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,
(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. 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.
(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. 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 Assesment
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 scripting
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
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
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".