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MINISTERO
DELLE COMUNICAZIONI ISPETTORATO TERRITORIALE LAZIO |
| FIRST DRAFT
GUIDANCE
FOR MARKET SURVEILLANCE STAFF |
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CONTENTS
1 SCOPE OF THE DIRECTIVE 3 |
| 1 SCOPE OF THE DIRECTIVE 1.1 GENERAL INTRODUCTION 1.1.1 Area of application The RTTE Directive provides a market-led approach throughout the radio and telecommunication terminals sector, and removes the previous regime of type approvals. Conformity to the essential requirements of the Directive (Article 3) is shown by supplier's declaration, and can be based on harmonised standards, or other means. The Directive is transposed into national law in each of the Member States of the Community. In addition, the national laws of EEA member countries and of Switzerland are recognised as equivalent to those of the Community members, and the laws of countries due to join the Community through its enlargement programme are being aligned, or have already been aligned, to those of the Community. The Directive is therefore recognised and applied in practice in approximately 30 countries. 1.1.2 Scope of the Directive Certain kinds of equipment are specifically excluded
from the Directive's scope: For equipment within its scope, the Directive covers all aspects of placing on the market and putting into service, except for licensing of radio equipment, which remains a national matter. Safety and EMC requirements for RE and TTE are covered under the RTTE Directive, although the supplier has the option of using the procedures of the LVD and EMCD as a means to demonstrate conformity. 1.1.3 Essential requirements |
| which this has been done
- all are concerned with safety of life in difficult environments. The essential
requirements relate to equipment when installed and in normal use, and not
under fault conditions, or when misused by the customer, deliberately or otherwise.
The supplier can choose to declare conformity with the essential requirements by using harmonised standards, whose references are published in the Official Journal of the EU.[References to be added]. Alternatively, the supplier can declare conformity against a technical construction file (TCF), covering the design, manufacture and operation of the product, in sufficient detail to allow the conformity with the essential requirements to be assessed. Suppliers can also choose an intermediate path, using a harmonised standard, but omitting some applicable parts, provided that, for the parts omitted, they give descriptions and explanations of the solutions adopted to meet the essential requirements. [See Section 5.1.1 of ETSI Guide EG 201 399 on the production of candidate harmonised standards for application under the RTTE Directive]. 1.2 IDENTIFICATION OF SOME PARTICULAR TYPES OF EQUIPMENT The RTTED exempts classes of aeronautical equipment that are covered by other community measures (see Annex 1 at http://europa.eu.int/comm/enterprise/rtte/dir99-5.htm#ANNEX I for the full list of these classes). The specific aeronautical equipment which are not covered are: • Products, appliances and components within the meaning of Article
2 of Council Regulation (EEC) No 3922/91 of 16 December 1991 on the harmonisation
of technical requirements and administrative procedures in the field of civil
aviation. • 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. 1.2.2 Antennas Antennas may be subdivided into "active" and "passive" types. In this categorisation, an "active" antenna is one that, as supplied, includes one or more electronic components interacting with the signal. All other antennas are in principle considered "passive", irrespective of gain or directional properties. Active antennas are subject to the RTTED
under Article 2(c), if placed on the market as a single commercial unit for
distribution or final use. Passive antennas fall outside the scope of the
Directive if placed on the market as a single commercial unit, but would
be subject to the requirements of the RTTED as part of the overall radio
product if marketed in conjunction with a radio product. |
| Where a radio system is
integrated on site, the system integrator is responsible for ensuring it complies
with the Directive.
Blinking Antennas Blinking Antennas are small devices that can be connected to the antenna socket of a mobile telephone, and which “blink” when a call is received. The product is considered to be a "relevant component" because of its inherent non-linearity in the signal path. Manufacturers should specify the intended use of the antenna and confirm that the handheld will still comply with the Directive once the antenna is attached. The manufacturer of the mobile telephone could specify which antennas are suitable to be used with their product. For further guidance on Antennas refer to:
Avalanche Beacons must be fully operational at all times, and therefore it must be ensured they are technically compatible with other beacons on 457 kHz. The standard ETS 300 718 must be ensured, but it contains requirements beyond the scope of the RTTED. Reflecting this, the Directive needs to review this area. For the full Commission Decision on the beacons see http://europa.eu.int/comm/enterprise/rtte/decision/aval-en.pdf .
