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31999L0005
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
Official Journal L 091 , 07/04/1999 P. 0010 - 0028
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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
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in
particular Article 100a,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting
in accordance with the procedure laid down in Article 189b of the
Treaty(3), in the light of the joint text approved by the Conciliation
Committee on 8 December 1998,
(1) Whereas the radio equipment and
telecommunications terminal equipment sector is an essential part of
the telecommunications market, which is a key element of the economy in
the Community; whereas the directives applicable to the
telecommunications terminal equipment sector are no longer capable of
accommodating the expected changes in the sector caused by new
technology, market developments and network legislation;
(2)
Whereas in accordance with the principles of subsidiarity and
proportionality referred to in Article 3b of the Treaty, the objective
of creating an open competitive single market for telecommunications
equipment cannot be sufficiently achieved by the Member States and can
therefore be better achieved by the Community; whereas this Directive
does not go beyond what is necessary to achieve this aim;
(3) Whereas Member States may rely upon Article 36 of the Treaty to
exclude certain classes of equipment from this Directive;
(4)
Whereas Directive 98/13/EC(4) consolidated the provisions relating to
telecommunications terminal equipment and satellite earth station
equipment, including measures for the mutual recognition of their
conformity;
(5) Whereas that Directive does not cover a substantial proportion of
the radio equipment market;
(6)
Whereas dual-use goods are subject to the Community regime of export
controls introduced by Council Regulation (EC) No 3381/94(5);
(7)
Whereas the broad scope of this Directive requires new definitions of
the expressions "radio equipment" and "telecommunications terminal
equipment"; whereas a regulatory regime aimed at the development of a
single market for radio equipment and telecommunications terminal
equipment should permit investment, manufacture and sale to take place
at the pace of technology and market developments;
(8) Whereas,
given the increasing importance of telecommunications terminal
equipment and networks using radio transmission besides equipment
connected through wired links, any rules governing the manufacturing,
marketing and use of radio equipment and telecommunications terminal
equipment should cover both classes of such equipment;
(9) Whereas
Directive 98/10/EC of the European Parliament and of the Council of 26
February 1998 on the application of open network provision (ONP) to
voice telephony and on universal service for telecommunications in a
competitive environment(6) calls on national regulatory authorities to
ensure the publication of details of technical interface specifications
for network access for the purpose of ensuring a competitive market for
the supply of terminal equipment;
(10) Whereas the objectives of
Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of
the laws of the Member States relating to electrical equipment designed
for use within certain voltage limits(7) are sufficient to cover radio
equipment and telecommunications terminal equipment, but with no lower
voltage limit applying;
(11) Whereas the electromagnetic
compatibility related protection requirements laid down by Council
Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of
Member States relating to electromagnetic compatibility(8) are
sufficient to cover radio equipment and telecommunications terminal
equipment;
(12) Whereas Community law provides that obstacles to
the free movement of goods within the Community, resulting from
disparities in national legislation relating to the marketing of
products, can only be justified where any national requirements are
necessary and proportionate; whereas, therefore, the harmonisation of
laws must be limited to those requirements necessary to satisfy the
essential requirements relating to radio equipment and
telecommunications terminal equipment;
(13) Whereas the essential
requirements relevant to a class of radio equipment and
telecommunications terminal equipment should depend on the nature and
the needs of that class of equipment; whereas these requirements must
be applied with discernment in order not to inhibit technological
innovation or the meeting of the needs of a free-market economy;
(14)
Whereas care should be taken that radio equipment and
telecommunications terminal equipment should not represent an avoidable
hazard to health;
(15) Whereas telecommunications are important to
the well-being and employment of people with disabilities who represent
a substantial and growing proportion of the population of Europe;
whereas radio equipment and telecommunications terminal equipment
should therefore in appropriate cases be designed in such a way that
disabled people may use it without or with only minimal adaptation;
(16)
Whereas radio equipment and telecommunications terminal equipment can
provide certain functions required by emergency services;
(17)
Whereas some features may have to be introduced on the radio equipment
and telecommunications terminal equipment in order to prevent the
infringement of personal data and privacy of the user and of the
subscriber and/or the avoidance of fraud;
(18) Whereas in some
cases interworking via networks with other apparatus within the meaning
of this Directive and connection with interfaces of the appropriate
type throughout the Community may be necessary;
(19) Whereas it
should therefore be possible to identify and add specific essential
requirements on user privacy, features for users with a disability,
features for emergency services and/or features for avoidance of fraud;
(20) Whereas it is recognised that in a competitive market,
voluntary certification and marking schemes developed by consumer
organisations, manufacturers, operators and other industry actors
contribute to quality and are a useful means of improving consumers'
confidence in telecommunications products and services; whereas Member
States may support such schemes; whereas such schemes should be
compatible with the competition rules of the Treaty;
(21) Whereas
unacceptable degradation of service to persons other than the user of
radio equipment and telecommunications terminal equipment should be
prevented; whereas manufacturers of terminals should construct
equipment in a way which prevents networks from suffering harm which
results in such degradation when used under normal operating
conditions; whereas network operators should construct their networks
in a way that does not oblige manufacturers of terminal equipment to
take disproportionate measures to prevent networks from being harmed;
whereas the European Telecommunications Standards Institute (ETSI)
should take due account of this objective when developing standards
concerning access to public networks;
(22) Whereas effective use
of the radio spectrum should be ensured so as to avoid harmful
interference; whereas the most efficient possible use, according to the
state of the art, of limited resources such as the radio frequency
spectrum should be encouraged;
(23) Whereas harmonised interfaces
between terminal equipment and telecommunications networks contribute
to promoting competitive markets both for terminal equipment and
network services;
(24) Whereas, however, operators of public
telecommunications networks should be able to define the technical
characteristics of their interfaces, subject to the competition rules
of the Treaty; whereas, accordingly, they should publish accurate and
adequate technical specifications of such interfaces so as to enable
manufacturers to design telecommunications terminal equipment which
satisfies the requirements of this Directive;
(25) Whereas,
nevertheless, the competition rules of the Treaty and Commission
Directive 88/301/EEC of 16 May 1988 on competition in the markets in
telecommunications terminal equipment(9) establish the principle of
equal, transparent and non-discriminatory treatment of all technical
specifications having regulatory implications; whereas therefore it is
the task of the Community and the Member States, in consultation with
the economic players, to ensure that the regulatory framework created
by this Directive is fair;
(26) Whereas it is the task of the
European standardisation organisations, notably ETSI, to ensure that
harmonised standards are appropriately updated and drafted in a way
which allows for unambiguous interpretation; whereas maintenance,
interpretation and implementation of harmonised standards constitute
very specialised areas of increasing technical complexity; whereas
