The R&TTE Directive: A Year of Transition
With the Radio & Telecommunications Terminal Equipment
Directive (R&TTE) now in effect, manufacturers must
take action to ensure compliance within the year.
Directive
1999/5/EC of March 9, 1999, on radio and telecommunications
terminal equipment, known as the R&TTE Directive,
has been a long time coming. The frenzy of public debate
about scope and content during 1997 and 1998 gave way
in 1999 to the more-private preparation for implementation
in the member states of the European Union (EU). Now,
with an effective date of April 8, 2000, in member states,
and a deadline of April 7, 2001, for complete compliance
of all products, attention has shifted from the well-rehearsed
principles to the uncertain practice.
Progress on the transportation of the directive into
each member state's law is generally encouraging, but
because the mechanisms are different in each country there
will certainly be inconsistencies and the timetable will
overrun. This should not be taken to mean, however, that
the absence of a full legal implementation in a given
member state will necessarily prevent certain provisions
of the directive from applying directly. For example,
while manufacturers are not likely to have difficulties
in cases where equipment may be placed on the market on
the basis of their own declaration, they may encounter
problems where intervention of a notified body is required
and none has been appointed by the member state in question.
How the transition this year to full compliance in the
EU will be handled by the administrations in the various
member states remains to be seen, but it is clear that
there will be at least two different scenarios. Equipment
that was within the scope of the old TTE directive (98/13/EC)
will enjoy a simple, straightforward route to market after
April 8, 2000, whereas equipment that was previously subject
to national control may have a difficult course to navigate
through the minutiae of the new EU regulations.
Regardless of whether an existing product complies with
the old TTE or not, it is certain that any manufacturer
who wishes to sell existing radio or telecommunications
terminal equipment or new products in the EU after April
7, 2001, must take action now during this transitional
year. This article examines the practical issues manufacturers
will have to address to optimize their chances for success
in the new regime.
Scope and Compliance Options
The scope of the R&TTE
Directive is much wider than that of its predecessor;
the new directive now encompasses all manner of radio
terminals and infrastructure equipment that was previously
subject to national regulation. Its compliance options
range from a simple manufacturer's declaration, which
may be used for all terminal equipment intended for fixed
networks and all radio equipment complying with harmonized
standards, through advice from a notified body, to full
quality assurance (see R&TTE Directive Compliance
Procedures). The more-involved options are intended primarily
for radio terminals using nonharmonized standards.
The R&TTE Directive has transitional provisions that
are intended to assist manufacturers in bridging from
the old system to the new.
Such provisions have been common throughout the development
of an open market for terminal equipment. The usual effect
of transitional provisions is to allow any equipment that
was previously on the market in accordance with the old
regulations to remain on the market and in use indefinitely
when new regulations come into effect, provided that the
equipment is not modified in any way.
However, the R&TTE Directive's transitional period
for placing on the market and putting into service equipment
that complies with the TTE Directive or old national rules
is strictly time limited. The wording of the R&TTE
Directive in regard to these provisions can seem a little
ambiguous, with such phrases as "first placed on the market"
and "two years after this directive entered into force."
However, the harsh reality is that the directive calls
for complete compliance to the new regulations by April
7, 2001. After this deadline, all radio and telecommunications
terminal equipment must be supplied in full accordance
with the new provisions of the R&TTE Directive. There
will be no grandfathering, i.e., allowing previously approved
products to stay on the market beyond that date.
The R&TTE Directive states that before the 2001 deadline,
in order to enjoy the transitional provisions, the full
requirements of the TTE Directive and national regulations
must be met and all conditions of relevant approvals must
be observed, although this statement may seem a little
odd since the R&TTE Directive clearly states that
the TTE Directive is repealed as of April 8, 2000.
What this means is that continued compliance with the
technical standards that held validity under the old regulations
is not sufficient. The full compliance mechanism under
the TTE Directive, whatever that may be, must be maintained
during this year. Clearly what this maintenance requires
will vary from one member state to another, but so far
the European Commission has made it clear that notified
bodies under the TTE Directive must maintain all the necessary
services to support manufacturers until April 8, 2001.
Action Required This Year
The very limited transitional
provisions of the R&TTE mean that every manufacturer
who wishes to supply existing or new equipment beyond
April 7, 2001, must take action this year; to carry on
as before is simply not an option.
Manufacturers can choose to switch existing products
to the new directive at any time during the transitional
year, and they do not need to switch over every product
at the same time. However, they cannot introduce a new
product based on the TTE Directive or national regulations
unless all the formalities are completed before April
8, 2000, and they cannot continue to supply a product
based on compliance with the TTE Directive or national
regulations after April 7, 2001. In other words, manufacturers
must use the R&TTE Directive for all new products
from April 8, 2000, and for all products, new or not,
from April 8, 2001.
