive.

Article 43
Transitional provisions

Member States shall not impede the making available on the market
and/or the putting into service of equipment covered by Directive
2004/108/EC which is in conformity with that Directive and which
was placed on the market before 20 April 2016.

Article 44
Transposition

1. Member States shall adopt and publish, by 19 April 2016, the

laws, regulations and administrative provisions necessary to comply
with Article 2(2), points (9) to (25) of Article 3(1), Article 4,
Article 5(1), Articles 7 to 12, Articles 15, 16 and 17, the first subpara­
graph of Article 19(1), Articles 20 to 43, and Annexes II, III and IV.
They shall forthwith communicate the text of those measures to the
Commission.

They shall apply those measures from 20 April 2016.

When Member States adopt those measures, they shall contain a

reference to this Directive or be accompanied by such a reference on
the occasion of their official publication. They shall also include a
statement that references in existing laws, regulations and administrative
provisions to the Directive repealed by this Directive shall be construed
as references to this Directive. Member States shall determine how such
reference is to be made and how that statement is to be formulated.

2. Member States shall communicate to the Commission the texts of

the main provisions of national law which they adopt in the field
covered by this Directive.
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Article 45
Repeal

Directive 2004/108/EC is repealed with effect from 20 April 2016,

without prejudice to the obligations of the Member States relating to
the time-limit for transposition into national law and the dates of appli­
cation of the Directive set out in Annex V.
References to the repealed Directive shall be construed as references to
this Directive and shall be read in accordance with the correlation table
in Annex VI.

Article 46
Entry into force and application

This Directive shall enter into force on the twentieth day following that
of its publication in the Official Journal of the European Union.
Article 1, Article 2, points (1) to (8) of Article 3(1), Article 3(2),
Article 5(2) and (3), Article 6, Article 13, Article 19(3) and Annex I
shall apply from 20 April 2016.

Article 47
Addressees

This Directive is addressed to the Member States.

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ANNEX I

ESSENTIAL REQUIREMENTS

1. General requirements
Equipment shall be so designed and manufactured, having regard to the state
of the art, as to ensure that:

(a) the electromagnetic disturbance generated does not exceed the level above
which radio and telecommunications equipment or other equipment
cannot operate as intended;

(b) it has a level of immunity to the electromagnetic disturbance to be

expected in its intended use which allows it to operate without
unacceptable degradation of its intended use.

2. Specific requirements for fixed installations

Installation and intended use of components

A fixed installation shall be installed applying good engineering practices and

respecting the information on the intended use of its components, with a view
to meeting the essential requirements set out in point 1.
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ANNEX II

MODULE A: INTERNAL PRODUCTION CONTROL

1. Internal production control is the conformity assessment procedure whereby

the manufacturer fulfils the obligations laid down in points 2, 3, 4 and 5 of
this Annex, and ensures and declares on his sole responsibility that the
apparatus concerned satisfy the requirements of this Directive that apply
to it.

2. Electromagnetic compatibility assessment

The manufacturer shall perform an electromagnetic compatibility assessment
of the apparatus, on the basis of the relevant phenomena, with a view to
meeting the essential requirements set out in point 1 of Annex I.

The electromagnetic compatibility assessment shall take into account all

normal intended operating conditions. Where the apparatus is capable of
taking different configurations, the electromagnetic compatibility assessment
shall confirm whether the apparatus meets the essential requirements set out
in point 1 of Annex I in all the possible configurations identified by the
manufacturer as representative of its intended use.

3. Technical documentation
The manufacturer shall establish the technical documentation. The documen­
tation shall make it possible to assess the apparatus conformity to 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 apparatus. The technical documentation shall, wherever
applicable, contain at least the following elements:

(a) a general description of the apparatus;

(b) conceptual design and manufacturing drawings and schemes of

components, sub-assemblies, circuits, etc.;

(c) descriptions and explanations necessary for the understanding of those

drawings and schemes and the operation of the apparatus;

(d) a list of the harmonised standards applied in full or in part the references
of which have been published in the Official Journal of the European
Union and, where those harmonised standards have not been applied,
descriptions of the solutions adopted to meet the essential requirements
of this Directive, including a list of other relevant technical specifi­
cations applied. In the event of partly applied harmonised standards,
the technical documentation shall specify the parts which have been
applied;

(e) results of design calculations made, examinations carried out, etc.;

(f) test reports.

