CELEX: 52011PC0765
Language: en
Date: 2011-11-21
Title: Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the harmonisation of the laws of the Member States relating to electromagnetic compatibility

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		52011PC0765
		
			Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the harmonisation of the laws of the Member States relating to electromagnetic compatibility /* COM/2011/0765 final - 2011/0351 (COD) */
			
				
		
		
			
			   	EXPLANATORY MEMORANDUM

1.                      
context of the proposal

General context, reasons for and
objectives of this proposal 
This proposal is presented in the framework
of the implementation of the “goods package” adopted in 2008. It is part
of a package of proposals aligning ten product directives to Decision No
768/2008/EC establishing
a common framework for the marketing of products.
Union (EU) harmonisation legislation
ensuring the free movement of products has contributed considerably to the
completion and operation of the Single Market. It is based on a high level of
protection and provides economic operators with the means to demonstrate
conformity, thus ensuring free movement through trust in the products. 
Directive 2004/108/EC is an example of that
Union harmonisation legislation, ensuring the free movement of apparatus. It
sets out essential electromagnetic compatibility requirements that apparatus
must comply with in order to be made available on the EU market. These
essential requirements also apply to fixed installations. Manufacturers must demonstrate
that an apparatus has been designed and manufactured in compliance with the
essential requirements and affix the CE marking. The responsible persons for
fixed installations must also guarantee that fixed installations comply with
the essential requirements. 
Experience with the implementation of Union
harmonisation legislation has shown – on a cross-sector scale - certain
weaknesses and inconsistencies in the implementation and enforcement of this
legislation, leading to
–     
the presence of non-compliant or dangerous
products on the market and consequently a certain lack of trust in CE marking
–     
competitive disadvantages for economic operators
complying with the legislation as opposed to those circumventing the rules
–     
unequal treatment in the case of non-compliant
products and distortion of competition amongst economic operators due to
different enforcement practices
–     
differing practices in the designation of
conformity assessment bodies by national authorities
–     
problems with the quality of certain notified
bodies
Furthermore the regulatory environment has
become more and more complex, as frequently several pieces of legislation apply
simultaneously to one and the same product. Inconsistencies in these pieces of
legislation make it increasingly difficult for economic operators and
authorities to correctly interpret and apply that legislation.
To remedy these horizontal shortcomings in
Union harmonisation legislation observed across several industrial sectors, the
“New Legislative Framework” was adopted in 2008 as part of the goods
package. Its objective is to strengthen and
complete the existing rules and to improve practical aspects of their
application and enforcement. The New Legislative Framework (NLF) consists of
two complementary instruments, Regulation (EC) No 765/2008 on
accreditation and market surveillance and Decision No 768/2008/EC establishing
a common framework for the marketing of products.
The NLF Regulation has introduced rules on accreditation
(a tool for the evaluation of competence of conformity assessment bodies) and requirements
for the organisation and performance of market surveillance and controls of
products from third countries. Since 1 January 2010 these rules apply directly
in all Member States.
The NLF Decision sets out a common
framework for EU product harmonisation legislation. This framework consists of
the provisions which are commonly used in EU product legislation (e.g.
definitions, obligations of economic operators, notified bodies, safeguard
mechanisms, etc). These common provisions have been reinforced to ensure that
the directives can be applied and enforced more effectively in practice. New
elements, such as obligations on importers, have been introduced, which are
crucial for improving the safety of products on the market. 
The provisions of the NLF Decision and
those of the NLF Regulation are complementary and closely interlinked. The NLF
Decision contains the corresponding obligations for economic operators and
notified bodies allowing market surveillance authorities and authorities
responsible for notified bodies to properly perform the tasks imposed on them
by the NLF Regulation and to ensure an effective and consistent enforcement of
EU product legislation. 
However, unlike the NLF Regulation, the provisions
of the NLF Decision are not directly applicable. To ensure that all economic
sectors subject to Union harmonisation legislation benefit from the
improvements of the NLF, the provisions of the NLF Decision need to be
integrated into the existing product legislation.
A survey after the adoption of the goods
package in 2008 showed that a majority of Union harmonisation legislation on
products was due to be revised within the following 3 years, not only to
address the problems observed throughout all sectors but also for
sector-specific reasons. Any such revision would automatically include an
alignment of the legislation concerned to the NLF Decision since Parliament, Council
and Commission have committed themselves to use its provisions as much as
possible in future legislation on products in order to further the utmost
coherence of the regulatory framework. 
For a number of other Union harmonisation
directives, including Directive 2004/108/EC no revision for sector-specific
problems had been envisaged within this timeframe. To ensure that the problems
in relation to non-compliance and notified bodies are nevertheless addressed in
these sectors, and for the sake of consistency of the overall regulatory
environment on products, it was decided to align these directives within a
package to the provisions of the NLF Decision.
Consistency with other policies and
objectives of the Union
This initiative is in
line with the Single Market Act[1],
which has stressed the need to restore consumer confidence in the quality of
products on the market and the importance of reinforcing market surveillance.
Furthermore it supports
the Commission’s policy on Better Regulation and simplification of the
regulatory environment.

2.                      
consultation of interested parties and impact
assessment

Consultation of interested parties
The alignment of Directive 2004/108/EC to
the NLF Decision has been discussed with national experts responsible for the
implementation of this Directive, the notified body group, the administrative
cooperation group as well as in bilateral meetings with industry associations.
From June to October 2010 a public
consultation was organised that comprised all the sectors involved in this
initiative. It consisted of four targeted questionnaires for economic
operators, authorities, notified bodies and users and the Commission services
received 300 replies. The results are published at: 
http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-products/new-legislative-framework/index_en.htm
In addition to the general consultation a
specific SME consultation was carried out. 603 SMEs were consulted through the
Enterprise Europe Network in May/June 2010. The results are available at http://ec.europa.eu/enterprise/policies/single-market-goods/files/new-legislative-framework/smes_statistics_en.pdf
The consultation process revealed
widespread support for the initiative. There is unanimity on the need to
improve market surveillance and the system for assessing and monitoring
Notified Bodies. Authorities fully support the exercise because it will
strengthen the existing system and improve cooperation at EU level. Industry
expects a more level playing field resulting from more effective actions
against products that do not comply with the legislation, as well as a
simplification effect from the alignment of legislation. Certain concerns were
expressed on some obligations which are, however, indispensable for increasing
the efficiency of market surveillance. These measures will not entail
significant costs for industry, and the benefits resulting from improved market
surveillance should by far outweigh the costs. 
Collection and use of expertise
The impact assessment for this
implementation package has largely built on the impact assessment carried out
for the New Legislative Framework. In addition to the expertise collected and
analysed in that context, further consultation of sector-specific experts and
interest groups, as well as horizontal experts active in the area of technical
harmonisation, conformity assessment, accreditation and market surveillance,
has taken place.
Impact assessment 
Based on the information collected, the
Commission carried out an impact assessment which examined and compared three
options.
Option 1 - No changes to the current
situation
This option proposes no changes to the
current directive and relies exclusively on certain improvements that can be
expected from the NLF Regulation.
Option 2 – Alignment to the NLF Decision
by non-legislative measures
Option 2 considers the possibility of
encouraging a voluntary alignment to the provisions set out in the NLF Decision
by, e.g., presenting them as best practices in guidance documents.
Option 3 – Alignment to NLF Decision by
legislative measures
This option consists in integrating the
provisions of the NLF Decision into the existing directives.
Option 3 was
found to be the preferred option because
–     
it will improve the competitiveness of companies
and notified bodies taking their obligations seriously, as opposed to those
cheating on the system;
–     
it will improve the functioning of the internal
market by ensuring equal treatment of all economic operators, notably importers
and distributors, as well as notified bodies;
–     
it does not entail significant costs for
economic operators and notified bodies; for those who are already acting
responsibly, no extra costs or only negligible costs are expected;
–     
it is considered more effective than option 2:
due to the lack of enforceability of option 2 it is questionable that the
positive impacts would materialise under that option;
–     
options 1 and 2 do not provide answers to the
problem of inconsistencies in the regulatory framework and therefore have no
positive impact on the simplification of the regulatory environment.

