1999L0005 — EN — 20.11.2003 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B DIRECTIVE1999/5/ECOFTHEEUROPEANPARLIAMENTANDOFTHECOUNCIL
of9March1999
on radio equipment and telecommunications terminal equipment and the mutual recognition of
theirconformity
(OJ L 91, 7.4.1999, p. 10)
Amended by:
Official Journal
No page date
►M1Regulation (EC) No 1882/2003 of the European Parliament and of the
Council of 29 September 2003L 284 1 31.10.2003
▼B
DIRECTIVE 1999/5/EC OF THE EUROPEAN PARLIAMENT
ANDOFTHECOUNCIL
of9March1999
on radio equipment and telecommunications terminal equipment
andthemutualrecognitionoftheirconformity
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 terminalequipment sector is an essential part of the telecommunications
market, which is a key element of the economy in the Commu-
nity; whereas the directives applicable to the telecommunicationsterminal equipment sector are no longer capable of accommo-dating the expected changes in the sector caused by newtechnology, market developments and network legislation;
(2)Whereas in accordance with the principles of subsidiarity andproportionality referred to in Article 3b of the Treaty, the objec-tive of creating an open competitive single market fortelecommunications equipment cannot be sufficiently achievedby 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 Treatyto exclude certain classes of equipment from this Directive;
(4)Whereas Directive 98/13/EC (4) consolidated the provisions
relating to telecommunications terminal equipment and satelliteearth station equipment, including measures for the mutualrecognition 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 defini-tions of the expressions ‘radio equipment’ and‘telecommunications terminal equipment’; whereas a regulatoryregime aimed at the development of a single market for radioequipment 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 telecommunicationsterminal equipment and networks using radio transmissionbesides equipment connected through wired links, any rules1999L0005 — EN — 20.11.2003 — 001.001 — 2
(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.
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governing the manufacturing, marketing and use of radio equip-
ment and telecommunications terminal equipment should coverboth classes of such equipment;
(9)Whereas Directive 98/10/EC of the European Parliament and ofthe Council of 26 February 1998 on the application of opennetwork provision (ONP) to voice telephony and on universalservice for telecommunications in a competitive environment (
1)
calls on national regulatory authorities to ensure the publication
of details of technical interface specifications for network accessfor the purpose of ensuring a competitive market for the supplyof terminal equipment;
(10)Whereas the objectives of Council Directive 73/23/EEC of 19February 1973 on the harmonisation of the laws of the MemberStates relating to electrical equipment designed for use withincertain voltage limits (
2) are sufficient to cover radio equipment
and telecommunications terminal equipment, but with no lowervoltage limit applying;
(11)Whereas the electromagnetic compatibility related protectionrequirements laid down by Council Directive 89/336/EEC of 3May 1989 on the approximation of the laws of Member Statesrelating to electromagnetic compatibility (
3) are sufficient to
cover radio equipment and telecommunications terminal equip-
ment;
(12)Whereas Community law provides that obstacles to the freemovement of goods within the Community, resulting from dispa-
rities in national legislation relating to the marketing of products,
can only be justified where any national requirements are neces-sary and proportionate; whereas, therefore, the harmonisation oflaws must be limited to those requirements necessary to satisfythe essential requirements relating to radio equipment and tele-communications terminal equipment;
(13)Whereas the essential requirements relevant to a class of radioequipment and telecommunications terminal equipment shoulddepend 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 telecom-munications 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 substan-tial 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 waythat disabled people may use it without or with only minimaladaptation;
(16)Whereas radio equipment and telecommunications terminalequipment can provide certain functions required by emergencyservices;
(17)Whereas some features may have to be introduced on the radioequipment 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 otherapparatus within the meaning of this Directive and connection1999L0005 — EN — 20.11.2003 — 001.001 — 3
(1) OJ L 101, 1.4.1998, p. 24.
(2) OJ L 77, 26.3.1973, p. 29. Directive as amended by Directive 93/68/EEC
(OJ L 220, 30.8.1993, p. 1).
(3) OJ L 139, 23.5.1989, p. 19. Directive as last amended by Directive 93/68/
EEC.