4. Manufacturing
The manufacturer shall take all measures necessary so that the manufac­
turing process and its monitoring ensure compliance of the manufactured
apparatus with the technical documentation referred to in point 3 of this
Annex and with the essential requirements set out in point 1 of Annex I.
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5. CE marking and EU declaration of conformity
5.1. The manufacturer shall affix the CE marking to each individual apparatus
that satisfies the applicable requirements of this Directive.

5.2. The manufacturer shall draw up a written EU declaration of conformity for

an apparatus model and keep it together with the technical documentation at
the disposal of the national authorities for 10 years after the apparatus has
been placed on the market. The EU declaration of conformity shall identify
the apparatus for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the

relevant authorities upon request.

6. Authorised representative
The manufacturer’s obligations set out in point 5 may be fulfilled by his
authorised representative, on his behalf and under his responsibility,
provided that they are specified in the mandate.
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ANNEX III

PART A

Module B: EU-type examination

1. EU-type examination is the part of a conformity assessment procedure in

which a notified body examines the technical design of an apparatus and
verifies and attests that the technical design of the apparatus meets the
essential requirements set out in point 1 of Annex I.

2. EU-type examination shall be carried out by assessment of the adequacy of

the technical design of the apparatus through examination of the technical
documentation referred to in point 3, without examination of a specimen
(design type). It may be restricted to some aspects of the essential
requirements as specified by the manufacturer or his authorised represen­
tative.

3. The manufacturer shall lodge an application for EU-type examination with a

single notified body of his choice.

The application shall specify the aspects of the essential requirements for
which examination is requested and shall include:

(a) the name and address of the manufacturer and, if the application is
lodged by the authorised representative, his name and address as well;

(b) a written declaration that the same application has not been lodged with
any other notified body;

(c) the technical documentation. The technical documentation shall make it

possible to assess the apparatus conformity with the applicable
requirements of this Directive 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 apparatus.
The technical documentation shall contain, wherever applicable, at
least the following elements:

(i) a general description of the apparatus;

(ii) conceptual design and manufacturing drawings and schemes of

components, sub-assemblies, circuits, etc.;

(iii) descriptions and explanations necessary for the understanding of

those drawings and schemes and the operation of the apparatus;

(iv) a list of the harmonised standards applied in full or in part the

references of which have been published in the Official Journal
of the European Union, and, where those harmonised standards
have not been applied, descriptions of the solutions adopted to
meet the essential requirements of this Directive, including a list
of other relevant technical specifications applied. In the event of
partly applied harmonised standards, the technical documentation
shall specify the parts which have been applied;

(v) results of design calculations made, examinations carried out, etc.;

(vi) test reports.

4. The notified body shall examine the technical documentation to assess the
adequacy of the technical design of the apparatus in relation to the aspects
of the essential requirements for which examination is requested.
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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 this Directive that apply to the
apparatus concerned, the notified body shall issue an EU-type examination
certificate to the manufacturer. That certificate shall contain the name and
address of the manufacturer, the conclusions of the examination, the aspects
of the essential requirements covered by the examination, the conditions (if
any) for its validity and the necessary data for identification of the approved
type. The EU-type examination certificate may have one or more annexes
attached.

The EU-type examination certificate and its annexes shall contain all
relevant information to allow the conformity of manufactured apparatus
with the examined type to be evaluated and to allow for in-service control.

Where the type does not satisfy the applicable requirements of this
Directive, the notified body shall refuse to issue an EU-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 this Directive, 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 EU-type examination certificate of all modi­
fications to the approved type that may affect the conformity of the
apparatus with the essential requirements of this Directive or the conditions
for validity of that certificate. Such modifications shall require additional
approval in the form of an addition to the original EU-type examination
certificate.

8. Each notified body shall inform its notifying authority concerning the EU-
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 authority the list of such certificates and/or any
additions thereto refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies concerning the
EU-type examination certificates and/or any additions thereto which it has
refused, withdrawn, suspended or otherwise restricted, and, upon request,
concerning such 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 EU-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 EU-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 that certificate.
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9. The manufacturer shall keep a copy of the EU-type examination certificate,
its annexes and additions together with the technical documentation at the
disposal of the national authorities for 10 years after the apparatus 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.

