DIRECTIVE 2004/108/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2004
on the approximation of the laws of the Member States relating to electromagnetic compatibility
and repealing Directive 89/336/EEC
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community,
and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and
Social Committee (1),
Acting in accordance with the procedure referred to in Article
251 of the Treaty (2),
Whereas:
(1) Council Directive 89/336/EEC of 3 May 1989 on the approximation of laws of the Member States relating to
electromagnetic compatibility (3) has been the subject of
a review under the initiative known as Simpler Legislation
for the Internal Market (SLIM). Both the SLIM process and a subsequent in-depth consultation have
revealed the need to complete, reinforce and clarify the
framework established by Directive 89/336/EEC.
(2) Member States are responsible for ensuring that radiocommunications,
including radio broadcast reception
and the amateur radio service operating in accordance
with International Telecommunication Union (ITU) radio
regulations, electrical supply networks and telecommunications
networks, as well as equipment connected
thereto, are protected against electromagnetic disturbance
(3) Provisions of national law ensuring protection against electromagnetic disturbance should be harmonised in
order to guarantee the free movement of electrical and
electronic apparatus without lowering justified levels of
protection in the Member States.
(4) Protection against electromagnetic disturbance requires
obligations to be imposed on the various economic
operators. Those obligations should be applied in a fair
and effective way in order to achieve such protection.
(5) The electromagnetic compatibility of equipment should
be regulated with a view to ensuring the functioning of
the internal market, that is to say, of an area without
internal frontiers in which the free movement of goods,
persons, services and capital is assured.
(6) The equipment covered by this Directive should include
both apparatus and fixed installations. However, separate
provision should be made for each. This is so because,
whereas apparatus as such may move freely within the
Community, fixed installations on the other hand are
installed for permanent use at a predefined location, as
assemblies of various types of apparatus and, where
appropriate, other devices. The composition and function
of such installations correspond in most cases to
the particular needs of their operators.
(7) Radio equipment and telecommunications terminal
equipment should not be covered by this Directive since
they are already regulated by Directive 1999/5/EC of the
European Parliament and of the Council of 9 March
1999 on radio equipment and telecommunications terminal
equipment and the mutual recognition of their
conformity (4). The electromagnetic compatibility
requirements in both Directives achieve the same level
of protection.
(8) Aircraft or equipment intended to be fitted into aircraft
should not be covered by this Directive, since they are
already subject to special Community or international
rules governing electromagnetic compatibility.
(9) This Directive need not regulate equipment which is
inherently benign in terms of electromagnetic compatibility.
(10) This Directive should not deal with the safety of equipment,
since that is dealt with by separate Community or
national legislation.
(11) Where this Directive regulates apparatus, it should refer to finished apparatus commercially available for the first
time on the Community market. Certain components or sub-assemblies should, under certain conditions, be
considered to be apparatus if they are made available to the end-user.
(1) OJ C 220, 16.9.2003, p. 13.
(2) Opinion of the European Parliament of 9 March 2004 (not yet
published in the Official Journal) and Council Decision of 29
November 2004.
(3) OJ L 139, 23.5.1989, p. 19. Directive as last amended by Directive
93/68/EEC (OJ L 220, 30.8.1993, p. 1).
(4) OJ L 91, 7.4.1999, p. 10. Directive as amended by Regulation (EC)
No 1882/2003 (OJ L 284, 31.10.2003, p. 1).
(12) The principles on which this Directive is based are those
set out in the Council Resolution of 7 May 1985 on a
new approach to technical harmonization and standards
(1). In accordance with that approach, the design
and manufacture of equipment is subject to essential
requirements in relation to electromagnetic compatibility.
Those requirements are given technical expression
by harmonised European standards, to be adopted by
the various European standardisation bodies, European
Committee for Standardisation (CEN), European
Committee for Electro-technical Standardisation
(CENELEC) and European Telecommunications Standards
Institute (ETSI). CEN, CENELEC and ETSI are recognised
as the competent institutions in the field of this Directive
for the adoption of harmonised standards, which they
draw up in accordance with the general guidelines for
cooperation between themselves and the Commission,
and with the procedure laid down in 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 regulations
and of rules on Information Society services (2).
(13) Harmonised standards reflect the generally acknowledged
state of the art as regards electromagnetic compatibility
matters in the European Union. It is thus in the
interest of the functioning of the internal market to have
standards for the electromagnetic compatibility of equipment
which have been harmonised at Community level.
