R&TTE Directive 99/5/EC
KCS Certification (Netherlands)
On April 7, 1999, the European Commission published
a directive in the Official Journal of the
European Communities that will have a significant
impact on the marketing of telecommunications
equipment in Europe.1 Titled Directive
99/5/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 and
known as R&TTE Directive 99/5/EC, it will
become effective on April 8, 2000. This article
provides an overview of the directive's scope,
essential requirements, and other significant
elements. Many details still need to be elaborated,
and several working groups are contributing to
that effort. Thus, some practical details may
change before the implementation date next year.
The European Community, now the European
Union (EU), did not address the concept of pan-European
approval of telecommunications equipment for several
decades following its founding in the 1950s. The
most important forum in Europe on that issue was
the Conférence Européenne des
Postes et des Télécommunications
(CEPT), whose members are the national telecommunication
administrations and operators known as PTTs.
In 1985, an initiative by CEPT resulted
in the drafting of a memorandum of understanding
covering the mutual recognition of test results
for terminal equipment, provided those results
showed conformity with common technical specifications,
which were designated Normes Européenne
de Télécommunications (NETs).
Then, on July 24, 1986, Council Directive 86/361/EEC,
also known as the first-phase directive, was adopted.2
One of the major principles laid down in this
directive was the obligation of EC member states
to implement in national law the mutual recognition
of test results against NETs. In response, CEPT
launched a rather ambitious program to develop
common technical specifications. Major problems
were encountered, however, and only a few NETs
were adopted, most of which contained national
requirements alongside common specifications.
As a result, mutual acceptance of test results
under this directive was limited. The standards
adopted covered X.21, X.25, ISDN, and GSM technology.
While NETs presented a basis for Europewide
approvals, it soon became clear that the pace
of progress was not satisfactory. The European
Commission's release of a green paper on telecommunications
in 1987 that stressed the necessity of free movement
of telecommunications equipment within the European
Community was a trigger to speed up the standardization
work.3 There appeared to be a need
for an independent standards development organization
whose members would not only be PTTs and regulators
but also other interested parties, such as manufacturers
and users. Consequently, the European Telecommunications
Standards Institute (ETSI) was founded in 1988.
In 1991 the TTE Directive 91/263/EEC (the
second-phase directive) was adopted by the European
Council.4 The major objective of this
directive was to establish full mutual recognition
of type approvals for telecommunications terminal
equipment (TTE) throughout the European Community.
Sometimes known as one-stop shopping, full
mutual recognition basically means that once a
product's conformity with the legal requirements
is shown, access to all European markets is automatically
established. This principle was supported by the
development of common technical regulations (CTRs)
based on essential requirements to which compliance
is mandatory. Developed gradually over the years,
CTRs covering almost all technical areas are now
available. In 1993 the SES Directive 93/97/EC
extended the TTE Directive's provisions to satellite
earth stations (SES). These two directives were
combined in 1998 into TTE-SES Directive 98/13/EC.
Although the TTE and SES Directives provide a
workable basis for pan-European approvals, their
real success was limited because of the slow development
of CTRs and the fact that most radio equipment
was not included.
In June 1995, the European Commission released
a working paper titled Telecommunications Certification:
The Way Ahead, which set the direction for
new legislation.5 Its recommendations
were based on the need for
-
Simplified and relaxed procedures.
-
Minimizing the essential requirements to
achieve unification objectives.
-
Consistency with new and global approaches
and other horizontal legislation.
-
Responsiveness to market needs.
The elements of the R&TTE Directive reflect
those goals.
Overview of the R&TTE Directive
The scope of the R&TTE Directive is
much wider than that of its predecessors. In principle,
the directive covers all radio equipment (RE)
and TTE, but exceptions are provided for equipment
used exclusively for activities concerning public
security, defense, state security, and the activities
of the state in the area of criminal law. Also
excluded are the following:
-
Radio equipment and subparts used by radio
amateurs, unless the equipment is available
commercially.
-
Equipment falling within the scope of Marine
Equipment Directive 96/98/EC.
-
-
Receive-only radio equipment.
-
Products, appliances, and components
used in the field of civil aviation.
-
Air traffic management equipment
and systems.