3.                      
Main elements of the proposal
3.1.                
Horizontal definitions

The proposal
introduces harmonised definitions of terms which are commonly used throughout
Union harmonisation legislation and should therefore be given a consistent
meaning throughout that legislation. 

3.2.                
Obligations of economic operators and
traceability requirements

The proposal clarifies the obligations of
manufacturers and authorised representatives and introduces obligations for
importers and distributors. Importers must verify that the manufacturer has
carried out the applicable conformity assessment procedure and has drawn up a
technical documentation. They must also make sure with the manufacturer that
this technical documentation can be made available to authorities upon request.
Furthermore importers must verify that apparatus are correctly marked and
accompanied by the required documentation. They must keep a copy of the
Declaration of conformity and indicate their name and address on the product, or
where this is not possible on the packaging or the accompanying documentation.
Distributors must verify that apparatus bear the CE marking, the name of the
manufacturer and of the importer, if relevant, and that it is accompanied by
the required documentation and instructions.
Importers and distributors must cooperate
with market surveillance authorities and take appropriate actions when they
have supplied non-compliant apparatus.
Enhanced traceability obligations are introduced for all economic operators. Apparatus have to bear
the manufacturer’s name and address and a number allowing to identify and link
the apparatus to its technical documentation. When an apparatus is imported the
importer’s name and address must also be on the apparatus. Furthermore every
economic operator must be able to identify towards authorities the economic
operator who has supplied him with an apparatus or to whom he has supplied an
apparatus.

3.3.                
Harmonised standards

Compliance with harmonised standards
provides a presumption of conformity with the essential requirements. On 1 June
2011 the Commission adopted a proposal for a Regulation on European
Standardisation[2]
that sets out a horizontal legal framework for European standardisation. The
proposal for the Regulation contains inter alia provisions on standardisation
requests from the Commission to the European Standardisation Organisations, on
the procedure for objections to harmonised standards and on stakeholder
participation in the standardisation process. Consequently the provisions of Directive
2004/108/EC which cover the same aspects have been deleted in this proposal for
reasons of legal certainty. 
The provision conferring presumption of
conformity to harmonised standards has been modified to clarify the extent of
the presumption of conformity when standards only partially cover the essential
requirements.

3.4.                
Conformity assessment and CE marking

Directive 2004/108/EC has selected the
appropriate conformity assessment procedures which manufacturers have to apply
in order to demonstrate that their apparatus comply with the essential
requirements. The proposal aligns these procedures to their updated versions
set out in the NLF Decision maintaining certain specific elements, regarding to
the electromagnetic compatibility conformity assessment. The Directive also
introduces a model for the EU Declaration of conformity.
General principles of the CE marking are set
out in Article 30 of Regulation 765/2008, while the detailed provisions on the
affixing of the CE marking to apparatus have been inserted in this proposal.

3.5.                
Notified Bodies

The proposal reinforces the notification
criteria for notified bodies. It clarifies that subsidiaries or subcontractors
must also comply with the notification requirements. Specific requirements for
notifying authorities are introduced, and the procedure for notification of
notified bodies is revised. The competence of a notified body must be
demonstrated by an accreditation certificate. Where accreditation has not been
used to evaluate the competence of a notified body, the notification must
comprise the documentation demonstrating how the competence of that body has
been evaluated. Member States will have the possibility to object to a
notification.

3.6.                
Market surveillance and the safeguard clause
procedure

The proposal revises the existing safeguard
clause procedure. It introduces a phase of information exchange between Member
States, and specifies the steps to be taken by the authorities concerned, when
a non-compliant apparatus is found. A real safeguard clause procedure – leading
to a Decision at Commission level on whether a measure is justified or not - is
only launched when another Member State objects to a measure taken against an
apparatus. Where there is no disagreement on the restrictive measure taken, all
Member States must take the appropriate action on their territory.

4.                      
legal elements of the proposal

Legal basis
The proposal is based on Article 114 of the
Treaty on the Functioning of the European Union.
Subsidiarity principle
The internal market is a competence that is
shared between the Union and the Member States. The subsidiarity principle
arises in particular with regard to the newly added provisions aiming at the
improvement of effective enforcement of Directive 2004/108/EC namely, the
importer and distributor obligations, the traceability provisions, the
provisions on the assessment and notification of notified bodies, and the
enhanced cooperation obligations in the context of the revised market
surveillance and safeguard procedures. 
Experience with the enforcement of the legislation
has shown that measures taken at national level have led to divergent
approaches and to a different treatment of economic operators inside the EU,
which undermines the objective of this directive. If actions are taken at
national level to address the problems, this risks creating obstacles to the
free movement of goods. Furthermore action at national level is limited to the
territorial competence of a Member State. In view of the increasing
internationalisation of trade, the number of cross-border cases is constantly
rising. Coordinated action at EU level can much better achieve the objectives
set, and will in particular render market surveillance more effective. Hence it
is more appropriate to take action at EU level.
As regards the problem of inconsistencies
throughout the directives, this is a problem which can only be solved by the EU
legislator.
Proportionality
In accordance with the principle of
proportionality, the proposed modifications do not go beyond what is necessary
to achieve the objectives set. 
The new or modified obligations do not
impose unnecessary burdens and costs on industry - especially on small and
medium sized enterprises - or administrations. Where modifications have been
identified to have negative impacts, the analysis of the impacts of the option
serves to provide the most proportionate response to the problems identified. A
number of modifications concern the improvement of clarity of the existing
Directive without introducing new requirements that entail added cost. 
Legislative technique used
The alignment to the NLF Decision requires
a number of substantive amendments to the provisions of Directive 2004/108/EC.
To ensure the readability of the amended text the technique of recasting has
been chosen in line with the Interinstitutional Agreement of 28 November 2001
on a more structured use of the recasting technique for legal acts[3]. 
The changes made to the provisions of
Directive 2004/108/EC concern: the definitions, the obligations of economic
operators, the presumption of conformity provided by harmonised standards, the
declaration of conformity, CE marking, notified bodies, the safeguard clause
procedure and the conformity assessment procedures.
The proposal does not change the scope of
Directive 2004/108/EC and the essential requirements. 

