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
Date: 1999-03-09
Institutions: Council of the European Union, European Parliament
Subjects: Community certification, harmonisation of standards, marketing standard, satellite communications, technical standard, telecommunications equipment

L 91/10

EN

Official Journal of the European Communities

7. 4. 1999

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,

(5) Whereas that Directive does not cover a substantial

proportion of the radio equipment market;

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 telecommunica-
tions 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;

the Treaty,

(2) Whereas in accordance with the principles of sub-
sidiarity and proportionality referred to in Article 3b
of
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;

(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 Euro-
pean 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.

(6) Whereas

dual-use

the
Community regime of export controls introduced by
Council Regulation (EC) No 3381/94 (5);

subject

goods

are

to

‘telecommunications

(7) Whereas the broad scope of this Directive requires
new definitions of the expressions ‘radio equipment'
and
equipment';
whereas a regulatory regime aimed at the develop-
ment of a single market for radio equipment and
telecommunications
should
terminal
permit
investment, manufacture and sale to take
place at the pace of technology and market develop-
ments;

equipment

terminal

radio

(8) Whereas, given the increasing importance of tele-
communications terminal equipment and networks
equipment
using
connected through wired links, any rules governing
the manufacturing, marketing and use of
radio
equipment and telecommunications terminal equip-
ment should cover both classes of such equipment;

transmission

besides

(9) Whereas Directive 98/10/EC of the European Parlia-
ment and of the Council of 26 February 1998 on the
application of open network provision (ONP)
to
voice telephony and on universal service for telecom-
munications in a competitive environment (6) calls
on national
to ensure the
publication of details of technical interface specifica-
tions for network access for the purpose of ensuring
a competitive market
terminal
equipment;

regulatory authorities

for the supply of

(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;

(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).

7. 4. 1999

EN

Official Journal of the European Communities

L 91/11

(11) Whereas the electromagnetic compatibility related
protection requirements
laid down by Council
Directive 89/336/EEC of 3 May 1989 on the approx-
imation of the laws of Member States relating to
to
electromagnetic compatibility (1) are sufficient
cover
and telecommunications
terminal equipment;

radio equipment

in national

(12) Whereas Community law provides that obstacles to
the free movement of goods within the Community,
resulting from disparities
legislation
relating to the marketing of products, can only be
justified where any national requirements are neces-
the
sary and proportionate; whereas,
laws must be limited to those
harmonisation of
requirements necessary
essential
requirements relating to radio equipment and tele-
communications terminal equipment;

to satisfy

therefore,

the

(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 discern-
ment in order not to inhibit technological innova-
tion 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 disabil-
ities who represent a substantial and growing propor-
tion of
the population of Europe; whereas radio
equipment and telecommunications terminal equip-
should therefore in appropriate cases be
ment
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 infringe-
ment 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
this
with other apparatus within the meaning of
the
Directive and connection with interfaces of

(1) OJ L 139, 23.5.1989, p. 19. Directive as last amended by

Directive 93/68/EEC.

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 consu-
mers’ 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
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 Telecommuni-
cations Standards Institute (ETSI) should take due
account of this objective when developing standards
concerning access to public networks;

operators

(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 contri-
bute to promoting competitive markets both for
terminal equipment and network services;

(24) Whereas, however, operators of public telecommuni-
cations networks should be able to define the tech-
nical 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
telecommunications
design
terminal equipment which satisfies the requirements
of this Directive;

to

L 91/12

EN

Official Journal of the European Communities

7. 4. 1999

(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 telecom-
terminal equipment (1) establish the
munications
principle of equal, transparent and non-discrimin-
atory 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
the regulatory framework created by this
that
Directive is fair;

of

increasing

specialised areas

(26) Whereas it is the task of the European standardisa-
tion organisations, notably ETSI,
to ensure that
harmonised standards are appropriately updated and
drafted in a way which allows for unambiguous inter-
pretation; whereas maintenance, interpretation and
implementation of harmonised standards constitute
very
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
inter-
pretation 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 infor-
mation in the field of technical standards and regula-
tions and of rules on information society services (2);

telecommunications

(27) Whereas it is in the public interest to have har-
monised standards at European level in connection
with the design and manufacture of radio equipment
and
equipment;
whereas compliance with such harmonised standards
gives rise to a presumption of conformity to the
requirements; whereas other means of
essential
demonstrating conformity to the essential require-
ments are permitted;

terminal

(28) Whereas the assignment of equipment class identi-
fiers 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
the Member
monitor market control effectively,
States
information
should provide the relevant
concerning types of interfaces, inadequate or incor-

(1) OJ L 131, 27.5.1988, p. 73. Directive as amended by Directive

94/46/EC (OJ L 268, 19.10.1994, p. 15).