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with interfaces of the appropriate type throughout the Commu-
nity may be necessary;
(19)Whereas it should therefore be possible to identify and addspecific 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, voluntarycertification and marking schemes developed by consumer orga-nisations, manufacturers, operators and other industry actorscontribute 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 rulesof the Treaty;
(21)Whereas unacceptable degradation of service to persons otherthan the user of radio equipment and telecommunications term-inal equipment should be prevented; whereas manufacturers ofterminals should construct equipment in a way which prevents
networks from suffering harm which results in such degradation
when used under normal operating conditions; whereas networkoperators should construct their networks in a way that does notoblige manufacturers of terminal equipment to take dispropor-tionate measures to prevent networks from being harmed;
whereas the European Telecommunications Standards Institute
(ETSI) should take due account of this objective when devel-oping standards concerning access to public networks;
(22)Whereas effective use of the radio spectrum should be ensuredso as to avoid harmful interference; whereas the most efficientpossible use, according to the state of the art, of limitedresources such as the radio frequency spectrum should be
encouraged;
(23)Whereas harmonised interfaces between terminal equipment andtelecommunications networks contribute to promoting competi-
tive markets both for terminal equipment and network services;
(24)Whereas, however, operators of public telecommunicationsnetworks should be able to define the technical characteristicsof their interfaces, subject to the competition rules of the Treaty;whereas, accordingly, they should publish accurate and adequatetechnical specifications of such interfaces so as to enable manu-
facturers to design telecommunications terminal equipment
which satisfies the requirements of this Directive;
(25)Whereas, nevertheless, the competition rules of the Treaty andCommission Directive 88/301/EEC of 16 May 1988 on competi-tion in the markets in telecommunications terminal equipment (
1)
establish the principle of equal, transparent and non-discrimina-tory 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 economicplayers, to ensure that the regulatory framework created by thisDirective is fair;
(26)Whereas it is the task of the European standardisation organisa-tions, notably ETSI, to ensure that harmonised standards areappropriately updated and drafted in a way which allows for
unambiguous interpretation; whereas maintenance, interpretation
and implementation of harmonised standards constitute veryspecialised areas of increasing technical complexity; whereasthose tasks require the active participation of experts drawnfrom amongst the economic players; whereas in some circum-
stances it may be necessary to provide more urgent
interpretation of or corrections to harmonised standards than ispossible through the normal procedures of the European standar-1999L0005 — EN — 20.11.2003 — 001.001 — 4
(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).
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disation organisations operating in conformity with Directive 98/
34/EC of 22 June 1998 of the European Parliament and of theCouncil laying down a procedure for the provision of informa-
tion in the field of technical standards and regulations and of
rules on information society services (
1);
(27)Whereas it is in the public interest to have harmonised standardsat European level in connection with the design and manufactureof 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 essen-tial requirements are permitted;
(28)Whereas the assignment of equipment class identifiers shoulddraw on the expertise of CEPT/ERC and of the relevantEuropean standards bodies in radio matters; whereas other formsof cooperation with those bodies is to be encouraged where
possible;
(29)Whereas, in order to enable the Commission to monitor marketcontrol effectively, the Member States should provide the rele-
vant information concerning types of interfaces, inadequate orincorrectly applied harmonised standards, notified bodies andsurveillance authorities;
(30)Whereas notified bodies and surveillance authorities shouldexchange information on radio equipment and telecommunica-tions 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 cooperationshould enable national authorities to be informed about radioequipment placed on their market operating in frequency bandsnot harmonised in the Community;
(31)Whereas manufacturers should notify Member States of theirintention 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 inplace procedures for such notification; whereas such proceduresshould be proportionate and should not constitute a conformityassessment 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 byelectronic means and one-stop-shopping;
(32)Whereas radio equipment and telecommunications terminalequipment which complies with the relevant essential require-ments should be permitted to circulate freely; whereas suchequipment 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 andthe provision of the service concerned;
(33)Whereas, for trade fairs, exhibitions, etc., it must be possible toexhibit radio equipment and telecommunications terminal equip-ment 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 puttinginto service, including the switching on, of such exhibited radioequipment for reasons related to the effective and appropriateuse of the radio spectrum, avoidance of harmful interference ormatters 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 neces-sary to include a safeguard provision permitting Member States,1999L0005 — EN — 20.11.2003 — 001.001 — 5
(1) OJ L 204, 21.7.1998, p. 37. Directive as amended by Directive 98/48/EC
(OJ L 217, 5.8.1998, p. 18).