5.                      
budgetary implications

This proposal does not have any
implications for the EU budget.

6.                      
additional information

Repeal of existing legislation
The adoption of the proposal will lead to
repeal of Directive 2004/108/EC.
European Economic Area
The proposal concerns the EEA and should
therefore be extended to the European Economic Area.
ê 2004/108
(adapted)
2011/0351 (COD)
Proposal for a
DIRECTIVE OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
on theapproximation Ö harmonisation Õ of the laws of
the Member States relating to electromagnetic compatibilityand repealing Directive 89/336/EEC
(Recast)
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, Ö on the
Functioning of the European Union, Õ and in
particular Article 95 Ö 114 Õ thereof,
Having regard to the proposal from the
European Commission,
After transmission of the draft legislative
act to the national Parliaments,
Having regard to the opinion of the
European Economic and Social Committee[4],
Acting in accordance with the ordinary
legislative procedure,
Whereas:
ê 2004/108
recital 1 (adapted)
Council
Directive 89/336/EEC of 3 May 1989 on the approximation of laws of the Member
States relating to electromagnetic compatibility[5] 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.
ò new 
(1)              
A number of substantive
changes are to be made to 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[6].
In the interests of clarity, that Directive should be recast.
(2)              
Regulation (EC) No
765/2008 of the European Parliament and of the Council of 9 July 2008 setting
out the requirements for accreditation and market surveillance relating to the
marketing of products and repealing Regulation (EEC) No 339/93[7] lays down rules on the
accreditation of conformity assessment bodies, provides a framework for the
market surveillance of products and for controls on products from third
countries, and lays down the general principles of the CE marking.
(3)              
Decision No
768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a
common framework for the marketing of products, and repealing Council Decision
93/465/EEC[8]
lays down a common framework of general principles and reference provisions
intended to apply across the legislation harmonising the conditions for the
marketing of products in order to provide a coherent basis for revision or
recasts of that legislation. Directive 2004/108/EC should therefore be adapted
to that Decision.
ê 2004/108
recital 2
(4)              
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.
ê 2004/108
recital 3 (adapted)
(5)              
Provisions of national law ensuring protection
against electromagnetic disturbanceshould Ö need to Õ be harmonised
in order to guarantee the free movement of electrical and electronic apparatus
without lowering justified levels of protection in the Member States.
ê 2004/108
recital 4
(6)              
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.
ê 2004/108
recital 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.
ê 2004/108
recital 6 (adapted)
(7)              
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 Ö Union Õ 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.
ê 2004/108
recital 7 (adapted)
(8)              
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[9].
The electromagnetic compatibility requirements in both Directives achieve the
same level of protection.
ê 2004/108
recital 8 (adapted)
(9)              
Aircraft or equipment intended to be fitted into
aircraft should not be covered by this Directive, since they are already
subject to special Community Ö Union Õ or
international rules governing electromagnetic compatibility.
ê 2004/108
recital 9
(10)          
This Directive need not regulate equipment which
is inherently benign in terms of electromagnetic compatibility.
ê 2004/108
recital 10 (adapted)
(11)          
This Directive should not deal with the safety
of equipment, since that is dealt with by separate Community Ö Union Õ or national
legislation.
ê 2004/108 recital
11 (adapted)
(12)          
Where this Directive regulates apparatus, it
should refer to finished apparatus commercially available for the first time on the Community Ö placed on
the Õ market.
Certain components or sub-assemblies should, under certain conditions, be
considered to be apparatus if they are made available to the end-user.
ê 2004/108
recital 12 (adapted)
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[10]. 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[11].
ê 2004/108
recital 13 (adapted)
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.
ê 2004/108
recital 14
(13)          
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.
ê 2004/108
recital 15 (adapted)
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.
ò new
(14)          
Economic operators should
be responsible for the compliance of products, in relation to their respective
roles in the supply chain, so as to ensure a high level of protection of public
interests, and the protection of end-users, and to guarantee fair competition
on the Union market.
(15)          
All economic operators
intervening in the supply and distribution chain should take appropriate
measures to ensure that they only make available on the market products which
are in conformity with this Directive. It is necessary to provide for a clear
and proportionate distribution of obligations which correspond to the role of
each operator in the supply and distribution process.
(16)          
The manufacturer, having
detailed knowledge of the design and production process, is best placed to
carry out the complete conformity assessment procedure. Conformity assessment
should therefore remain the obligation of the manufacturer alone.
(17)          
It is necessary to ensure
that products from third countries entering the Union market comply with the
requirements of this Directive, and in particular that appropriate assessment
procedures have been carried out by manufacturers with regard to those
products. Provision should therefore be made for importers to make sure that
the products they place on the market comply with the requirements of this
Directive and that they do not place on the market products which do not comply
with such requirements or present a risk. Provision should also be made for
importers to make sure that conformity assessment procedures have been carried
out and that product marking and documentation drawn up by manufacturers are
available for inspection by the supervisory authorities.
(18)          
The distributor makes a
product available on the market after it has been placed on the market by the
manufacturer or the importer and should act with due care to ensure that its
handling of the product does not adversely affect the compliance of the
product.
(19)          
When placing a product on
the market, every importer should indicate on the product his name and the
address at which he can be contacted. Exceptions should be provided for in
cases where the size or nature of the product does not allow it. This includes
cases where the importer would have to open the packaging to put his name and
address on the product.
(20)          
Any economic operator
that either places a product on the market under his own name or trademark or
modifies a product in such a way that compliance with the requirements of this
Directive may be affected should be considered to be the manufacturer and
should assume the obligations of the manufacturer.
(21)          
Distributors and
importers, being close to the market place, should be involved in market
surveillance tasks carried out by the competent national authorities, and
should be prepared to participate actively, providing those authorities with
all necessary information relating to the product concerned.
(22)          
Ensuring traceability of
a product throughout the whole supply chain helps to make market surveillance
simpler and more efficient. An efficient traceability system facilitates market
surveillance authorities' task of tracing economic operators who made
non-compliant products available on the market.
ê 2004/108
recital 18 (adapted)
(23)          
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.
ò new
(24)          
This Directive should be
limited to the expression of the essential requirements. In order to facilitate
conformity assessment with those requirements it is necessary to provide for
presumption of conformity for equipment which is in conformity with harmonised
standards that are adopted in accordance with Regulation (EU) No [../..] of the European Parliament
