CELEX: 52012PC0584
Language: en
Date: 2012-10-17
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 the making available on the market of radio equipment

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		52012PC0584
		
			Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment /* COM/2012/0584 final - 2012/0283 (COD) */
			
				
		
		
			
			   	EXPLANATORY MEMORANDUM
1.           CONTEXT OF THE PROPOSAL
·      Context, objectives and grounds for the proposal
The R&TTE Directive, 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, establishes a framework for the placing on the
market, free movement and putting into service in the EU of radio equipment and
telecommunications terminal equipment. The Directive entered into force in 1999
and has been crucial to achieving an internal market in this area. 
The Directive includes essential
requirements for the protection of health and safety, of electromagnetic
compatibility and for the avoidance of harmful interference. These requirements
are translated into technical requirements within non-mandatory harmonised
standards, as in other ‘New Approach’ legislation. The regulatory approach is
considered to remain valid, a fundamental revision of the Directive is
therefore not necessary. Nevertheless, experience in the operation of the
Directive has highlighted a number of issues to be addressed[1].
The main objectives of the draft proposal are:
–              
To improve the level of compliance with the
requirements in the Directive, and to increase the confidence of all
stakeholders in the regulatory framework;
–              
To clarify and simplify the Directive, including
some limited adaptations of scope, so as to facilitate its application and
eliminate unnecessary burden for economic operators and public authorities.
The proposed revision also allows to better
integrate the Directive with other related EU legislation managed by DGConnect,
in particular the Radio Spectrum Decision[2].
The proposed text is built on the alignment of the Directive with the new
legislative framework for the marketing of products (NLF), with Regulation No
182/2011 on the Commission’s exercise of implementing powers and with the
Treaty on the Functioning of the European Union (TFEU). 
The proposal is based on Articles 26
(Internal Market) and 114 (Approximation of Laws) of the TFEU. 
·      Existing provisions in the area of the proposal
The R&TTE Directive fully harmonises
the placing on the EU market of the products falling within its scope.
Only equipment complying with the requirements of the Directive may be placed
on the market, and Member States may not introduce further restrictions
addressing at national level the same requirements, namely the protection of health and safety, electromagnetic compatibility, and
the avoidance of harmful interference. Other EU legislation on environmental
aspects also applies to these products, in particular the Directives on RoHS[3],
WEEE[4] and Batteries[5], as well as
implementing measures under the EcoDesign Directive[6].
Putting into service and use of radio
equipment is subject to national regulation. When exercising this competence,
Member States must comply with applicable EU law, in particular:
–              
The general framework for spectrum policy set
out in the Radio Spectrum Policy Programme[7];
–              
General criteria laid down in Directive
2002/21/EC (Framework Directive[8]) within the regulatory
framework for electronic communications;
–              
Conditions for authorisations for the use of
spectrum laid down in Directive 2002/20/EC (Authorisation Directive[9])
within the regulatory framework for electronic communications;
–              
Implementing measures under Decision 676/2002/EC
(Radio Spectrum Decision[10]) harmonising the
technical conditions for the use of certain spectrum bands in the EUand that are
binding on all Member States. Examples of bands harmonised at EU level include
the bands for GSM, UMTS and short-range devices;
–              
Consistency with the other policies and
objectives of the Union.
The proposal is
consistent with the principles of the Commission’s ‘Smart Regulation’ policy[11], with the policy for Europe
2020, in particular as regards the regulatory review foreseen within the policy
for an Innovation Union[12],
as well as with the Radio Spectrum Policy Programme[13].
The initiative is consistent with the New
Legislative Framework package approved in 2008, composed of Regulation 765/2008
on accreditation and market surveillance and of Decision 768/2008 establishing
a common framework for the marketing of products. The Decision provides (Article
2) that its provisions are to be used when legislation is drafted or revised.
2.           RESULTS OF CONSULTATIONS WITH THE
INTERESTED PARTIES AND IMPACT ASSESSMENTS
·      Consultation of interested parties
A first public consultation on the
operation of the Directive took place in 2007. Issues identified through this
consultation were included in the Second Progress Report on the operation of
the Directive[14].
The Commission conducted a further public
consultation in 2010 focusing on the impact of some of the measures under
consideration. The Commission received contributions from 122 respondents,
including 50 SMEs, 36 other economic operators, national authorities, notified
bodies, and standardisation bodies[15].

·      Collection and use of expertise
During 2009, a external study was conducted
on the impact of different options addressing the need to improve traceability
of products and their compliance with the requirements in the Directive[16]. 
Overall, there is a high level of consensus
and support for aligning the Directive with the New Legislative Framework
package and for clarifying and simplifying the Directive. Opinions are more
divided on the possible introduction of a requirement to register products
prior to their placing on the market, and on some measures for administrative
simplification 
3.           LEGAL ELEMENTS OF THE PROPOSAL
·      Legal basis
Articles 26 and 114 TFEU.
·      Subsidiarity and proportionality principles
Action at EU level is necessary in order to
adapt, clarify or simplify provisions of Internal Market legislation in this
area. The proposal harmonises essential and administrative requirements
compliance with which enables access to the EU market, and its advantages compared
to multiple similar measures by Member States acting individually are clear.
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 as
having negative impacts, their analysis has made it possible 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.
·      Choice of instrument
The proposal is to replace current
Directive 1999/5/EC with a new Directive, to be transposed by Member States by
way of national legal instruments.
4.           BUDGETARY IMPLICATION
The proposal is compatible with the current
multiannual financial framework: all measures or actions included in the
proposed directive are consistent and compatible with the current and the next
multiannual financial framework (2014 to 2020) as proposed by the Commission.
The proposal includes the possibility of
requiring registration of certain categories of radio equipment prior to their
placing on the market. Were this possibility to come into effect, a database
should be put in place and administered by the Commission. The available
estimation of costs includes an investment of €300000 and an annual maintenance
cost of €30000.
5.           OPTIONAL ELEMENTS 
·      Simplification and reduction of administrative costs
The proposal aims to clarify the
application of the Directive and to eliminate unnecessary administrative burden
for businesses and administrations by increasing spectrum flexibility and
easing administrative procedures for spectrum use. It is part of the Commission’s
rolling programme for updating and simplifying acquis communautaire and
its Work and Legislative Programme under reference 2009/ENTR/021.
·      Review
The proposal requires the Commission to
review the operation of the Directive and report thereon 4 years after the
entry into force of the Directive and every five years thereafter
·      Information from Member States
Member States shall inform the Commission on
the transposition of the Directive and send to the Commission a report on its
application three years after the entry into force of the Directive and every
two years thereafter.
·      European Economic Area
The proposed act is of relevance to the EEA
and should therefore extend thereto.
·      Detailed explanation of the proposal
The most significant elements of the
proposal for a revision of the Directive are the following:
1.           Alignment with Decision
768/2008/EC on a common framework for the marketing of products:
–              
Article 2 includes the definitions set out in
chapter R1 of Decision 768/2008/EC
–              
Articles 10-to-15 include the obligations of
economic operators set out in chapter R2 of Decision 768/2008/EC
–              
Article 17 and Annexes III, IV and V include
three modules for conformity assessment set out in Annex II of Decision
768/2008/EC
–              
Articles 22-to-38 include the obligations for
the notification of conformity assessment bodies set out in chapter R4 of
Decision 768/2008/EC
–              
Articles 39-to-43 include the simplified
safeguard procedures set out in chapter R5 of Decision 768/2008/EC
2.           Article 2(1) sets out a
new definition of ‘radio equipment’ which demarcates the modified scope of the
Directive: this includes all and only equipment which intentionally transmits
signals using radio spectrum, whether for the purpose of communication or
other. The essential requirement in Article 3(2) has been correspondingly
adapted and only refers to transmitted signals.
In consequence, the proposed new title for the
Directive is: “Directive on the harmonisation of the laws of the Member States
relating to the making available on the market of radio equipment”
3.           Article 3(3) (a) makes it
possible to require radio equipment to interoperate with accessories such as
chargers
4.           Article 3(3) (g) makes it
possible to require software-defined radio equipment to ensure that only
compliant combinations of software and hardware come together. Article 4 makes
it possible to adopt measures to avoid that this regulatory requirement creates
barriers to competition in the market for third-party software
5.           Article 5 introduces the
possibility to require the registration within a central system of products
within categories showing low levels of compliance, on the basis of information
on compliance provided by Member States in accordance with Article 47(1)
6.           Article 7 clarifies the
relation between the R&TTE Directive and EU and national legislation on the
use of radio spectrum
7.           Simplification and
reduction of administrative obligations: 
–              
The new definition of radio equipment set out in
Article 2(1) establishes a clear demarcation of scope with Directive
2004/108/EC (the EMC Directive[17]);

–              
Pure receivers and fixed-line terminals cease to
fall within the scope of the Directive, falling instead within the scope of
Directive 2004/108/EC and Directive 2006/95/EC[18],
or depending on their voltage falling within the scope of Directive 2004/108/EC
and Directive 2001/95/EC[19];
this entails some reduction of administrative obligations;
–              
The requirement to notify the placing on the
market of equipment using frequency bands which are not EU-wide harmonised
(current Article 6(4)) is removed;
–              
The obligation to affix an equipment class
identifier on the product (current Annex VII(5)) is removed;
–              
The requirement to affix CE marking on user
instructions (current Annex VII(3)) is removed;
–              
Requirements supporting competition in the
market for terminals (current Articles 4(2), 7(3)-to(5)) are removed from the
text of the Directive. Similar requirements are in force under Directive
2008/63/EC[20].
8.           Alignment with the Treaty
on the Functioning of the European Union and with Regulation No 182/2011 on the
Commission’s exercise of implementing powers:
–              
The procedures for the exercise of implementing
and delegated powers are laid out in Articles 44 (Committee procedure) and 45
(Exercise of the delegation)
–              
Implementing powers are proposed in Article 8(3)
(determination of equipment classes) and Article 10(9) (presentation of
information on geographical area for use and on restrictions to use of radio
equipment)
–              
Delegated powers are proposed in Article 2(3)
(adaptation to technical progress of Annex II listing some equipment falling or
not within the definition of radio equipment), Article 3(3) (additional
essential requirements), Article 4(2) (provision of information on the
compliance of software-defined radio equipment), and Article 5(2) (requirement
to register radio equipment within some categories)
2012/0283 (COD)
Proposal for a
DIRECTIVE OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
on the harmonisation of the laws of the
Member States relating to the making available on the market of radio equipment

(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the
Functioning of the European Union, and in particular Article 114 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
Economic and Social Committee[21],
After consulting the European Data
Protection Supervisor[22],
Acting in accordance with the ordinary
legislative procedure,
Whereas:
(1)       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[23] has been substantially amended several
times. Since further amendments are to be made, it should be replaced in the
interests of clarity. 
(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[24] 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[25] 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 1999/5/EC should therefore be adapted to that Decision. 
(4)       The essential requirements in Directive 1999/5/EC which are
relevant to fixed-line terminal equipment, i.e. the protection of health and
safety and the protection of electromagnetic compatibility, are appropriately
covered by Directive 2006/95/EC of the European Parliament and of the Council
of 12 December 2006 on the harmonisation of the laws of the Member States
relating to electrical equipment designed for use within certain voltage limits[26]
and 2004/108/EC of the European Parliament and of the Council of 15 December
2004 on the approximation of the laws of Member States relating to
electromagnetic compatibility and repealing Directive 89/336/EEC[27]. This Directive should
therefore not apply to fixed-line terminal equipment.
(5)       Competition issues in the
market for terminal equipment are appropriately covered by Commission Directive
2008/63/EC of 20 June 2008 on competition in the markets in telecommunications
terminal equipment[28],
in particular through the obligation for national regulatory authorities to
ensure the publication of details of technical interface specifications for
network access. It is therefore not necessary to include in this Directive requirements
facilitating competition in the market for terminal equipment covered by
Directive 2008/63/EC. 
(6)       Equipment which
intentionally transmits radio waves in order to serve its purpose makes
systematic use of radio spectrum. In order to ensure an efficient use of
spectrum so as to avoid harmful interference, all such equipment should fall
within the scope of this Directive, whether equipment is capable of
communication or not.
(7)       Experience has shown the
difficulty of establishing whether some products fall within the scope of
Directive 1999/5/EC. In particular, in respect of products resulting from
technological progress and presenting difficulties of categorisation, it is
necessary to identify categories of products which fall or not within the
definition of radio equipment. In order to supplement or amend certain
non-essential elements of this Directive, the power to adopt acts in accordance
with Article 290 of the Treaty on the Functioning of the European Union should
be delegated to the Commission in respect of amendments of Annex II so as to
adapt it to technical progress.
