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THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE apply across sectoral legislation in order to provide a
EUROPEAN UNION, coherent basis for revision or recasts of that legislation.
Directive 2004/108/EC should be adapted to that
Decision.
Having regard to the Treaty on the Functioning of the European
Union, and in particular Article 114 thereof,
(4) Member States should be responsible for ensuring that
radiocommunications, including radio broadcast
Having regard to the proposal from the European Commission, reception and the amateur radio service operating in
accordance with International Telecommunication
Union (ITU) radio regulations, electrical supply
After transmission of the draft legislative act to the national networks and telecommunications networks, as well as
parliaments, equipment connected thereto, are protected against elec
tromagnetic disturbance.
Whereas:
(6) This Directive covers products which are new to the
Union market when they are placed on the market;
(1) A number of amendments are to be made to Directive that is to say they are either new products made by a
2004/108/EC of the European Parliament and of the manufacturer established in the Union or products,
Council of 15 December 2004 on the approximation whether new or second-hand, imported from a third
of the laws of the Member States relating to electrom country.
agnetic compatibility and repealing Directive 89/
336/EEC (3). In the interests of clarity, that Directive
should be recast. (7) This Directive should apply to all forms of supply,
including distance selling.
since they are already regulated by Directive 1999/5/EC (18) In order to facilitate communication between economic
of the European Parliament and of the Council of operators, market surveillance authorities and consumers,
9 March 1999 on radio equipment and telecommuni Member States should encourage economic operators to
cations terminal equipment and the mutual recognition include a website address in addition to the postal
of their conformity (1). The electromagnetic compatibility address.
requirements in both Directives achieve the same level of
protection.
(19) The manufacturer, having detailed knowledge of the
(11) Aircraft or equipment intended to be fitted into aircraft design and production process, is best placed to carry
should not be covered by this Directive, since they are out the conformity assessment procedure. Conformity
already subject to special Union or international rules assessment should therefore remain solely the obligation
governing electromagnetic compatibility. of the manufacturer.
(12) This Directive should not regulate equipment which is (20) It is necessary to ensure that products from third
inherently benign in terms of electromagnetic compati countries entering the Union market comply with this
bility. Directive, and in particular that appropriate conformity
assessment procedures have been carried out by manu
facturers with regard to those apparatus. Provision should
(13) This Directive should not deal with the safety of therefore be made for importers to make sure that the
equipment, since that is dealt with by separate Union apparatus they place on the market comply with the
or national legislation. requirements of this Directive and that they do not
place on the market apparatus which do not comply
with such requirements or present a risk. Provision
(14) Manufacturers of equipment intended to be connected to should also be made for importers to make sure that
networks should construct such equipment in a way that conformity assessment procedures have been carried
prevents networks from suffering unacceptable degra out and that marking of apparatus and documentation
dation of service when used under normal operating drawn up by manufacturers are available for inspection
conditions. Network operators should construct their by the competent national authorities.
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
(21) When placing apparatus on the market, every importer
networks from suffering an unacceptable degradation of
should indicate on the apparatus his name, registered
service. The European standardisation organisations
trade name or registered trade mark and the postal
should take due account of that objective (including the
address at which he can be contacted. Exceptions
cumulative effects of the relevant types of electrom
should be provided for in cases where the size or
agnetic phenomena) when developing harmonised stan
nature of the apparatus does not allow it. This includes
dards.
cases where the importer would have to open the
packaging to put his name and address on the apparatus.
(15) Protection against electromagnetic disturbance requires
obligations to be imposed on the various economic oper
ators. Those obligations should be applied in a fair and (22) The distributor makes apparatus available on the market
effective way in order to achieve such protection. after it has been placed on the market by the manu
facturer or the importer and should act with due care
to ensure that its handling of the apparatus does not
(16) Economic operators should be responsible for the adversely affect the compliance of the apparatus.
compliance of apparatus with this Directive, in relation
to their respective roles in the supply chain, so as to
ensure a high level of protection of public interests
covered by this Directive, and to guarantee fair (23) Any economic operator that either places apparatus on
competition on the Union market. the market under his own name or trade mark or
modifies apparatus in such a way that compliance with
this Directive may be affected should be considered to be
the manufacturer and should assume the obligations of
(17) All economic operators intervening in the supply and the manufacturer.
distribution chain should take appropriate measures to
ensure that they only make available on the market
apparatus which are in conformity with this Directive.