PART B
Module C: conformity to type based on internal production control
1. Conformity to type based on internal production control is the part of a
conformity assessment procedure whereby the manufacturer fulfils the obli­
gations laid down in points 2 and 3, and ensures and declares that the
apparatus concerned are in conformity with the type described in the EU-
type examination certificate and satisfy the requirements of this Directive
that apply to them.

2. Manufacturing
The manufacturer shall take all measures necessary so that the manufac­
turing process and its monitoring ensure conformity of the manufactured
apparatus with the approved type described in the EU-type examination
certificate and with the requirements of this Directive that apply to them.

3. CE marking and EU declaration of conformity

3.1. The manufacturer shall affix the CE marking to each individual apparatus
that is in conformity with the type described in the EU-type examination
certificate and satisfies the applicable requirements of this Directive.

3.2. The manufacturer shall draw up a written EU declaration of conformity for

each apparatus model and keep it at the disposal of the national authorities
for 10 years after the apparatus has been placed on the market. The EU
declaration of conformity shall identify the apparatus model for which it has
been drawn up.

A copy of the EU declaration of conformity shall be made available to the

relevant authorities upon request.

4. Authorised representative
The manufacturer’s obligations set out in point 3 may be fulfilled by his
authorised representative, on his behalf and under his responsibility,
provided that they are specified in the mandate.
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ANNEX IV

EU declaration of conformity (No Xxxx) (1)

1. Apparatus model/Product (product, type, batch or serial number):

2. Name and address of the manufacturer or his authorised representative:

3. This declaration of conformity is issued under the sole responsibility of the

manufacturer.

4. Object of the declaration (identification of apparatus allowing traceability; it

may include a colour image of sufficient clarity where necessary for the
identification of the apparatus):

5. The object of the declaration described above is in conformity with the

relevant Union harmonisation legislation:

6. References to the relevant harmonised standards used, including the date of

the standard, or references to the other technical specifications, including the
date of the specification, in relation to which conformity is declared:

7. Where applicable, the notified body … (name, number) performed …

(description of intervention) and issued the certificate:

8. Additional information:

Signed for and on behalf of:

(place and date of issue):

(name, function) (signature):

(1) It is optional for the manufacturer to assign a number to the declaration of conformity.
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ANNEX V

Time-limit for transposition into national law and date of application

(referred to in Article 45)

Directive Time-limit for transposition Date of application

2004/108/EC 20 January 2007 20 July 2007

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ANNEX VI

Correlation table

Directive 2004/108/EC This Directive

Article 1(1) Article 1 and Article 2(1)

Article 1(2) Article 2(2)(a) to (c)

Article 1(3) Article 2(2)(d)

Article 1(4) Article 2(3)

Article 1(5) Article 2(4)

Article 2(1)(a) Article 3(1)(1)

Article 2(1)(b) Article 3(1)(2)

Article 2(1)(c) Article 3(1)(3)

Article 2(1)(d) Article 3(1)(4)

Article 2(1)(e) Article 3(1)(5)

Article 2(1)(f) Article 3(1)(6)

Article 2(1)(g) Article 3(1)(7)

Article 2(1)(h) Article 3(1)(8)

Article 2(2) Article 3(2)

Article 3 Article 4

Article 4 Article 5

Article 5 Article 6

Article 6 Article 13

Article 7 Article 14

Article 8 Articles 16 and 17

Article 9(1) Article 7(5)

Article 9(2) Article 7(6)

Article 9(3) Article 18(1)

Article 9(4) Article 18(2)

Article 9(5) Article 18(3)

Articles 10 and 11 Articles 37, 38 and 39

Article 12 Chapter 4

Article 13 Article 19

Article 14 Article 45
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Directive 2004/108/EC This Directive

Article 15 Article 43

Article 16 Article 44

Article 17 Article 46

Article 18 Article 47

Annex I Annex I

Annex II and point 1 of Annex IV Annex II

Annex III Annex III

Point 2 of Annex IV Annex IV

Annex V Articles 16 and 17

Annex VI Article 24

Annex VII Annex VI

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STATEMENT OF THE EUROPEAN PARLIAMENT

The European Parliament considers that only when and in so far as implementing
acts in the sense of Regulation (EU) No 182/2011 are discussed in meetings of
committees, can the latter be considered as ‘comitology committees’ within the
meaning of Annex I to the Framework Agreement on the relations between the
European Parliament and the European Commission. Meetings of committees
thus fall within the scope of point 15 of the Framework Agreement when and
insofar as other issues are discussed.