(8)       The essential requirements
in the area of safety laid down by Directive 2006/95/EC are sufficient to cover
radio equipment, and should therefore be the reference and made applicable by
virtue of this Directive. In order to avoid unnecessary duplications of
provisions, other than the essential requirements, Directive 2006/95/EC should
not apply to radio equipment.
(9)       The essential requirements
in the area of electromagnetic compatibility laid down by Directive 2004/108/EC
are sufficient to cover radio equipment, and should therefore be the reference
and made applicable by virtue of this Directive. In order to avoid unnecessary
duplications of provisions, other than essential requirements, , Directive 2004/108/EC
should not apply to radio equipment.
(10)     Efficient use of the radio
spectrum, according to the state of the art, should be ensured so as to avoid
harmful interference. 
(11)     Although receivers do not
themselves cause harmful interference, reception capabilities are an
increasingly important factor in ensuring the efficient use of radio spectrum
by way of an increased resilience of receivers against interference and
unwanted signals on the basis of the essential requirements of Directive
2004/108/EC.
(12)     Receiver capabilities of
receive-only equipment are subject to the essential requirements of Directive
2004/108/EC in particular with regard to unwanted signals resulting from the
efficient use of shared or adjacent frequency bands, and it is therefore not
necessary to include such equipment within the scope of this Directive.
(13)     In some cases interworking
via networks with other radio equipment and connection with interfaces of the
appropriate type throughout the Union may be necessary. Interoperability
between radio equipment and accessories such as chargers may simplify use of
radio equipment and reduce unnecessary waste.
(14)     The protection of personal
data and privacy of users of radio equipment and the protection from fraud may
be enhanced by particular features of radio equipment. Radio equipment should
therefore in appropriate cases be designed in such a way that it supports those
features.
(15)     Radio equipment can be
instrumental in providing access to emergency services. Radio equipment should
therefore in appropriate cases be designed in such a way that it supports those
features required for access to those services.
(16)     Radio equipment is
important to the well-being and employment of people with disabilities who
represent a substantial and growing proportion of the population of Member
States. Radio equipment should therefore in appropriate cases be designed in
such a way that disabled people may use it without or with only minimal
adaptation. 
(17)     The compliance of some
categories of radio equipment with the essential requirements may be affected
by the inclusion of software or modification of its existing software. The user,
the radio equipment or a third party should only be able to load software into
the radio equipment where this does not compromise the subsequent compliance of
the radio equipment with the applicable essential requirements.
(18)     It is necessary to provide
for a possibility to introduce supplementary requirements addressing needs
related to interoperability, user privacy, fraud prevention, use by users with
a disability, access to emergency services or the prevention of non-compliant combinations
of software and radio equipment. In order to supplement or amend certain
non-essential elements of this Directive, the power to adopt acts in accordance
with Article 290 of the Treaty on the Functioning of the European Union should
be delegated to the Commission in respect of specification of categories or
classes of radio equipment that need to comply with additional essential
requirements on interoperability, user privacy, fraud prevention, use by users
with a disability, access to emergency services or the prevention of
non-compliant combinations of software and radio equipment. 
(19)     Verification by radio
equipment of the compliance of its combination with software should not be
abused in order to prevent its use with software provided by independent
parties. The availability to public authorities, manufacturers and users of
information on the compliance of intended combinations of radio equipment and
software should contribute to facilitate competition. In order to supplement or
amend certain non-essential elements of this Directive, the power to adopt acts
in accordance with Article 290 of the Treaty on the Functioning of the European
Union should be delegated to the Commission in respect of specifying categories
or classes of radio equipment for which manufacturers need to provide information
on the compliance of intended combinations of radio equipment and software, the
information to be communicated and the rules on making that information
available.
(20)     A requirement to register
in a central database radio equipment to be placed on the market may enhance
the efficiency and effectiveness of market surveillance and therefore
contribute to ensure a high level of compliance with the Directive. Such a
requirement entails additional burden to economic operators and should
therefore be introduced only for those categories of radio equipment where a
high level of compliance has not been attained. In order to supplement or amend
certain non-essential elements of this Directive, the power to adopt acts in
accordance with Article 290 of the Treaty on the Functioning of the European
Union should be delegated to the Commission in respect of identifying the
relevant categories of radio equipment to be registered in a central database
on the basis of information on compliance to be provided by Member States, and of
specifying the information to be registered, the rules applicable for
registration and affixation of the registration number. 
(21)     Radio equipment which
complies with the relevant essential requirements should be allowed to
circulate freely. Such equipment should be allowed to be put into service and
used for its intended purpose, where applicable in accordance with rules on
authorisations for the use of radio spectrum and the provision of the service
concerned.
(22)     In order to avoid
unnecessary barriers to trade in radio equipment within the Internal Market of
the Union, Member States should notify under 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[29] to other Member States and to
the Commission their projects in the area of technical regulations, such as
radio interfaces, but not where these allow Member States to comply with
binding Union acts such as implementing measures under Decision No 676/2002/EC
of the European Parliament and of the Council of 7 March 2002 on a regulatory
framework for radio spectrum policy in the European Community[30]. 
(23)     The provision of
information on the equivalence of regulated radio interfaces and their
conditions of use reduces barriers for the access of radio equipment to the
internal market. The Commission should therefore assess and establish the
equivalence of those regulated radio interfaces and make available such
information in the form of radio equipment classes.
(24)     In accordance with
Commission Decision 2007/344/EC of 16 May 2007 on harmonised availability of
information regarding spectrum use within the Community[31], Member States have to use the
ERO Frequency Information System (EFIS) set up by the European
Radiocommunications Office (ERO) in order to make comparable information
regarding the use of spectrum in each Member State available to the public via
the Internet. Manufacturers can search in EFIS frequency information for all Union
Member States prior to the placing on the market of radio equipment and so
evaluate whether and under which conditions such radio equipment may be used
within each Member State. Therefore in this Directive there is no need to
include additional provisions, such as prior notification, allowing to inform
manufacturers of the conditions of use of radio equipment using non-harmonised
frequency bands. 
(25)     For the purpose of
promotion of research and demonstration activities it should be possible, in
the context of trade fairs, exhibitions and similar events, to exhibit radio
equipment which does not conform to this Directive and cannot be placed on the
market, on the condition that exhibitors ensure sufficient information to the
visiting public.
(26)     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 health
and safety, of electromagnetic compatibility, an efficient use of spectrum so
as to avoid harmful interference, and to guarantee fair competition on the
Union market.
(27)     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.
(28)     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.
(29)     The manufacturer should
provide sufficient information on the intended use of the equipment so as to
allow its use in compliance with the essential requirements. Such information
may need to include description of accessories such as antennas, components
such as software and specifications of the installation process of the
equipment.
(30)     The requirement in
Directive 1999/5/EC to include an EU declaration of conformity with equipment
has been found to simplify and to enhance the information and the efficiency of
market surveillance. The possibility to provide a simplified EU declaration of
conformity has allowed to reduce the burden associated with this requirement without
reduction of its effectiveness and should be provided for within this
Directive.
(31)     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.
(32)     The distributor makes radio
equipment 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 radio equipment does not adversely affect the compliance of the
radio equipment.
(33)     When placing radio
equipment on the market, every importer should indicate on the radio equipment
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 equipment does not allow
it. This includes cases where the importer would have to open the packaging to
put his name and address on the radio equipment.
(34)     Any economic operator that
either places radio equipment on the market under his own name or trademark or
modifies radio equipment 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.
(35)     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 radio equipment concerned.
(36)     Ensuring traceability of
radio equipment 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 radio equipment available on the market.
(37)     This Directive should be
limited to the expression of essential requirements. In order to facilitate
conformity assessment with those requirements it is necessary to provide for
presumption of conformity for radio equipment which is in conformity with
harmonised standards that are adopted in accordance with Regulation (EU) No
[../..] [on European Standardisation][32]
for the purpose of expressing detailed technical specifications of those
requirements. 
(38)     Regulation (EU) No [../..]
[on European Standardisation] provides for a procedure for objections to
harmonised standards where those standards do not entirely satisfy requirements
of this Directive. 
(39)     In order to enable economic
operators to demonstrate and the competent authorities to ensure that radio
equipment made available on the market conforms 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.
(40)     Manufacturers should draw
up an EU declaration of conformity to provide detailed information on the
conformity of radio equipment with the requirements of this Directive and of the
other relevant Union harmonisation legislation.
(41)     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.
(42)     The requirement to affix
the CE marking on products is important for the information of consumers and
public authorities. The possibility in Directive 1999/5/EC to affix a reduced
CE mark on small equipment, provided that it remains visible and legible, has
allowed to simplify application of this requirement without reducing its
effectiveness and should therefore be included in this Directive.
(43)     The requirement in
Directive 1999/5/EC to affix the CE marking on the packaging of equipment has
been found to simplify the task of market surveillance and should therefore be included
in this Directive.
(44)     The conformity assessment
procedures set out in this Directive require the intervention of conformity
assessment bodies, which are notified by the Member States to the Commission.
(45)     Experience has shown that
the criteria set out in Directive 1999/5/EC that the 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.
(46)     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.
(47)     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.
(48)     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.
(49)     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.
(50)     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 radio equipment 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.
(51)     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.
(52)     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.
(53)     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.
(54)     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 radio equipment.
(55)     Directive 1999/5/EC already
provides for a safeguard procedure which applies only in the event of
disagreement between Member States over measures taken by a Member State. 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.
(56)     The existing system should
be supplemented by a procedure under which interested parties are informed of
measures intended to be taken with regard to radio equipment presenting a risk
to the health and safety of persons or to other aspects of public interest covered
by the essential requirements in this Directive. It should also allow market
surveillance authorities, in cooperation with the relevant economic operators,
to act at an earlier stage in respect of such equipment.
(57)     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.
(58)     In order to ensure uniform
conditions for the implementation of this Directive, implementing powers
should be conferred on the Commission. Those powers should be exercised in accordance
with Regulation (EU) 182/2011 of the European Parliament and of the Council of
16 February 2011 laying down the rules and general principles concerning
mechanisms for control byMember States of the Commission's exercise of
implementing powers[33].

(59)     It is of particular
importance that the Commission carry out appropriate consultations during its
preparatory work of delegated acts, including at expert level. The Commission,
when preparing and drawing-up delegated acts, should ensure a simultaneous,
timely and appropriate transmission of relevant documents to the European
Parliament and the Council.
(60)     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.
(61)     It is necessary to provide for transitional arrangements that allow
making available on the market and putting into service radio equipment that
have already been placed on the market in accordance with Directive 1999/5/EC.
(62)     Since the objective of this Directive, namely to ensure that radio
equipment on the market fulfils requirements providing a high level of
protection of health and safety, of electromagnetic compatibility and an
efficient use of spectrum so as to avoid harmful interference while guaranteeing the functioning of the
internal market, cannot be sufficiently achieved by the Member States and can
therefore, by reason of its scale and effects, be better achieved at Union
level, the Union may adopt measures, in accordance with the principle of
subsidiarity as set out in Article 5 of the Treaty on European Union. 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. 
(63)     In accordance with the Joint Political Declaration of Member States and
the Commission on explanatory documents of 28 September 2011, Member States
have undertaken to accompany, in justified cases, the notification of their
transposition measures with one or more documents explaining the relationship
between the components of a directive and the corresponding parts of national
transposition instruments. With regard to this Directive, the legislator
considers the transmission of such documents to be justified.
HAVE ADOPTED THIS DIRECTIVE:
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter and scope
1.           This Directive establishes
a regulatory framework for the making available on the market and putting into
service in the Union of radio equipment.
2.           This Directive shall not
apply to equipment listed in Annex I.
3.           This Directive shall not
apply to radio equipment exclusively used for activities concerning public security,
defence, State security, including the economic well-being of the State in the
case of activities pertaining to State security matters, and the activities of
the State in the area of criminal law.
4.           Radio equipment falling
within the scope of this Directive shall not be subject to Directive 2006/95/EC,
except as set out in Article 3(1)(a) of this Directive.