those tasks require the active participation of experts drawn from
amongst the economic players; whereas in some circumstances it may be
necessary to provide more urgent interpretation of or corrections to
harmonised standards than is possible through the normal procedures of
the European standardisation organisations operating in conformity with
Directive 98/34/EC of 22 June 1998 of the European Parliament and of
the Council laying down a procedure for the provision of information in
the field of technical standards and regulations and of rules on
information society services(10);
(27) Whereas it is in the public
interest to have harmonised standards at European level in connection
with the design and manufacture of radio equipment and
telecommunications terminal equipment; whereas compliance with such
harmonised standards gives rise to a presumption of conformity to the
essential requirements; whereas other means of demonstrating conformity
to the essential requirements are permitted;
(28) Whereas the
assignment of equipment class identifiers should draw on the expertise
of CEPT/ERC and of the relevant European standards bodies in radio
matters; whereas other forms of cooperation with those bodies is to be
encouraged where possible;
(29) Whereas, in order to enable the
Commission to monitor market control effectively, the Member States
should provide the relevant information concerning types of interfaces,
inadequate or incorrectly applied harmonised standards, notified bodies
and surveillance authorities;
(30) Whereas notified bodies and
surveillance authorities should exchange information on radio equipment
and telecommunications terminal equipment with a view to efficient
surveillance of the market; whereas such cooperation should make the
utmost use of electronic means; whereas, in particular, such
cooperation should enable national authorities to be informed about
radio equipment placed on their market operating in frequency bands not
harmonised in the Community;
(31) Whereas manufacturers should
notify Member States of their intention to place radio equipment on the
market using frequency bands whose use is not harmonised throughout the
Community; whereas Member States therefore need to put in place
procedures for such notification; whereas such procedures should be
proportionate and should not constitute a conformity assessment
procedure additional to those provided for in Annexes IV or V; whereas
it is desirable that those notification procedures should be harmonised
and preferably implemented by electronic means and one-stop-shopping;
(32)
Whereas radio equipment and telecommunications terminal equipment which
complies with the relevant essential requirements should be permitted
to circulate freely; whereas such equipment should be permitted to be
put into service for its intended purpose; whereas the putting into
service may be subject to authorisations on the use of the radio
spectrum and the provision of the service concerned;
(33) Whereas,
for trade fairs, exhibitions, etc., it must be possible to exhibit
radio equipment and telecommunications terminal equipment which does
not conform to this Directive; whereas, however, interested parties
should be properly informed that such equipment does not conform and
cannot be purchased in that condition; whereas Member States may
restrict the putting into service, including the switching on, of such
exhibited radio equipment for reasons related to the effective and
appropriate use of the radio spectrum, avoidance of harmful
interference or matters relating to public health;
(34) Whereas
radio frequencies are allocated nationally and, to the extent that they
have not been harmonised, remain within the exclusive competence of the
Member States; whereas it is necessary to include a safeguard provision
permitting Member States, in conformity with Article 36 of the Treaty,
to prohibit, restrict or require the withdrawal from its market of
radio equipment which has caused, or which it reasonably considers will
cause, harmful interference; whereas interference with nationally
allocated radio frequencies constitutes a valid ground for Member
States to take safeguard measures;
(35) Whereas manufacturers are
liable for damage caused by defective apparatus according to the
provisions of Council Directive 85/374/EEC(11); whereas without
prejudice to any liability on the part of the manufacturer, any person
who imports apparatus into the Community for sale in the course of his
business is liable according to that Directive; whereas the
manufacturer, his authorised representative or the person responsible
for placing the apparatus on the Community market is liable according
to the rules of the law of contractual or non-contractual liability in
the Member States;
(36) Whereas the measures which are appropriate
to be taken by the Member States or the Commission where apparatus
declared to be compliant with the provisions of this Directive causes
serious damage to a network or harmful radio interference shall be
determined in accordance with the general principles of Community law,
in particular, the principles of objectivity, proportionality and
non-discrimination;
(37) Whereas on 22 July 1993 the Council
adopted Decision 93/465/EEC concerning the modules for the various
phases of the conformity assessment procedures and the rules for the
affixing and the use of EC conformity marking which are intended to be
used in the technical harmonisation directives(12); whereas the
applicable conformity assessment procedures should preferably be chosen
from among the available modules laid down by that Decision;
(38)
Whereas Member States may request that notified bodies they designate
and their surveillance authorities be accredited according to
appropriate European standards;
(39) Whereas it is appropriate
that compliance of radio equipment and telecommunications terminal
equipment with the requirements of Directives 73/23/EEC and 89/336/EEC
may be demonstrated using the procedures specified in those Directives
where the apparatus is within their scope; whereas, as a result, the
procedure provided for in Article 10(1) of Directive 89/336/EEC may be
used where the application of harmonised standards gives rise to a
presumption of conformity with the protection requirements; whereas the
procedure provided for in Article 10(13) may be used where the
manufacturer has not applied harmonised standards or where no such
standards exist;
(40) Whereas Community undertakings should have
effective and comparable access to third countries' markets and enjoy
treatment in third countries similar to that offered in the Community
to undertakings owned wholly, controlled through majority ownership or
effectively controlled by nationals of the third countries concerned;
(41)
Whereas it is desirable to establish a committee bringing together
parties directly involved in the implementation of regulation of radio
equipment and telecommunications terminal equipment, in particular the
national conformity assessment bodies and national bodies responsible
for market surveillance, in order to assist the Commission in achieving
a harmonised and proportionate application of the provisions so as to
meet the needs of the market and the public at large; whereas
representatives of telecommunications operators, users, consumers,
manufacturers and service providers should be consulted where
appropriate;
(42) Whereas a modus vivendi between the European
Parliament, the Council and the Commission concerning the implementing
measures for acts adopted in accordance with the procedure laid down in
Article 189b of the Treaty was concluded on 20 December 1994(14);
(43)
Whereas the Commission should keep under review the implementation and
practical application of this and other relevant directives and take
steps to ensure coordination of the application of all relevant
directives in order to avoid disturbance to telecommunications
equipment which affects the health of humans or is harmful to property;
(44) Whereas the functioning of this Directive should be reviewed
in due course in the light of the development of the telecommunications
sector and of experience gained from application of the essential
requirements and the conformity assessment procedures provided for in
this Directive;
(45) Whereas it is necessary to ensure that with
the introduction of changes to the regulatory regime there is a smooth
transition from the previous regime in order to avoid disruption to the
market and legal uncertainty;
(46) Whereas this Directive replaces
Directive 98/13/EC, which should accordingly be repealed; whereas
Directives 73/23/EEC and 89/336/EEC will no longer apply to apparatus
within the scope of this Directive, with the exception of protection
and safety requirements and certain conformity assessment procedures,
HAVE ADOPTED THIS DIRECTIVE:
CHAPTER I
GENERAL ASPECTS
Article 1
Scope and aim
1.