It is necessary to provide for a clear and proportionate (24) Distributors and importers, being close to the market
distribution of obligations which correspond to the role place, should be involved in market surveillance tasks
of each economic operator in the supply and distribution carried out by the competent national authorities, and
chain. should be prepared to participate actively, providing
those authorities with all necessary information relating
(1) OJ L 91, 7.4.1999, p. 10. to the apparatus concerned.
29.3.2014 EN Official Journal of the European Union L 96/81
(25) Ensuring traceability of apparatus throughout the whole (30) The conformity assessment obligation should require the
supply chain helps to make market surveillance simpler manufacturer to perform an electromagnetic compati
and more efficient. An efficient traceability system bility assessment of apparatus, based on relevant
facilitates market surveillance authorities task of tracing phenomena, in order to determine whether or not it
economic operators who made non-compliant apparatus meets the essential requirements of this Directive.
available on the market. When keeping the information
required under this Directive for the identification of
other economic operators, economic operators should
not be required to update such information in respect (31) Where apparatus is capable of taking different configur
of other economic operators who have either supplied ations, the electromagnetic compatibility assessment
them with apparatus or to whom they have supplied should confirm whether the apparatus meets the
apparatus. essential 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
(26) Fixed installations, including large machines and and the configuration most susceptible to disturbance.
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 (32) It is not appropriate to carry out the conformity
apparatus, and vice versa. In terms of electromagnetic assessment of apparatus placed on the market for incor
compatibility, it is irrelevant whether the electromagnetic poration into a given fixed installation, and otherwise not
disturbance is produced by apparatus or by a fixed instal made available on the market, in isolation from the fixed
lation. Accordingly, fixed installations and apparatus installation into which it is to be incorporated. Such
should be subject to a coherent and comprehensive apparatus should therefore be exempted from the
regime of essential requirements. 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
(27) This Directive should be limited to the expression of the
fixed installation, identifying the electromagnetic
essential requirements. In order to facilitate conformity
compatibility characteristics of these installations should
assessment with those requirements it is necessary to
be sufficient to ensure exemption from the conformity
provide for a presumption of conformity for equipment
assessment procedure.
which is in conformity with harmonised standards that
are adopted in accordance with Regulation (EU)
No 1025/2012 of the European Parliament and of the
Council of 25 October 2012 on European Standard (33) Manufacturers should draw up an EU declaration of
isation (1) for the purpose of expressing detailed conformity to provide information required under this
technical specifications of those requirements. Directive on the conformity of an apparatus with this
Harmonised standards reflect the generally acknowledged Directive and with other relevant Union harmonisation
state of the art as regards electromagnetic compatibility legislation.
in the Union.
(37) One of the conformity assessment procedures set out in assessment tasks. Therefore, it is important that the
this Directive requires the intervention of conformity assessment of the competence and the performance of
assessment bodies, which are notified by the Member bodies to be notified and the monitoring of bodies
States to the Commission. already notified cover also activities carried out by
subcontractors and subsidiaries.
(51) In order to ensure uniform conditions for the implemen equipment to comply with an adequate level of electrom
tation of this Directive, implementing powers should be agnetic compatibility, cannot be sufficiently achieved by
conferred on the Commission. Those powers should be the Member States but can rather, by reason of its scale
exercised in accordance with Regulation (EU) and effects, be better achieved at Union level, the Union
No 182/2011 of the European Parliament and of the may adopt measures, in accordance with the principle of
Council of 16 February 2011 laying down the rules subsidiarity as set out in Article 5 of the Treaty on
and general principles concerning mechanisms for European Union. In accordance with the principle of
control by Member States of the Commissions exercise proportionality, as set out in that Article, this Directive
of implementing powers (1). does not go beyond what is necessary in order to achieve
that objective.