Applying the R&TTE Directive principles for
new products is relatively straightforward. However, manufacturers
can find it a little more confusing to handle transitioning
existing products. For existing equipment, there are four
basic effects of the regulations that manufacturers need
to be aware of.
First, marking applied under the old regulations must
be replaced, including the CE mark of the TTE. The symbol
of the TTE Directive, sometimes described as a set of
crossed hockey sticks, will no longer be valid. The notified
body number will also be invalid, unless the notified
body has played some role in the conformity assessment
process under the R&TTE Directive, which will not
typically be the case for fixed network terminals or radio
products complying with harmonized standards.
Second, a new declaration of conformity with the essential
requirements will be required. This declaration must include
a reference to safety and EMC requirements, as well as
any specific radio or telecommunications standards. A
possible exception to this requirement exists in the case
of fixed network equipment, for which, arguably, the extant
declarations under the Low Voltage Directive (LVD) and
Electromagnetic Compatibility (EMC) Directive will suffice.
Third, a copy of the relevant declaration of conformity
must be supplied with the equipment. The format of the
declaration is not prescribed, but it is clear that the
information is intended for the user rather than the authorities.
R&TTE Directive
Compliance Procedures
Annex 2, Module A: Internal
Production Control.
The manufacturer or authorized
representative draws up written declaration of conformity
and affixes CE marking. Technical documentation,
including test reports, that establish conformity
with the essential requirements must be compiled
and maintained for 10 years after the last manufacturing
cycle.
Annex 3: Internal Production
Control Plus Specific Tests.
Unless essential radio tests defined
in a harmonized standard, a notified body determines
which radio tests must be carried out. However,
the manufacturer can choose where and how the tests
are performed. Procedures are the same as those
required by Annex 2, but CE marking must include
a notified body number.
Annex 4: Technical Construction
File.
Annex 4 adds the requirement of
a technical construction file (TCF) to the technical
documentation and declaration requirements of Annexes
2 and 3. The TCF must be presented to a notified
body for review. The notified body must give an
opinion within four weeks on whether the TCF demonstrates
that the requirements have been met.
Annex 5: Full Quality Assurance.
A notified body assesses the manufacturer's quality
system to ensure that it will maintain compliance
within the requirements of the directive. Design,
production, and testing aspects are considered.
A declaration of conformity and CE marking are
required for each product, but the notified body
is not involved on a product-by-product basis.
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Fourth, there are now explicit requirements for user information.
This information must be prominently displayed and must
make clear the intended use of the equipment.
For terminal equipment for fixed networks, this
requirement means identifying the public network interfaces
for which the equipment is suitable. For radio equipment,
there is a more onerous information requirement to mark
the packaging with the countries or geographical areas
in which the equipment may be used.
In addition to these four general changes, there are some other changes that
are specific to either terminal equipment for fixed networks
or radio equipment.
Terminal Equipment for Fixed Networks. For terminal
equipment for fixed networks, the preferred compliance
option is likely to be Annex 2, which described internal
production control. This section of the R&TTE calls
for the compilation of technical documentation showing
conformity of the product with the essential requirements
and that will usually contain relevant test reports. In
this documentation, existing material about compliance
with the LVD and EMC Directive will need to be reviewed
in the context of the R&TTE Directive.
An important point to note is that the lower voltage
limit that typically constrains application of the LVD
is removed in the R&TTE Directive. So, for example,
telephones formerly considered outside the scope of the
LVD will now be subject to acoustic shock safety requirements,
and evidence of compliance with such requirements must
appear in the technical documentation.
On the other hand, CTRs, the
standards that addressed essential requirements under
the TTE Directive, will now be largely superfluous for
terminal equipment for fixed networks. The only possible
exception to this would be if the European Commission
decides that special essential requirements should apply
under Article 3.3 of the directive for a product, and
where there is a relevant CTR. There are no such cases
at this time, and none are anticipated in the transitional
period.
Radio Equipment. For radio equipment, the transition
will generally be less smooth than for terminal equipment
for fixed networks. Where there is no harmonized standard
now, the choice of a compliance option is likely to be
more difficult and will also entail the choice of a notified
body. Again, technical documentation needs to be reviewed
in the context of the R&TTE Directive and will include
radio essential requirements in addition to the LVD and
EMC Directives.
Compliance may mean performing some radio testing,
but the European Commission has made it clear that it
does not expect notified bodies to demand further testing
of parameters already covered by testing for earlier national
approvals, even if the notified body receiving the submission
was not involved. Compliance with CTRs, where CTRs exist,
will give a presumption of conformity, but may be excessive
in the sense that CTRs may go beyond the R&TTE concept
of essential requirements until such time as they are
explicitly reviewed in the light of the new legislation.