This Directive establishes a regulatory framework for the placing on
the market, free movement and putting into service in the Community of
radio equipment and telecommunications terminal equipment.
2. Where apparatus as defined in Article 2(a) incorporates, as an
integral part, or as an accessory:
(a)
a medical device within the meaning of Article 1 of Council Directive
93/42/EEC of 14 June 1993 concerning medical devices(15), or
(b) an
active implantable medical device within the meaning of Article 1 of
Council Directive 90/385/EEC of 20 June 1990 on the approximation of
the laws of the Member States relating to active implantable medical
devices(16),
the apparatus shall be governed by this Directive,
without prejudice to the application of Directives 93/42/EEC and
90/385/EEC to medical devices and active implantable medical devices,
respectively.
3. Where apparatus constitutes a component or a
separate technical unit of a vehicle within the meaning of Council
Directive 72/245/EEC(17) relating to the radio interference
(electromagnetic compatibility) of vehicles or a component or a
separate technical unit of a vehicle within the meaning of Article 1 of
Council Directive 92/61/EEC of 30 June 1992 relating to the
type-approval of two or three-wheel motor vehicles, the apparatus shall
be governed by this Directive without prejudice to the application of
Directive 72/245/EEC or of Directive 92/61/EEC respectively.
4. This Directive shall not apply to equipment listed in Annex I.
5.
This Directive shall not apply to apparatus 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.
Article 2
Definitions
For the purpose of this Directive the following definitions shall apply:
(a) "apparatus" means any equipment that is either radio equipment or
telecommunications terminal equipment or both;
(b)
"telecommunications terminal equipment" means a product enabling
communication or a relevant component thereof which is intended to be
connected directly or indirectly by any means whatsoever to interfaces
of public telecommunications networks (that is to say,
telecommunications networks used wholly or partly for the provision of
publicly available telecommunications services);
(c) "radio
equipment" means a product, or relevant component thereof, capable of
communication by means of the emission and/or reception of radio waves
utilising the spectrum allocated to terrestrial/space
radiocommunication;
(d) "radio waves" means electromagnetic waves
of frequencies from 9 kHz to 3000 GHz, propagated in space without
artificial guide;
(e) "interface" means
(i) a network
termination point, which is a physical connection point at which a user
is provided with access to public telecommunications network, and/or
(ii) an air interface specifying the radio path between radio equipment
and their technical specifications;
(f)
"equipment class" means a class identifying particular types of
apparatus which under this Directive are considered similar and those
interfaces for which the apparatus is designed. Apparatus may belong to
more than one equipment class;
(g) "technical construction file"
means a file describing the apparatus and providing information and
explanations as to how the applicable essential requirements have been
implemented;
(h) "harmonised standard" means a technical
specification adopted by a recognised standards body under a mandate
from the Commission in conformity with the procedures laid down in
Directive 98/34/EC for the purpose of establishing a European
requirement, compliance with which is not compulsory.
(i) "harmful
interference" means interference which endangers the functioning of a
radionavigation service or of other safety services or which otherwise
seriously degrades, obstructs or repeatedly interrupts a
radiocommunications service operating in accordance with the applicable
Community or national regulations.
Article 3
Essential requirements
1. The following essential requirements are applicable to all apparatus:
(a)
the protection of the health and the safety of the user and any other
person, including the objectives with respect to safety requirements
contained in Directive 73/23/EEC, but with no voltage limit applying;
(b) the protection requirements with respect to electromagnetic
compatibility contained in Directive 89/336/EEC.
2.
In addition, radio equipment shall be so constructed that it
effectively uses the spectrum allocated to terrestrial/space radio
communication and orbital resources so as to avoid harmful interference.
3.
In accordance with the procedure laid down in Article 15, the
Commission may decide that apparatus within certain equipment classes
or apparatus of particular types shall be so constructed that:
(a)
it interworks via networks with other apparatus and that it can be
connected to interfaces of the appropriate type throughout the
Community; and/or that
(b) it does not harm the network or its
functioning nor misuse network resources, thereby causing an
unacceptable degradation of service; and/or that
(c) it incorporates
safeguards to ensure that the personal data and privacy of the user and
of the subscriber are protected; and/or that
(d) it supports certain features ensuring avoidance of fraud; and/or
that
(e) it supports certain features ensuring access to emergency services;
and/or that
(f) it supports certain features in order to facilitate its use by
users with a disability.
Article 4
Notification and publication of interface specifications
1.
Member States shall notify the interfaces which they have regulated to
the Commission insofar as the said interfaces have not been notified
under the provisions of Directive 98/34/EC. After consulting the
committee in accordance with the procedure set out in Article 15, the
Commission shall establish the equivalence between notified interfaces
and assign an equipment class identifier, details of which shall be
published in the Official Journal of the European Communities.
2.
Each Member State shall notify to the Commission the types of interface
offered in that State by operators of public telecommunications
networks. Member States shall ensure that such operators publish
accurate and adequate technical specifications of such interfaces
before services provided through those interfaces are made publicly
available, and regularly publish any updated specifications. The
specifications shall be in sufficient detail to permit the design of
telecommunications terminal equipment capable of utilising all services
provided through the corresponding interface. The specifications shall
include, inter alia, all the information necessary to allow
manufacturers to carry out, at their choice, the relevant tests for the
essential requirements applicable to the telecommunications terminal
equipment. Member States shall ensure that those specifications are
made readily available by the operators.
Article 5
Harmonised standards
1.
Where apparatus meets the relevant harmonised standards or parts
thereof whose reference numbers have been published in the Official
Journal of the European Communities, Member States shall presume
compliance with those of the essential requirements referred to in
Article 3 as are covered by the said harmonised standards or parts
thereof.
2. Where a Member State or the Commission considers that
conformity with a harmonised standard does not ensure compliance with
the essential requirements referred to in Article 3 which the said
standard is intended to cover, the Commission or the Member State
concerned shall bring the matter before the committee.
3. In the
case of shortcomings of harmonised standards with respect to the
essential requirements, the Commission may, after consulting the
committee and in accordance with the procedure laid down in Article 14,
publish in the Official Journal of the European Communities guidelines
on the interpretation of harmonised standards or the conditions under
which compliance with that standard raises a presumption of conformity.