Article 2
Definitions
1.           For the purpose of this
Directive the following definitions shall apply:
(1)                   
‘radio equipment’ means a product which intentionally
emits radio waves in order to serve its purpose, or a product which must be
completed with an accessory, such as antenna, so as to emit radio waves in
order to serve its purpose;
(2)                   
‘radio waves’ means electromagnetic waves of
frequencies from 9 kHz to 3000 GHz, propagated in space without
artificial guide;
(3)                   
‘interface’ means an air interface specifying
the radio path between radio equipment and their technical specifications;
(4)                   
‘radio equipment class’ means a class
identifying particular categories of radio equipment which under this Directive
are considered similar and those interfaces for which the equipment is designed;
(5)                   
‘harmful interference’ means harmful
interference as defined in Directive 2002/21/EC of the European Parliament and
of the Council[34];
(6)                   
‘making available on the market’ means any
supply of radio equipment for distribution, consumption or use in the European
Union market in the course of a commercial activity, whether in return for
payment or free of charge;
(7)                   
‘placing on the market’ means the first making
available of radio equipment on the European Union market;
(8)                   
‘manufacturer’ means any natural or legal person
who manufactures radio equipment or has radio equipment designed or
manufactured, and markets that equipment under his name or trademark;
(9)                   
‘authorised representative’ means any natural or
legal person established within the European Union who has received a written
mandate from a manufacturer to act on his behalf in relation to specified
tasks;
(10)               
‘importer’ means any natural or legal person
established within the European Union who places radio equipment from a third
country on the European Union market;
(11)               
‘distributor’ means any natural or legal person
in the supply chain, other than the manufacturer or the importer, who makes
radio equipment available on the market;
(12)               
‘economic operators’ means the manufacturer, the
authorised representative, the importer and the distributor;
(13)               
‘technical specification’ means a document that
prescribes technical requirements to be fulfilled by radio equipment;
(14)               
‘harmonised standard’ means harmonised standard as
defined in Article 2(1)(c) of Regulation (EU) No [../..] [on European
Standardisation][35];
(15)               
‘accreditation’ means accreditation as defined
in Regulation (EC) No 765/2008;
(16)               
‘national accreditation body’ means national
accreditation body as defined in Regulation (EC) No 765/2008;
(17)               
‘conformity assessment’ means the process
demonstrating whether the essential requirements relating to radio equipment have
been fulfilled;
(18)               
‘conformity assessment body’ means a body that
performs conformity assessment activities;
(19)               
‘recall’ means any measure aimed at achieving
the return of radio equipment that has already been made available to the user;
(20)               
‘withdrawal’ means any measure aimed at
preventing radio equipment in the supply chain from being made available on the
market;
(21)               
‘CE marking’ means a marking by which the
manufacturer indicates that radio equipment is in conformity with the
applicable requirements set out in European Union harmonisation legislation
providing for its affixing;
(22)               
‘ Union harmonisation legislation’ means any
Union legislation harmonising the conditions for the marketing of products.
2.           For the purposes of point
1 of paragraph 1 of this Article, products listed under point 1 of Annex II
shall be deemed to be radio equipment, and products listed under point 2 of
Annex II shall not be deemed to be radio equipment. 
3.           The Commission shall be
empowered to adopt delegated acts in accordance with Article 45 modifying Annex
II in order to adapt it to technical progress.
Article 3
Essential requirements
1.           Radio equipment shall be
constructed so as to ensure:
(a)         
the protection of the health and the safety of
the user and any other person, including the objectives with respect to safety
requirements set out in Directive 2006/95/EC, but with no voltage limit
applying;
(b)         
the protection of electromagnetic compatibility as
set out in Directive 2004/108/EC, including in particular levels of immunity
which lead to improvements in the efficient use of shared or adjacent frequency
bands. 
2.           Radio equipment shall be
so constructed that its transmitted signals efficiently use the spectrum
allocated to terrestrial/space radio communication and orbital resources so as
to avoid harmful interference. Only radio equipment that can be operated in at
least one Member State without infringing applicable requirements on the use of
spectrum can comply with this requirement.
3.           Radio equipment shall be
so constructed that it complies with the following essential requirements: 
(a)         
radio equipment interworks with accessories,
and/or it interworks via networks with other radio equipment, and/or it can be
connected to interfaces of the appropriate type throughout the Union;
(b)         
radio equipment does not harm the network or its
functioning nor misuse network resources, thereby causing an unacceptable
degradation of service;
(c)         
radio equipment incorporates safeguards to
ensure that the personal data and privacy of the user and of the subscriber are
protected;
(d)         
radio equipment supports certain features
ensuring avoidance of fraud;
(e)         
radio equipment supports certain features
ensuring access to emergency services;
(f)           
radio equipment supports certain features in
order to facilitate its use by users with a disability;
(g)         
radio equipment supports certain features in
order to ensure that software can only be loaded into the radio equipment where
the compliance of the combination of software and the radio equipment has been
demonstrated.
The Commission shall be empowered to adopt
delegated acts in accordance with Article 45 specifying which categories or
classes of radio equipment are concerned by each of the requirements (a) to (g)
in the first subparagraph. 
Article 4
Provision
of information on the compliance of combinations of software and radio
equipment
1.           Manufacturers of radio
equipment and of software allowing radio equipment to be used as intended shall
provide the Member States and the Commission with information on the compliance
of intended combinations of radio equipment and software with the essential
requirements set out in Article 3.
2.           The Commission shall be
empowered to adopt delegated acts in accordance with Article 45 specifying
which categories or classes of radio equipment are concerned by the requirement
in the paragraph 1, the required information and the operational rules for
making the information on compliance available.
Article 5
Registration
of radio equipment within some categories 
1.           As from [date - four
years after the date of entry into force of the Directive], manufacturers
shall register radio equipment types within categories of equipment affected by
a low level of compliance with the essential requirements set out in Article 3 within
a central system referred to in paragraph 3 prior to radio equipment within
those categories being placed on the market. The Commission shall allocate to
each registered type a registration number, which manufacturers shall affix on
radio equipment placed on the market.
2.           The Commission shall be
empowered to adopt delegated acts in accordance with Article 45 specifying
which categories of radio equipment are concerned by the requirement set out in
the paragraph 1, taking into account information on the compliance of equipment
provided by Member States in accordance with Article 47(1), the information to
be registered, the operational rules for registration and the operational rules
for affixation of the registration number on radio equipment. 
3.           The Commission shall make
available a central system allowing manufacturers to register the required
information. 
Article 6
Placing on the market 
Member States
shall ensure that radio equipment is made available on the market only if it
complies with this Directive when it is properly installed and maintained and
used for its intended purpose.
Article 7
Putting into service and use
Member States shall allow the putting into
service and use of radio equipment for its intended purpose where it complies
with this Directive. Without prejudice to their obligations under Decision No
676/2002/EC, and to the conditions attached to authorisations for the use of
frequencies in conformity with Union law, in particular under Articles 9(3) and
9(4) of Directive 2002/21/EC, Member States may only introduce additional
requirements for the putting into service and/or use of radio equipment for
reasons related to the efficient use of the radio spectrum, avoidance of
harmful interference or matters relating to public health.
Article 8
Notification of interface
specifications and radio equipment classes
1.           Member States shall notify
in accordance with the procedure set out in Directive 98/34/EC the interfaces
which they intend to regulate. 
2.           When assessing correspondence
between radio equipment and regulated interfaces, Member States shall take into
account the equivalence with radio interfaces notified by other Member States. 
3.           The Commission shall
establish the equivalence between notified interfaces and assign a radio
equipment class, details of which shall be published in the Official Journal of
the European Union. Those implementing acts shall be adopted in accordance with
the advisory procedure referred to in Article 44(2).
Article 9
Free movement of radio equipment
1.           Member States shall not
prohibit, restrict or impede, for reasons relating to those aspects covered by
this Directive, the placing on the market in their territory of radio equipment
complying with this Directive. 
2.           At trade fairs,
exhibitions, demonstrations and similar events, Member States shall not create
any obstacles to the display of radio equipment which does not comply with this
Directive, provided that a visible sign clearly indicates that such radio
equipment may not be marketed or used until it has been made to comply.
CHAPTER II
OBLIGATIONS OF ECONOMIC OPERATORS 
Article 10
Obligations
of manufacturers
1.           When placing radio
equipment on the market, manufacturers shall ensure that it has been designed
and manufactured in accordance with the essential requirements set out in Article
3.
2.           Manufacturers shall draw
up the technical documentation referred to in Article 21 and carry out the
conformity assessment procedure referred to in Article 17 or have it carried
out.
Where compliance of radio equipment 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 radio equipment has been placed on the market.
4.           Manufacturers shall ensure
that procedures are in place for series production to remain in conformity.
Changes in radio equipment 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. 
When deemed appropriate with regard to the
risks presented by radio equipment, manufacturers shall carry out sample
testing of radio equipment made available on the market, investigate, and, if
necessary, keep a register of complaints, of non-conforming radio equipment and
radio equipment recalls, and shall keep distributors informed of any such
monitoring.
5.           Manufacturers shall ensure
that radio equipment bears a type, batch or serial number or other element
allowing their identification, or, where the size or nature of radio equipment
does not allow it, that the required information is provided on the packaging,
or in a document accompanying radio equipment.
6.           Manufacturers shall
indicate their name, registered trade name or registered trade mark and the
address at which they can be contacted on radio equipment or, where the size or
nature of radio equipment does not allow it, on its packaging, or in a document
accompanying radio equipment. The address must indicate a single point at which
the manufacturer can be contacted.
7.           Manufacturers shall ensure
that radio equipment is accompanied by instructions and safety information in a
language which can be easily understood by consumers and other users, as
determined by the Member State concerned. Instructions shall include the
information required to use radio equipment in accordance with its intended
use. Such information shall include, where applicable, a description of
accessories and/or components, including software, which allow the radio equipment
to operate as intended. 
The following information shall also be
included:
frequency band(s) in which the radio equipment
operates;
radio-frequency power transmitted in the
frequency band(s) in which the radio equipment operates.
8.           A copy of the full EU
declaration of conformity shall accompany each piece of radio equipment. This
requirement may also be fulfilled by the provision of a simplified EU
declaration of conformity. Where only a simplified EU declaration of conformity
is provided, it shall be immediately followed by the exact internet or e-mail address
where the full EU declaration of conformity can be obtained. 
9.           Information available on
the packaging shall allow to identify the Member States or the geographical
area within a Member State where radio equipment can be put into service, and
shall alert the user to potential restrictions or requirements for
authorisation of use in certain Member States. Such information shall be
completed in the instructions accompanying radio equipment. The Commission may
adopt implementing acts specifying how to present this information. Those
implementing acts shall be adopted in accordance with the advisory procedure
referred to in Article 44(2).
10.         Manufacturers who consider
or have reason to believe that radio equipment which they have placed on the
market is not in conformity with this Directive shall immediately take the
necessary corrective measures to bring that radio equipment into conformity, to
withdraw it or recall it, if appropriate. Furthermore, where radio equipment
presents a risk, manufacturers shall immediately inform the competent national
authorities of the Member States in which they made radio equipment available
to that effect, giving details, in particular, of the non-compliance and of any
corrective measures taken.
11.         Manufacturers shall,
further to a reasoned request from a competent national authority, provide it
without delay with all the information and documentation necessary to
demonstrate the conformity of radio equipment, 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 radio
equipment which they have placed on the market.
Article 11
Authorised
representatives
1.           A manufacturer may, by a
written mandate, appoint an authorised representative. 
The obligations laid down in Article 10(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 radio equipment 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 radio equipment;
(c)         
cooperate with the competent national
authorities, at their request, on any action taken to eliminate the risks posed
by radio equipment covered by the authorised representative’s mandate.
Article 12
Obligations
of importers
1.           Importers shall place only
compliant radio equipment on the market.
2.           Before placing radio
equipment 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
radio equipment bears the CE marking and is accompanied by the information for
users and regulatory authorities referred to in Article 10(7), (8) and (9), and
that the manufacturer has complied with the requirements set out in Article 10(5)
and (6).
Where an importer considers or has reason to
believe that radio equipment is not in conformity with the essential
requirements set out in Article 3, he shall not place the radio equipment on
the market until it has been brought into conformity. Furthermore, where radio
equipment 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 radio equipment or, where that is not
possible, on its packaging or in a document accompanying the radio equipment.
This includes cases where the size of radio equipment does not allow it, or
where importers would have to open the packaging in order to indicate their
name and address on radio equipment.
4.           Importers shall ensure
that the radio equipment is accompanied by instructions and safety information
in a language which can be easily understood by consumers and other users, as
determined by the Member State concerned.
5.           Importers shall ensure
that, while radio equipment is under their responsibility, storage or transport
conditions do not jeopardise its compliance with the essential requirements set
out in Article 3.