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in conformity with Article 36 of the Treaty, to prohibit, restrict
or require the withdrawal from its market of radio equipmentwhich has caused, or which it reasonably considers will cause,
harmful interference; whereas interference with nationally allo-
cated radio frequencies constitutes a valid ground for MemberStates to take safeguard measures;
(35)Whereas manufacturers are liable for damage caused by defec-tive apparatus according to the provisions of Council Directive85/374/EEC (
1); 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, hisauthorised representative or the person responsible for placingthe apparatus on the Community market is liable according tothe rules of the law of contractual or non-contractual liability inthe Member States;
(36)Whereas the measures which are appropriate to be taken by theMember 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 bedetermined in accordance with the general principles of Commu-nity 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 theconformity 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 the
applicable conformity assessment procedures should preferablybe chosen from among the available modules laid down by thatDecision;
(38)Whereas Member States may request that notified bodies theydesignate and their surveillance authorities be accreditedaccording to appropriate European standards;
(39)Whereas it is appropriate that compliance of radio equipmentand telecommunications terminal equipment with the require-
ments of Directives 73/23/EEC and 89/336/EEC may be
demonstrated using the procedures specified in those Directiveswhere 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 Article10(
2) may be used where the manufacturer has not applied
harmonised standards or where no such standards exist;
(40)Whereas Community undertakings should have effective andcomparable access to third countries' markets and enjoy treat-ment in third countries similar to that offered in the Communityto undertakings owned wholly, controlled through majority
ownershipor effectively controlled by nationals of the third
countries concerned;
(41)Whereas it is desirable to establish a committee bringingtogether parties directly involved in the implementation of regu-lation of radio equipment and telecommunications terminalequipment, in particular the national conformity assessmentbodies 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 repre-sentatives of telecommunications operators, users, consumers,1999L0005 — EN — 20.11.2003 — 001.001 — 6
(1) OJ L 210, 7.8.1985, p. 29.
(2) OJ L 220, 30.8.1993, p. 23.
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manufacturers and service providers should be consulted where
appropriate;
(42)Whereas a modus vivendi between the European Parliament, theCouncil and the Commission concerning the implementingmeasures for acts adopted in accordance with the procedure laid
down in Article 189b of the Treaty was concluded on 20
December 1994 (
1);
(43)Whereas the Commission should keepunder review the imp le-mentation and practical application of this and other relevantdirectives and take steps to ensure coordination of the applica-tion of all relevant directives in order to avoid disturbance totelecommunications equipment which affects the health ofhumans or is harmful to property;
(44)Whereas the functioning of this Directive should be reviewed indue course in the light of the development of the telecommuni-
cations sector and of experience gained from application of the
essential requirements and the conformity assessment proceduresprovided for in this Directive;
(45)Whereas it is necessary to ensure that with the introduction ofchanges to the regulatory regime there is a smooth transitionfrom the previous regime in order to avoid disruption to themarket and legal uncertainty;
(46)Whereas this Directive replaces Directive 98/13/EC, whichshould accordingly be repealed; whereas Directives 73/23/EECand 89/336/EEC will no longer apply to apparatus within thescope of this Directive, with the exception of protection and
safety requirements and certain conformity assessment proce-
dures,
HAVE ADOPTED THIS DIRECTIVE:
CHAPTER I
GENERALASPECTS
Article 1
Scopeandaim
1. This Directive establishes a regulatory framework for the placing
on the market, free movement and putting into service in the Commu-
nity 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 Direc-
tive 93/42/EEC of 14 June 1993 concerning medical devices (2), 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 approx-
imation of the laws of the Member States relating to active
implantable medical devices (3),
the apparatus shall be governed by this Directive, without prejudice to
the application of Directives 93/42/EEC and 90/385/EEC to medicaldevices 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 (
4) relating to the radio interference (electromagnetic compat-1999L0005 — EN — 20.11.2003 — 001.001 — 7
(1) OJ C 102, 4.4.1996, p. 1.