After consultation of the committee and in accordance with the
procedure laid down in Article 14, the Commission may withdraw
harmonised standards by publication of a notice in the Official Journal
of the European Communities.
Article 6
Placing on the market
1.
Member States shall ensure that apparatus is placed on the market only
if it complies with the appropriate essential requirements identified
in Article 3 and the other relevant provisions of this Directive when
it is properly installed and maintained and used for its intended
purpose. It shall not be subject to further national provisions in
respect of placing on the market.
2. In taking a decision regarding
the application of essential requirements under Article 3(3), the
Commission shall determine the date of application of the requirements.
If it is determined that an equipment class needs to comply with
particular essential requirements under Article 3(3), any apparatus of
the equipment class in question which is first placed on the market
before the date of application of the Commission's determination can
continue to be placed on the market for a reasonable period. Both the
date of application and the period shall be determined by the
Commission in accordance with the procedure laid down in Article 14.
3.
Member States shall ensure that the manufacturer or the person
responsible for placing the apparatus on the market provides
information for the user on the intended use of the apparatus, together
with the declaration of conformity to the essential requirements. Where
it concerns radio equipment, such information shall be sufficient to
identify on the packaging and the instructions for use of the apparatus
the Member States or the geographical area within a Member State where
the equipment is intended to be used and shall alert the user by the
marking on the apparatus referred to in Annex VII, paragraph 5, to
potential restrictions or requirements for authorisation of use of the
radio equipment in certain Member States. Where it concerns
telecommunications terminal equipment, such information shall be
sufficient to identify interfaces of the public telecommunications
networks to which the equipment is intended to be connected. For all
apparatus such information shall be prominently displayed.
4. In the
case of radio equipment using frequency bands whose use is not
harmonised throughout the Community, the manufacturer or his authorised
representative established within the Community or the person
responsible for placing the equipment on the market shall notify the
national authority responsible in the relevant Member State for
spectrum management of the intention to place such equipment on its
national market.
This notification shall be given no less than four
weeks in advance of the start of placing on the market and shall
provide information about the radio characteristics of the equipment
(in particular frequency bands, channel spacing, type of modulation and
RF-power) and the identification number of the notified body referred
to in Annex IV or V.
Article 7
Putting into service and right to connect
1.
Member States shall allow the putting into service of apparatus for its
intended purpose where it complies with the appropriate essential
requirements identified in Article 3 and the other relevant provisions
of this Directive.
2. Not withstanding paragraph 1, and without
prejudice to conditions attached to authorisations for the provision of
the service concerned in conformity with Community law, Member States
may restrict the putting into service of radio equipment only for
reasons related to the effective and appropriate use of the radio
spectrum, avoidance of harmful interference or matters relating to
public health.
3. Without prejudice to paragraph 4, Member States
shall ensure that operators of public telecommunications networks do
not refuse to connect telecommunications terminal equipment to
appropriate interfaces on technical grounds where that equipment
complies with the applicable requirements of Article 3.
4. Where a
Member State considers that apparatus declared to be compliant with the
provisions of this Directive causes serious damage to a network or
harmful radio interference or harm to the network or its functioning,
the operator may be authorized to refuse connection, to disconnect such
apparatus or to withdraw it from service. The Member States shall
notify each such authorisation to the Commission, which shall convene a
meeting of the committee for the purpose of giving its opinion on the
matter. After the committee has been consulted, the Commission may
initiate the procedures referred to in Article 5(2) and (3). The
Commission and the Member States may also take other appropriate
measures.
5. In case of emergency, an operator may disconnect
apparatus if the protection of the network requires the equipment to be
disconnected without delay and if the user can be offered, without
delay and without costs for him, an alternative solution. The operator
shall immediately inform the national authority responsible for the
implementation of paragraph 4 and Article 9.
Article 8
Free movement of apparatus
1.
Member States shall not prohibit, restrict or impede the placing on the
market and putting into service in their territory of apparatus bearing
the CE marking referred to in Annex VII, which indicates its conformity
with all provisions of this Directive, including the conformity
assessment procedures set out in Chapter II. This shall be without
prejudice to Articles 6(4), 7(2) and 9(5).
2. At trade fairs,
exhibitions, demonstrations, etc., Member States shall not create any
obstacles to the display of apparatus which does not comply with this
Directive, provided that a visible sign clearly indicates that such
apparatus may not be marketed or put into service until it has been
made to comply.
3. Where the apparatus is subject to other
directives which concern other aspects and also provide for the
affixing of the CE marking, the latter shall indicate that such
apparatus also fulfils the provisions of those other directives.
However, should one or more of those directives allow the manufacturer,
during a transitional period, to choose which arrangements to apply,
the CE marking shall indicate that the apparatus fulfils the provisions
only of those directives applied by the manufacturer. In this case, the
particulars of those directives, as published in the Official Journal
of the European Communities, must be given in the documents, notices or
instructions required by those directives and accompanying such
products.
Article 9
Safeguards
1. Where a Member State
ascertains that apparatus within the scope of this Directive does not
comply with the requirements of this Directive, it shall take all
appropriate measures in its territory to withdraw the apparatus from
the market or from service, prohibit its placing on the market or
putting into service or restrict its free movement.
2. The Member
State concerned shall immediately notify the Commission of any such
measures indicating the reasons for its decision and whether
non-compliance is due to:
(a) incorrect application of the harmonised standards referred to in
Article 5(1);
(b) shortcomings in the harmonised standards referred to in Article
5(1);
(c)
failure to satisfy the requirements referred to in Article 3 where the
apparatus does not meet the harmonised standards referred to in Article
5(1).
3. If the measures referred to in paragraph 1 are attributed
to incorrect application of the harmonised standards referred to in
Article 5(1) or to a failure to satisfy the requirements referred to in
Article 3 where the apparatus does not meet the harmonised standards
referred to in Article 5(1), the Commission shall consult the parties
concerned as soon as possible. The Commission shall forthwith inform
the Member States of its findings and of its opinion as to whether the
measures are justified, within two months of notification of the said
measures to the Commission.
4. Where the decision referred to in
paragraph 1 is attributed to shortcomings in the harmonised standards
referred to in Article 5(1), the Commission shall bring the matter
before the committee within two months. The committee shall deliver an
opinion in accordance with the procedure laid down in Article 14. After
such consultation, the Commission shall inform the Member States of its
findings and of its opinion as to whether the action by the Member
State is justified. If it finds that the action is justified it shall
forthwith initiate the procedure referred to in Article 5(2).