6.           When deemed appropriate
with regard to the risks presented by radio equipment, importers shall, to
protect the health and safety of consumers, carry out sample testing of radio
equipment made available on the market, investigate, and, if necessary, keep a
register of complaints, of non-conforming radio equipment and radio equipment
recalls, and shall keep distributors informed of such monitoring.
7.           Importers who consider or
have reason to believe that radio equipment which they have placed on the
market is not in conformity with this Directive shall immediately take the
corrective measures necessary to bring that radio equipment into conformity, to
withdraw it or recall it, if appropriate. Furthermore, where the radio
equipment presents a risk, importers shall immediately inform the competent
national authorities of the Member States in which they made the radio
equipment available to that effect, giving details, in particular, of the
non-compliance and of any corrective measures taken.
8.           Importers shall, for a
period of ten years after the radio equipment 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.
9.           Importers shall, further
to a reasoned request from a competent national authority, provide it without
delay with all the information and documentation necessary to demonstrate the
conformity of radio equipment 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 the radio equipment which they
have placed on the market.
Article 13
Obligations
of distributors
1.           When making radio
equipment available on the market distributors shall act with due care in
relation to the requirements of this Directive.
2.           Before making radio equipment
available on the market distributors shall verify that the radio equipment
bears the required CE marking, that it is accompanied by the required documents
and by instructions and safety information in a language which can be easily
understood by consumers and other users in the Member State in which the radio
equipment is to be made available on the market, and that the manufacturer and
the importer have complied with the requirements set out in Article 10(5) to (9),
and Article 12(3).
Where a distributor considers or has reason to
believe that radio equipment is not in conformity with the essential
requirements set out in Article 3, he shall not make the radio equipment
available on the market until it has been brought into conformity. Furthermore,
where radio equipment 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 radio equipment is under their responsibility, storage or transport
conditions do not jeopardise its compliance with the essential requirements set
out in Article 3. 
4.           Distributors who consider
or have reason to believe that radio equipment which they have made available
on the market is not in conformity with this Directive shall make sure that the
corrective measures necessary to bring that radio equipment into conformity, to
withdraw it or recall it, if appropriate, are taken. Furthermore, where radio
equipment presents a risk, distributors shall immediately inform the competent
national authorities of the Member States in which they made the radio
equipment 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 without
delay with all the information and documentation necessary to demonstrate the
conformity of radio equipment. They shall cooperate with that authority, at its
request, on any action taken to eliminate the risks posed by radio equipment
which they have made available on the market.
Article 14
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 10, where he
places radio equipment on the market under his name or trademark or modifies
radio equipment already placed on the market in such a way that compliance with
the requirements of this Directive may be affected.
Article 15
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
radio equipment;
(b)                   
any economic operator to whom they have supplied
radio equipment.
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 radio equipment and for a period of 10
years after they have supplied the radio equipment.
CHAPTER III
CONFORMITY OF RADIO EQUIPMENT
Article 16
Presumption of conformity and harmonised
standards
1.           Radio equipment which is
in conformity with harmonised standards or parts thereof the references of
which have been published in the Official Journal of the European Union shall
be presumed to be in conformity with the essential requirements covered by
those standards or parts thereof, set out in Article 3 
2.           Where a harmonised
standard satisfies the requirements which it covers and which are set out in Article
3 or Article 27, the Commission shall publish the references of those standards
in the Official Journal of the European Union. 
Article 17
Conformity assessment procedures
1.           Manufacturers may
demonstrate compliance of radio equipment with the essential requirements
identified in Articles 3(1)(a) and (b) using any of the following conformity
assessment procedures:
(a)         
 internal production control procedure set out
in Annex III;
(b)         
 EU-type examination followed by the conformity
to type procedure set out in Annex IV;
(c)         
 full quality assurance procedure set out in Annex
V.
2.           Where in assessing the
compliance of radio equipment with the essential requirements identified in Articles
3(2) and (3), the manufacturer has applied harmonised standards, the reference
number of which has been published in the Official Journal of the European
Union, he may use any of the following procedures:
(a)         
internal production control procedure set out in
Annex III;
(b)         
EU-type examination followed by the conformity
to type procedure set out in Annex IV;
(c)         
full quality assurance procedure set out in
Annex V.
3.           Where in assessing the
compliance of radio equipment with the essential requirements identified in Articles
3(2) and (3), the manufacturer has not applied or has applied only in part
harmonised standards the reference number of which has been published in the Official
Journal of the European Union, or where such harmonised standards do not exist,
radio equipment shall be submitted with regard to those essential requirements
to the procedure set out in either of the following procedures:
(a)         
EU-type examination followed by the conformity
to type procedure set out in Annex IV;
(b)         
full quality assurance procedure set out in
Annex V.
Article 18
EU
declaration of conformity
1.           The EU declaration of
conformity shall state that the fulfilment of the essential requirements set
out in Article 3 has been demonstrated.
2.           The EU declaration of
conformity shall have the model structure and shall contain the elements set
out in Annex VII and shall be continuously updated. It shall be translated into
the language or languages required by the Member State in which market the radio
equipment is placed or made available.
The simplified EU declaration of conformity
referred to in Article 10(8) shall contain the elements set out in Annex VIII
and shall be continuously updated. It shall be translated into the language or
languages required by the Member State in which market the radio equipment is
placed or made available. The full EU declaration of conformity accessible
through internet or e-mail address shall be available in a language or
languages required by the Member State in which market the radio equipment is placed
or made available.
3.           Where the radio equipment
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 radio equipment.
Article 19
General
principles of the CE marking
1.           The CE marking shall be
subject to the general principles set out in Article 30 of Regulation (EC) No
765/2008. 
2.           On account of the nature
of radio equipment, the height of the CE marking affixed to radio equipment may
be lower than 5 mm, provided that it remains visible and legible.
Article 20
Rules
and conditions for affixing the CE marking
1.           The CE marking shall be
affixed visibly, legibly and indelibly to the radio equipment or to its data
plate, unless that is not possible or not warranted on account of the nature of
radio equipment. The CE marking shall also be affixed visibly and legibly to
the packaging.
2.           The CE marking shall be
affixed before radio equipment is placed on the market. 
3.           The CE marking shall be
followed by the identification number of the notified body where the conformity
assessment procedure set out in Annex V is applied.
The identification number of the notified
body shall have the same height as the CE marking. 
It shall be affixed by the body itself or,
under its instructions, by the manufacturer or his authorised representative.
Article 21
Technical
documentation 
1.           The technical
documentation shall contain all relevant data or details of the means used by
the manufacturer to ensure that radio equipment complies with the requirements
set out in Article 3. It shall, at least, contain the documents listed in Annex
VI. 
2.           The technical
documentation shall be drawn up before radio equipment is placed on the market
and shall be continuously updated.
3.           The technical documentation
and correspondence relating to any EU-type examination procedures shall be
drawn up in an official language of the Member State in which the notified body
is established or in a language acceptable to that body. 
4.           Technical documentation
drawn up in accordance with the corresponding specifications of the national
standard that implements the relevant harmonised standard and/or technical
specification shall be presumed to provide an adequate basis for the assessment
of conformity.
5.           Following a reasoned
request from the market surveillance authority of a Member State, the
manufacturer shall provide a translation of the relevant parts of the technical
documentation into the language of that Member State. 
When a market surveillance authority requests
the technical documentation from a manufacturer, it shall be transmitted
without delay. When a market surveillance authority requests from a
manufacturer a translation of technical documentation or parts thereof, it may
fix a deadline for receipt of such translation, which shall be 30 days, unless
a shorter deadline is justified in the case of serious and immediate risk. 
6.           Where the technical documentation
does not comply with paragraphs 1, 2 or 3 of this Article, and in so doing
fails to present sufficient relevant data or means used to ensure compliance of
radio equipment with the requirements set out in Article 3, the market
surveillance authority may require the manufacturer to have a test performed by
a body acceptable to the market surveillance authority at the expense of the
manufacturer within a specified period in order to verify compliance with the
essential requirements set out in Article 3. 
CHAPTER IV
NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
Article 22
Notification
Member States shall notify the Commission
and the other Member States of bodies authorised to carry out third-party
conformity assessment tasks under this Directive. 
Article 23
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 28.
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 24(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 24
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 25
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 26
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 radio
equipment 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 radio equipment 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 radio
equipment which they assess, nor the authorised representative of any of those
parties. This shall not preclude the use of assessed radio equipment that is necessary
for the operations of the conformity assessment body or the use of such radio
equipment 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 that radio
equipment, 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 this Directive 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 radio equipment 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 radio equipment 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.
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 Article 3, of the applicable harmonised standards
and of the relevant provisions of Union harmonisation legislation and of national
legislation;
(d)         
the ability to draw up certificates, records and
reports demonstrating that assessments have been carried out.
8.           The impartiality of the
conformity assessment bodies, their top level management and of the 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 this Directive 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, the regulatory activities
in the area of radio equipment and frequency planning, 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 27
Presumption
of conformity of conformity assessment bodies
Where a conformity assessment body
demonstrates its conformity with the criteria laid down in the relevant
harmonised standards or parts thereof the references of which have been
published in the Official Journal of the European Union it shall be
presumed to comply with the requirements set out in Article 26 in so far as the
applicable harmonised standards cover those requirements.
Article 28
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 26 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 this Directive.
Article 29
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 categories of radio equipment 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 26.
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 26.
Article 30
Notification
procedure
1.           Notifying authorities may
notify only conformity assessment bodies which have satisfied the requirements
laid down in Article 26.
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 categories of the radio equipment concerned
and the relevant attestation of competence.
4.           Where a notification is
not based on an accreditation certificate as referred to in Article 29(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 26.
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 31
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 32
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 26, 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 33
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 34
Operational
obligations of notified bodies
1.           Notified bodies shall
carry out conformity assessments in accordance with the conformity assessment
procedures provided for in Annexes IV and V.
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 product
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
radio equipment with this Directive.
Where a notified body finds that the essential
requirements set out in Article 3 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.
3.           Where, in the course of
the monitoring of conformity following the issue of a certificate, a notified
body finds that radio equipment no longer complies, it shall require the
manufacturer to take appropriate corrective measures and shall suspend or
withdraw the certificate if necessary.
4.           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 35
Appeal
against decisions of notified bodies
Member States shall ensure that an appeal
procedure against decisions of the notified bodies is available.
Article 36
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 categories of radio
equipment with relevant information on issues relating to negative and, on
request, positive conformity assessment results.
3.           Notified bodies shall
fulfil information obligations under Annexes IV and V.
Article 37
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 38
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 V
UNION MARKET SURVEILLANCE, CONTROL OF PRODUCTS
ENTERING THE UNION MARKET AND SAFEGUARD PROCEDURES
Article 39
Union
market surveillance and control of products entering the Union market
Article 15(3) and Articles 16 to 29 of
Regulation (EC) No 765/2008 shall apply to radio equipment. 
Article 40
Procedure
for dealing with radio equipment 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 radio equipment covered by this Directive presents a risk to the
health or safety of persons or to other aspects of public interest protection
covered by this Directive, they shall carry out an evaluation in relation to
the radio equipment 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 radio equipment 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 radio equipment into compliance with those requirements, to
withdraw the radio equipment 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
radio equipment 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 radio equipment being made available on their national market, to
withdraw radio equipment 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 radio equipment, the
origin of radio equipment, 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 any of the following:
(a)         
failure of radio equipment to meet requirements
relating to the health or safety of persons or to other aspects of public
interest protection laid down in this Directive; 
(b)         
shortcomings in the harmonised standards
referred to in Article 16 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
radio equipment concerned, and, in the event of disagreement with the notified
national measure, of their objections.
7.           Where, within 8 weeks 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 41
Union
safeguard procedure
1.           Where, on completion of
the procedure set out in Articles 40(3) and 40(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 radio equipment is withdrawn or recalled 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 radio equipment is
attributed to shortcomings in the harmonised standards referred to in Article 16
of this Directive, the Commission shall apply the procedure provided for in
Article [8] of Regulation (EU)No[../..] [on European Standardisation].
Article 42
Compliant
radio equipment which presents a risk to health and safety
1.           Where, having performed an
evaluation under Article 40(1), a Member State finds that although radio
equipment is in compliance with this Directive, it presents a risk to the
health or safety of persons or to other aspects of public interest protection
covered by this Directive it shall require the relevant economic operator to
take all appropriate measures to ensure that the radio equipment concerned,
when placed on the market, no longer presents that risk, to withdraw the radio
equipment from the market or to recall it within a reasonable period, commensurate
with the nature of the risk, as it may prescribe.