(2) OJ L 169, 12.7.1993, p. 1.
(3) OJ L 152, 6.7.1972, p. 15. Directive as last amended by Commission Direc-
tive 95/54/EC (OJ L 266, 8.11.1995, p. 1).
(4) OJ L 225, 10.8.1992, p. 72. Directive as amended by the 1994 Act of
Accession.
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ibility) 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 ofDirective 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 (includingthe economic well-being of the State in the case of activities pertainingto State security matters) and the activities of the State in the area ofcriminal law.
Article 2
Definitions
For the purpose of this Directive the following definitions shall apply:
(a) ‘apparatus’ means any equipment that is either radio equipment or
telecommunications terminal equipment or both;
(b) ‘telecommunications terminal equipment’ means a product enabling
communication or a relevant component thereof which is intended
to be connected directly or indirectly by any means whatsoever to
interfaces of public telecommunications networks (that is to say,telecommunications networks used wholly or partly for the provi-sion 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 recep-tion 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 telecom-
munications network, and/or
(ii) an air interface specifying the radio path between radio equip-
ment
and their technical specifications;
(f) ‘equipment class’ means a class identifying particular types of
apparatus which under this Directive are considered similar andthose 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 applic-
able 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, compli-ance with which is not compulsory.
(i) ‘harmful interference’ means interference which endangers the
functioning of a radionavigation service or of other safety servicesor which otherwise seriously degrades, obstructs or repeatedlyinterrupts a radiocommunications service operating in accordancewith the applicable Community or national regulations.1999L0005 — EN — 20.11.2003 — 001.001 — 8
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Article 3
Essentialrequirements
1. The following essential requirements are applicable to all appa-
ratus:
(a) the protection of the health and the safety of the user and any other
person, including the objectives with respect to safety requirementscontained in Directive 73/23/EEC, but with no voltage limitapplying;
(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 effec-
tively uses the spectrum allocated to terrestrial/space radio
communication and orbital resources so as to avoid harmful interfer-ence.
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 theCommunity; 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
Notificationandpublicationofinterface specifications
1. Member States shall notify the interfaces which they have regu-
lated to the Commission insofar as the said interfaces have not been
notified under the provisions of Directive 98/34/EC. After consultingthe committee in accordance with the procedure set out in Article 15,the Commission shall establish the equivalence between notified inter-faces and assign an equipment class identifier, details of which shall bepublished 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 telecommunica-tions networks. Member States shall ensure that such operatorspublish accurate and adequate technical specifications of such inter-
faces 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 oftelecommunications terminal equipment capable of utilising all servicesprovided through the corresponding interface. The specifications shallinclude,inter alia, all the information necessary to allow manufacturers
to carry out, at their choice, the relevant tests for the essential require-
ments applicable to the telecommunications terminal equipment.Member States shall ensure that those specifications are made readilyavailable by the operators.
Article 5
Harmonisedstandards
1. Where apparatus meets the relevant harmonised standards or parts
thereof whose reference numbers have been published in the Official1999L0005 — EN — 20.11.2003 — 001.001 — 9
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Journal of the European Communities , Member States shall presume
compliance with those of the essential requirements referred to inArticle 3 as are covered by the said harmonised standards or parts
thereof.
2. Where a Member State or the Commission considers that confor-
mity 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 concernedshall 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 Article14, publish in the Official Journal of the European Communities guide-
lines on the interpretation of harmonised standards or the conditionsunder 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 with-draw harmonised standards by publication of a notice in the Official
Journal of the European Communities .