Once the reference to such a standard has been
published in the Official Journal of the European Union,
compliance with it should raise a presumption of
conformity with the relevant essential requirements,
although other means of demonstrating such conformity
should be permitted. Compliance with a harmonised
standard means conformity with its provisions and
demonstration thereof by the methods the harmonised
standard describes or refers to.
(14) Manufacturers of equipment intended to be connected to
networks should construct such equipment in a way that
prevents networks from suffering unacceptable degradation
of service when used under normal operating conditions.
Network operators should construct their
networks in such a way that manufacturers of equipment
liable to be connected to networks do not suffer a
disproportionate burden in order to prevent networks
from suffering an unacceptable degradation of service.
The European standardisation organisations should take
due account of that objective (including the cumulative
effects of the relevant types of electromagnetic
phenomena) when developing harmonised standards.
(15) It should be possible to place apparatus on the market
or put it into service only if the manufacturers
concerned have established that such apparatus has been
designed and manufactured in conformity with the
requirements of this Directive. Apparatus placed on the
market should bear the ‘CE’ marking attesting to compliance
with this Directive. Although conformity assessment
should be the responsibility of the manufacturer,
without any need to involve an independent conformity
assessment body, manufacturers should be free to use
the services of such a body.
(16) The conformity assessment obligation should require the
manufacturer to perform an electromagnetic compatibility
assessment of apparatus, based on relevant
phenomena, in order to determine whether or not it
meets the protection requirements under this Directive.
(17) Where apparatus is capable of taking different configurations,
the electromagnetic compatibility assessment
should confirm whether the apparatus meets the protection
requirements in the configurations foreseeable by
the manufacturer as representative of normal use in the
intended applications; in such cases it should be sufficient
to perform an assessment on the basis of the
configuration most likely to cause maximum disturbance
and the configuration most susceptible to disturbance.
(18) Fixed installations, including large machines and
networks, may generate electromagnetic disturbance, or
be affected by it. There may be an interface between
fixed installations and apparatus, and the electromagnetic
disturbances produced by fixed installations may
affect apparatus, and vice versa. In terms of electromagnetic
compatibility, it is irrelevant whether the electromagnetic
disturbance is produced by apparatus or by a
fixed installation. Accordingly, fixed installations and
apparatus should be subject to a coherent and comprehensive
regime of essential requirements. It should be
possible to use harmonised standards for fixed installations
in order to demonstrate conformity with the essential
requirements covered by such standards.
(19) Due to their specific characteristics, fixed installations
need not be subject to the affixation of the ‘CE’ marking
or to the declaration of conformity.
(20) It is not pertinent to carry out the conformity assessment
of apparatus placed on the market for incorporation into
a given fixed installation, and otherwise not commercially
available, in isolation from the fixed installation
into which it is to be incorporated. Such apparatus
should therefore be exempted from the conformity
assessment procedures normally applicable to apparatus.
However, such apparatus should not be permitted to
compromise the conformity of the fixed installation into
which it is incorporated. Should apparatus be incorporated
into more than one identical fixed installation,
identifying the electromagnetic compatibility characteristics
of these installations should be sufficient to ensure
exemption from the conformity assessment procedure.
31.12.2004 EN Official Journal of the European Union L 390/25
(1) OJ C 136, 4.6.1985, p. 1.
(2) OJ L 204, 21.7.1998, p. 37. Directive as last amended by the 2003
Act of Accession.
(21) A transitional period is necessary in order to ensure that
manufacturers and other concerned parties are able to
adapt to the new regulatory regime.
(22) Since the objective of this Directive, namely to ensure
the functioning of the internal market by requiring
equipment to comply with an adequate level of electromagnetic
compatibility, cannot be sufficiently achieved
by Member States and can therefore, by reason of its
scale and effects, be better achieved at Community level,
the Community may adopt measures, in accordance
with the principle of subsidiarity as set out in Article 5
of the Treaty. In accordance with the principle of
proportionality, as set out in that Article, this Directive
does not go beyond what is necessary in order to
achieve that objective.
(23) Directive 89/336/EEC should therefore be repealed,
HAVE ADOPTED THIS DIRECTIVE:
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter and scope
1. 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. This Directive applies to
equipment as defined in Article 2.