(2) OJ L 204, 21.7.1998, p. 37. Directive as amended by Directive

98/48/EC (OJ L 217, 5.8.1998, p. 18).

rectly 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,
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;

in particular,

(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 proced-
ures 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 desir-
able that those notification procedures should be
harmonised and preferably implemented by elec-
tronic means and one-stop-shopping;

(32) Whereas radio equipment and telecommunications
terminal equipment which complies with the rel-
evant 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;

terminal

(33) Whereas, for trade fairs, exhibitions, etc., it must be
possible to exhibit radio equipment and telecommu-
nications
equipment which does not
conform to this Directive; whereas, however, inter-
ested 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 interfer-
ence or matters relating to public health;

(34) Whereas radio frequencies are allocated nationally
and, to the extent that they have not been har-
monised, 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,

7. 4. 1999

EN

Official Journal of the European Communities

L 91/13

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 (1); whereas without
prejudice to any liability on the part of the manufac-
turer, any person who imports apparatus into the
Community for sale in the course of his business is
liable according to that Directive; whereas the manu-
facturer, his authorised representative or the person
responsible
apparatus on the
Community market is liable according to the rules of
the law of contractual or non-contractual liability in
the Member States;

for placing the

(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 (2);
whereas
assessment
procedures should preferably be chosen from among
the available modules laid down by that Decision;

conformity

applicable

the

(38) Whereas Member States may request that notified
bodies they designate and their surveillance author-
ities be accredited according to appropriate European
standards;

(39) Whereas it is appropriate that compliance of radio
equipment and telecommunications terminal equip-
ment 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 (3) 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 under-
takings owned wholly, controlled through majority
ownership or effectively controlled by nationals of
the third countries concerned;

(41) Whereas it

terminal equipment,

is desirable to establish a committee
bringing together parties directly involved in the
implementation of regulation of radio equipment
in
and telecommunications
particular the national conformity assessment bodies
and national bodies responsible for market surveil-
lance, 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 tele-
communications operators, users, consumers, manu-
facturers and service providers should be consulted
where appropriate;

the Council

(42) Whereas a modus vivendi between the European
Parliament,
and the Commission
for acts
concerning the implementing measures
adopted in accordance with the procedure laid down
in Article 189b of the Treaty was concluded on 20
December 1994 (4);

(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 direct-
ives in order to avoid disturbance to telecommunica-
tions 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 develop-
ment of
sector and of
experience gained from application of the essential
requirements and the conformity assessment proced-
ures provided for in this Directive;

the telecommunications

(45) Whereas it is necessary to ensure that with the intro-
duction 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 uncer-
tainty;

(1) OJ L 210, 7.8.1985, p. 29.
(2) OJ L 220, 30.8.1993, p. 23.

(3) OJ L 220, 30.8.1993, p. 23.
(4) OJ C 102, 4.4.1996, p. 1.

L 91/14

EN

Official Journal of the European Communities

7. 4. 1999

(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) incorpor-
ates, 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 (1), 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 (2),

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 sep-
arate technical unit of a vehicle within the meaning of
Council Directive 72/245/EEC (3) 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.

This Directive shall not apply to equipment listed in

4.
Annex I.

This Directive shall not apply to apparatus exclu-
5.
sively used for activities concerning public security,
defence, State security (including the economic well-

(1) OJ L 169, 12.7.1993, p. 1.
(2) 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).
(3) OJ L 225, 10.8.1992, p. 72. Directive as amended by the 1994

Act of Accession.

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)

(b)

‘apparatus' means any equipment that is either radio
equipment or telecommunications terminal equip-
ment or both;

enabling communication or

‘telecommunications terminal equipment' means a
product
relevant
component thereof which is intended to be connected
directly or indirectly by any means whatsoever to
interfaces of public telecommunications networks
telecommunications networks used
(that
wholly or partly for the provision of publicly available
telecommunications services);

is to say,

a

(c)

relevant
‘radio equipment' means a product, or
thereof, capable of communication by
component
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 frequen-
cies from 9 kHz to 3 000 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)

(g)

(h)

‘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;

‘technical construction file' means a file describing
the apparatus and providing information and explana-
tions as to how the applicable essential requirements
have been implemented;

‘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.

7. 4. 1999

EN

Official Journal of the European Communities

L 91/15

(i)

interference' means

interference which
‘harmful
endangers the functioning of a radionavigation service
or of other safety services or which otherwise seriously
degrades, obstructs or repeatedly interrupts a radio-
communications service operating in accordance with
the applicable Community or national regulations.