GENERAL PROVISIONS
(55) The Commission should, by means of implementing acts Article 1
and, given their special nature, acting without the appli
cation of Regulation (EU) No 182/2011, determine Subject matter
whether measures taken by Member States in respect of
non-compliant apparatus are justified or not. 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
(56) Member States should lay down rules on penalties level of electromagnetic compatibility.
applicable to infringements of the provisions of
national law adopted pursuant to this Directive and
ensure that those rules are enforced. The penalties Article 2
provided for should be effective, proportionate and
dissuasive. Scope
1. This Directive shall apply to equipment as defined in
Article 3.
(57) It is necessary to provide for reasonable transitional
arrangements that allow the making available on the
market and putting into service, without the need to
comply with further product requirements, of apparatus 2. This Directive shall not apply to:
that has already been placed on the market in accordance
with Directive 2004/108/EC before the date of appli
cation of national measures transposing this Directive. (a) equipment covered by Directive 1999/5/EC;
Distributors should therefore be able to supply
apparatus that has been placed on the market, namely
stock that is already in the distribution chain, before the (b) aeronautical products, parts and appliances as referred to in
date of application of national measures transposing this Regulation (EC) No 216/2008 of the European Parliament
Directive. and of the Council of 20 February 2008 on common rules
in the field of civil aviation and establishing a European
Aviation Safety Agency, and repealing Council Directive
(58) Since the objective of this Directive, namely to ensure the 91/670/EEC, Regulation (EC) No 1592/2002 and Directive
functioning of the internal market by requiring 2004/36/EC (2);
(c) radio equipment used by radio amateurs within the meaning (3) fixed installation means a particular combination of
of the Radio Regulations adopted in the framework of the several types of apparatus and, where applicable, other
Constitution of the International Telecommunication Union devices, which are assembled, installed and intended to
and the Convention of the International Telecommunication be used permanently at a predefined location;
Union (1), unless the equipment is made available on the
market;
(4) electromagnetic compatibility means the ability of
equipment to function satisfactorily in its electromagnetic
(d) equipment the inherent nature of the physical characteristics environment without introducing intolerable electrom
of which is such that: agnetic disturbances to other equipment in that
environment;
(i) it is incapable of generating or contributing to electrom
agnetic emissions which exceed a level allowing radio
and telecommunication equipment and other equipment (5) electromagnetic disturbance means any electromagnetic
to operate as intended; and phenomenon which may degrade the performance of
equipment; an electromagnetic disturbance may be elec
tromagnetic noise, an unwanted signal or a change in
(ii) it operates without unacceptable degradation in the the propagation medium itself;
presence of the electromagnetic disturbance normally
consequent upon its intended use;
(6) immunity means the ability of equipment to perform as
intended without degradation in the presence of an elec
(e) custom built evaluation kits destined for professionals to be tromagnetic disturbance;
used solely at research and development facilities for such
purposes.
(7) safety purposes means the purposes of safeguarding
For the purposes of point (c) of the first subparagraph, kits of human life or property;
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 (8) electromagnetic environment means all electromagnetic
on the market. phenomena observable in a given location;
3. Where, for the equipment referred to in paragraph 1, the (9) making available on the market means any supply of
essential requirements set out in Annex I are wholly or partly apparatus for distribution, consumption or use on the
laid down more specifically by other Union legislation, this Union market in the course of a commercial activity,
Directive shall not apply, or shall cease to apply, to that whether in return for payment or free of charge;
equipment in respect of such requirements from the date of
implementation of that Union legislation.
(10) placing on the market means the first making available of
4. This Directive shall not affect the application of Union or apparatus on the Union market;
national legislation regulating the safety of equipment.
(15) economic operators means the manufacturer, the auth (2) mobile installations defined as a combination of apparatus
orised representative, the importer and the distributor; and, where applicable, other devices, intended to be moved
and operated in a range of locations.
(17) harmonised standard means harmonised standard as Member States shall take all appropriate measures to ensure that
defined in point (c) of point 1 of Article 2 of Regulation equipment is made available on the market and/or put into
(EU) No 1025/2012; service only if it complies with this Directive when properly
installed, maintained and used for its intended purpose.
(19) national accreditation body means national accreditation 1. Member States shall not impede, for reasons relating to
body as defined in point 11 of Article 2 of Regulation (EC) electromagnetic compatibility, the making available on the
No 765/2008; market and/or the putting into service in their territory of
equipment which complies with this Directive.