2.           The economic operator
shall ensure that corrective action is taken in respect of all the radio
equipment concerned. 
3.           The Member State shall
immediately inform the Commission and the other Member States. That information
shall include all available details, in particular the data necessary for the
identification of the radio equipment concerned, the origin and the supply
chain of radio equipment, the nature of the risk involved and the nature and
duration of the national measures taken.
4.           The Commission shall
without delay enter into consultation with the Member States and the relevant
economic operator or operators and shall evaluate the national measures taken.
On the basis of the results of that evaluation, the Commission shall decide
whether the measure is justified or not, and where necessary, propose
appropriate measures.
5.           The Commission shall
address its decision to all Member States and shall immediately communicate it
to them and the relevant economic operator or operators.
Article 43
Formal
non-compliance
1.           Without prejudice to
Article 40, 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 19 or 20 of this
Directive;
(b)         
the CE marking has not been affixed;
(c)         
the EU declaration of conformity has not been
drawn up;
(d)         
the EU declaration of conformity has not been
drawn up correctly;
(e)         
technical documentation is either not available
or not complete;
(f)           
product does not comply with the requirements
set out in Articles 10(5), (6) and 12(3);
(g)         
information on intended use of radio equipment,
EU declaration of conformity and usage restrictions as set out in Article 10(7),
(8) and (9) does not accompany radio equipment;
(h)         
requirements on identification of economic
operators set out in article 15 are not fulfilled;
(i)           
non compliance with Article 5.
2.           Where the non-compliance
referred to in paragraph 1 persists, the Member State concerned shall take all
appropriate measures to restrict or prohibit corresponding radio equipment
being made available on the market or ensure that it is recalled or withdrawn
from the market.
CHAPTER VI
THE COMMITTEE, IMPLEMENTING ACTS AND DELEGATED ACTS
Article 44
Committee
procedure
1.           The Commission shall be
assisted by the Telecommunication Conformity Assessment and Market Surveillance
Committee. That committee shall be a committee within the meaning of Regulation
(EU) No 182/2011.
2.           Where reference is made to
this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
Article 45
Exercise
of the delegation
1.           The power to adopt
delegated acts is conferred on the Commission subject to the conditions laid
down in this Article. 
2.           The delegation of power
referred to in Articles 2(3), 3(3), 4(2) and 5(2) shall be conferred for an
indeterminate period of time from the [date of entry into force]
3.           The delegation of power
referred to in Articles 2(3), 3(3), 4(2) and 5(2) may be revoked at any time by
the European Parliament or by the Council. A decision of revocation shall put
an end to the delegation of the power specified in that decision. It shall take
the day following the publication of the decision in the Official Journal of
the European Union or at a later date specified therein. It shall not affect
the validity of any delegated acts already in force. 
4.           As soon as it adopts a
delegated act, the Commission shall notify it simultaneously to the European
Parliament and to the Council.
5.           A delegated act adopted
pursuant to Articles 2(3), 3(3), 4(2) and 5(2) shall enter into force only if
no objection has been expressed either by the European Parliament or the
Council within a period of two months of notification of that act to the
European Parliament and the Council or if, before the expiry of that period,
the European Parliament and the Council have both informed the Commission that
they will not object. That period shall be extended by two months at the
initiative of the European Parliament or the Council.
CHAPTER VII
FINAL AND TRANSITIONAL PROVISIONS
Article 46
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 [insert date – the date set out in the second subparagraph
of Article Transposition(1)] at the latest and shall notify it without
delay of any subsequent amendment affecting them.
Article 47
Review and reporting
1.           Member States shall send
the Commission regular reports on the application of this Directive by [date, -
three years after the entry into force of this Directive] and at least every
two years thereafter. The report shall contain a presentation of the market
surveillance activities performed by the Member States and provide information
on whether and to what extent compliance with the requirements of this
Directive has been attained, including in particular requirements on
identification of economic operators.
2.           The Commission shall
review the operation of this Directive and report thereon to the European
Parliament and to the Council, by [date - 4 years after the entry into force of
this Directive] and every five years thereafter. The report shall cover
progress on drawing up the relevant standards, as well as any problems that
have arisen in the course of implementation. The report shall also outline the
activities of the Committee, assess progress in achieving an open competitive
market for radio equipment at Union level and examine how the regulatory framework
for the placing on the market and putting into service of radio equipment
should be developed in order to achieve the following:
(a)         
ensure that a coherent system is achieved at
Union level for all radio equipment;
(b)         
allow for convergence of the telecommunications,
audiovisual and information technology sectors;
(c)         
enable harmonisation of regulatory measures at
international level.
It shall in particular examine whether
essential requirements are still necessary for all categories of radio
equipment covered. Where necessary, further measures may be proposed in the
report for full implementation of the aim of this Directive.
Article 48
Transitional
provisions
Member States shall not impede the making
available on the market and/or putting into service of radio equipment covered
by Directive 1999/5/EC which is in conformity with that Directive and which was
placed on the market before [date set out in the second subparagraph of Article
Transposition(1)].
Article 49
Transposition
1.           Member States shall adopt
and publish, by [insert date - 18 months after adoption] at the latest, the
laws, regulations and administrative provisions necessary to comply with this
Directive. They shall forthwith communicate to the Commission the text of those
provisions.
They shall apply those provisions from [day
after the date set out in the first subparagraph].
When Member States adopt those provisions, they
shall contain a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. They shall also
include a statement that references in existing laws, regulations and
administrative provisions to the directive repealed by this Directive shall be
construed as references to this Directive. Member States shall determine how
such reference is to be made and how that statement is to be formulated. 
2.           Member States shall
communicate to the Commission the texts of the main provisions of national laws
which they adopt in the field covered by this Directive.
Article 50
Repeal
Directive 1999/5/EC is repealed with effect
from [date set out in the second subparagraph of Article Transposition(1)of
this Directive]. 
References to the repealed Directive shall
be construed as references to this Directive and shall be read in accordance
with the correlation table in Annex IX. 
Article 51
Entry
into force
This Directive shall enter into force on
the twentieth day following that of its publication in the Official Journal
of the European Union.
Article 52
Addressees
This
Directive is addressed to the Member States.
ANNEX I
EQUIPMENT NOT COVERED BY THIS
DIRECTIVE 
1.           Radio equipment used by
radio amateurs within Article 1, definition 56, of the International
Telecommunications Union (ITU) radio regulations 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.
2.           Marine equipment falling
within the scope of Council Directive 96/98/EC[36].
3.           Cabling and wiring.
4.           Test equipment exclusively
intended for the testing of radio equipment by professional users.
5.           Aeronautical products,
parts and appliances within the meaning of Article 3 of Regulation (EC) No
216/2008 of the European Parliament and of the Council[37].
ANNEX II
PRODUCTS FALLING WITHIN THE DEFINITION
OF RADIO EQUIPMENT
1.           For the purposes of this
Directive the following products shall be deemed to be radio equipment:
(a)         
active antennas;
(b)         
jammers.
2.           For the purposes of this
Directive the following products shall not be deemed to be radio equipment:
(a)         
passive antennas;
(b)         
cochlear implants;
(c)         
microwave ovens.
ANNEX III
CONFORMITY ASSESSMENT 
Module A (internal production
control)
1.           Internal production
control is the conformity assessment procedure whereby the manufacturer fulfils
the obligations laid down in points 2, 3 and 4, and ensures and declares on his
sole responsibility that radio equipment concerned satisfies the requirements
set out in Article 3 and where applicable other harmonisation legislation
applying to them.
2.           Technical documentation
The manufacturer shall establish the technical
documentation according to Article 21. 
3.           Manufacturing
The manufacturer shall take all measures
necessary so that the manufacturing process and its monitoring ensure
compliance of the manufactured radio equipment with the technical documentation
referred to in point 2 and with the relevant essential requirements in Article
3.
4.           CE marking and declaration
of conformity
4.1.        The manufacturer shall
affix the required CE marking according to Articles 19 and 20 to each piece of
radio equipment that satisfies the applicable requirements.
4.2.        The manufacturer shall draw
up a written declaration of conformity for each radio equipment type and keep
it together with the technical documentation at the disposal of the national
authorities for 10 years after radio equipment has been placed on the market.
The declaration of conformity shall identify theradio equipment for which it
has been drawn up.
A copy of the 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.
ANNEX IV
CONFORMITY ASSESSMENT MODULES
Modules B + C
EU-Type examination + Conformity to
type based on internal production control
When
reference is made to this Annex, the conformity assessment procedure shall
follow Modules B (EU-Type examination) and C (Conformity to type based on
internal production control) below.
Module
B
EU-type
examination
1.           EU-type examination is the
part of a conformity assessment procedure in which a notified body examines the
technical design of radio equipment and verifies and attests that the technical
design of radio equipment meets the requirements of the legislative instrument
that apply to it.
2.           EU-type examination shall
be carried out in the following manner:
assessment of the adequacy of the technical
design of radio equipment through examination of the technical documentation
and supporting evidence referred to in point 3, without examination of a
specimen (design type).
3.           The manufacturer shall
lodge an application for EU-type examination with a single notified body of his
choice.
The application shall include:
–              
the name and address of the manufacturer and, if
the application is lodged by the authorised representative, his name and
address as well,
–              
a written declaration that the same application
has not been lodged with any other notified body,
–              
the technical documentation. The technical
documentation shall make it possible to assess radio equipment's conformity
with the applicable requirements of the legislative instrument 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 radio
equipment. The technical documentation shall contain, wherever applicable, the
elements in Annex V to this Directive,
–              
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 radio equipment;
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 as provided in paragraph 8 below, 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 the specific legislative instrument that apply to radio
equipment 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
assessed 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 radio
equipment with the examined type to be evaluated and to allow for in-service
control.
Where the type does not satisfy the applicable
requirements of the legislative instrument, 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 the legislative instrument, 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 assessed type that may affect the
conformity of radio equipment 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.
Each notified body shall inform Member States
of EU-type examination certificates it has issued and/or additions thereto in
those cases where harmonised standards, the reference of which have been
published in the Official Journal of the European Union, are available and have
not been fully applied. The Member States, the Commission and the other
notified bodies may, on request, obtain a copy of the EU-type examination
certificates and/or additions thereto. On request, the Member States and the
Commission 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 for a period of 10 years after radio equipment has been assessed
or 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 radio equipment has been placed on the market.
10.         The manufacturer's
authorised representative may lodge the application referred to in point 3 and
fulfil the obligations set out in points 7 and 9, provided that they are
specified in the mandate.
Module
C
Conformity
to type based on internal production control
1.           Conformity to type based
on internal production control is the part of a conformity assessment procedure
whereby the manufacturer fulfils the obligations laid down in points 2 and 3,
and ensures and declares that radio equipments concerned are in conformity with
the type described in the EU-type examination certificate and satisfy the
requirements of the legislative instrument 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 radio equipment with the approved type described
in the EU-type examination certificate and with the requirements of the
legislative instrument that apply to them.
3.           CE marking and declaration
of conformity
3.1.        The manufacturer shall
affix the CE marking according to Articles 19 and 20 to each piece of radio
equipment that is in conformity with the type described in the EU-type
examination certificate and satisfies the applicable requirements of the
legislative instrument.
3.2.        The manufacturer shall draw
up a written declaration of conformity for each radio equipment type and keep
it at the disposal of the national authorities for 10 years after radio
equipment has been placed on the market. The EU declaration of conformity shall
identify the radio equipment type 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.
ANNEX V
CONFORMITY ASSESSMENT 
Module H
Full Quality Assurance
1.           Conformity based on full
quality assurance is the conformity assessment procedure whereby the
manufacturer fulfils the obligations laid down in points 2 and 5, and ensures
and declares on his sole responsibility that radio equipment concerned
satisfies the requirements of the legislative instrument that apply to them.
2.           Manufacturing
The manufacturer shall operate an approved
quality system for design, manufacture and final product inspection and testing
of radio equipment concerned as specified in point 3 and shall be subject to
surveillance as specified in point 4.
3.           Quality system
3.1.        The manufacturer shall
lodge an application for assessment of his quality system with the notified
body of his choice, for radio equipment concerned.
The application shall include:
–              
the name and address of the manufacturer and, if
the application is lodged by the authorised representative, his name and
address as well,
–              
the technical documentation for one type of each
category of radio equipment intended to be manufactured. The technical
documentation shall contain, wherever applicable, the elements in Annex VI to
this Directive,
–              
the documentation concerning the quality system,
and
–              
a written declaration that the same application
has not been lodged with any other notified body.