and of the Council of […..] on European Standardisation and amending Council
Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC,
97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/105/EC and 2009/23/EC of the
European Parliament and of the Council[12] for the purpose of expressing detailed
technical specifications of those requirements.
(25)          
Regulation (EU) No [../..] [on European
Standardisation] provides for a procedure for objections to harmonised
standards where those standards do not entirely satisfy the requirements of
this Directive. 
(26)          
In order to enable
economic operators to demonstrate and the competent authorities to ensure that
products made available on the market conform to the essential requirements it
is necessary to provide for conformity assessment procedures. Decision No
768/2008/EC establishes modules for conformity assessment procedures, which
include procedures from the least to the most stringent, in proportion to the
level of risk involved and the level of safety required. In order to ensure
inter-sectoral coherence and to avoid ad-hoc variants, conformity assessment
procedures should be chosen from among those modules.
ê 2004/108
recital 16
(27)          
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.
ê 2004/108
recital 17
(28)          
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;. iIn
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.
ê 2004/108
recital 20
(29)          
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.
ò new
(30)          
Manufacturers should draw
up an EU declaration of conformity to provide detailed information on the
conformity of an apparatus with the requirements of this Directive and of the
other relevant Union harmonisation legislation. 
(31)          
The CE marking,
indicating the conformity of a product, is the visible consequence of a whole
process comprising conformity assessment in a broad sense. General principles
governing the CE marking are set out in Regulation (EC) No 765/2008. Rules
governing the affixing of the CE marking should be laid down in this Directive.
ê 2004/108
recital 19 (adapted)
(32)          
Due to their specific characteristics, fixed
installations need not be subject to theaffixation Ö affixing Õ of the ‘CE’
marking or to the Ö EU Õ declaration of
conformity.
ò new
(33)          
One of the conformity
assessment procedures set out in this Directive requires the intervention of
conformity assessment bodies, which are notified by the Member States to the
Commission.
(34)          
Experience has shown that
the criteria set out in Directive 2004/108/EC that conformity assessment bodies
have to fulfil to be notified to the Commission are not sufficient to ensure a
uniformly high level of performance of notified bodies throughout the Union. It
is, however, essential that all notified bodies perform their functions to the
same level and under conditions of fair competition. That requires the setting
of obligatory requirements for conformity assessment bodies wishing to be
notified in order to provide conformity assessment services.
(35)          
In order to ensure a
consistent level of conformity assessment quality it is also necessary to set
requirements for notifying authorities and other bodies involved in the
assessment, notification and monitoring of notified bodies.
(36)          
If a conformity
assessment body demonstrates conformity with the criteria laid down in
harmonised standards, it should be presumed to comply with the corresponding
requirements set out in this Directive.
(37)          
The system set out in
this Directive should be complemented by the accreditation system provided for
in Regulation (EC) No 765/2008. Since accreditation is an essential means of
verifying the competence of conformity assessment bodies, it should also be
used for the purposes of notification.
(38)          
Transparent accreditation
as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of
confidence in conformity certificates, should be considered by the national
public authorities throughout the Union as the preferred means of demonstrating
the technical competence of conformity assessment bodies. However, national
authorities may consider that they possess the appropriate means of carrying
out this evaluation themselves. In such cases, in order to ensure the
appropriate level of credibility of evaluations carried out by other national
authorities, they should provide the Commission and the other Member States
with the necessary documentary evidence demonstrating the compliance of the
conformity assessment bodies evaluated with the relevant regulatory
requirements.
(39)          
Conformity assessment
bodies frequently subcontract parts of their activities linked to the
assessment of conformity or have recourse to a subsidiary. In order to
safeguard the level of protection required for the products to be placed on the
Union market, it is essential that conformity assessment subcontractors and
subsidiaries fulfil the same requirements as notified bodies in relation to the
performance of conformity assessment tasks. Therefore, it is important that the
assessment of the competence and the performance of bodies to be notified and
the monitoring of bodies already notified cover also activities carried out by
subcontractors and subsidiaries.
(40)          
It is necessary to
increase the efficiency and transparency of the notification procedure and, in
particular, to adapt it to new technologies so as to enable online
notification.
(41)          
Since notified bodies may
offer their services throughout the Union, it is appropriate to give the other
Member States and the Commission the opportunity to raise objections concerning
a notified body. It is therefore important to provide for a period during which
any doubts or concerns as to the competence of conformity assessment bodies can
be clarified before they start operating as notified bodies.
(42)          
In the interests of
competitiveness, it is crucial that notified bodies apply the conformity
assessment procedures without creating unnecessary burdens for economic
operators. For the same reason, and to ensure equal treatment of economic
operators, consistency in the technical application of the conformity
assessment procedures needs to be ensured. That can best be achieved through
appropriate coordination and cooperation between notified bodies.
(43)          
In order to ensure legal
certainty, it is necessary to clarify that rules on Union market surveillance
and control of products entering the Union market provided for in Regulation
(EC) No 765/2008 apply to equipment covered by this Directive. This Directive
should not prevent Member States from choosing the competent authorities to
carry out those tasks.
(44)          
Directive 2004/108/EC
already provides for a safeguard procedure. In order to increase transparency
and to reduce processing time, it is necessary to improve the existing
safeguard clause procedure, with a view to making it more efficient and drawing
on the expertise available in Member States.
(45)          
The existing system
should be supplemented by a procedure under which interested parties are
informed of measures intended to be taken with regard to products presenting a
risk to aspects of public interest protection. It should also allow market
surveillance authorities, in cooperation with the relevant economic operators,
to act at an earlier stage in respect of such products.
(46)          
Where the Member States
and the Commission agree as to the justification of a measure taken by a Member
State, no further involvement of the Commission should be required, except
where non-compliance can be attributed to shortcomings of a harmonised
standard.
(47)          
The Member States should
lay down rules on penalties applicable to infringements of the national
provisions adopted pursuant to this Directive and ensure that they are
implemented. Those penalties should be effective, proportionate and dissuasive.
(48)          
It is necessary to
provide for transitional arrangements that allow making available on the market
and putting into service of apparatus that has already been placed on the
market in accordance with Directive 2004/108/EC.
ê 2004/108
recital 22 (adapted)
(49)          
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 Ö Union Õ level, the Community Ö Union Õ may adopt
measures, in accordance with the principle of subsidiarity as set out in
Article 5 of the Treaty Ö on
European Union Õ . 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.
ò new
(50)          
The