(22) recall means any measure aimed at achieving the return of (b) measures taken for safety reasons to protect public telecom
apparatus that has already been made available to the end- munications networks or receiving or transmitting stations
user; when used for safety purposes in well-defined spectrum
situations.
5. Manufacturers shall ensure that apparatus which they have (a) keep the EU declaration of conformity and the technical
placed on the market bear a type, batch or serial number or documentation at the disposal of national market
other element allowing their identification, or, where the size or surveillance authorities for 10 years after the apparatus
nature of the apparatus does not allow it, that the required has been placed on the market;
information is provided on the packaging or in a document
accompanying the apparatus.
(b) further to a reasoned request from a competent national
authority, provide that authority with all the information
6. Manufacturers shall indicate, on the apparatus, their name, and documentation necessary to demonstrate the
registered trade name or registered trade mark and the postal conformity of the apparatus;
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 (c) cooperate with the competent national authorities, at their
manufacturer can be contacted. The contact details shall be in a request, on any action taken to eliminate the risks posed by
language easily understood by end-users and market surveillance the apparatus covered by the authorised representatives
authorities. mandate.
29.3.2014 EN Official Journal of the European Union L 96/87
Article 11 aspects of the essential requirements, provided that for the other
aspects of the essential requirements the procedure referred to
Cases in which obligations of manufacturers apply to in point (a) of the first paragraph is applied.
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 Article 15
obligations of the manufacturer under Article 7, where he
places apparatus on the market under his name or trade EU declaration of conformity
mark or modifies apparatus already placed on the market in
such a way that compliance with this Directive may be affected. 1. The EU declaration of conformity shall state that the
fulfilment of the essential requirements set out in Annex I has
been demonstrated.
Article 12
Identification of economic operators 2. The EU declaration of conformity shall have the model
Economic operators shall, on request, identify the following to structure set out in Annex IV, shall contain the elements
the market surveillance authorities: 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
(a) any economic operator who has supplied them with the apparatus is placed or made available on the market.
apparatus;
Article 13
Article 16
Presumption of conformity of equipment
General principles of the CE marking
Equipment which is in conformity with harmonised standards
or parts thereof the references of which have been published in The CE marking shall be subject to the general principles set out
the Official Journal of the European Union shall be presumed to be in Article 30 of Regulation (EC) No 765/2008.
in conformity with the essential requirements set out in Annex I
covered by those standards or parts thereof.
Article 17
Conformity assessment procedures for apparatus 1. The CE marking shall be affixed visibly, legibly and
indelibly to the apparatus or to its data plate. Where that is
Compliance of apparatus with the essential requirements set out not possible or not warranted on account of the nature of the
in Annex I shall be demonstrated by means of either of the apparatus, it shall be affixed to the packaging and to the accom
following conformity assessment procedures: panying documents.
Notification
3. The information required to enable apparatus to be used Member States shall notify the Commission and the other
in accordance with the intended purpose of the apparatus shall Member States of bodies authorised to carry out third-party
be included in the instructions accompanying the apparatus. conformity assessment tasks under this Directive.
Article 19 Article 21
1. Apparatus which has been made available on the market 1. Member States shall designate a notifying authority that
and which may be incorporated into a fixed installation shall be shall be responsible for setting up and carrying out the
subject to all relevant provisions for apparatus set out in this necessary procedures for the assessment and notification of
Directive. conformity assessment bodies and the monitoring of notified
bodies, including compliance with Article 26.
However, the requirements of Articles 6 to 12 and Articles 14 2. Member States may decide that the assessment and moni
to 18 shall not be compulsory in the case of apparatus which is toring referred to in paragraph 1 shall be carried out by a
intended for incorporation into a particular fixed installation national accreditation body within the meaning of and in
and is otherwise not made available on the market. accordance with Regulation (EC) No 765/2008.