The directive defines radio equipment
as "a product, or relevant component thereof,
capable of communication by means of the emission
and/or reception of radio waves utilizing the
spectrum allocated to terrestrial and/or space
radio communication," whereas telecommunications
terminal equipment is defined as "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." Another
important definition is that of equipment class,
meaning a class identifying particular types of
equipment that are considered similar under the
R&TTE Directive and those interfaces for which
the apparatus is designed. Equipment may belong
to more than one equipment class.
The Essential Requirements
The R&TTE Directive is a so-called
New Approach directive, which means, among other
things, that it defines essential requirements
that are applicable to all apparatus falling within
its scope and that establish the legal basis for
compliance. The three general essential requirements
that are applicable to all apparatus under the
R&TTE Directive are
-
The protection of the health and safety of
the user and any other person, including the
objectives with respect to safety requirements
contained in Low Voltage Directive 73/23/EEC,
but without that directive's voltage limit
of 501500 V.
-
The protection requirements with
respect to electromagnetic compatibility
(EMC) contained in EMC Directive 89/336/EEC.
-
The requirement that radio equipment
shall be so constructed that it effectively
uses the spectrum allocated to terrestrial
and/or space radio communication and orbital
resources so as to avoid harmful interference.
Thus, the Low Voltage Directive and the EMC Directive,
which are horizontal directives, are no longer
applicable for equipment falling under the R&TTE
Directive. The safety requirements have been strengthened,
since voltage limits no longer apply.
The European Commission also may decide
that products within certain equipment classes
or of particular types must meet one or more of
the following additional essential requirements.
-
Equipment interworks via networks with other
equipment and that it can be connected to
interfaces of the appropriate type throughout
the EU.
-
Equipment does not harm the network
or its functioning nor misuse network resources,
thereby causing an unacceptable degradation
of service.
-
Equipment incorporates safeguards
to ensure that the personal data and privacy
of the user and of the subscriber are
protected.
-
Equipment supports certain features
ensuring avoidance of fraud.
-
Equipment supports certain
features ensuring access to emergency
services.
-
Equipment supports certain
features in order to facilitate
its use by users with a disability.
The success of the R&TTE Directive
will depend to a large extent on the timely publication
of interface specifications, for fixed networks
as well as for air (spectrum) interfaces. The
EU member states have the obligation to make these
interfaces known quickly, whereas operators will
need to provide sufficient data regarding the
interfaces they offer to enable manufacturers
to design properly functioning products. A concern
that has already been raised is that it is questionable
whether all these interfaces will be specified
soon enough, or specified in sufficient detail,
to enable manufacturers to develop new products
prior to implementation of the directive.
Although essential requirements form the
legal basis for compliance with the various new
approach directives, it would be highly impractical
and may even be impossible to design and verify
products directly against these highly abstract
requirements. To overcome this problem, specific
standards are developed by ETSI, the European
Committee for Standardization (CEN), and the European
Committee for Electrotechnical Standardization
(CENELEC). Once adopted and published in the Official
Journal of the European Communities, these
technical standards gain the status of harmonized
standards. Then, if the relevant harmonized standards
are met, products are considered in compliance
with the essential requirements of the directive;
in other words, their compliance with those essential
requirements will not be in dispute.
ETSI has started a program to develop harmonized
standards for all areas covered under the R&TTE
Directive, but to date no such standards have
been established. As a transitional arrangement,
the directive provides that the standards adopted
for application under the Low Voltage Directive
and the EMC Directive may be applied to cover
the general essential requirements for safety
and EMC. Additionally all adopted TBR (Technical
Basis for Regulation) requirements under the TTE-SES
Directive may be applied to cover the other essential
requirements. These measures will help smooth
the transition from the current regime to that
of the R&TTE Directive. However, the mismatch
in the essential requirements (the voltage limits
of the Low Voltage Directive, for example) is
not addressed.
Conformity Assessment Procedures
In order to prove a product is in compliance
with the provisions of the R&TTE Directive,
the manufacturer must follow a conformity assessment
procedure. The directive identifies four procedures
that can be applied depending on the type of equipment
and whether harmonized standards have been applied.