obligation to transpose this Directive into national law should be confined to
those provisions which represent a substantive change as compared with Directive
2004/108/EC. The obligation to transpose the provisions which are unchanged
arises under Directive 2004/108/EC.
(51)          
This
Directive should be without prejudice to the obligations of the Member States
relating to the time-limits for transposition into national law and application
of Directive 2004/108/EC set out in Annex V.
ê 2004/108
recital 21 (adapted)
A transitional period
is necessary in order to ensure that manufacturers and other concerned parties
are able to adapt to the new regulatory regime.
ê 2004/108
(adapted)
HAVE ADOPTED THIS DIRECTIVE:
CHAPTER 1I
GENERAL PROVISIONS
Article 1
Subject matter and scope
ê 2004/108 
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. 
ê 2004/108 (adapted)
Article 2
Ö Scope Õ
1. This Directive applies Ö shall
apply Õ to equipment
as defined in Article 23.
2. This Directive shall not apply to Ö the
following Õ :
ê 2004/108 
(a)          equipment covered by Directive
1999/5/EC;
(b)          aeronautical products, parts and
appliances as referred to in Regulation (EC) No 1592/2002 216/2008 of the European Parliament and of the Council[13] of 15 July 2002 on common rules in
the field of civil aviation and establishing a European Aviation Safety Agency[14];
ê 2004/108
(adapted)
(c)          radio equipment used by radio
amateurs within the meaning of the Radio Regulations adopted in the framework
of the Constitution Ö of the
International Telecommunication Union Õ and Ö the Õ Convention of
the ITU Ö International
Telecommunication Union Õ[15], 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.
(d)          3. This Directive shall
not apply to equipment the inherent nature of
the physical characteristics of which is such that:
ê 2004/108
(ai)    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
ê 2004/108
(adapted)
(bii)   it will operate Ö operates Õ without
unacceptable degradation in the presence of the electromagnetic disturbance
normally consequent upon its intended use.
Ö For the
purposes of point (c) of the first subparagraph, 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. Õ
43.
Where, for the equipment referred to in paragraph 1, the essential requirements
referred to Ö set out Õ in
Annex I are wholly or partly laid down more specifically by other Ö Union Õ 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.
ê 2004/108
(adapted)
54.
This Directive shall not affect the application of Ö Union Õ Community or
national legislation regulating the safety of equipment.
Article32 [Article
R1 of Decision No 768/2008/EC]
Definitions 
ê 2004/108
(adapted)
For the purposes of this Directive, the following
definitions shall apply:
ê 2004/108 
(a1)        ‘equipment’ means any apparatus or fixed installation;
(b2)        ‘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; 
(c3)        ‘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; 
(d4)        ‘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;
ê 2004/108 (adapted) 
(e5)        ‘electromagnetic disturbance’ means any electromagnetic
phenomenon which may degrade the performance of equipmentÖ , including, Õ . An electromagnetic disturbance may be electromagnetic noise, an unwanted signal or a change in the
propagation medium itself;
ê 2004/108 
(f6)         ‘immunity’ means the ability of equipment to perform as
intended without degradation in the presence of an electromagnetic disturbance;
(g7)        ‘safety purposes’ means the purposes of safeguarding human
life or property;
(h8)        ‘electromagnetic environment’ means all electromagnetic
phenomena observable in a given location.;
ò new
(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 manufactures apparatus or has apparatus
designed or manufactured, and markets that apparatus under his name or
trademark;
(12)        'authorised
representative' means any natural or legal person established 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 Article 2(1)(c) of Regulation
(EU) No [../..] [on European
Standardisation];
(18)        'accreditation'
means accreditation as defined
in Article 2(10) of
Regulation (EC) No 765/2008;
(19)        'national
accreditation body' means
national accreditation body as defined in Article 2(11) of Regulation (EC) No 765/2008;
(20)        'conformity
assessment' means the process demonstrating whether the requirements 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;
(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)        '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;
(25)        'Union
harmonisation legislation' means any Union legislation harmonising the
conditions for the marketing of products.
ê 2004/108
(adapted)
2. For the purposes of this
Directive Ö point (2)
of the first subparagraph Õ the following
shall be deemed to be Ö considered Õ an apparatus within the meaning of paragraph 1(b) :
ê 2004/108 (adapted)
ð new
              (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 43
Placing ð Making available ï on the market and/or putting into service
Member States shall take all appropriate
measures to ensure that equipment is placed ð made available ï 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 54
Free movement of equipment
1. Member States shall not impede, for
reasons relating to electromagnetic compatibility, the placing ð making available ï 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 ð made available ï 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 65
Essential requirements
ê 2004/108 (adapted)
The equipment referred to in Article 1 shall meet
the essential requirements set out in Annex I.
ò new 
CHAPTER 2
OBLIGATIONS OF
ECONOMIC OPERATORS
Article 7
[Article R2 of Decision No 768/2008/EC]
Obligations of
manufacturers
1. When placing
their apparatus on the market and/or putting them into service, 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 and Annex III
and carry out the conformity assessment procedure referred to in Article 15 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.
Changes in apparatus design or characteristics and changes in the harmonised
standards or in technical specifications by reference to which conformity of
apparatus is declared shall be adequately taken into account.
5. Manufacturers
shall ensure that their apparatus 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 their name, registered trade name or registered trade mark and
the address at which they can be contacted on the apparatus or, where that is
not possible, on its packaging or in a document accompanying the apparatus. The
address must indicate a single point at which the manufacturer can be
contacted.
7. Manufacturers
shall ensure that the apparatus is accompanied by instructions and other 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.
8. Manufacturers
who consider or have reason to believe that apparatus which they have placed on
the market and/or put into service is not in conformity with this Directive
shall immediately take the necessary corrective measures 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 and/or put it into service 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 necessary to demonstrate
the conformity of the apparatus, 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 and/or put into service.
Article 8
[Article R3 of Decision No 768/2008/EC]
Authorised
representatives
1. A manufacturer
may, by a written mandate, appoint an authorised representative.
The obligations
laid down in Article 7(1) and the drawing up of technical documentation 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 documentation at the disposal of
national 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
[Article R4 of Decision No 768/2008/EC]
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 has been carried out by the manufacturer. They shall
ensure that the 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
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 their name, registered trade name or registered trade mark and
the address at which they can be contacted on the apparatus or, where that is
not possible, on its packaging or in a document accompanying the apparatus.
4. Importers
shall ensure that the apparatus is accompanied by instructions and other 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 apparatus is under their responsibility, 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 apparatus which they have placed on the
market is not in conformity with the requirements of 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 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 necessary to demonstrate