The removal of the voltage limit on the LVD also
has significance for radio terminals, because it means
that handheld devices will be subject to safe radiation
limits, providing the need for specific absorption rate
(SAR) assessment of mobile handsets, which was missing
under the earlier directive.
For radio terminals that do not use the harmonized spectrum,
even if harmonized standards have been applied, there
is, strictly speaking, an obligation to notify the member
states wherein the equipment is to be supplied. In practice,
this is unlikely to be necessary where a terminal is already
in use, but it may be required if there is a change in
authority in a member state or the product is introduced
into another member state.
The compliance option set
out in Annex 5 of the R&TTE Directive is full quality
assurance. This is the only option that is relatively unchanged
from the TTE Directive.
The quality management system requirements under the
two directives are identical. A difference arises only
in the technical scope of the activity, which, under the
R&TTE Directive, explicitly addresses safety and EMC
issues. The R&TTE requirements include the relevant
standards for safety and EMC among the technical specifications
that are needed. Indeed, safety and EMC standards are
the only requirements applied in the case of most terminal
equipment intended for use with fixed networks.
Full quality assurance can be thought of as a bonus for
absorbing whatever procedures were needed to demonstrate
compliance with the LVD and EMC Directive. This new compliance
option for safety and EMC allows considerable freedom,
particularly in the extent to which the format and content
of compliance documentation is prescribed.
Full quality assurance is the only option that avoids
the case-by-case involvement of a notified body, even
for radio terminals that do not make use of harmonized
standards. It also applies to spectrum use that is not
harmonized. It is, therefore, likely to be the favored
choice of those manufacturers looking to provide wireless
equipment.
Other Dimensions to Consider
In reading through the R&TTE
Directive and considering its implications, one could
easily form the impression that manufacturers should pick
one compliance option or another and apply it to every
product they manufacture. However, the directive is actually
open to more-liberal interpretation, and a certain degree
of mixing and matching of options is possible.
With the exception of full quality assurance (Annex
5), the compliance options build on one another. So, Annex
3 (which calls for specific tests identified by a notified
body) adds to Annex 2 (which requires internal production
control and manufacturer's declaration), and Annex 4 (which
describes the technical construction file) adds to Annex
3.
In practice, then, it should be possible to apply
the principles of Annex 2 to aspects covered by harmonized
standards and then add to this to Annex 3 or Annex 4 for
radio or nonharmonized aspects. The procedures of compliance
to the respective directives, such as safety and EMC testing,
are always chosen by the manufacturer, so a notified body
can never insist that a more onerous compliance procedure
for EMC or safety be used.
For radio equipment, the R&TTE Directive is not the
only technical barrier to be overcome before equipment
can be freely circulated and used in the member states.
National licensing laws will remain in effect. These laws
seek to distinguish between spectrum management, which
controls intended emissions and which is a national affair,
and the effective use of the spectrum, which is regulated
under the R&TTE Directive. Such a distinction is clearly
open to a degree of manipulation, and it remains to be
seen whether member states will abuse the situation. It
is clear that member states are free to impose technical
constraints under the terms of national licenses. What
they must not do is seek to enforce a type-approval scheme
in the guise of such technical constraints.
In addition, there is a requirement to inform the relevant
authorities whenever nonharmonized spectrum is intended
to be used. There is then a four-week window in which
objections can be raised, but the grounds for refusal
are restricted to improper use of spectrum, harmful interference,
or public health issues.
Transition Requires Action
During this year of transition,
manufacturers must take action if they intend to supply
existing or new radio or telecommunications terminal equipment
beyond April 7, 2001. Because the R&TTE Directive
requires changed product marking and user information
for all items, it will be easy for authorities to notice
if R&TTE Directive provisions have not been conscientiously
applied. It is true that the R&TTE Directive requirements
are actually unlikely to affect the technical performance
of an existing product and that these new requirements
may represent a reduction in the overall burden of regulation.
However, these two facts should not be used as excuses
for not moving to transition products to compliance this
year. The bottom line is that if manufacturers do not
transition products to the R&TTE Directive, after
this year member states will have an excuse for refusing
free access to the market for EU products.
This article is based on revised,
updated material first presented in a talk at the BABT Product
Service Telecoms 2000 event, which was held in November
1999.
Barry Cartman left his post as managing director of BABT
(Walton-on-Thames, UK) at the end of May 2000 after 18
years in the business of approval and certification of
telecommunications terminal equipment. During this period,
he has been a major contributor to changes in both UK
national and the EU regulatory systems. In anticipation
of a fully liberalized terminal equipment market, he helped
to establish BABT Product Service (http://www.babtps.com),
a joint venture with TÜV Süddeutschland (München,
Germany), to provide global support to BABT's clients
in the future. He can be contacted at mail@cartman.org.uk.
Photo by Andrew Brookes/The Stock Market