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 noti-
fied interfaces and assign an equipment class identifier,
details of which shall be published in the Official
Journal of the European Communities.

Article 3

Essential requirements

The following essential requirements are applicable

1.
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 electro-
magnetic compatibility contained in Directive 89/
336/EEC.

2.
In addition, radio equipment shall be so constructed
that it effectively uses the spectrum allocated to terres-
trial/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 partic-
ular types shall be so constructed that:

(a) it interworks via networks with other apparatus and
that it can be connected to interfaces of the appro-
priate type throughout the Community; and/or that

(b) it does not harm the network or its functioning nor
misuse network resources, thereby causing an unac-
ceptable 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 emer-

gency 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 specifica-
tions

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

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 avail-
able, 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 manu-
facturers to carry out, at their choice, the relevant tests for
the essential requirements applicable to the telecommu-
nications 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
requirements
ensure
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.

compliance with the

essential

3.
In the case of shortcomings of harmonised standards
with respect to the essential requirements, the Commis-
sion may, after consulting the committee and in accord-
ance 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 consul-
the committee and in accordance with the
tation of
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.

L 91/16

EN

Official Journal of the European Communities

7. 4. 1999

Article 6

Article 7

Placing on the market

Putting into service and right to connect

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 prop-
erly installed and maintained and used for its intended
purpose. It shall not be subject to further national provi-
sions in respect of placing on the market.

In taking a decision regarding the application of
2.
essential requirements under Article 3(3), the Commis-
sion 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 instruc-
tions 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.

In the case of radio equipment using frequency
4.
bands whose use is not harmonised throughout
the
Community, the manufacturer or his authorised repres-
entative established within the Community or the person
responsible for placing the equipment on the market
shall notify the national authority responsible in the rel-
evant 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
channel
equipment
spacing, type of modulation and RF-power) and the iden-
tification number of
the notified body referred to in
Annex IV or V.

frequency bands,

(in particular

1. Member States shall allow the putting into service of
apparatus for its intended purpose where it complies with
identified in
the appropriate essential
Article 3 and the other
this
Directive.

requirements
relevant provisions of

2. Not withstanding paragraph 1, and without preju-
dice to conditions attached to authorisations for the provi-
sion 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 applic-
able 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 func-
tioning, the operator may be authorized to refuse connec-
tion, to disconnect such apparatus or to withdraw it from
service. The Member States shall notify each such author-
isation 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 meas-
ures.

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 imme-
diately 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
including the
with all provisions of
conformity assessment procedures set out in Chapter II.
This shall be without prejudice to Articles 6(4), 7(2) and
9(5).

this Directive,

7. 4. 1999

EN

Official Journal of the European Communities

L 91/17

At

trade fairs, exhibitions, demonstrations, etc.,
2.
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 direct-
ives 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
instructions
be given in the documents, notices or
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 appro-
priate 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.

The Member State concerned shall

2.
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 attrib-
uted 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 consul-
tation, 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 equip-
ment, which has caused or which it reasonably
considers will
interference,
including interference with existing or planned
services on nationally allocated frequency bands.

harmful

cause

(b) Where a Member State takes measures in accord-
ance with subparagraph (a)
immediately
inform the Commission of the said measures, spe-
cifying the reasons for adopting them.

it shall

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
considers that:

such consultation,

the Commission

(cid:190) the measure is justified, it shall immediately so inform
the Member State which took the initiative and the
other Member States,

(cid:190) the measure is unjustified,

immediately so
inform the Member State and request it to withdraw
the measure.

it shall

The Commission shall maintain a record of the
7.
cases notified by Member States, which shall be made
available to them on request.

CHAPTER II

CONFORMITY ASSESSMENT

Article 10

Conformity assessment procedures

The conformity assessment procedures identified in
1.
this Article shall be used to demonstrate the compliance
of the apparatus with all the relevant essential require-
ments identified in Article 3.

L 91/18

EN

Official Journal of the European Communities

7. 4. 1999

At the choice of the manufacturer, compliance of
2.
the apparatus with the essential requirements identified in
Article 3(1)(a) and (b) may be demonstrated using the
procedures
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.

specified in Directive

CHAPTER III

CE CONFORMITY MARKING AND INSCRIPTIONS

Article 12

CE marking

Telecommunications

terminal equipment which
3.
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.

Apparatus complying with all

relevant essential
1.
requirements shall bear
the EC conformity marking
referred to in Annex VII. It shall be affixed under the
responsibility of the manufacturer, his authorized repres-
entative within the Community or the person responsible
for placing the apparatus on the market.