the conformity of apparatus 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 10
[Article R5 of Decision No 768/2008/EC]
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 other information referred to in Article 18 in a
language which can be easily understood by consumers and other end-users in the
Member State in which the apparatus is to be made available on the market
and/or to be put into service, and that the manufacturer and the importer have complied
with the requirements set out in Article
7(5) and (6) and
Article 9(3).
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, 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 the requirements of 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 authorities of the Member States in
which they made the apparatus available 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 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
[Article R6 of Decision No 768/2008/EC]
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 trademark
or modifies apparatus already placed on the market in such a way that
compliance with the requirements of this Directive may be affected.
Article 12
[Article R7 of Decision No 768/2008/EC]
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 a period of 10 years after they have been supplied with the
apparatus and for a period of 10 years after they have supplied the apparatus.
ê 2004/108
(adapted)
CHAPTER 3III
Ö CONFORMITY
OF EQUIPMENT Õ
Article 613 [Article
R8 of Decision No 768/2008/EC]
Harmonised
standards Ö Presumption
of conformity Õ 
ê 2004/108
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.
ê 2004/108
(adapted)
2. The compliance of eEquipment
Ö which is
in conformity Õ with the relevant
harmonised standards Ö or parts
thereof the Õ whose
references Ö of
which Õ have been
published in the Official Journal of the European Union shall Ö be
presumed to be in Õ raise a presumption, on the part of the Member
States, of conformity with the essential requirements
Ö covered
by those standards or parts thereof, set out Õ 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.
ò new
[Where a
harmonised standard satisfies the requirements which it covers and which are
set out in Annex I or Article 24, the Commission shall publish the references
of those standards in the Official Journal of the European Union.]
ê 2004/108 (adapted)
Article 147
Conformity assessment procedure for
apparatus
Compliance of apparatus with the essential
requirements referred to Ö set
out Õ in Annex I
shall be demonstrated by means of the procedure Ö either of
the following procedures Õ: 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.
Ö (a) internal
production control set out in Annex II; Õ
Ö (b) EU
type examination that is followed by Conformity to type based on internal
production control set out in Annex III. Õ
ê 2004/108 
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
ò new 
Article 15
[Article R10 of Decision No 768/2008/EC]
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 to
this Directive and it shall be continuously updated. It shall be translated
into the language or languages required by the Member State in which market the
apparatus is placed or made available. 
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 acts concerned including the publication references.
4. By drawing up
the EU declaration of conformity, the manufacturer shall assume responsibility
for the compliance of the apparatus. 
Article 16 [Article
R11 of Decision No 768/2008/EC]
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.
Article 17
[Article R12 of Decision No 768/2008/EC]
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.
ê 2004/108
(adapted)
Article 189
Other marks and information
ê 2004/108 
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.
ê 2004/108
(adapted)
13.
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 Ö essential Õ requirements
set out in Annex I, point 1 of Annex I.
24.
Apparatus for which compliance with the protection Ö essential Õ requirements Ö set out
in point 1 of Annex I Õ is not ensured
in residential areas shall be accompanied by a clear indication of this Ö such Õ restriction of
use, where appropriate also on the packaging.
35.
The information required to enable apparatus to be used in accordance with the
intended purpose of the apparatus shall be contained Ö included Õ in the
instructions accompanying the apparatus.
ê 2004/108 
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.
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.
ê 2004/108
(adapted)
ð new
FIXED
INSTALLATIONS
Article 1913
Fixed installations
1. Apparatus which has been placed ð made available ï on the market and which may be incorporated into a fixed
installation is Ö shall
be Õ subject to all
relevant provisions for apparatus set out in this Directive.
However, the provisions Ö requirements Õ of Articles 5, 7, 8 and 9 Ö 6 to 11
and Articles 15 to 18 Õ shall not be
compulsory in the case of apparatus which is intended for incorporation into a given Ö particular Õ fixed
installation and is otherwise not commercially Ö made Õ available Ö on the
market Õ. 
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 Ö also Õ include the
information referred to in Articles 9(1)
and (2) 7(5),
7(6) and 9(3).
ê 2004/108 
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.
ê 2004/108
(adapted)
Where non-compliance is established, the
competent authorities may impose appropriate measures to bring the fixed
installation into compliance with the protection Ö essential Õ 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.
ò new
CHAPTER 4
NOTIFICATION
OF CONFORMITY ASSESSMENT BODIES 
Article 20
[Article R13 of Decision No 768/2008/EC]
Notification
of Notified Bodies
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
[Article R14 of Decision No 768/2008/EC]
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 (1) to (6). 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
[Article R15 of Decision No 768/2008/EC]
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.
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
[Article R16 of Decision No 768/2008/EC]
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
[Article R17 of Decision No 768/2008/EC]
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 and have legal
personality.
3. A conformity
assessment body shall be a third-party body independent 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 authorised 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 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, objectivity 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 professional 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.
It 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 activities 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;
(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 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 assessment personnel shall be guaranteed.
The remuneration
of the top level management and assessment personnel 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 assessment
personnel are informed of, the relevant standardisation activities and the
activities of the notified body coordination group established under the
relevant Union harmonisation legislation and apply as general guidance the
administrative decisions and documents produced as a result of the work of that
group.
Article 25
[Article R18 of Decision No 768/2008/EC]
Presumption of
conformity
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
[Article R20 of Decision No 768/2008/EC]
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 established.
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
[Article R22 of Decision No 768/2008/EC]
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. That
application shall be accompanied by a description of the conformity assessment
activities, the conformity assessment module or modules and the apparatus or
apparatuses 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
[Article R23 of Decision No 768/2008/EC]
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 or
apparatuses 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 accreditation 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. 
6. The Commission
and the other Member States shall be notified of any subsequent relevant
changes to the notification.
Article 29
[Article R24 of Decision No 768/2008/EC]
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 allocated to
them and the activities for which they have been notified.
The Commission
shall ensure that that list is kept up to date.
Article 30