An overview of the possibilities is given in Table
I.
|
Equipment Type:
Standards or Notified
Body Used
|
Module A
|
Module Aa
|
Module H
|
Technical
Construction
File
|
|
Telecommunications terminal equipment
|
X
|
|
X
|
X
|
|
Radio equipment; harmonized standard applied
|
|
X
|
X
|
X
|
|
Radio equipment; harmonized standard not
(or only partly) applied
|
|
|
X
|
X
|
|
Telecommunications terminal and radio equipment;
notified body involvement
|
|
X
|
X
|
X
|
| Table I. Conformity assessment
procedures under the R&TTE Directive.
|
Module A (Internal Production Control)
This procedure is only applicable to telecommunications
terminal equipment. Under this module the manufacturer
must verifyor have verified by an accredited
bodythe product's compliance with the provisions
of the directive. The way in which such verification
is carried out is not prescribed; however, the
manufacturer is directed to take all necessary
measures to ensure the equipment is in compliance.
The manufacturer must draw up a written declaration
of conformity and must affix the appropriate CE
mark to each product.
The manufacturer also must create a technical
dossier that shows the product is in compliance
with the requirements. This dossier must be kept
for 10 years after the last product unit has been
manufactured and be made available to the relevant
national authorities for inspection purposes.
The technical dossier should cover the design,
manufacture, and operation of the product and
include the following documents:
-
A general description of the product.
-
Design and manufacturing drawings and schematics
of components, subassemblies, circuits, etc.
-
Descriptions and explanations necessary
for the understanding of the said drawings
and schematics and the operation of the
product.
-
A list of the harmonized standards
applied in full or in part and/or other
technical solutions adopted to meet the
essential requirements of the directive.
-
A copy of the declaration of
conformity.
-
Results of any design calculations
made, examinations carried out, etc.
-
Module Aa (Internal Production Control
Plus Specific Tests)
Applicable to radio equipment that meets
the requirements of harmonized standards, Module
Aa consists of Module A supplemented by the following
requirements:
-
For each radio type a certain set of essential
radio tests must be carried out by, or on
behalf of, the manufacturer.
-
The manufacturer must declare that all selected
tests have been carried out and that compliance
is established.
-
The manufacturer must affix the notified
body's number together with the CE mark
on the product.
Module H (Full Quality Assurance)
Module H is applicable to both RE and TTE
and is based on international standard ISO 9001
requirements. Under this module, the manufacturer
must have a quality system that covers design
and verification, manufacture, and final inspection
and testing. The quality system must be approved
by a notified body, which may rely to some extent
on assessments performed by other accredited certification
bodies. The manufacturer must draw up a written
declaration of conformity and must affix the appropriate
CE mark to each product unit.
The manufacturer also must keep records
of the product assessments carried out and the
quality system used for at least 10 years after
the last product unit is manufactured.
Technical Construction File
The procedure known as a technical construction
file can be used for RE or TTE and consists
of Module Aa supplemented by the following requirements:
-
The manufacturer must present its technical
dossier (containing all information as described
previously for Module A) to one or more notified
bodies.
-
The notified bodies shall review the file
and render an opinion regarding whether the
information is sufficient to demonstrate that
the requirements of the directive have been
met.
-
Each notified body shall give its
opinion within four weeks; after that period
the product may be marketed.
CE Marking and Market Entry
As do most new approach directives, the
R&TTE Directive prescribes the use of the
CE mark on all products that conform to the requirements
of the directive. The responsibility to affix
these marks is with the manufacturer. It is illegal
to apply the CE mark if conformity with the requirements
has not been established or to use other markings
that may be confused with the CE mark. In cases
where a notified body was involved in the assessment
process, the identification number of the notified
body must be affixed to the product alongside
the CE mark.
The directive also prescribes that when
equipment class identifiers have been assigned
for radio equipment, the appropriate identifier
must also be affixed to each product unit. To
date, it is not clear what kind of identifiers
will be assigned, but there is a strong preference
for the use of only one kind, an alert symbol.
If a class identifier must be used, the directive
also requires that detailed information be included
in the user manual to clarify the product's limited
use or specific application.
Equipment that conforms to the provisions
of the R&TTE Directive may be placed on the
European market without delay and shall not be
subject to further national provisions. There
are, however, several specific conditions that
must be taken into account when placing such equipment
on the market.