2. This Directive shall not apply to:
(a) equipment covered by Directive 1999/5/EC;
(b) aeronautical products, parts and appliances as referred to in Regulation (EC) No 1592/2002 of the European Parliament
and of the Council of 15 July 2002 on common rules in the field of civil aviation and establishing a European Aviation
Safety Agency (1);
(c) radio equipment used by radio amateurs within the meaning of the Radio Regulations adopted in the framework
of the Constitution and Convention of the ITU (2),unless the equipment is available commercially. Kits of
components to be assembled by radio amateurs and commercial equipment modified by and for the use of radio amateurs are not regarded as commercially available equipment.
3. This Directive shall not apply to equipment the inherent nature of the physical characteristics of which is such that:
(a) it is incapable of generating or contributing to electromagnetic emissions which exceed a level allowing radio and
telecommunication equipment and other equipment to operate as intended; and
(b) it will operate without unacceptable degradation in the presence of the electromagnetic disturbance normally
consequent upon its intended use.
4. Where, for the equipment referred to in paragraph 1, the essential requirements referred to in Annex I are wholly or
partly laid down more specifically by other Community directives,this Directive shall not apply, or shall cease to apply, to
that equipment in respect of such requirements from the date of implementation of those directives.
5. This Directive shall not affect the application of Community or national legislation regulating the safety of equipment.
Article 2
Definitions
1. For the purposes of this Directive, the following definitions
shall apply:
(a) ‘equipment’ means any apparatus or fixed installation;
(b) ‘apparatus’ means any finished appliance or combination thereof made commercially available 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;
(c) ‘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;
(d) ‘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;
(e) ‘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;
L 390/26 EN Official Journal of the European Union 31.12.2004
(1) OJ L 240, 7.9.2002, p. 1. Regulation as amended by Commission
Regulation (EC) No 1701/2003 (OJ L 243, 27.9.2003, p. 5).
(2) Constitution and Convention of the International Telecommunication
Union adopted by the Additional Plenipotentiary Conference
(Geneva, 1992) as amended by the Plenipotentiary Conference
(Kyoto, 1994).
(f) ‘immunity’ means the ability of equipment to perform as intended without degradation in the presence of an electromagnetic disturbance;
(g) ‘safety purposes’ means the purposes of safeguarding human life or property;
(h) ‘electromagnetic environment’ means all electromagnetic phenomena observable in a given location.
2. For the purposes of this Directive the following shall be deemed to be an apparatus within the meaning of paragraph
1(b):
(a) ‘components’ or ‘sub-assemblies’ intended for incorporation into an apparatus by the end user, which are liable to
generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance;
(b) ‘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 3
Placing on the market and/or putting into service
Member States shall take all appropriate measures to ensure
that equipment is placed on the market and/or put into service
only if it complies with the requirements of this Directive when
properly installed, maintained and used for its intended
purpose.
Article 4
Free movement of equipment
1. Member States shall not impede, for reasons relating to
electromagnetic compatibility, the placing 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
compatibility problem at a specific site;
(b) measures taken for safety reasons to protect public telecommunications
networks or receiving or transmitting stations
when used for safety purposes in well-defined spectrum
situations.
Without prejudice to Directive 98/34/EC, Member States shall
notify those special measures to the Commission and to the
other Member States.
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 placed 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 are taken to avoid electromagnetic disturbances.
Article 5
Essential requirements
The equipment referred to in Article 1 shall meet the essential
requirements set out in Annex I.
Article 6
Harmonised standards
1. ‘Harmonised standard’ means a technical specification
adopted by a recognised European standardisation body under
a mandate from the Commission in conformity with the procedures
laid down in Directive 98/34/EC for the purpose of
establishing a European requirement. Compliance with a
‘harmonised standard’ is not compulsory.
2. The compliance of equipment with the relevant harmonised
standards whose references have been published in the
Official Journal of the European Union shall raise a presumption,
on the part of the Member States, of conformity with the essential
requirements referred to in Annex I to which such standards
relate. This presumption of conformity is limited to the
scope of the harmonised standard(s) applied and the relevant
essential requirements covered by such harmonised standard(s).
3. Where a Member State or the Commission considers that
a harmonised standard does not entirely satisfy the essential
requirements referred to in Annex I, it shall bring the matter
before the Standing Committee set up by Directive 98/34/EC
(hereinafter ‘the Committee’), stating its reasons. The
Committee shall deliver an opinion without delay.