[Article R25 of Decision No 768/2008/EC]
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 notification, 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 authorities at their request.
Article 31
[Article R26 of Decision No 768/2008/EC]
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 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 inform the notifying Member State
accordingly and request it to take the necessary corrective measures, including
de-notification if necessary.
Article 32
[Article R27 of Decision No 768/2008/EC]
Operational
obligations of notified bodies
1. Notified
bodies shall carry out conformity assessments in accordance with the conformity
assessment procedure 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 technical specifications have not been
met by a manufacturer, it shall require that manufacturer to take appropriate
corrective measures and shall not issue a conformity 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
[Article R28 of Decision No 768/2008/EC]
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 and conditions for notification;
(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.
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[Article
R29 of Decision No 768/2008/EC]
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
[Article R30 of Decision No 768/2008/EC]
Coordination
of notified bodies
The Commission
shall ensure that appropriate coordination and cooperation 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 representatives.
CHAPTER 5
UNION MARKET
SURVEILLANCE AND CONTROL OF APPARATUS ENTERING THE UNION MARKET AND
SAFEGUARD PROCEDURES
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
[Article R31 of Decision No 768/2008/EC]
Procedure for
dealing with apparatus presenting a risk at national level
1. Where the
market surveillance authorities of one Member State have taken action pursuant
to Article 20 of Regulation (EC) No 765/2008, or where they 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 the
requirements laid down in this Directive. The relevant economic operators shall
cooperate as necessary with the market surveillance authorities.
Where, in the
course of that evaluation, 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
appropriate corrective action 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.
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.
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 subparagraph 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 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 reasons:
(a) failure of
the apparatus to meet the requirements relating to aspects of public interest
protection covered by this Directive; 
(b) shortcomings
in the harmonised standards referred to in Article 12 conferring a presumption
of conformity.
6. Member States
other than the Member State initiating the procedure 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 notified national
measure, of their objections.
7. Where, within
2 months of receipt of the information referred to in 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 are taken in respect of the
apparatus concerned without delay.
Article 39
[Article R32 of Decision No 768/2008/EC]
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 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 decide 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
measures necessary to ensure that the non-compliant apparatus is withdrawn from
their market, and shall inform the Commission accordingly. If the national
measure is considered unjustified, the Member State concerned shall withdraw
the 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 Article 38(5)(b) of this
Directive, the Commission
shall apply the procedure provided for in Article [8] of Regulation (EU) No [../..] [on European
Standardisation].
Article 40
[Article R34 of Decision No 768/2008/EC]
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.
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.
ê 2004/108
(adapted)
CHAPTER IV6
Ö TRANSITIONAL ANDÕ FINAL
PROVISIONS
ò new
Article 41
Penalties
Member States
shall lay down rules on penalties applicable to infringements of the national
provisions adopted pursuant to this Directive and shall take all measures
necessary to ensure that they are enforced. 
The penalties
provided for shall be effective, proportionate and dissuasive. 
Member States
shall notify those provisions to the Commission by [the date set out in the
second subparagraph of Article 43(1)] at the latest and shall notify it
without delay of any subsequent amendment affecting them.
ê 2004/108 (adapted)
ð new
Article 4215
Transitional provisions
Member States
shall not impede the placing ð making available ï 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 ð covered by Directive 2004/108/EC
which is in conformity with that Directive and which was placed on the market before
[the date set out in the second subparagraph of Article 43(1)] ï .
ê 2004/108
(adapted)
Article 4316
Transposition
1. Member States shall adopt and publish Ö by
[insert date - 2 years after adoption] at the latest Õ , the
laws, regulations and administrative provisions necessary to comply with this Directive Ö Article 3
first subparagraph points (9) to (25), Article 4, Article 5(1), Articles 7 to
12, Articles 15 to 17, Article 19 (1) first subparagraph, Articles 20 to 42, and
Annexes II, III and IV. Õ by 20 January 2007. They shall forthwith inform Ö communicate
to Õ the Commission
thereof Ö the text
of those provisions and a correlation table between those provisions and this
Directive Õ.
They shall apply those provisions as from 20 July 2007 Ö [day
after date mentioned in first subparagraph] Õ.
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. ÖThey 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. Õ
2. Member States shall communicate to the
Commission the texts of the Ö main Õ provisions of
national law which they adopt in the field covered by this Directive.
Article 4414
Repeal
Directive 89/336/EEC 2004/108/EC is hereby repealed as from 20
July 2007 Ö with
effect from [the date set out in the second subparagraph of Article 43(1)],
without prejudice to the obligations of the Member States relating to the
time-limit for transposition into national law and application of the said
Directive set out in Annex V. Õ
References to Ö the
repealed Õ Directive 89/336/EEC shall
be construed as references to this Directive and should Ö shall Õ be read in
accordance with the correlation table set out in Annex VII.
Article 4517
Entry into force
This Directive shall enter into force on
the twentieth day after Ö following
that of Õ its
publication in the Official Journal of the European Union.
ê
Article 1, Article 2, Article 3 first
subparagraph, points (1) to (8) and second subparagraph, Article 5(2) and (3), Article
6, Article 13 first subparagraph, Article 19 (3) and Annex I shall apply from
[the date set out in the second subparagraph of Article 43(1)].
ê 2004/108
Article 4618
Addressees
This Directive
is addressed to the Member States.
Done at […],
For the European Parliament                       For
the Council
The
President                                                 The President
ê 2004/108
(adapted)
ANNEX I
ESSENTIAL REQUIREMENTS REFERRED TO IN ARTICLE 5
1. Protection Ö Essential Õ requirements
ê 2004/108
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
ê 2004/108
(adapted)
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 Ö essential Õ requirements
set out in Ppoint
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.
ê 2004/108
(adapted)
ANNEX II
CONFORMITY
ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 7
ê 2004/108
(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.
ò new
1. Internal
production control is the conformity assessment procedure whereby the
manufacturer performs 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 and fulfils the
obligations laid down in points 2, 3 and 4, and ensures and declares on his
sole responsibility that the apparatus concerned satisfy the requirements of
this Directive.
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.
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. 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:
— a general
description of the apparatus;
— a list of the
harmonised standards and/or other relevant technical specifications the
references of which have been published in the Official Journal of the
European Union, applied in full or in part, and descriptions of the
solutions adopted to meet the essential requirements of this Directive where
those harmonised standards have not been applied. In the event of partly