-
The manufacturer, or the person responsible
for placing the equipment on the market must
provide users with information on the intended
use of the equipment (for example, network
connection) together with a declaration of
conformity to the essential requirements.
-
For radio equipment, the geographical area(s)
where the equipment is intended to be used
must be given on the package label and in
the instruction manual.
-
In cases where radio frequencies
are used that are not harmonized throughout
the EU, the labeling must alert the user
to potential restrictions or requirements
for authorization of use of the radio equipment
in certain countries. The manufacturer or
the person responsible must also notify
the relevant authorities responsible for
spectrum management of the intention to
market the products in their countries.
Such notification must be given at least
four weeks before placing the equipment
on the market and must include information
about the equipment's radio characteristics.
Equipment that complies with the provisions of
the R&TTE Directive also may be used directly,
with some exceptions.
Implementation of the R&TTE Directive
The European Commission is responsible
for implementing the R&TTE Directive with
the assistance of the Telecommunications Conformity
Assessment and Market Surveillance Committee (TCAM).
TCAM is made up of representatives of the EU member
states and technical experts and is chaired by
a commission representative.
TCAM will advise the European Commission
on such issues as the adoption of harmonized standards,
the identification of equipment classes, and the
solution to technical problems or nonconformities.
In its capacity as a regulatory committee, TCAM
will also provide opinions on the determination
of optional essential requirements, the assignment
of equipment classes, and the equivalency of notified
interfaces. Although it is expected that the European
Commission will accept the opinion of the committee,
it has the power to decide differently. In those
cases the measure under consideration will be
forwarded to the European Council for a final
decision.
The R&TTE Directive Workplan
The Commission took the early initiative
implementing the directive in a thorough and timely
manner by elaborating a plan in spring of 1998.
An interim steering group was created and held
its first meeting on July 9, 1998. At that meeting
five ad hoc working groups were assigned to resolve
some critical issues, as outlined in Table II.
So far these working groups have met several times
and prepared proposals for endorsement by TCAM,
which had its first meeting on April 1920,
1999. The approach being taken by the European
Commission is significantly different from previous
directive implementation efforts. The aim is to
create an environment that is as open as possible,
whereby all interested parties are requested to
participate and to resolve any critical issues
before the R&TTE Directive becomes effective.
|
Group
|
Scope
|
|
Radio equipment classes
|
Inventory of national regulations on interfaces.
Proposal for equipment classes.
|
|
Interface notification
|
Notification of types of interfaces offered
by operators. Publication of interfaces
by operators.
|
|
Essential requirements
|
Equipment classes for which special requirements
should apply. Common understanding on guidelines
for informing users.
|
|
Suveillance
|
Cooperation in market suveillance.
One-stop notification of intention to place
nonharmonized radio equipment on the market.
|
|
ETSI (coordination)
|
Development of work program for harmonized
standards. Guidelines for the drafting of
harmonized standards.
|
| Table II. Scope of the R&TTE
Directive working groups |
Under the R&TTE Directive 99/5/EC, radio
and telecommunications terminal equipment will
be marketable throughout the EU if it conforms
to the directive's essential requirements. Four
conformity assessment procedures are described
in the directive, some of which involve the application
of harmonized standards being developed by ETSI.
Work on the details of the directive's implementation
is progressing, and it is hoped that the transition
from the regimes of earlier directives will be
smooth.
1.Directive 99/5/EC of the European Parliament
and of the Council of 9 March 1999 on Radio Equipment
and Telecommunications Terminal Equipment and
the Mutual Recognition of Their Conformity, Official
Journal of the European Communities, No. L.91
(April 7, 1999).
2.Council Directive 86/361/EEC on the Initial
Stage of the Mutual Recognition of Type Approval
for Telecommunications Terminal Equipment, Official
Journal of the European Communities, No. L.217
(August 5, 1986).
3.The Development of a Common Market for
Telecommunications Services and Equipment Green
Paper COM (87)290 (Brussels: European Commission,
November 26, 1987).
4.Council Directive 91/263/EEC on the Approximation
of the Laws of the Member States Concerning Telecommunications
Terminal Equipment, Including the Mutual Recognition
of Their Conformity, No. L.128 (May 23, 1991).