3.2.        The quality system shall
ensure compliance of radio equipment with the requirements of the legislative
instrument that apply to them.
All the elements, requirements and provisions
adopted by the manufacturer shall be documented in a systematic and orderly
manner in the form of written policies, procedures and instructions. That
quality system documentation shall permit a consistent interpretation of the
quality programmes, plans, manuals and records.
It shall, in particular, contain an adequate
description of:
–              
the quality objectives and the organisational
structure, responsibilities and powers of the management with regard to design
and product quality,
–              
the technical design specifications, including
standards, that will be applied and, where the relevant harmonised standards
and/or technical specifications will not be applied in full, the means that
will be used to ensure that the essential requirements of this Directive that
apply to radio equipments will be met,
–              
the design control and design verification
techniques, processes and systematic actions that will be used when designing
radio equipment pertaining to radio equipment category covered,
–              
the corresponding manufacturing, quality control
and quality assurance techniques, processes and systematic actions that will be
used,
–              
the examinations and tests that will be carried
out before, during and after manufacture, and the frequency with which they
will be carried out,
–              
the quality records, such as inspection reports
and test data, calibration data, qualification reports on the personnel
concerned, etc.,
–              
the means of monitoring the achievement of the
required design and product quality and the effective operation of the quality
system.
3.3.        The notified body shall
assess the quality system to determine whether it satisfies the requirements
referred to in point 3.2 of this Annex.
It shall presume conformity with those
requirements in respect of the elements of the quality system that comply with
the corresponding specifications of the national standard that implements the
relevant harmonised standard and/or technical specification.
In addition to experience in quality management
systems, the auditing team shall have at least one member experienced as an
assessor in the relevant radio equipment field and radio equipment technology
concerned, and knowledge of the applicable requirements of the legislative
instrument. The audit shall include an assessment visit to the manufacturer's
premises. The auditing team shall review the technical documentation referred
to in point 3.1, second indent, to verify the manufacturer's ability to
identify the applicable requirements of the legislative instrument and to carry
out the necessary examinations with a view to ensuring compliance of radio
equipment with those requirements.
The manufacturer or his authorised
representative shall be notified of the decision.
The notification shall contain the conclusions
of the audit and the reasoned assessment decision.
3.4.        The manufacturer shall
undertake to fulfil the obligations arising out of the quality system as
approved and to maintain it so that it remains adequate and efficient.
3.5.        The manufacturer shall keep
the notified body that has approved the quality system informed of any intended
change to the quality system.
The notified body shall evaluate any proposed
changes and decide whether the modified quality system will continue to satisfy
the requirements referred to in point 3.2 or whether a reassessment is
necessary.
It shall notify the manufacturer of its
decision. The notification shall contain the conclusions of the examination and
the reasoned assessment decision.
4.           Surveillance under the
responsibility of the notified body
4.1.        The purpose of surveillance
is to make sure that the manufacturer duly fulfils the obligations arising out
of the approved quality system.
4.2.        The manufacturer shall, for
assessment purposes, allow the notified body access to the design, manufacture,
inspection, testing and storage sites, and shall provide it with all necessary
information, in particular:
–              
the quality system documentation,
–              
the quality records as provided for by the
design part of the quality system, such as results of analyses, calculations,
tests, etc.,
–              
the quality records as provided for by the
manufacturing part of the quality system, such as inspection reports and test
data, calibration data, qualification reports on the personnel concerned, etc.
4.3.        The notified body shall
carry out periodic audits to make sure that the manufacturer maintains and
applies the quality system and shall provide the manufacturer with an audit
report.
4.4.        In addition, the notified
body may pay unexpected visits to the manufacturer. During such visits, the
notified body may, if necessary, carry out radio equipment tests, or have them
carried out, in order to check the proper functioning of the quality system. It
shall provide the manufacturer with a visit report and, if tests have been
carried out, with a test report.
5.           CE marking and declaration
of conformity
5.1.        The manufacturer shall
affix the CE marking according to Articles 19 and 20 and, under the
responsibility of the notified body referred to in point 3.1, the latter's
identification number to each piece of radio equipment that satisfies the
applicable requirements set out in Article 3.
5.2.        The manufacturer shall draw
up a written EU declaration of conformity for each type of radio equipment and
keep it at the disposal of the national authorities for 10 years after radio
equipment has been placed on the market. The EU declaration of conformity shall
identify the radio equipment type for which it has been drawn up.
A copy of the EU declaration of conformity
shall be made available to the relevant authorities upon request.
6.           The manufacturer shall,
for a period ending at least 10 years after radio equipment has been placed on
the market, keep at the disposal of the national authorities:
–              
the technical documentation referred to in point
3.1,
–              
the documentation concerning the quality system
referred to in point 3.1,
–              
the change referred to in point 3.5, as
approved,
–              
the decisions and reports of the notified body
referred to in points 3.5, 4.3 and 4.4.
7.           Each notified body shall
inform its notifying authorities of quality system approvals issued or
withdrawn, and shall, periodically or upon request, make available to its
notifying authorities the list of quality system approvals refused, suspended
or otherwise restricted.
Each notified body shall inform the other
notified bodies of quality system approvals which it has refused, suspended or
withdrawn, and, upon request, of quality system approvals which it has issued.
8.           Authorised representative
The manufacturer's obligations set out in
points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on
his behalf and under his responsibility, provided that they are specified in
the mandate.
.
ANNEX VI
Contents of Technical Documentation
The technical documentation shall, wherever
applicable, contain at least the following elements:
(a)                   
a general description of the radio equipment
including: photographs or illustrations showing external features, marking and
internal layout; versions of software or firmware affecting compliance with
essential requirements; user information and installation instructions;
(b)                   
conceptual design and manufacturing drawings and
schemes of components, sub-assemblies, circuits and other relevant similar
elements;
(c)                   
descriptions and explanations necessary for the
understanding of those drawings and schemes and the operation of the radio
equipment;
(d)                   
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 in Article 3 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;
(e)                   
copy of the EU declaration of conformity;
(f)                     
where the conformity assessment module in Annex
IV has been applied, copy of the EU-type examination
certificate and its annexes as delivered by the involved notified body;
(g)                   
results of design calculations made,
examinations carried out, and other relevant similar elements;
(h)                   
test reports.
ANNEX VII
Declaration of Conformity
1.           No … (unique
identification of the radio equipment):
2.           Name and address of the
manufacturer or his authorised representative:
3.           This declaration of
conformity is issued under the sole responsibility of the manufacturer.
4.           Object of the declaration
(identification of the radio equipment allowing traceability. It may include a
photograph, where appropriate):
5.           The object of the declaration
described above is in conformity with the relevant European Union harmonisation
legislation:
Radio Equipment Directive XXXX/xx
Other European Union harmonisation legislation where
applicable
6.           References to the relevant
harmonised standards used or references to the specifications in relation to
which conformity is declared. References shall be listed with their
identification number and version and where applicable date of issue:
7.           Where applicable, the
notified body ... (name, number) … performed … (description of intervention) …
and issued the EU-type examination certificate: …
8.           Additional information:
Where applicable, description of accessories
and/or components, including software, which allow the radio equipment to operate
as intended and covered by the Declaration of Conformity
Signed for and on behalf of: …………………………………
(place and date of issue):
(name, function) (signature):
ANNEX VIII
Simplified Declaration of Conformity
The simplified EU declaration of conformity
referred to in the third subparagraph of Article 10(8) shall be provided as
follows: 
Hereby,
[Name of manufacturer] declares that the radio equipment type [designation of type
of radio equipment] is in compliance with Radio Equipment Directive XXXX/xx.
ANNEX IX
Correlation table
 CORRELATION TABLE 
 Directive 1999/5/EC || This Directive 
 Article 1 || Article 1 
 Article 2 || Article 2 
 Article 3 || Article 3, with the exception of Article 3(3)(g) 
 Article 4(1) || Article 8 
 Article 4(2) || deleted 
 Article 5 || Article 16 
 Article 6(1) || Article 6 
 Article 6(2) || deleted 
 Article 6(3) || Article 10(7), 10(8), 10(9) 
 Article 6(4) || deleted 
 Article 7(1), 7(2) || Article 7 
 Article 7(3), 7(4), 7(5) || deleted 
 Article 8 || Article 9 
 Article 9 || Articles 39-43 
 Article 10 || Article 17 
 Article 11 || Articles 22-38 
 Article 12 || Articles 19, 20, 10(5), 10(6) 
 Articles 13 to 15 || Article 44 
 Article 16 || deleted 
 Article 17 || Article 47 
 Article 18 || Article 48 
 Article 19 || Article 49 
 Article 20 || Article 50 
 Article 21 || Article 51 
 Article 22 || Article 52 
 Annex I || Annex I 
 Annex II || Annex III 
 Annex III || deleted 
 Annex IV || Annex IV 
 Annex V || Annex V 
 Annex VI || Article 26 
 Annex VII(1) to (4) || Articles 19, 20 
 Annex VII(5) || Article 10(9) 
 New Articles || Article 3(3)(g) 
   || Article 4 
   || Article 5 
   || Articles 10(1) to (4), 10(10), 10(11), Articles 11 to 15 
   || Article 18 
   || Article 21 
   || Article 45 
   || Article 46 
   || Annex II 
   || Annex VI 
   || Annex VII 
   || Annex VIII 
LEGISLATIVE FINANCIAL STATEMENT
1.           FRAMEWORK OF THE PROPOSAL/INITIATIVE 
1.1.                  Title of the
proposal/initiative:          
1.2.                  Policy area(s)
concerned in the ABM/ABB structure         
1.3.                  Nature of the
proposal/initiative:      
1.4.                  Objective(s): 
1.4.1.     The Commission's
multiannual strategic objective(s) targeted by the proposal: 
1.4.2.     Specific objective(s) and
ABM/ABB activity(ies) concerned
1.5.                  Grounds for the
proposal/initiative:  
1.6.                  Duration and
financial impact:          
1.7.                  Management
method(s) envisaged: 
2.           MANAGEMENT MEASURES 
2.1.                  Monitoring and
reporting rules 
2.2.                  Management and
control system 
2.3.                  Measures to
prevent fraud and irregularities
3.           ESTIMATED FINANCIAL IMPACT OF THE
PROPOSAL/INITIATIVE 
3.1.                  Heading(s) of
the multiannual financial framework and expenditure         budget line(s)
affected: 
3.2.                  Estimated impact
on expenditure 
3.2.1.               Summary of
estimated impact on expenditure 
3.2.2.               Estimated impact
on operational appropriations 
3.2.3.               Estimated impact
on appropriations of an administrative nature:    
3.2.4.               Compatibility
with the current multiannual financial framework
3.2.5.               Third-party
participation in financing 
3.3.                  Estimated impact
on revenue
LEGISLATIVE FINANCIAL STATEMENT
1.           FRAMEWORK OF THE PROPOSAL/INITIATIVE 
1.1.        Title of the
proposal/initiative 
Proposal for a Directive of the European Parliament and of the
Council on the harmonisation of the laws of the Member States relating to radio
equipment (the Radio Equipment Directive), and repealing Directive 1999/5/EC,
Directive on Radio and Telecommunications Terminal Equipment, the R&TTE
Directive
1.2.        Policy area(s) concerned
in the ABM/ABB structure[38] 
Title 2 – Enterprise – Chapter 02 03: Internal Market for Goods and
Sectoral Policies
1.3.        Nature of the
proposal/initiative 
¨ The
proposal/initiative relates to a new action 
¨ The
proposal/initiative relates to a new action following a pilot
project/preparatory action[39]

X¨ The proposal/initiative relates to the extension of an existing
action 
¨ The
proposal/initiative relates to an action redirected towards a new action 
1.4.        Objectives
1.4.1.     The Commission's
multiannual strategic objective(s) targeted by the proposal/initiative 
1.4.2.     Specific objective(s) and
ABM/ABB activity(ies) concerned 
Specific objective No.1.
To continually renew existing internal market acquis and propose new
legislative or non-legislative action whenever appropriate [IP, IU, DA]. See
1.5.1 below for further detail.
ABM/ABB activity(ies) concerned
02 03
1.4.3.     Expected result(s) and
impact
Specify the effects
which the proposal/initiative should have on the beneficiaries/groups targeted.