4. Upon receipt of the Committee's opinion, the Commission
shall take one of the following decisions with regard to
the references to the harmonised standard concerned:
(a) not to publish;
(b) to publish with restrictions;
(c) to maintain the reference in the Official Journal of the European
Union;
(d) to withdraw the reference from the Official Journal of the
European Union.
The Commission shall inform the Member States of its decision
without delay.
31.12.2004 EN Official Journal of the European Union L 390/27
CHAPTER II
APPARATUS
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.
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.
2. Member States shall take the necessary measures to
prohibit the affixing to the apparatus, or to its packaging, or to
the instructions for its use, of marks which are likely to mislead
third parties in relation to the meaning and/or graphic form of
the ‘CE’ marking.
3. Any other mark may be affixed to the apparatus, its
packaging, or the instructions for its use, provided that neither
the visibility nor the legibility of the ‘CE’ marking is thereby
impaired.
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 9
Other marks and information
1. Each apparatus shall be identified in terms of type, batch,
serial number or any other information allowing for the identification
of the apparatus.
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.
3. The manufacturer shall provide 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 protection requirements set out in Annex I, point 1.
4. Apparatus for which compliance with the protection
requirements is not ensured in residential areas shall be accompanied
by a clear indication of this restriction of use, where
appropriate also on the packaging.
5. The information required to enable apparatus to be used
in accordance with the intended purpose of the apparatus shall
be contained in the instructions accompanying the apparatus.
Article 10
Safeguards
1. Where a Member State ascertains that apparatus bearing
the ‘CE’ marking does not comply with the requirements of this
Directive, it shall take all appropriate measures to withdraw the
apparatus from the market, to prohibit its placing on the
market or its putting into service, or to restrict the free movement
thereof.
2. The Member State concerned shall immediately inform
the Commission and the other Member States of any such
measure, indicating the reasons and specifying, in particular,
whether non-compliance is due to:
(a) failure to satisfy the essential requirements referred to in
Annex I, where the apparatus does not comply with the
harmonised standards referred to in Article 6;
(b) incorrect application of the harmonised standards referred
to in Article 6;
(c) shortcomings in the harmonised standards referred to in Article 6.
3. The Commission shall consult the parties concerned as
soon as possible, following which it shall inform the Member
States whether or not it finds the measure to be justified.
4. Where the measure referred to in paragraph 1 is attributed
to a shortcoming in harmonised standards, the Commission,
after consulting the parties, shall, if the Member State
concerned intends to uphold the measure, bring the matter
before the Committee and initiate the procedure laid down in Article 6(3) and (4).
5. Where the non-compliant apparatus has been subject to
the conformity assessment procedure referred to in Annex III,
the Member State concerned shall take appropriate action in
respect of the author of the statement referred to in Annex III,
point 3, and shall inform the Commission and the other
Member States accordingly.
L 390/28 EN Official Journal of the European Union 31.12.2004
Article 11
Decisions to withdraw, prohibit or restrict the free movement
of apparatus
1. Any decision taken pursuant to this Directive to withdraw
apparatus from the market, prohibit or restrict its placing on
the market or its putting into service, or restrict the free movement
thereof, shall state the exact grounds on which it is based.
Such decisions shall be notified without delay to the party
concerned, who shall at the same time be informed of the
remedies available to him under the national law in force in
the Member State in question and of the time limits to which
such remedies are subject.
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.
Article 12
Notified bodies
1. Member States shall notify the Commission of the bodies
which they have designated to carry out the tasks referred to in
Annex III. When determining the bodies to be designated,
Member States shall apply the criteria laid down in Annex VI.
Such notification shall state whether the bodies are designated
to carry out the tasks referred to in Annex III for all apparatus
covered by this Directive, and/or the essential requirements
referred to in Annex I or whether the scope of designation is
limited to certain specific aspects and/or categories of apparatus.
2. Bodies which comply with the assessment criteria established
by the relevant harmonised standards shall be presumed
to comply with the criteria set out in Annex VI covered by
such harmonised standards. The Commission shall publish in
the Official Journal of the European Union the references of those
standards.
3. The Commission shall publish in the Official Journal of the
European Union a list of notified bodies. The Commission shall
ensure that the list is kept up to date.
4. If a Member State finds that a notified body no longer
meets the criteria listed in Annex VI, it shall inform the
Commission and the other Member States accordingly. The
Commission shall withdraw the reference to that body from
the list referred to in paragraph 3.