5. (a)
Notwithstanding the provisions of Article 6, a Member State may, acting
in conformity with the Treaty, and in particular Articles 30 and 36
thereof, adopt any appropriate measures with a view to:
(i) prohibiting or restricting the placing on its market, and/or
(ii) requiring the withdrawal from its market,
of
radio equipment, including types of radio equipment, which has caused
or which it reasonably considers will cause harmful interference,
including interference with existing or planned services on nationally
allocated frequency bands.
(b) Where a Member State takes measures
in accordance with subparagraph (a) it shall immediately inform the
Commission of the said measures, specifying the reasons for adopting
them.
6. When a Member State notifies the Commission of a measure
referred to in paragraph 1 or 5 the Commission shall in turn inform
other Member States and consult the committee on the matter.
Where, after such consultation, the Commission considers that:
-
the measure is justified, it shall immediately so inform the Member
State which took the initiative and the other Member States,
- the measure is unjustified, it shall immediately so inform the Member
State and request it to withdraw the measure.
7.
The Commission shall maintain a record of the cases notified by Member
States, which shall be made available to them on request.
CHAPTER II
CONFORMITY
ASSESSMENT
Article 10
Conformity assessment procedures
1.
The conformity assessment procedures identified in this Article shall
be used to demonstrate the compliance of the apparatus with all the
relevant essential requirements identified in Article 3.
2. At the
choice of the manufacturer, compliance of the apparatus with the
essential requirements identified in Article 3(1)(a) and (b) may be
demonstrated using the procedures specified in Directive 73/23/EEC and
Directive 89/336/EEC respectively, where the apparatus is within the
scope of those Directives, as an alternative to the procedures laid out
below.
3. Telecommunications terminal equipment which does not make
use of the spectrum allocated to terrestrial/space radio communication
and receiving parts of radio equipment shall be subject to the
procedures described in any one of Annexes II, IV or V at the choice of
the manufacturer.
4. Where a manufacturer has applied the harmonised
standards referred to in Article 5(1), radio equipment not within the
scope of paragraph 3 shall be subject to the procedures described in
any one of Annexes III, IV or V at the choice of the manufacturer.
5.
Where a manufacturer has not applied or has only applied in part the
harmonised standards referred to in Article 5(1), radio equipment not
within the scope of paragraph 3 of this Article shall be subject to the
procedures described in either of Annexes IV or V at the choice of the
manufacturer.
6. Records and correspondence relating to the
conformity assessment procedures referred to in paragraphs 2 to 5 shall
be in an official language of the Member State where the procedure will
be carried out, or in a language accepted by the notified body involved.
Article 11
Notified bodies and surveillance authorities
1.
Member States shall notify the Commission of the bodies which they have
designated to carry out the relevant tasks referred to in Article 10.
Member States shall apply the criteria laid down in Annex VI in
determining the bodies to be designated.
2. Member States shall
notify the Commission of the authorities established within their
territory which are to carry out the surveillance tasks related to the
operation of this Directive.
3. The Commission shall publish a list
of the notified bodies, together with their identification numbers and
the tasks for which they have been notified, in the Official Journal of
the European Communities. The Commission shall also publish a list of
surveillance authorities in the Official Journal of the European
Communities. Member States shall provide the Commission with all
information necessary to keep these lists up to date.
CHAPTER III
CE CONFORMITY
MARKING AND INSCRIPTIONS
Article 12
CE marking
1.
Apparatus complying with all relevant essential requirements shall bear
the EC conformity marking referred to in Annex VII. It shall be affixed
under the responsibility of the manufacturer, his authorized
representative within the Community or the person responsible for
placing the apparatus on the market.
Where the procedures identified
in Annex III, IV or V are used, the marking shall be accompanied by the
identification number of the notified body referred to in Article
11(1). Radio equipment shall in addition be accompanied by the
equipment class identifier where such indentifier has been assigned.
Any other marking may be affixed to the equipment provided that the
visibility and legibility of the EC marking is not thereby reduced.
2.
No apparatus, whether or not it complies with the relevant essential
requirements, may bear any other marking which is likely to deceive
third parties as to the meaning and form of the EC marking specified in
Annex VII.
3. The competent Member State shall take appropriate
action against any person who has affixed a marking not in conformity
with paragraphs 1 and 2. If the person who affixed the marking is not
identifiable, appropriate action may be taken against the holder of the
apparatus at the time when non-compliance was discovered.
4.
Apparatus shall be identified by the manufacturer by means of type,
batch and/or serial numbers and by the name of the manufacturer or the
person responsible for placing the apparatus on the market.
CHAPTER IV
THE COMMITTEE
Article 13
Constitution of the committee
The
Commission shall be assisted by a committee, the Telecommunication
Conformity Assessment and Market Surveillance Committee (TCAM),
composed of representatives of the Member States and chaired by a
representative of the Commission.
Article 14
Advisory committee procedure
1. The committee shall be consulted on the matters covered by Articles
5, 6(2), 7(4), 9(4) and Annex VII(5).
2.
The Commission shall consult the committee periodically on the
surveillance tasks related to the application of this Directive, and,
where appropriate, issue guidelines on this matter.
3. The
representative of the Commission shall submit to the committee a draft
of the measures to be taken. The committee shall deliver its opinion on
the draft within a time limit which the chairman may lay down according
to the urgency of the matter, if necessary by taking a vote.
The
opinion shall be recorded in the minutes; in addition, each Member
State shall have the right to ask to have its position recorded in the
minutes.
The Commission shall take the utmost account of the opinion
delivered by the committee. It shall inform the committee of the manner
in which its opinion has been taken into account and decide within one
month after having received the opinion of the committee.
4. The
Commission shall periodically consult the representatives of the
telecommunications networks providers, the consumers and the
manufacturers. It shall keep the committee regularly informed of the
outcome of such consultations.
Article 15
Regulatory committee procedure
1.
Notwithstanding the provisions of Article 14, the following procedure
shall apply in respect of the matters covered by Articles 3(3) and 4(1).
2.
The representative of the Commission shall submit to the committee a
draft of the measures to be taken. The committee shall deliver its
opinion on the draft within a time limit which the chairman may lay
down according to the urgency of the matter. The opinion shall be
delivered by the majority laid down in Article 148(2) of the Treaty in
the case of decisions which the Council is required to adopt on a
proposal from the Commission. The votes of the representatives of the
Member States within the committee shall be weighted in the manner set
out in that Article. The chairman shall not vote.
3. The Commission shall adopt the measures envisaged if they are in
accordance with the opinion of the committee.