Article 6
Placingonthemarket
1. Member States shall ensure that apparatus is placed on the market
only if it complies with the appropriate essential requirements identi-fied in Article 3 and the other relevant provisions of this Directivewhen it is properly installed and maintained and used for its intendedpurpose. 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 require-
ments under Article 3(3), the Commission shall determine the date ofapplication 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 whichis first placed on the market before the date of application of theCommission's determination can continue to be placed on the marketfor a reasonable period. Both the date of application and the periodshall be determined by the Commission in accordance with the proce-
dure 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 informa-
tion for the user on the intended use of the apparatus, together with the
declaration of conformity to the essential requirements. Where itconcerns radio equipment, such information shall be sufficient to iden-tify on the packaging and the instructions for use of the apparatus theMember States or the geographical area within a Member State wherethe 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 theradio equipment in certain Member States. Where it concerns telecom-munications terminal equipment, such information shall be sufficient toidentify interfaces of the public telecommunications networks to which
the equipment is intended to be connected. For all apparatus such infor-
mation 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 notifythe national authority responsible in the relevant Member State forspectrum management of the intention to place such equipment on itsnational 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 aboutthe radio characteristics of the equipment (in particular frequencybands, channel spacing, type of modulation and RF-power) and the1999L0005 — EN — 20.11.2003 — 001.001 — 10
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identification number of the notified body referred to in Annex IV or
V.
Article 7
Puttingintoservice andrighttoconnect
1. Member States shall allow the putting into service of apparatus
for its intended purpose where it complies with the appropriate essen-
tial 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 inconformity 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 ofharmful 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 inter-faces on technical grounds where that equipment complies with theapplicable 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 itsfunctioning, the operator may be authorized to refuse connection, todisconnect such apparatus or to withdraw it from service. The MemberStates shall notify each such authorisation to the Commission, whichshall 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 otherappropriate measures.
5. In case of emergency, an operator may disconnect apparatus if the
protection of the network requires the equipment to be disconnectedwithout delay and if the user can be offered, without delay and withoutcosts for him, an alternative solution. The operator shall immediatelyinform the national authority responsible for the implementation ofparagraph 4 and Article 9.
Article 8
Free movementofapparatus
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 itsconformity with all provisions of this Directive, including the confor-mity assessment procedures set out in Chapter II. This shall bewithout 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 doesnot comply with this Directive, provided that a visible sign clearly indi-cates that such apparatus may not be marketed or put into service untilit 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, thelatter shall indicate that such apparatus also fulfils the provisions ofthose other directives. However, should one or more of those directivesallow 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 manufac-turer. In this case, the particulars of those directives, as published in theOfficial Journal of the European Communities , must be given in the
documents, notices or instructions required by those directives andaccompanying such products.1999L0005 — EN — 20.11.2003 — 001.001 — 11
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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 Direc-
tive, it shall take all appropriate measures in its territory to withdrawthe apparatus from the market or from service, prohibit its placing onthe 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 deci-sion 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 incor-
rect 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 inArticle 5(1), the Commission shall consult the parties concerned assoon as possible. The Commission shall forthwith inform the MemberStates 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 withintwo months. The committee shall deliver an opinion in accordancewith the procedure laid down in Article 14. After such consultation,the Commission shall inform the Member States of its findings and ofits 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 proce-
dure 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 measureswith 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 Commissionof 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 informother 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.1999L0005 — EN — 20.11.2003 — 001.001 — 12
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CHAPTER II
CONFORMITYASSESSMENT
Article 10
Conformityassessmentprocedures
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 apparatusis within the scope of those Directives, as an alternative to the proce-
dures laid out below.
3. Telecommunications terminal equipment which does not make
use of the spectrum allocated to terrestrial/space radio communicationand receiving parts of radio equipment shall be subject to the proce-dures described in any one of Annexes II, IV or V at the choice ofthe manufacturer.
4. Where a manufacturer has applied the harmonised standards
referred to in Article 5(1), radio equipment not within the scope ofparagraph 3 shall be subject to the procedures described in any one ofAnnexes 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 ofthe manufacturer.
6. Records and correspondence relating to the conformity assess-
ment procedures referred to in paragraphs 2 to 5 shall be in anofficial language of the Member State where the procedure will be
carried out, or in a language accepted by the notified body involved.
Article 11
Notifiedbodiesandsurveillance authorities
1. Member States shall notify the Commission of the bodies which
they have designated to carry out the relevant tasks referred to inArticle 10. Member States shall apply the criteria laid down in AnnexVI 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 theyhave been notified, in the Official Journal of the European Commu-
nities. 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 keepthese lists upto date.