3. A notifying authority shall be organised in such a way A conformity assessment body, its top level management and
that each decision relating to notification of a conformity the personnel responsible for carrying out the conformity
assessment body is taken by competent persons different assessment tasks shall not be directly involved in the design,
from those who carried out the assessment. manufacture or construction, the marketing, installation, use or
maintenance of those apparatus, or represent the parties
engaged in those activities. They shall not engage in any
4. A notifying authority shall not offer or provide any activity that may conflict with their independence of
activities that conformity assessment bodies perform or judgement or integrity in relation to conformity assessment
consultancy services on a commercial or competitive basis. activities for which they are notified. This shall in particular
apply to consultancy services.
A conformity assessment body shall have the means necessary harmonisation legislation and shall apply as general guidance
to perform the technical and administrative tasks connected the administrative decisions and documents produced as a result
with the conformity assessment activities in an appropriate of the work of that group.
manner and shall have access to all necessary equipment or
facilities.
Article 25
7. The personnel responsible for carrying out conformity Presumption of conformity of notified bodies
assessment tasks shall have the following: 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
(a) sound technical and vocational training covering all the have been published in the Official Journal of the European Union
conformity assessment activities in relation to which the it shall be presumed to comply with the requirements set out in
conformity assessment body has been notified; Article 24 in so far as the applicable harmonised standards
cover those requirements.
8. The impartiality of the conformity assessment bodies, their 3. Activities may be subcontracted or carried out by a
top level management and of the personnel responsible for subsidiary only with the agreement of the client.
carrying out the conformity assessment tasks shall be guar
anteed.
4. Notified bodies shall keep at the disposal of the notifying
authority the relevant documents concerning the assessment of
The remuneration of the top level management and personnel the qualifications of the subcontractor or the subsidiary and the
responsible for carrying out the conformity assessment tasks of work carried out by them under Annex III.
a conformity assessment body shall not depend on the number
of assessments carried out or on the results of those assess
ments. Article 27
11. Conformity assessment bodies shall participate in, or 3. Where the conformity assessment body concerned cannot
ensure that their personnel responsible for carrying out the provide an accreditation certificate, it shall provide the notifying
conformity assessment tasks are informed of, the relevant authority with all the documentary evidence necessary for the
standardisation activities and the activities of the notified body verification, recognition and regular monitoring of its
coordination group established under the relevant Union compliance with the requirements laid down in Article 24.
L 96/92 EN Official Journal of the European Union 29.3.2014
Article 28 Article 30
3. The notification shall include full details of the conformity 2. In the event of restriction, suspension or withdrawal of
assessment activities, the conformity assessment module or notification, or where the notified body has ceased its activity,
modules and apparatus concerned and the relevant attestation the notifying Member State shall take appropriate steps to
of competence. ensure that the files of that body are either processed by
another notified body or kept available for the responsible
notifying and market surveillance authorities at their request.
4. Where a notification is not based on an accreditation
certificate as referred to in Article 27(2), the notifying
Article 31
authority shall provide the Commission and the other
Member States with documentary evidence which attests to Challenge of the competence of notified bodies
the conformity assessment bodys competence and the
arrangements in place to ensure that that body will be 1. The Commission shall investigate all cases where it
monitored regularly and will continue to satisfy the doubts, or doubt is brought to its attention regarding, the
requirements laid down in Article 24. competence of a notified body or the continued fulfilment by
a notified body of the requirements and responsibilities to
which it is subject.
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 2. The notifying Member State shall provide the
a notification where an accreditation certificate is used or within Commission, on request, with all information relating to the
two months of a notification where accreditation is not used. basis for the notification or the maintenance of the competence
of the notified body concerned.
It shall assign a single such number even where the body is Article 32
notified under several Union acts.
Operational obligations of notified bodies
1. Notified bodies shall carry out conformity assessments in
2. The Commission shall make publicly available the list of accordance with the conformity assessment procedures provided
the bodies notified under this Directive, including the identifi for in Annex III.
cation numbers that have been assigned to them and the
activities for which they have been notified.
2. Conformity assessments shall be carried out in a propor
tionate manner, avoiding unnecessary burdens for economic
The Commission shall ensure that the list is kept up to date. operators.
29.3.2014 EN Official Journal of the European Union L 96/93
Conformity assessment bodies shall perform their activities activities covering the same apparatus with relevant information
taking due account of the size of an undertaking, the sector on issues relating to negative and, on request, positive
in which it operates, its structure, the degree of complexity of conformity assessment results.
the apparatus technology in question and the mass or serial
nature of the production process.