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 proced-
ures described in either of Annexes IV or V at the choice
of the manufacturer.

and

Records

6.
the
correspondence
conformity assessment procedures referred to in para-
graphs 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.

relating

to

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 rele-
vant 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.

Where the procedures identified in Annex III, IV or V are
used, the marking shall be accompanied by the identifica-
tion 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.

Apparatus shall be identified by the manufacturer by
4.
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 repres-
entatives of the Member States and chaired by a repres-
entative 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).

7. 4. 1999

EN

Official Journal of the European Communities

L 91/19

the committee
The Commission shall consult
2.
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.

The Commission shall periodically consult

the
4.
telecommunications networks
representatives of
providers, the consumers and the manufacturers. It shall
keep the committee regularly informed of the outcome of
such consultations.

the

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 15

Article 17

Regulatory committee procedure

Review and reporting

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 deliv-
ered 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 envis-
aged 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,
to the
the Commission shall, without delay, submit
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 Commis-
sion.

review the operation of

The Commission shall
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 activi-
ties 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 ap-
paratus 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 inter-

national level.

It shall in particular examine whether essential require-
ments 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 appa-
ratus covered by that Annex. Where necessary, further
measures may be proposed in the report for full imple-
mentation of the aim of the Directive.

L 91/20

EN

Official Journal of the European Communities

7. 4. 1999

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
regulations under
Article 3(1)(b). Common technical
been
have
98/13/EC whose
Directive
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 require-
ments referred to in Article 3. The Commission shall
publish a list of references to those standards in the
Official Journal of the European Communities imme-
diately after this Directive enters into force.

references

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
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.

equipment not

terminal

The Member State shall inform the Commission of the
reasons for requesting a continuation of such a require-
ment, 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 continua-
tion 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

forthwith inform the Commission thereof. They

shall
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 accom-
panied 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.

This Directive is not a specific directive within the
2.
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.

falling within the scope of

The provisions of Directive 73/23/EEC shall not
3.
this
apply to apparatus
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

For the Council

The President

J. M. GIL-ROBLES

W. RIESTER

7. 4. 1999

EN

Official Journal of the European Communities

L 91/21

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 Telecommuni-

cations 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 pro-
cedures 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).

L 91/22

EN

Official Journal of the European Communities

7. 4. 1999

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 author-
ised 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:

(cid:190) a general description of the product,

(cid:190) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits,

etc.,

(cid:190) descriptions and explanations necessary for the understanding of said drawings and schemes and the

operation of the product,

(cid:190) 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,

(cid:190) results of design calculations made, examinations carried out, etc.,

(cid:190) 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.

7. 4. 1999

EN

Official Journal of the European Communities

L 91/23

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 re-
sponsible 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.

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 respon-
sible 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.

(1) Annex based on Module A with additional requirements appropriate to the sector.

L 91/24

EN

Official Journal of the European Communities

7. 4. 1999

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:

(cid:190) all relevant information for the products envisaged,

(cid:190) 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:

(cid:190) the quality objectives and the organisational structure, responsibilities and powers of the management

with regard to design and product quality,

(cid:190) 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,

(cid:190) 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,

(cid:190) the corresponding manufacturing, quality control and quality assurance techniques, processes and

systematic actions that will be used,

(cid:190) 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,

(cid:190) the means by which it is ensured that the test and examination facilities respect the appropriate

requirements for the performance of the necessary test,

(cid:190) the quality records, such as inspection reports and test data, calibration data, qualification reports of

the personnel concerned, etc.,

(cid:190) 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.

7. 4. 1999

EN

Official Journal of the European Communities

L 91/25

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:

(cid:190) the quality system documentation,

(cid:190) the quality records as foreseen by the design part of the quality system, such as results of analyses,

calculations, tests, etc.,

(cid:190) 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:

(cid:190) the documentation referred to in the second indent of point 3.1,

(cid:190) the updating referred to in the second paragraph of point 3.4,

(cid:190) 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.

L 91/26

EN

Official Journal of the European Communities

7. 4. 1999

ANNEX VI

MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMBER STATES WHEN DESIG-
NATING 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:

(cid:190) sound technical and professional training,

(cid:190) satisfactory knowledge of the requirements of the tests or inspections that are carried out and adequate

experience of such tests or inspections,

(cid:190) 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-(cid:133)-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.

7. 4. 1999

EN

Official Journal of the European Communities

L 91/27

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:

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'.

L 91/28

EN

Official Journal of the European Communities

7. 4. 1999

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.