CHAPTER III
CECONFORMITYMARKINGANDINSCRIPTIONS
Article 12
CEmarking
1. Apparatus complying with all relevant essential requirements
shall bear the EC conformity marking referred to in Annex VII. It shallbe affixed under the responsibility of the manufacturer, his authorized1999L0005 — EN — 20.11.2003 — 001.001 — 13
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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 noti-fied body referred to in Article 11(1). Radio equipment shall inaddition be accompanied by the equipment class identifier where suchindentifier has been assigned. Any other marking may be affixed to theequipment 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 essen-
tial requirements, may bear any other marking which is likely todeceive third parties as to the meaning and form of the EC markingspecified in Annex VII.
3. The competent Member State shall take appropriate action against
any person who has affixed a marking not in conformity with para-graphs 1 and 2. If the person who affixed the marking is notidentifiable, appropriate action may be taken against the holder of theapparatus 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 manufactureror the person responsible for placing the apparatus on the market.
CHAPTER IV
THECOMMITTEE
Article 13
ConstitutionoftheCommittee
1. The Commission shall be assisted by the Telecommunication
Conformity Assessment and Market Surveillance Committee (TCAM),hereinafter referred to as ‘the Committee’.
2. The Committee shall adopt its rules of procedure.
Article 14
Advisorycommittee procedure
1. The Committee shall be consulted on the matters covered by Arti-
cles 5, 6(2), 7(4), 9(4) and Annex VII(5).
2. The Commission shall consult the Committee periodically on the
surveillance tasks relating to the application of this Directive, and,
where appropriate, issue guidelines on this matter.
3. Articles 3 and 7 of Decision 1999/468/EC (
1) shall apply, having
regard to the provisions of Article 8 thereof.
4. The Commission shall periodically consult the representatives of
the telecommunications networks providers, the consumers and the
manufacturers. It shall keepthe Committee regularly informed of the
outcome of such consultations.
Article 15
Regulatorycommittee procedure
1. The procedure laid down in paragraph 2 shall apply in respect of
the matters covered by Articles 3(3) and 4(1).1999L0005 — EN — 20.11.2003 — 001.001 — 14
(1) Council Decision 1999/468/EC of 28 June 1999 laying down the procedures
for the exercise of implementing powers conferred on the Commission (OJ
L 184, 17.7.1999, p. 23).▼M1
▼M1
2. Where reference is made to this Article, Articles 5 and 7 of Deci-
sion 1999/468/EC (1) shall apply, having regard to the provisions of
Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be
set at three months.
3. The Committee shall adopt its rules of procedure.
CHAPTER V
FINALANDTRANSITIONALPROVISIONS
Article 16
Thirdcountries
1. Member States may inform the Commission of any general diffi-
culties encountered, de jure or de facto, by Community undertakings
with respect to placing on the market in third countries, which havebeen 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 undertak-ings in these third countries. The Council shall decide by qualifiedmajority.
3. Measures taken pursuant to paragraph 2 shall be without preju-
dice to the obligations of the Community and of the Member States
under relevant international agreements.
Article 17
Reviewandreporting
The Commission shall review the operation of this Directive and report
thereon to the European Parliament and to the Council, on the firstoccasion not later than 7 October 2000 18 months after the entry intoforce 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 reportshall also outline the activities of the committee, assess progress inachieving an open competitive market for apparatus at Communitylevel 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 proportionateto the aim of ensuring that the essential requirements are met for appa-ratus covered by that Annex. Where necessary, further measures maybe proposed in the report for full implementation of the aim of theDirective.1999L0005 — EN — 20.11.2003 — 001.001 — 15
(1) Council Decision 1999/468/EC of 28 June 1999 laying down the procedures
for the exercise of implementing powers conferred on the Commission (OJ
L 184, 17.7.1999, p. 23).▼B
▼B
Article 18
Transitionalprovisions
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 inArticle 3. The Commission shall publish a list of references to thosestandards in the Official Journal of the European Communities imme-
diately 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 provi-sions in Directive 98/13/EC or rules in force in their territory and wasplaced 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 30months 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 causingunacceptable deterioration of a voice telephony service accessiblewithin the framework of the universal service as defined in Directive98/10/EC.