The proposed legislative revision is expected to increase compliance
of radio equipment with the essential requirements in the Directive, namely the
protection of health and safety, electromagnetic
compatibility, and the avoidance of harmful interference. It should therefore improve protection of users and of fair competition, to
bring increased legal certainty, smoother and more consistent application of
the Directive and more comprehensive prevention of harmful interference, with
limited additional burden for market operators
1.4.4.     Indicators of results and
impact 
Specify the
indicators for monitoring implementation of the proposal/initiative.
Core indicators of progress towards meeting the objectives for the
revision of the Directive are the following:
   || Indicator || Approach 
 Compliance || Administrative and technical compliance ratios || Periodic reports from Member States 
 Administrative simplification and legal adaptations || Induced administrative cost and burden, number and relative relevance of issues of interpretation || Regular exchange with stakeholders — economic operators, authorities and notified bodies 
 Regulatory barriers to innovation || Perceived simplicity of introducing innovations || Regular exchange with stakeholders 
In accordance with the proposal, Member States would have a new
obligation to send to the Commission biannual reports on the application of the
Directive. The reports should cover market surveillance activities performed
and provide information on the level of compliance with the essential
requirements laid down in the Directive
Further information is to be collected through regular exchanges
within TCAM, the standing committee set up by the Directive, which in addition
to Member States includes representatives from industry, European Standards
Organisations, Notified Bodies and consumer organisations. The Commission plans
to review the operation of this Directive and report thereon to the European
Parliament and to the Council every five years.
1.5.        Grounds for the
proposal/initiative 
1.5.1.     Requirement(s) to be met in
the short or long term 
The Directive has been essential to achieve a single market for
radio equipment and for telecommunication terminals. It includes essential
requirements for the protection of health and safety and for the prevention of
harmful interference. These requirements are translated into technical
requirements within non-mandatory harmonised standards, as in other ‘New
Approach’ legislation.
The regulatory approach is considered to remain valid, a fundamental
revision of the Directive is therefore not necessary; Nevertheless, experience
in the operation of the Directive has highlighted a number of issues to be
addressed[40]. The main objectives of
the draft proposal are:
- to redress the current situation of low level of compliance with
the requirements in the Directive, and to increase the confidence of all
stakeholders in the regulatory framework,
- to clarify and simplify the Directive including some limited
adaptations of scope so as to facilitate its application and eliminate
unnecessary burden for economic operators and public authorities.
1.5.2.     Added value of EU
involvement
The revised Directive is to be based on Articles 26 (Internal
Market) and 114 (Approximation of Laws) TFEU. Action at EU level is necessary
in order to adapt, clarify or simplify provisions which are the keystone of the
Single Market in this area. This cannot be achieved by Member States acting
individually. A possible new obligation to register at EU level manufacturers
and/or equipment would enable access to the EU market, and its advantages
compared to multiple similar measures at national level are clear
1.5.3.     Lessons learned from
similar experiences in the past
Overall, the regulatory framework set up by the Directive has
allowed to achieve its intended goals, i.e. a high level of protection of
health and safety for users, the electromagnetic compatibility (EMC) for
telecommunication terminals and radio equipment as well as the avoidance of
harmful interference. The main issues to be addressed are the low level of
compliance with the Directive and the ambiguity and complexity of some
provisions in the Directive.
1.5.4.     Coherence and possible
synergy with other relevant instruments
The proposed revision will be consistent with the principles of the
Commission’s ‘Smart Regulation’ policy, with the policy for Europe 2020, in
particular as regards the regulatory review foreseen within the policy for an
Innovation Union , as well as with the proposed Radio Spectrum Policy Programme
.
The initiative will also be consistent with the New Legislative
Framework package approved in 2008. This consists of two complementary
instruments, Regulation 765/2008 on accreditation and market surveillance and
Decision 768/2008 establishing a common framework for the marketing of
products. The Decision complements the Regulation. While the latter basically
sets out the obligations on Member States and their authorities to ensure that
products on their market are safe and comply with the legal requirements, the
Decision deals with the relevant obligations imposed on economic operators such
as manufacturers, importers and distributors, as well as the bodies testing and
certifying products. Hence, the two instruments are inextricably linked and
their elements mutually support and complement each other. Unlike the
Regulation, the Decision does not have immediate legal effects on economic
operators, individuals or Member States, and provides (Article 2) that its
provisions are to be used when legislation is drafted or revised.
1.6.        Duration and financial
impact 
¨ Proposal/initiative of limited duration

–     
¨  Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY 
–     
¨  Financial impact from YYYY to YYYY 
X¨ Proposal/initiative of unlimited duration
–     
Implementation with a start-up period from 2013
–     
followed by full-scale operation.
1.7.        Management mode(s)
envisaged[41] 
1.8.        X¨ Centralised direct management by the Commission 
¨ Centralised indirect management with the delegation of implementation tasks to:
–     
¨  executive agencies 
–     
¨  bodies set up by the Communities[42]

–     
¨  national public-sector bodies/bodies with public-service mission 
–     
¨  persons entrusted with the implementation of specific actions
pursuant to Title V of the Treaty on European Union and identified in the
relevant basic act within the meaning of Article 49 of the Financial Regulation

¨ Shared management with the Member States 
¨ Decentralised management with third countries 
¨ Joint management with international organisations (to be specified)
If more than one
management mode is indicated, please provide details in the
"Comments" section.
Comments 
2.           MANAGEMENT MEASURES 
2.1.        Monitoring and reporting
rules 
Specify frequency
and conditions.
In accordance with the proposal, Member States would have a new
obligation to send to the Commission biannual reports on the application of the
Directive. The reports should cover market surveillance activities performed
and provide information on the level of compliance with the essential
requirements laid down in the Directive. 
Further information is to be collected through regular exchanges
within TCAM, the standing committee set up by the Directive, which in addition
to Member States includes representatives from industry, European Standards
Organisations, Notified Bodies and consumer organisations. The Commission plans
to review the operation of this Directive and report thereon to the European
Parliament and to the Council every five years.
2.2.        Management and control
system 
2.2.1.     Risk(s) identified 
-Divergent implementation of the revised Directive by Member States
might become an issue. 
-EU-level expenses associated to the revised Directive are limited
to human resources and possibly to the creation of a database for registration
of some categories of products prior to their placing on the market where
following the entry into force of the revised Directive a high level of
compliance has not been achieved. 
2.2.2.     Control method(s) envisaged

-In order to facilitate the transposition of the Directive in a way
which is consistent across Member States and with the intention of the EU
legislator, the Commission plans to organise one or more workshops with
responsible national ministries during the period provided for transposition of
the Directive by Member States.
-The possible set-up of database for the registration of products
for an estimated budget of 300000 EUR would be subject to tendering under the
rules of the Financial Regulation. 
2.3.        Measures to prevent fraud
and irregularities 
Specify existing or
envisaged prevention and protection measures.
-No specific measures beyond the application of the Financial
Regulation
3.           ESTIMATED FINANCIAL IMPACT OF THE
PROPOSAL/INITIATIVE 
3.1.        Heading(s) of the
multiannual financial framework and expenditure budget line(s) affected 
·      Existing expenditure budget lines 
 Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution 
 Number [Description………………………...……….] || Diff./non-diff. ([43]) || from EFTA[44] countries || from candidate countries[45] || from third countries || within the meaning of Article 18(1)(aa) of the Financial Regulation 
 1a Competitiveness for growth and employment || 02.03.01, Operation and development of the internal market, particularly in the fields of notification, certification and sectoral approximation. || Diff. || NO || NO || NO || NO 
·      New budget lines requested: NO
In order of multiannual financial framework
headings and budget lines.
 Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution 
 Number [Heading……………………………………..] || Diff./non-diff. || from EFTA countries || from candidate countries || from third countries || within the meaning of Article 18(1)(aa) of the Financial Regulation 
   || [XX.YY.YY.YY]   ||   || YES/NO || YES/NO || YES/NO || YES/NO 
3.2.        Estimated impact on
expenditure 
3.2.1.     Summary of estimated impact
on expenditure 
EUR million (to 3 decimal places)
 Heading of multiannual financial framework: || Number || 1a. Competitiveness for growth and employment 
 DG: ENTR ||   ||   || Year N[46] || Year N+1 || Year N+2 || Year N+3 || … enter as many years as necessary to show the duration of the impact (see point 1.6) || TOTAL 
  Operational appropriations ||   ||   ||   ||   ||   ||   ||   ||   
 02.03.01, Operation and development of the internal market, particularly in the fields of notification, certification and sectoral approximation. || Commitments || (1) || 0 || 0 || 0 || 0.3 || 0.03 || 0.03 || 0.03 || Proposal of unlimited duration 
 Payments || (2) || 0 || 0 || 0 || 0.3 || 0.03 || 0.03 || 0.03 || Proposal of unlimited duration 
 Number of budget line || Commitments || (1a) ||   ||   ||   ||   ||   ||   ||   ||   
 Payments || (2a) ||   ||   ||   ||   ||   ||   ||   ||   
 Appropriations of an administrative nature financed  from the envelope for specific programmes[47] ||   ||   ||   ||   ||   ||   ||   ||   
 Number of budget line ||   || (3) ||   ||   ||   ||   ||   ||   ||   ||   
 TOTAL appropriations for DG ENTR || Commitments || =1+1a +3 || 0 || 0 || 0 || 0.3 || 0.03 || 0.03 || 0.03 || Proposal of unlimited duration 
 Payments || =2+2a +3 || 0 || 0 || 0 || 0.3 || 0.03 || 0.03 || 0.03 || Proposal of unlimited duration 
  TOTAL operational appropriations || Commitments || (4) ||   ||   ||   ||   ||   ||   ||   ||   
 Payments || (5) ||   ||   ||   ||   ||   ||   ||   ||   
  TOTAL appropriations of an administrative nature financed from the envelope for specific programmes || (6) ||   ||   ||   ||   ||   ||   ||   ||   
 TOTAL appropriations under HEADING 1a. Competitiveness for growth and employment of the multiannual financial framework || Commitments || =4+ 6 || 0 || 0 || 0 || 0.3 || 0.03 || 0.03 || 0.03 || Proposal of unlimited duration 
 Payments || =5+ 6 || 0 || 0 || 0 || 0.3 || 0.03 || 0.03 || 0.03 || Proposal of unlimited duration 
If more than one heading is affected by the proposal /
initiative: NO
  TOTAL operational appropriations || Commitments || (4) ||   ||   ||   ||   ||   ||   ||   ||   
 Payments || (5) ||   ||   ||   ||   ||   ||   ||   ||   
  TOTAL appropriations of an administrative nature financed from the envelope for specific programmes || (6) ||   ||   ||   ||   ||   ||   ||   ||   
 TOTAL appropriations under HEADINGS 1 to 4 of the multiannual financial framework (Reference amount) || Commitments || =4+ 6 ||   ||   ||   ||   ||   ||   ||   ||   
 Payments || =5+ 6 ||   ||   ||   ||   ||   ||   ||   ||   
 Heading of multiannual financial framework: || 5 || " Administrative expenditure " 
   ||   ||   || Year N || Year N+1 || Year N+2 || Year N+3 || … enter as many years as necessary to show the duration of the impact (see point 1.6) || TOTAL 
 DG: ENTR || 
  Human resources || 0.635 || 0.635 || 0.635 || 0.635 || 0.635 || 0.635 || 0.635 || Proposal of unlimited duration 
  Other administrative expenditure || 0.092 || 0.092 || 0.092 || 0.092 || 0.092 || 0.092 || 0.092 || Proposal of unlimited duration 
 TOTAL DG ENTR || Appropriations || 0.727 || 0.727 || 0.727 || 0.727 || 0.727 || 0.727 || 0.727 || Proposal of unlimited duration 
 TOTAL appropriations under HEADING 5 of the multiannual financial framework || (Total commitments = Total payments) ||   ||   ||   ||   ||   ||   ||   ||   
3.2.2.     Estimated impact on
operational appropriations 
–     
¨  The proposal/initiative does not require the use of operational
appropriations 
–     
X¨           The proposal/initiative requires
the use of operational appropriations, as explained below:
Commitment appropriations in EUR million (to 3 decimal
places)
 Indicate objectives and outputs   ò ||   ||   || Year N || Year N+1 || Year N+2 || Year N+3 || … enter as many years as necessary to show the duration of the impact (see point 1.6) || TOTAL 
 OUTPUTS 
 Type of output[48] || Average cost of the output || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Total number of outputs || Total cost 
 SPECIFIC OBJECTIVE No 1: To continually renew existing internal market acquis and propose new legislative or non-legislative action whenever appropriate [49]… ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 Delivery of an IT database for product registration ||   ||   ||   ||   ||   ||   ||   ||   || 1 || 0.3 ||   ||   ||   ||   ||   ||   ||   ||   
 Maintenance of an IT database for product registration ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   || 1 || 0.03 || 1 || 0.03 || 1 || 0.03 ||   || Proposal of unlimited duration 
 - Output ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 Sub-total for specific objective N°1 ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 SPECIFIC OBJECTIVE No 2… ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 - Output ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 Sub-total for specific objective N°2 ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 TOTAL COST ||   ||   ||   ||   ||   ||   ||   || 0.3 ||   || 0.03 ||   || 0.03 ||   || 0.03 ||   || Proposal of unlimited duration 
3.2.3.     Estimated impact on
appropriations of an administrative nature
3.2.3.1.  Summary 
–     
¨  The proposal/initiative does not require the use of administrative
appropriations 
–     
X¨           The proposal/initiative requires
the use of administrative appropriations, as explained below:
EUR million (to 3
decimal places)
   || Year N [50] || Year N+1 || Year N+2 || Year N+3 || … enter as many years as necessary to show the duration of the impact (see point 1.6) || TOTAL 
 HEADING 5 of the multiannual financial framework ||   ||   ||   ||   ||   ||   ||   ||   
 Human resources || 0.635 || 0.635 || 0.635 || 0.635 || 0.635 || 0.635 || 0.635 || Proposal of unlimited duration 
 Other administrative expenditure || 0.092 || 0.092 || 0.092 || 0.092 || 0.092 || 0.092 || 0.092 ||   
 Subtotal HEADING 5 of the multiannual financial framework || 0.727 || 0.727 || 0.727 || 0.727 || 0.727 || 0.727 || 0.727 || Proposal of unlimited duration 
 Outside HEADING 5[51] of the multiannual financial framework ||   ||   ||   ||   ||   ||   ||   ||   
 Human resources ||   ||   ||   ||   ||   ||   ||   ||   
 Other expenditure of an administrative nature ||   ||   ||   ||   ||   ||   ||   ||   
 Subtotal outside HEADING 5 of the multiannual financial framework ||   ||   ||   ||   ||   ||   ||   ||   
 TOTAL || 0.727 || 0.727 || 0.727 || 0.727 || 0.727 || 0.727 || 0.727 || Proposal of unlimited duration 
3.2.3.2.   Estimated requirements of
human resources 
–     
¨  The proposal/initiative does not require the use of human
resources 
–     
X¨           The proposal/initiative requires
the use of human resources, as explained below:
Estimate to be expressed in full amounts
(or at most to one decimal place)
   || Year N || Year N+1 || Year N+2 || Year N+3 || … enter as many years as necessary to show the duration of the impact (see point 1.6) 
  Establishment plan posts (officials and temporary agents) 
 02 01 01 01 (Headquarters and Commission’s Representation Offices) || 5 || 5 || 5 || 5 || 5 || 5 || 5 
 XX 01 01 02 (Delegations) ||   ||   ||   ||   ||   ||   ||   
 XX 01 05 01 (Indirect research) ||   ||   ||   ||   ||   ||   ||   
 10 01 05 01 (Direct research) ||   ||   ||   ||   ||   ||   ||   
  External personnel (in Full Time Equivalent unit: FTE)[52] 
 XX 01 02 01 (CA, INT, SNE from the "global envelope") ||   ||   ||   ||   ||   ||   ||   
 XX 01 02 02 (CA, INT, JED, LA and SNE in the delegations) ||   ||   ||   ||   ||   ||   ||   
 XX 01 04 yy [53] || - at Headquarters[54] ||   ||   ||   ||   ||   ||   ||   
 - in delegations ||   ||   ||   ||   ||   ||   ||   
 XX 01 05 02 (CA, INT, SNE - Indirect research) ||   ||   ||   ||   ||   ||   ||   
 10 01 05 02 (CA, INT, SNE - Direct research) ||   ||   ||   ||   ||   ||   ||   
 Other budget lines (specify) ||   ||   ||   ||   ||   ||   ||   
 TOTAL || 5 || 5 || 5 || 5 || 5 || 5 || 5 
XX is the
policy area or budget title concerned.
The human resources required
will be met by staff from the DG who are already assigned to management of the action
and/or have been redeployed within the DG, together if necessary with any
additional allocation which may be granted to the managing DG under the annual
allocation procedure and in the light of budgetary constraints.
Description of
tasks to be carried out:
 Officials and temporary agents || 1 official as desk officer of the Directive, 3 officials in charge of specific areas: legal issues, secretariat of the Standing Committee, communication, coordination with DG Information Society on Spectrum Policy, assessment of Member States notifications of relevant technical regulations, coordination of enforcement by market surveillance authorities, screening of legislation by EU candidate/associated countries, support to DG Trade on negotiations with third countries -1 official as secretary of the team and responsible for logistics 
 External personnel ||   
3.2.4.     Compatibility with the
current multiannual financial framework 
–     
X¨           Proposal/initiative is
compatible the current multiannual financial framework: all measures or actions
included in this Directive are consistent and compatible with the current and
the next multiannual financial framework (2014 to 2020) as proposed by the
Commission.
–     
¨  Proposal/initiative will entail reprogramming of the relevant
heading in the multiannual financial framework.
Explain what reprogramming is required,
specifying the budget lines concerned and the corresponding amounts.
–     
¨  Proposal/initiative requires application of the flexibility
instrument or revision of the multiannual financial framework[55].
Explain what is required, specifying the
headings and budget lines concerned and the corresponding amounts.
3.2.5.     Third-party contributions 
–     
X The proposal/initiative does not provide for
co-financing by third parties 
–     
The proposal/initiative provides for the
co-financing estimated below:
Appropriations in EUR million (to 3 decimal places)
   || Year N || Year N+1 || Year N+2 || Year N+3 || … enter as many years as necessary to show the duration of the impact (see point 1.6) || Total 
 Specify the co-financing body ||   ||   ||   ||   ||   ||   ||   ||   
 TOTAL appropriations cofinanced ||   ||   ||   ||   ||   ||   ||   ||   
3.3.        Estimated impact on
revenue 
–     
X¨           Proposal/initiative has no
financial impact on revenue.
–     
¨  Proposal/initiative has the following financial impact:
·                   
¨    on own resources 
·                   
¨    on miscellaneous revenue 
EUR million (to 3 decimal places)
 Budget revenue line: || Appropriations available for the ongoing budget year || Impact of the proposal/initiative[56] 
 Year N || Year N+1 || Year N+2 || Year N+3 || … insert as many columns as necessary in order to reflect the duration of the impact (see point 1.6) 
 Article …………. ||   ||   ||   ||   ||   ||   ||   ||   
For miscellaneous
assigned revenue, specify the budget expenditure line(s) affected.
Specify the method for
calculating the impact on revenue. 
[1]               Second Progress Report on the operation of the
R&TTE Directive, COM(2010)43 final, of 9.2.2010
[2]               Decision No 676/2002/EC of the European Parliament
and of the Council of 7 March 2002 on a regulatory framework for radio spectrum
policy in the European Community
[3]               Directive 2002/95/EC on Restriction of Hazardous
Substances.
[4]               Directive 2002/96/EC on Waste
of Electrical and Electronic Equipment.
[5]               Directive 2006/66/EC on batteries and accumulators
and waste batteries and accumulators.
[6]               Directive 2009/125/EC establishing a framework for
the setting of ecodesign requirements for energy-related products. 
[7]               Decision No 243/2012/EU of the European Parliament
and of the Council of 14 March 2012 establishing a multiannual radio spectrum
policy programme.
[8]               Directive 2002/21/EC of the European Parliament and
of the Council of 7 March 2002 on a common regulatory framework for electronic
communications networks and services (Framework Directive)
[9]               Directive 2002/20/EC of the European Parliament and
of the Council of 7 March 2002 on the authorisation of electronic
communications networks and services (Authorisation Directive) 
[10]             Decision No 676/2002/EC of the European Parliament and
of the Council of 7 March 2002 on a regulatory framework for radio spectrum
policy in the European Community (Radio Spectrum Decision)
[11]             http://ec.europa.eu/governance/better_regulation/key_docs_en.htm#_br.
[12]             http://ec.europa.eu/research/innovation-union/index_en.cfm,
COM(2010) 546 final, Europe 2020 Flagship Initiative - Innovation Union.
[13]             Decision No 243/2012/EU of the European Parliament and
of the Council of 14 March 2012 establishing a multiannual radio spectrum
policy programme.
[14]             Report from the Commission to the Council and the
European Parliament. Second Progress Report on the operation of Directive
1999/5/EC, on radio equipment and telecommunications terminal equipment and the
mutual recognition of their conformity. [COM/2010/0043 final - Not published in
the Official Journal] - http://ec.europa.eu/enterprise/sectors/rtte/documents/legislation/review/index_en.htm#h2-2
[15]             Summary of the 2010 public consultation on the impact
of options under consideration for the revision of the R&TTE Directive. May
2011.
http://ec.europa.eu/enterprise/sectors/rtte/public-consultation/files-public-consultation/summary-2010-pc_en.pdf
[16]             Impact
Assessment concerning a proposed mandatory registration system in the scope of
Directive 1999/5/EC FINAL REPORT 5.10.2009. Technopolis Group
-http://ec.europa.eu/enterprise/sectors/rtte/files/technop-ia-radio-finrep_en.pdf
[17]             Directive 2004/108/EC of the European Parliament and of
the Council of 15 December 2004 on the approximation of the laws of Member
States relating to electromagnetic compatibility and repealing Directive
89/336/EEC
[18]             Directive 2006/95/EC of the European Parliament and of
the Council of 12 December 2006 on the harmonisation of the laws of the Member
States relating to electrical equipment designed for use within certain voltage
limits
[19]             Directive 2001/95/EC of the European Parliament and of
the Council of 3 December 2001 on general product safety 
[20]             Directive 2008/63/EC of 20 June 2008 on competition in
the markets in telecommunications terminal equipment
[21]             
[22]             
[23]             OJ L 91, 7.4.1999, p. 10.
[24]             OJ L 218, 13.8.2008, p. 30.
[25]             OJ L 218, 13.8.2008, p. 82.
[26]             OJ L 374, 27.12.2006, p. 10.
[27]             OJ L 390, 31.12.2004, p. 24.
[28]             OJ L 162, 21.6.2008, p. 20.
[29]             OJ L 204, 21.7.1998, p. 37.
[30]             OJ L 108, 24.4.2002, p. 1.
[31]             OJ L 129, 17.5.2007, p. 67.
[32]             OJ L […], […], p. […].
[33]             OJ L 55 of 28.2.2011, p. 13.
[34]             OJ L 108, 24.4.2002, p. 33.
[35]             OJ L […], […], p. […].
[36]             OJ L 46, 17.2.1997, p. 25
[37]             OJ L 79, 19.3.2008, p. 1
[38]             ABM: Activity-Based Management – ABB: Activity-Based
Budgeting.
[39]             As referred to in Article 49(6)(a) or (b) of the
Financial Regulation.
[40]             Second Progress Report on the operation of the
R&TTE Directive, COM(2010)43 final, of 9.2.2010
[41]             Details of management modes and references to the
Financial Regulation may be found on the BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html
[42]             As referred to in Article 185 of the Financial
Regulation.
[43]             Diff. = Differentiated appropriations / Non-diff. =
Non-Differentiated Appropriations
[44]             EFTA: European Free Trade Association. 
[45]             Candidate countries and, where applicable, potential
candidate countries from the Western Balkans.
[46]             Year N is the year in which implementation of the
proposal/initiative starts.
[47]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.
[48]             Outputs are products and services to be supplied (e.g.:
number of student exchanges financed, number of km of roads built, etc.).
[49]             As described in Section 1.4.2. "Specific
objective(s)…"
[50]             Year N is the year in which implementation of the
proposal/initiative starts.
[51]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.
[52]             CA= Contract Agent; INT= agency staff ("Intérimaire");
JED= "Jeune Expert en Délégation" (Young Experts in
Delegations); LA= Local Agent; SNE= Seconded National Expert; 
[53]             Under
the ceiling for external personnel from operational
appropriations (former "BA" lines).
[54]             Essentially for Structural Funds, European Agricultural
Fund for Rural Development (EAFRD) and European Fisheries Fund (EFF).
[55]             See points 19 and 24 of the Interinstitutional
Agreement.
[56]             As regards traditional own resources (customs duties,
sugar levies), the amounts indicated must be net amounts, i.e. gross amounts
after deduction of 25% for collection costs.