If
the measures envisaged are not in accordance with the opinion of the
committee, or if no opinion is delivered, the Commission shall, without
delay, submit to the Council a proposal relating to the measures to be
taken. The Council shall act by a qualified majority.
If, on the
expiry of a period of three months from the date of referral to the
Council, the Council has not acted, the proposed measures shall be
adopted by the Commission.
CHAPTER V
FINAL AND
TRANSITIONAL PROVISIONS
Article 16
Third countries
1.
Member States may inform the Commission of any general difficulties
encountered, de jure or de facto, by Community undertakings with
respect to placing on the market in third countries, which have been
brought to their attention.
2. Whenever the Commission is informed
of such difficulties, it may, if necessary, submit proposals to the
Council for an appropriate mandate for negotiation of comparable rights
for Community undertakings in these third countries. The Council shall
decide by qualified majority.
3. Measures taken pursuant to
paragraph 2 shall be without prejudice to the obligations of the
Community and of the Member States under relevant international
agreements.
Article 17
Review and reporting
The Commission
shall review the operation of this Directive and report thereon to the
European Parliament and to the Council, on the first occasion not later
than 7 October 2000 18 months after the entry into force of this
Directive and every third year 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 apparatus at Community level and examine
how the regulatory framework for the placing on the market and putting
into service of apparatus should be developed to:
(a) ensure that a coherent system is achieved at Community level for
all apparatus;
(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 apparatus covered and whether the
procedures contained in Annex IV, third paragraph, are proportionate to
the aim of ensuring that the essential requirements are met for
apparatus covered by that Annex. Where necessary, further measures may
be proposed in the report for full implementation of the aim of the
Directive.
Article 18
Transitional provisions
1. Standards
under Directive 73/23/EEC or 89/336/EEC whose references have been
published in the Official Journal of the European Communities may be
used as the basis for a presumption of conformity with the essential
requirements referred to in Article 3(1)(a) and Article 3(1)(b). Common
technical regulations under Directive 98/13/EC whose references have
been published in the Official Journal of the European Communities may
be used as the basis for a presumption of conformity with the other
relevant essential requirements referred to in Article 3. The
Commission shall publish a list of references to those standards in the
Official Journal of the European Communities immediately after this
Directive enters into force.
2. Member States shall not impede the
placing on the market and putting into service of apparatus which is in
accordance with the provisions in Directive 98/13/EC or rules in force
in their territory and was placed on the market for the first time
before this Directive entered into force or at the latest two years
after this Directive entered into force.
3. Apart from the essential
requirements referred to in Article 3(1), the Member States may request
to continue, for a period of up to 30 months following the date
referred to in the first sentence of Article 19(1), and in conformity
with the provisions of the Treaty, to require telecommunications
terminal equipment not to be capable of causing unacceptable
deterioration of a voice telephony service accessible within the
framework of the universal service as defined in Directive 98/10/EC.
The
Member State shall inform the Commission of the reasons for requesting
a continuation of such a requirement, the date by which the service
concerned will no longer need the requirement, and the measures
envisaged in order to meet this deadline. The Commission shall consider
the request taking into account the particular situation in the Member
State and the need to ensure a coherent regulatory environment at
Community level, and shall inform the Member State whether it deems
that the particular situation in that Member State justifies a
continuation and, if so, until which date such continuation is
justified.
Article 19
Transposition
1. Member States shall
not later than 7 April 2000 adopt and publish the laws, regulations and
administrative provisions necessary to comply with this Directive. They
shall forthwith inform the Commission thereof. They shall apply these
provisions as from 8 April 2000.
When Member States adopt these
measures, they shall contain a reference to this Directive or shall be
accompanied by such reference on the occasion of their official
publication. The methods of making such a reference shall be laid down
by Member States.
2. Member States shall inform the Commission of
the main provisions of domestic law which they adopt in the field
covered by this Directive.
Article 20
Repeal
1. Directive 98/13/EC is hereby repealed as from 8 April 2000.
2.
This Directive is not a specific directive within the meaning of
Article 2(2) of Directive 89/336/EEC. The provisions of Directive
89/336/EEC shall not apply to apparatus falling within the scope of
this Directive, with the exception of the protection requirements in
Article 4 and Annex III and the conformity assessment procedure in
Article 10(1) and (2) of, and Annex I to, Directive 89/336/EEC, as from
8 April 2000.
3. The provisions of Directive 73/23/EEC shall not
apply to apparatus falling within the scope of this Directive, with the
exceptions of the objectives with respect to safety requirements in
Article 2 and Annex I and the conformity assessment procedure in Annex
III, Section B, and Annex IV to Directive 73/23/EEC, as from 8 April
2000.
Article 21
Entry into force
This Directive shall enter into force on the day of its publication in
the Official Journal of the European Communities.
Article 22
Addressees
This Directive is addressed to the Member States.
Done at Brussels, 9 March 1999.
For the European Parliament
The President
J. M. GIL-ROBLES
For the Council
The President
W. RIESTER
(1) OJ C 248, 14.8.1997, p. 4.
(2) OJ C 73, 9.3.1998, p. 10.
(3)
Opinion of the European Parliament of 29 January 1998 (OJ C 56,
23.2.1998, p. 27), Council common position of 8 June 1998 (OJ C 227,
20.7.1998, p. 37) and Decision of the European Parliament of 6 October
1998 (OJ C 328, 26.10.1998, p. 32). Decision of the Council of 25
January 1999 and Decision of the European Parliament of 10 February
1999.
(4) OJ L 74, 12.3.1998, p. 1.
(5) OJ L 367, 31.12.1994, p. 1.
(6) OJ L 101, 1.4.1998, p. 24.
(7) OJ L 77, 26.3.1973, p. 29. Directive as amended by Directive
93/68/EEC (OJ L 220, 30.8.1993, p. 1).
(8) OJ L 139, 23.5.1989, p. 19. Directive as last amended by Directive
93/68/EEC.
(9) OJ L 131, 27.5.1988, p. 73. Directive as amended by Directive
94/46/EC (OJ L 268, 19.10.1994, p. 15).
(10) OJ L 204, 21.7.1998, p. 37. Directive as amended by Directive
98/48/EC (OJ L 217, 5.8.1998, p. 18).
(11) OJ L 210, 7.8.1985, p. 29.
(12) OJ L 220, 30.8.1993, p. 23.
(13) OJ L 220, 30.8.1993, p. 23.
(14) OJ C 102, 4.4.1996, p. 1.
(15) OJ L 169, 12.7.1993, p. 1.