CHAPTER III
FIXED INSTALLATIONS
Article 13
Fixed installations
1. Apparatus which has been placed on the market and which may be incorporated into a fixed
installation is subject to all relevant provisions for apparatus set out in this Directive.
However, the provisions of Articles 5, 7, 8 and 9 shall not be compulsory in the case of apparatus which is intended for incorporation into a given fixed installation and is otherwise not commercially available. 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 furthermore include the
information referred to in Article 9(1) and (2).
2. Where there are indications of non-compliance of the fixed installation, 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 installation, and,
when appropriate, initiate an assessment.
Where non-compliance is established, the competent authorities
may impose appropriate measures to bring the fixed installation
into compliance with the protection requirements set out
in Annex I, point 1.
3. Member States shall set out the necessary provisions for
identifying the person or persons responsible for the establishment
of compliance of a fixed installation with the relevant
essential requirements.
CHAPTER IV
FINAL PROVISIONS
Article 14
Repeal
Directive 89/336/EEC is hereby repealed as from 20 July 2007.
References to Directive 89/336/EEC shall be construed as references
to this Directive and should be read in accordance with
the correlation table set out in Annex VII.
31.12.2004 EN Official Journal of the European Union L 390/29
Article 15
Transitional provisions
Member States shall not impede the placing on the market and/
or the putting into service of equipment which is in compliance
with the provisions of Directive 89/336/EEC and which
was placed on the market before 20 July 2009.
Article 16
Transposition
1. Member States shall adopt and publish the laws, regulations
and administrative provisions necessary to comply with
this Directive by 20 January 2007. They shall forthwith inform
the Commission thereof. They shall apply those provisions as
from 20 July 2007. When Member States adopt those provisions,
they shall contain a reference to this Directive or shall be
accompanied by such reference on the occasion of their official
publication. The methods of making such reference shall be
laid down by Member States.
2. Member States shall communicate to the Commission the
texts of the provisions of national law which they adopt in the
field covered by this Directive.
Article 17
Entry into force
This Directive shall enter into force on the twentieth day after
its publication in the Official Journal of the European Union.
Article 18
Addressees
This Directive is addressed to the Member States.
Done at Strasbourg, 15 December 2004.
For the European Parliament
The President
J. BORRELL FONTELLES
For the Council
The President
A. NICOLAÏ
L 390/30 EN Official Journal of the European Union 31.12.2004
ANNEX I
ESSENTIAL REQUIREMENTS REFERRED TO IN ARTICLE 5
1. Protection 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 protection requirements set out in Point 1. Those good
engineering practices shall be documented and the documentation shall be held by the person(s) responsible at the
disposal of the relevant national authorities for inspection purposes for as long as the fixed installation is in operation.
31.12.2004 EN Official Journal of the European Union L 390/31
ANNEX II
CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 7
(internal production control)
1. The manufacturer shall perform an electromagnetic compatibility assessment of the apparatus, on the basis of the
relevant phenomena, with a view to meeting the protection requirements set out in Annex I, point 1. The correct
application of all the relevant harmonised standards whose references have been published in the Official Journal of the
European Union shall be equivalent to the carrying out of the electromagnetic compatibility assessment.
2. 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 protection requirements set out in Annex I, point 1, in all the possible
configurations identified by the manufacturer as representative of its intended use.
3. In accordance with the provisions set out in Annex IV, the manufacturer shall draw up technical documentation
providing evidence of the conformity of the apparatus with the essential requirements of this Directive.
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.
7. If neither the manufacturer nor his authorised representative is established within the Community, the obligation to
hold the EC declaration of conformity and the technical documentation at the disposal of the competent authorities
shall lie with the person who places the apparatus on the Community market.
8. The manufacturer must take all measures necessary to ensure that the products are manufactured in accordance with
the technical documentation referred to in point 3 and with the provisions of this Directive that apply to them.
9. The technical documentation and the EC declaration of conformity shall be drawn up in accordance with the provisions set out in Annex IV.
L 390/32 EN Official Journal of the European Union 31.12.2004
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.