Article 35
In so doing they shall nevertheless respect the degree of rigour Exchange of experience
and the level of protection required for the compliance of the
apparatus with this Directive. The Commission shall provide for the organisation of exchange
of experience between the Member States national authorities
responsible for notification policy.
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 Article 36
a manufacturer, it shall require that manufacturer to take appro
priate corrective measures and shall not issue a certificate. Coordination of notified bodies
The Commission shall ensure that appropriate coordination and
cooperation between bodies notified under this Directive are put
4. Where, in the course of the monitoring of conformity in place and properly operated in the form of a sectoral group
following the issue of a certificate, a notified body finds that of notified bodies.
an apparatus no longer complies, it shall require the manu
facturer to take appropriate corrective measures and shall
suspend or withdraw the certificate if necessary.
Member States shall ensure that the bodies notified by them
participate in the work of that group, directly or by means of
designated representatives.
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.
CHAPTER 5
The market surveillance authorities shall inform the relevant objection has been raised by either a Member State or the
notified body accordingly. Commission in respect of a provisional measure taken by a
Member State, that measure shall be deemed justified.
(b) shortcomings in the harmonised standards referred to in 1. Without prejudice to Article 38, where a Member State
Article 13 conferring a presumption of conformity. makes one of the following findings, it shall require the relevant
economic operator to put an end to the non-compliance
concerned:
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 (a) the CE marking has been affixed in violation of Article 30
adopted and of any additional information at their disposal of Regulation (EC) No 765/2008 or of Article 17 of this
relating to the non-compliance of the apparatus concerned, Directive;
and, in the event of disagreement with the adopted national
measure, of their objections.
(b) the CE marking has not been affixed;
Article 41 When Member States adopt those measures, they shall contain a
reference to this Directive or be accompanied by such a
Committee procedure reference on the occasion of their official publication. They
shall also include a statement that references in existing laws,
1. The Commission shall be assisted by the Committee on regulations and administrative provisions to the Directive
Electromagnetic Compatibility. That committee shall be a repealed by this Directive shall be construed as references to
committee within the meaning of Regulation (EU) this Directive. Member States shall determine how such
No 182/2011. reference is to be made and how that statement is to be formu
lated.
Repeal
The committee may furthermore examine any other matter Directive 2004/108/EC is repealed with effect from 20 April
concerning the application of this Directive raised either by its 2016, without prejudice to the obligations of the Member States
chair or by a representative of a Member State in accordance relating to the time-limit for transposition into national law and
with its rules of procedure. the dates of application of the Directive set out in Annex V.
Article 42
References to the repealed Directive shall be construed as
Penalties references to this Directive and shall be read in accordance
with the correlation table in Annex VI.
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 Article 46
rules may include criminal penalties for serious infringements.
Entry into force and application
This Directive shall enter into force on the twentieth day
The penalties provided for shall be effective, proportionate and following that of its publication in the Official Journal of the
dissuasive. European Union.
L 96/96 EN Official Journal of the European Union 29.3.2014
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.
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.
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
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.
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 documentation 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:
(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 specifications applied. In the event of partly applied harmonised standards, the technical documentation
shall specify the parts which have been applied;
4. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing 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.
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.
29.3.2014 EN Official Journal of the European Union L 96/99
6. Authorised representative
The manufacturers 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 representative.
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:
(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;
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.
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--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.
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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 modifications 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.
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 manufacturers 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 obligations 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 manufacturing 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.
3.2. 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 manufacturers 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
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:
(1) It is optional for the manufacturer to assign a number to the declaration of conformity.
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ANNEX V
ANNEX VI
Correlation table
Article 3 Article 4
Article 4 Article 5
Article 5 Article 6
Article 6 Article 13
Article 7 Article 14
Article 12 Chapter 4
Article 13 Article 19
Article 14 Article 45
Article 15 Article 43
Article 16 Article 44
Article 17 Article 46
Article 18 Article 47
Annex I Annex I
29.3.2014 EN Official Journal of the European Union L 96/105
Annex VI Article 24
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.