(16) OJ L 152, 6.7.1972, p. 15. Directive as last amended by Commission
Directive 95/54/EC (OJ L 266, 8.11.1995, p. 1).
(17) OJ L 225, 10.8.1992, p. 72. Directive as amended by the 1994 Act
of Accession.
ANNEX I
EQUIPMENT NOT COVERED BY THIS DIRECTIVE AS REFERRED TO IN ARTICLE 1(4)
1.
Radio equipment used by radio amateurs within Article 1, definition 53,
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. Equipment falling within the scope of Council Directive 96/98/EC of
20 December 1996 on marine equipment(1).
3. Cabling and wiring.
4. Receive only radio equipment intended to be used solely for the
reception of sound and TV broadcasting services.
5.
Products, appliances and components within the meaning of Article 2 of
Council Regulation (EEC) No 3922/91 of 16 December 1991 on the
harmonisation of technical requirements and administrative procedures
in the field of civil aviation(2).
6. Air-traffic-management
equipment and systems within the meaning of Article 1 of Council
Directive 93/65/EEC of 19 July 1993 on the definition and use of
compatible technical specifications for the procurement of
air-traffic-management equipment and systems(3).
(1) OJ L 46, 17.2.1997, p. 25.
(2) OJ L 373, 31.12.1991, p. 4. Regulation as amended by Commission
Regulation (EC) No 2176/96 (OJ L 291, 14.11.1996, p. 15).
(3) OJ L 187, 29.7.1993, p. 52. Directive as last amended by Commission
Directive 97/15/EC (OJ L 95, 10.4.1997, p. 16).
ANNEX II
CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 10(3)
Module A (internal production control)
1.
This module describes the procedure whereby the manufacturer or his
authorised representative established within the Community, who carries
out the obligations laid down in point 2, ensures and declares that the
products concerned satisfy the requirements of this Directive that
apply to them. The manufacturer or his authorised representative
established within the Community must affix the CE marking to each
product and draw up a written declaration of conformity.
2. The
manufacturer must establish the technical documentation described in
point 4 and he or his authorised representative established within the
Community must keep it for a period ending at least 10 years after the
last product has been manufactured at the disposal of the relevant
national authorities of any Member State for inspection purposes.
3.
Where neither the manufacturer nor his authorised representative is
established within the Community, the obligation to keep the technical
documentation available is the responsibility of the person who places
the product on the Community market.
4. The technical documentation
must enable the conformity of the product with the essential
requirements to be assessed. It must cover the design, manufacture and
operation of the product, in particular:
- a general description of the product,
- conceptual design and manufacturing drawings and schemes of
components, sub-assemblies, circuits, etc.,
- descriptions and explanations necessary for the understanding of said
drawings and schemes and the operation of the product,
-
a list of the standards referred to in Article 5, applied in full or in
part, and descriptions and explanations of the solutions adopted to
meet the essential requirements of the Directive where such standards
referred to in Article 5 have not been applied or do not exist,
- results of design calculations made, examinations carried out, etc.,
- test reports.
5.
The manufacturer or his authorised representative must keep a copy of
the declaration of conformity with the technical documentation.
6.
The manufacturer must take all measures necessary in order that the
manufacturing process ensures compliance of the manufactured products
with the technical documentation referred to in point 2 and with the
requirements of this Directive that apply to them.
ANNEX III
CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 10(4)
(Internal production control plus specific apparatus tests)(1)
This Annex consists of Annex II, plus the following supplementary
requirements:
For
each type of apparatus, all essential radio test suites must be carried
out by the manufacturer or on his behalf. The identification of the
test suites that are considered to be essential is the responsibility
of a notified body chosen by the manufacturer except where the test
suites are defined in the harmonised standards. The notified body must
take due account of previous decisions made by notified bodies acting
together.
The manufacturer or his authorised representative
established within the Community or the person responsible for placing
the apparatus on the market must declare that these tests have been
carried out and that the apparatus complies with the essential
requirements and must affix the notified body's identification number
during the manufacturing process.
(1) Annex based on Module A with additional requirements appropriate to
the sector.
ANNEX IV
CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 10(5)
(Technical construction file)
This Annex consists of Annex III plus the following supplementary
requirements:
The
technical documentation described in point 4 of Annex II and the
declaration of conformity to specific radio test suites described in
Annex III must form a technical construction file.
The manufacturer,
his authorised representative established within the Community or the
person responsible for placing the apparatus on the market, must
present the file to one or more notified bodies, each of the notified
bodies must be informed of others who have received the file.
The
notified body must review the file and if it is considered that it has
not been properly demonstrated that the requirements of the Directive
have been met, the notified body may issue an opinion to the
manufacturer, his representative or the person responsible for placing
the apparatus on the market and must inform the other notified bodies
who have received the file accordingly. Such an opinion must be given
within four weeks of receipt of the file by the notified body. On
receipt of this opinion, or after the end of the four-week period, the
apparatus may be placed on the market, without prejudice to Articles
6(4) and 9(5).
The manufacturer or his authorised representative
established within the Community or the person responsible for placing
the apparatus on the market must keep the file for a period ending at
least 10 years after the last apparatus has been manufactured at the
disposal of the relevant national authorities of any Member States for
inspection.
ANNEX V
CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 10
Full quality assurance
1.
Full quality assurance is the procedure whereby the manufacturer who
satisfies the obligations of point 2 ensures and declares that the
products concerned satisfy the requirements of the Directive that apply
to them. The manufacturer must affix the marks referred to in Article
12(1) to each product and draw up a written declaration of conformity.
2.
The manufacturer must operate an approved quality system for design,
manufacture and final product inspection and testing as specified in
point 3 and must be subject to surveillance as specified in point 4.
3. Quality system
3.1. The manufacturer must lodge an application for assessment of his
quality system with a notified body.
The application must include:
- all relevant information for the products envisaged,
- the quality system's documentation.
3.2.
The quality system must ensure compliance of the products with the
requirements of the Directive that apply to them. All the elements,
requirements and provisions adopted by the manufacturer must be
documented in a systematic and orderly manner in the form of written
policies, procedures and instructions. This quality system
documentation must ensure a common understanding of the quality
policies and procedures such as quality programmes, plans, manuals and
records.
It must contain in particular 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 specifications, including the
harmonised standards and technical regulations as well as relevant test
specifications that will be applied and, where the standards referred
to in Article 5(1) will not be applied in full, the means that will be
used to ensure that the essential requirements of the Directive that
apply to the products will be met,
- the design control and design
verification techniques, processes and systematic actions that will be
used when designing the products pertaining to the product 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, as well as the results of the tests carried out
before manufacture where appropriate,
- the means by which it is
ensured that the test and examination facilities respect the
appropriate requirements for the performance of the necessary test,
-
the quality records, such as inspection reports and test data,
calibration data, qualification reports of the personnel concerned,
etc.,
- the means to monitor the achievement of the required design
and product quality and the effective operation of the quality system.