31.12.2004 EN Official Journal of the European Union L 390/33
ANNEX IV
TECHNICAL DOCUMENTATION AND EC DECLARATION OF CONFORMITY
1. Technical documentation
The technical documentation must enable the conformity of the apparatus with the essential requirements to be
assessed. It must cover the design and manufacture of the apparatus, in particular:
— a general description of the apparatus;
— evidence of compliance with the harmonised standards, if any, applied in full or in part;
— where the manufacturer has not applied harmonised standards, or has applied them only in part, a description
and explanation of the steps taken to meet the essential requirements of the Directive, including a description of
the electromagnetic compatibility assessment set out in Annex II, point 1, results of design calculations made,
examinations carried out, test reports, etc.;
— a statement from the notified body, when the procedure referred to in Annex III has been followed.
2. EC declaration of conformity
The EC declaration of conformity must contain, at least, the following:
— a reference to this Directive,
— an identification of the apparatus to which it refers, as set out in Article 9(1),
— the name and address of the manufacturer and, where applicable, the name and address of his authorised representative
in the Community,
— a dated reference to the specifications under which conformity is declared to ensure the conformity of the apparatus
with the provisions of this Directive,
— the date of that declaration,
— the identity and signature of the person empowered to bind the manufacturer or his authorised representative.
L 390/34 EN Official Journal of the European Union 31.12.2004
ANNEX V
‘CE’ MARKING REFERRED TO IN ARTICLE 8
The ‘CE’ marking shall consist in the initials ‘CE’ taking the following form:
The ‘CE’ marking must have a height of at least 5 mm. If the ‘CE’ marking is reduced or enlarged the proportions given
in the above graduated drawing must be respected.
The ‘CE’ marking must be affixed to the apparatus or to its data plate. Where this is not possible or not warranted on
account of the nature of the apparatus, it must be affixed to the packaging, if any, and to the accompanying documents.
Where the apparatus is the subject of other Directives covering other aspects and which also provide for the ‘CE’
marking, the latter shall indicate that the apparatus also conforms with those other Directives.
However, where one or more of those Directives allow the manufacturer, during a transitional period, to choose which
arrangements to apply, the ‘CE’ marking shall indicate conformity only with the Directives applied by the manufacturer.
In that case, particulars of the Directives applied, as published in the Official Journal of the European Union, must be given
in the documents, notices or instructions required by the Directives and accompanying such apparatus.
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ANNEX VI
CRITERIA FOR THE ASSESSMENT OF THE BODIES TO BE NOTIFIED
1. The bodies notified by the Member States shall fulfil the following minimum conditions:
(a) availability of personnel and of the necessary means and equipment;
(b) technical competence and professional integrity of personnel;
(c) independence in preparing the reports and performing the verification function provided for in this Directive;
(d) independence of staff and technical personnel in relation to all interested parties, groups or persons directly or
indirectly concerned with the equipment in question;
(e) maintenance of professional secrecy by personnel;
(f) possession of civil liability insurance unless such liability is covered by the Member State under national law.
2. Fulfilment of the conditions laid down in point 1 shall be verified at intervals by the competent authorities of the
Member State.
L 390/36 EN Official Journal of the European Union 31.12.2004
ANNEX VII
CORRELATION TABLE
Directive 89/336/EEC This Directive
Article 1, point 1 Article 2(1)(a), (b) and (c)
Article 1, point 2 Article 2(1)(e)
Article 1, point 3 Article 2(1)(f)
Article 1, point 4 Article 2(1)(d)
Article 1, points 5 and 6 -
Article 2(1) Article 1(1)
Article 2(2) Article 1(4)
Article 2(3) Article 1(2)
Article 3 Article 3
Article 4 Article 5 and Annex I
Article 5 Article 4(1)
Article 6 Article 4(2)
Article 7(1)(a) Article 6(1) and (2)
Article 7(1)(b) -
Article 7(2). -
Article 7(3) -
Article 8(1) Article 6(3) and (4)
Article 8(2) -
Article 9(1) Article 10(1) and (2)
Article 9(2) Article 10(3) and (4)
Article 9(3) Article 10(5)
Article 9(4) Article 10(3)
Article 10(1), first sub-paragraph Article 7, Annexes II and III
Article 10(1), second sub-paragraph Article 8
Article 10(2) Article 7, Annexes II and III
Article 10(3) -
Article 10(4) -
Article 10(5) Article 7, Annexes II and III
Article 10(6) Article 12
Article 11 Article 14
Article 12 Article 16
Article 13 Article 18
Annex I, point 1 Annex IV, point 2
Annex I, point 2 Annex V
Annex II Annex VI
Annex III, last paragraph Article 9(5)
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