The Member State shall inform the Commission of the reasons for
requesting a continuation of such a requirement, the date by which theservice concerned will no longer need the requirement, and themeasures envisaged in order to meet this deadline. The Commissionshall consider the request taking into account the particular situationin 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 Statejustifies a continuation and, if so, until which date such continuationis 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 complywith 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 refer-
ence to this Directive or shall be accompanied by such reference on theoccasion of their official publication. The methods of making such areference shall be laid down by Member States.
2. Member States shall inform the Commission of the main provi-
sions of domestic law which they adopt in the field covered by thisDirective.
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 thisDirective, with the exception of the protection requirements in Article4 and Annex III and the conformity assessment procedure in Article10(1) and (2) of, and Annex I to, Directive 89/336/EEC, as from 8April 2000.1999L0005 — EN — 20.11.2003 — 001.001 — 16
▼B
3. The provisions of Directive 73/23/EEC shall not apply to appa-
ratus falling within the scope of this Directive, with the exceptions ofthe 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
Entryintoforce
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.1999L0005 — EN — 20.11.2003 — 001.001 — 17
▼B
ANNEX I
EQUIPMENT NOT COVERED BY THIS DIRECTIVE AS REFERRED
TOINARTICLE1(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 harmo-
nisation 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).1999L0005 — EN — 20.11.2003 — 001.001 — 18
(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).
▼B
ANNEX II
CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN
ARTICLE10(3)
ModuleA(internalproductioncontrol)
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 Commu-
nity 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 keepit for a p eriod ending at least 10 years after the last
product has been manufactured at the disposal of the relevant national autho-
rities of any Member State for inspection purposes.
3. Where neither the manufacturer nor his authorised representative is estab-
lished within the Community, the obligation to keepthe 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, manufac-
ture and operation of the product, in particular:
— a general description of the product,
— conceptual design and manufacturing drawings and schemes of compo-
nents, 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 manu-
facturing 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.1999L0005 — EN — 20.11.2003 — 001.001 — 19
▼B
ANNEX III
CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN
ARTICLE10(4)
(Internalproductioncontrolplusspecificapparatustests) (1)
This Annex consists of Annex II, plus the following supplementary require-
ments:
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 stan-
dards. The notified body must take due account of previous decisions made bynotified 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 iden-
tification number during the manufacturing process.1999L0005 — EN — 20.11.2003 — 001.001 — 20
(1) Annex based on Module A with additional requirements appropriate to the sector.
▼B
ANNEX IV
CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN
ARTICLE10(5)
(Technicalconstructionfile)
This Annex consists of Annex III plus the following supplementary require-
ments:
The technical documentation described in point 4 of Annex II and the declara-
tion 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 Commu-
nity 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.1999L0005 — EN — 20.11.2003 — 001.001 — 21
▼B
ANNEX V
CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN
ARTICLE10
Fullqualityassurance
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, require-
ments 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 neces-
sary 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 compli-
ance 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.1999L0005 — EN — 20.11.2003 — 001.001 — 22
▼B
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 parti-
cular:
— 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, quali-
fication 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 manufac-
turer. 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 autho-
rities:
— 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 refer-
ences to the product(s) concerned, issued and withdrawn.1999L0005 — EN — 20.11.2003 — 001.001 — 23
▼B
ANNEX VI
MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMBER
STATESWHENDESIGNATINGNOTIFIEDBODIESINACCORDANCE
WITHARTICLE11(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 theauthorised 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 manufac-
turer 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 induce-
ments, 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 asso-
ciated 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 upthe certificates, records and rep orts 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-visthe
competent administrative authorities of the Member State in which its activ-
ities are carried out) under this Directive or any provision of national law
giving effect thereto.1999L0005 — EN — 20.11.2003 — 001.001 — 24
▼B
ANNEX VII
MARKINGOFEQUIPMENTREFERREDTOINARTICLE12(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. Addition-
ally 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 informa-
tion 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’.1999L0005 — EN — 20.11.2003 — 001.001 — 25