3.3.
The notified body must assess the quality system to determine whether
it satisfies the requirements referred to in point 3.2. It must presume
compliance with these requirements in respect of quality systems that
implement the relevant harmonised standard.
The notified body must
assess in particular whether the quality control system ensures
conformity of the products with the requirements of the Directive in
the light of the relevant documentation supplied in respect of points
3.1 and 3.2 including, where relevant, test results supplied by the
manufacturer.
The auditing team must have at least one member
experienced as an assessor in the product technology concerned. The
evaluation procedure must include an assessment visit to the
manufacturer's premises.
The decision must be notified to the
manufacturer. The notification must contain the conclusions of the
examination and the reasoned assessment decision.
3.4. The
manufacturer must undertake to fulfil the obligations arising out of
the quality system as approved and to uphold it so that it remains
adequate and efficient.
The manufacturer or his authorised
representative must keep the notified body that has approved the
quality system informed of any intended updating of the quality system.
The
notified body must evaluate the modifications proposed and decide
whether the amended quality system will still satisfy the requirements
referred to in point 3.2 or whether a reassessment is required.
It
must notify its decision to the manufacturer. The notification must
contain the conclusions of the examination and the reasoned assessment
decision.
4. EC 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 must allow the notified body access for inspection
purposes to the locations of design, manufacture, inspection and
testing, and storage and must provide it with all necessary
information, in particular:
- the quality system documentation,
-
the quality records as foreseen by the design part of the quality
system, such as results of analyses, calculations, tests, etc.,
-
the quality records as foreseen by the manufacturing part of the
quality system, such as inspection reports and test data, calibration
data, qualification reports of the personnel concerned, etc.
4.3.
The notified body must carry out audits at reasonable intervals to make
sure that the manufacturer maintains and applies the quality system and
must provide an audit report to the manufacturer.
4.4. Additionally,
the notified body may pay unexpected visits to the manufacturer. At the
time of such visits, the notified body may carry out tests or have them
carried out in order to check the proper functioning of the quality
system where necessary; it must provide the manufacturer with a visit
report and, if a test has been carried out, with a test report.
5.
The manufacturer must, for a period ending at least 10 years after the
last product has been manufactured, keep at the disposal of the
national authorities:
- the documentation referred to in the second indent of point 3.1,
- the updating referred to in the second paragraph of point 3.4,
-
the decisions and reports from the notified body which are referred to
in the final paragraph of point 3.4 and in points 4.3 and 4.4.
6.
Each notified body must make available to the other notified bodies the
relevant information concerning quality system approvals including
references to the product(s) concerned, issued and withdrawn.
ANNEX VI
MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMBER STATES WHEN
DESIGNATING NOTIFIED BODIES IN ACCORDANCE WITH ARTICLE 11(1)
1.
The notified body, its director and the staff responsible for carrying
out the tasks for which the notified body has been designated must not
be a designer, manufacturer, supplier or installer of radio equipment
or telecommunications terminal equipment, or a network operator or a
service provider, nor the authorised representative of any of such
parties. They must be independent and not become directly involved in
the design, construction, marketing or maintenance of radio equipment
or telecommunications terminal equipment, nor represent the parties
engaged in these activities. This does not preclude the possibility of
exchanges of technical information between the manufacturer and the
notified body.
2. The notified body and its staff must carry out the
tasks for which the notified body has been designated with the highest
degree of professional integrity and technical competence and must be
free from all pressures and inducements, particularly financial, which
might influence their judgement or the results of any inspection,
especially from persons or groups of persons with an interest in such
results.
3. The notified body must have at its disposal the
necessary staff and facilities to enable it to perform properly the
administrative and technical work associated with the tasks for which
it has been designated.
4. The staff responsible for inspections must have:
- sound technical and professional training,
-
satisfactory knowledge of the requirements of the tests or inspections
that are carried out and adequate experience of such tests or
inspections,
- the ability to draw up the certificates, records and reports required
to authenticate the performance of the inspections.
5.
The impartiality of inspection staff must be guaranteed. Their
remuneration must not depend on the number of tests or inspections
carried out nor on the results of such inspections.
6. The notified
body must take out liability insurance unless its liability is assumed
by the Member State in accordance with national law, or the Member
State itself is directly responsible.
7. The staff of the notified
body is bound to observe professional secrecy with regard to all
information gained in carrying out its tasks (except vis-à-vis
the
competent administrative authorities of the Member State in which its
activities are carried out) under this Directive or any provision of
national law giving effect thereto.
ANNEX VII
MARKING OF EQUIPMENT REFERRED TO IN ARTICLE 12(1)
1. The CE conformity marking must consist of the initials "CE" taking
the following form:
>PIC FILE= "L_1999091EN.002702.EPS">
If the CE marking is reduced or enlarged, the proportions given in the
above graduated drawing must be respected.
2.
The CE marking must have a height of at least 5 mm except where this is
not possible on account of the nature of the apparatus.
3. The CE
marking must be affixed to the product or to its data plate.
Additionally it must be affixed to the packaging, if any, and to the
accompanying documents.
4. The CE marking must be affixed visibly, legibly and indelibly.
5.
The equipment class identifier must take a form to be decided by the
Commission in accordance with the procedure laid down in Article 14.
Where
appropriate it must include an element intended to provide information
to the user that the apparatus makes use of radio frequency bands where
their use is not harmonised throughout the Community.
It must have the same height as the initials "CE".
Joint Declaration of the European Parliament, the Council and the
Commission
The
European Parliament, the Council and the Commission recognise the
importance of the requirement relating to the prevention of harm to the
network or its functioning which causes an unacceptable degradation of
service taking into account in particular the need to safeguard the
interests of the consumer.
Therefore, they note that the Commission
will carry out a continuous assessment of the situation in order to
evaluate whether that risk occurs frequently and, in such a case, to
find an appropriate solution in the framework of the Committee acting
in accordance with the procedure laid down in Article 15.
Such a
solution will, where appropriate, consist of the systematic application
of the essential requirement provided for in Article 3(3)(b).
Furthermore,
the European Parliament, the Council and the Commission state that the
procedure described above applies without prejudice to the
possibilities foreseen in Article 7(5) and to the development of
voluntary certification and marking schemes to prevent either the
degradation of service or any harm to the network.
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