applied harmonised standards, the technical documentation shall specify the
parts which have been applied;
— results of
design calculations made, examinations carried out, etc; and
— test reports.
3. 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 2 and with the requirements of the
legislative instruments that apply to them.
4. CE marking and
EU declaration of conformity
4.1. The
manufacturer shall affix the CE marking to each individual apparatus that
satisfies the applicable requirements of this Directive.
4.2. 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 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.
5. Authorised
representative
The
manufacturer's obligations set out in point 4 may be fulfilled by his
authorised representative, on his behalf and under his responsibility, provided
that they are specified in the mandate.
ê 2004/108
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.
ò new
Part A
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 requirements of
this Directive.
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 and
supporting evidence 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
in the Union.
3. The
manufacturer shall lodge an application for EU-type examination with a single
notified body of his choice.
The application
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)      a list of
the harmonised standards and/or other relevant technical specifications the
references of which have been published in the Official Journal of the European
Union, applied in full or in part, and descriptions of the solutions adopted to
meet the essential requirements of this Directive where those harmonised
standards have not been applied. In the event of partly applied harmonised
standards, the technical documentation shall specify the parts which have been
applied;
(iii)     results of
design calculations made, examinations carried out, etc.; and
(iv)     test
reports;
(d)        the
supporting evidence for the adequacy of the technical design solution. This
supporting evidence shall mention any documents that have been used, in
particular where the relevant harmonised standards and/or technical
specifications have not been applied in full. The supporting evidence shall
include, where necessary, the results of tests carried out by the appropriate
laboratory of the manufacturer, or by another testing laboratory on his behalf
and under his responsibility.
4. The notified
body shall examine the technical documentation and supporting evidence to
assess the adequacy of the technical design of the apparatus.
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. The certificate shall contain the name and address of the
manufacturer, the conclusions of the examination, the conditions (if any) for
its validity and the necessary data for identification of the approved type.
The certificate may have one or more annexes attached.
The certificate
and its annexes shall contain all relevant information to allow the conformity
of manufactured 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 modifications to the approved
type that may affect the conformity of the apparatus with the essential
requirements of the legislative instrument or the conditions for validity of
the certificate. Such modifications shall require additional approval in the
form of an addition to the original EU-type examination certificate.
8. Each notified
body shall inform its notifying authorities 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
authorities the list of certificates and/or any additions thereto refused,
suspended or otherwise restricted.
Each notified
body shall inform the other notified bodies concerning the EU-type examination
certificates and/or any additions thereto which it has refused, withdrawn,
suspended or otherwise restricted, and, upon request, concerning the
certificates and/or additions thereto which it has issued. 
The Commission,
the Member States and the other notified bodies may, on request, obtain a copy
of the 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 the 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
manufacturer's authorised representative may lodge the application referred to
in point 3 and fulfill the obligations set out in points 7 and 9, provided that
they are specified in the mandate.
Part B
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. CE marking and
EU declaration of conformity
3.1. The manufacturer
shall affix the required CE marking set out in this Directive 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 an 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.
ê 2004/108
(adapted)
ANNEX IV
TECHNICAL
DOCUMENTATION AND EC Ö EU Õ DECLARATION OF CONFORMITY
ê 2004/108
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.
ò new
1. No … (unique
identification of the apparatus):
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 (or installer):
4. Object of the
declaration (identification of apparatus allowing traceability. It may include
a photograph, where appropriate):
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 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):
ê 2004/108
(adapted)
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.
ê 2004/108
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.
ê
ANNEX V
List of time-limits for transposition
into national law and application
(referred to in Article 44)
 Directive || Time-limit for transposition || Date of application 
 2004/108/EC || 20.1.2007 || 20.7.2007 
ê 2004/108 (adapted)
ANNEX VII
 CORRELATION TABLE 
 Directive 89/336/EEC Ö2004/108/ECÕ || 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) 
 Ö Article 1(1) Õ || Ö Article 1 and Article 2(1) Õ 
 Ö Article 1(2) Õ || Ö Article 2(2) Õ 
 Ö Article 1(3) Õ || Ö Article 2(2)(d) Õ 
 Ö Article 1(4) Õ || Ö Article 2(3) Õ 
 Ö Article 1(5) Õ || Ö Article 2(4) Õ 
 Ö Article 2(1)(a) Õ || Ö Article 3(1) Õ 
 Ö Article 2(1)(b) Õ || Ö Article 3(2) Õ 
 Ö Article 2(1)(c) Õ || Ö Article 3(3) Õ 
 Ö Article 2(1)(d) Õ || Ö Article 3(4) Õ 
 Ö Article 2(1)(e) Õ || Ö Article 3(5) Õ 
 Ö Article 2(1)(f) Õ || Ö Article 3(6) Õ 
 Ö Article 2(1)(g) Õ || Ö Article 3(7) Õ 
 Ö Article 2(1)(h) Õ || Ö Article 3(8) Õ 
 Ö Article 2(2) Õ || Ö Article 3, last paragraph Õ 
 Ö Article 3 Õ || Ö Article 4 Õ 
 Ö Article 4 Õ || Ö Article 5 Õ 
 Ö Article 5 Õ || Ö Article 6 Õ 
 Ö Article 6 Õ || Ö Article 13 Õ 
 Ö Article 7 Õ || Ö Article 14 Õ 
 Ö Article 8 Õ || Ö Article 16 and Article 17 Õ 
 Ö Article 9(1) Õ || Ö Article 7(5) Õ 
 Ö Article 9(2) Õ || Ö Article 7(6) Õ 
 Ö Article 9(3) Õ || Ö Article 18(1) Õ 
 Ö Article 9(4) Õ || Ö Article 18(2) Õ 
 Ö Article 9(5) Õ || Ö Article 18(3) Õ 
 Ö Article 10 and Article 11 Õ || Ö Article 37, Article 38, and Article 39Õ 
 Ö Article 12 and Annex VI Õ || Ö Chapter IV Õ 
 Ö Article 13 Õ || Ö Article 19 Õ 
 Ö Article 14 Õ || Ö Article 44 Õ 
 Ö Article 15 Õ || Ö Article 42 Õ 
 Ö Article 16 Õ || Ö Article 43 Õ 
 Ö Article 17 Õ || Ö Article 45 Õ 
 Ö Article 18 Õ || Ö Article 46 Õ 
 Ö Annex I Õ || Ö Annex I Õ 
 Ö Annex II Õ || Ö Annex II Õ 
 Ö Annex III Õ || Ö Annex III Õ 
 Ö Annex IV Õ || Ö Annex IV Õ 
 Ö Annex V Õ || Ö Article 16 and Article 17 Õ 
 Ö Annex VI Õ || Ö Chapter 4 Õ 
 Ö Annex VII Õ || Ö Annex VI Õ 
[1]               Communication from the Commission to the European
Parliament, the Council, the Economic and Social Committee and the Committee of
the Regions, COM(2011) 206 final.
[2]               COM(2011) 315 final: Proposal for a Regulation of the
European Parliament and of the Council on European Standardisation and amending
Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC,
95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/105/EC and 2009/23/EC
of the European Parliament and of the Council.
[3]               OJ C 77, 28.3.2002, p. 1.
[4]               OJ C 220, 16.9.2003, p. 13.
[5]               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).
[6]               OJ L 390, 31.12.2004, p. 24
[7]               OJ L 218, 13.8.2008, p. 30.
[8]               OJ L 218, 13.8.2008, p. 82.
[9]               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).
[10]             OJ C 136,
4.6.1985, p. 1.
[11]             OJ L 204,
21.7.1998, p. 37. Directive as last amended by the 2003 Act of Accession.
[12]             OJ L […], […], p. […]
[13]             OJ L 79, 19.3.2008, p. 1
[14]             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).
[15]             Constitution and Convention of
the International Telecommunication Union adopted by the Additional
Plenipotentiary Conference (Geneva, 1992) as amended by the Plenipotentiary
Conference (Kyoto, 1994).