Where other Community Directives cover equipment outside the scope of the RTTED, the rules of those Directives apply. Some classes of equipment (notably equipment used for non-civil purposes) remain covered by national rules. Radio equipment covered by the Motor Vehicle and Medical Devices Directives is clearly included in the scope of the R&TTE Directive (Articles 1.3 and 1.4). These Directives are more stringent when referring to safety requirements, but the RTTED includes the essential requirements. The following example illustrates how several Directives can efficiently cover radio equipment in context: An ambulance carrying a heart-monitor that is equipped with a TETRA terminal to communicate directly with other ambulances is covered by: • the Automotive Directive for EMC requirements
to avoid interference with the car-electronics, |
| • the R&TTE Directive
for the "TETRA-part" (and has to carry the Alert Sign because Tetra
is not harmonised)
The RTTE Directive directly relates to the EMC and LV Directives as it incorporates their essential requirements and allows a manufacturer to continue to use some of their conformity assessment procedures. In addition, Harmonised Standards under those Directives also have that status under the R&TTE Directive. Where equipment within the scope of RTTED is not within the LVD Directive, standards published under the latter do not apply. Where equipment is not within the scope of the RTTED but is in the EMC Directive scope, the provisions of EMCD Article 10 apply as normal. For further information on this subject refer to http://europa.eu.int/comm/enterprise/rtte/tcam2.htm#clarification , http://europa.eu.int/comm/enterprise/rtte/tcam3.htm#equipment , and the second and fourth FAQ at http://europa.eu.int/comm/enterprise/rtte/faq.htm . 1.2.8 Jammers GSM jammers do not comply with the RTTE or EMC Directives, and therefore cannot be legally placed on the market. All jammers should be taken off the market by market surveillance authorities, ensuring such actions are reported to the Commission. Studies are under way on selective traffic restriction systems, which might be used in public auditoria. For additional information see http://europa.eu.int/comm/enterprise/rtte/jammers.htm .
Only Radio equipment on board vessels which are not covered by IMO regulations (SOLAS - Safety of Life at Sea) falls within the scope of the RTTED, i.e. equipment on inland waterway vessels and smaller seagoing vessels. SOLAS equipment which meets the Marine Directive requirements also meets the RTTE requirements (although the marking is different), and therefore can be used on non-SOLAS vessels. A number of Commission Decisions have been produced covering non-SOLAS radio equipment used in certain inland waterways, or participating in the Global Marine Distress and Safety System (GMDSS). These Decisions apply specific requirements additional to the basic essential requirements of the RTTED. For further guidance on the Marine Directive see http://europa.eu.int/comm/enterprise/rtte/tcam6-7.htm#tcam6_2 , the fourth FAQ at http://europa.eu.int/comm/enterprise/rtte/faq.htm and the Commission Decision at http://europa.eu.int/comm/enterprise/rtte/decision/marit-en.pdf .
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| Articles 1.2a and 1.2b
state which equipment is covered by the RTTED as well as the Medical Devices
Directives:
1.2a) a medical device within the meaning of Article 1 of Council
Directive 93/42/EEC of 14 June 1993 concerning medical devices. The RTTE and the Medical Devices Directives both cover LV and EMC
requirements, so in theory both conformity assessment procedures must be
undertaken, but this is avoided in practice by the publication of the appropriate
Harmonised Standards under all relevant directives.. The fact that more than
one Directive covers a device should not be problematic.
Radars are devices that are “capable of communication” as they transmit signals, and are therefore covered by the RTTED. However the Directive does not contain specific provisions to ensure functional safety, so additional requirements may be imposed under other Directives. Certain marine radars are excluded from the RTTED (Annex I(2)). For further guidance on radars see http://europa.eu.int/comm/enterprise/rtte/tcam5.htm#tcam5_9 .
Receive-only equipment for sound and TV broadcasting is excluded from the Directive under Annex I(4) - this equipment must meet the EMC Directive. Article 9.5 of the RTTED cannot be used to bar receive-only equipment from the market. The Article states that radio equipment that causes harmful interference can be restricted, but, according to the Commission, this cannot be interpreted to apply to receive-only equipment where the equipment has been placed on the market in accordance with the RTTED. However, Article 7 can still be used to take action against cases of interference occurring in practice. For further information on this refer to
http://europa.eu.int/comm/enterprise/rtte/tcam2.htm#article9-5 and for Article
9.5 see http://europa.eu.int/comm/enterprise/rtte/dir99-5.htm#Article 9(5)
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| 2 DOCUMENTATION AND MARKING 2.1 IDENTIFICATION OF DOCUMENTATION AND MARKING DEFICIENCIES 2.1.1 Format for recording deficiencies See Format as used in Surveillance Campaign 2.2 MARKING REQUIREMENTS 2.2.1 CE-marking 2.2.2 The notified body number |
| A list of Notified Bodies,
in order of their numbering, is given on the Commission website [reference
to be added]. Some NBs are missing from this list, but their omission does
not of itself invalidate the marking on products with which they have been
involved.
2.2.3 The alert sign 2.2.4 Affixing of marking |
| 2.2.5 Type, batch and/or
serial numbers etc. Article 12(4) clause 1 of the R&TTE directive states: “Apparatus shall be identified by the manufacturer by means of type, batch and/or serial numbers and by the name of the manufacturer or the person responsible for placing the apparatus on the market.” Question Q21 on the Commissions R&TTE homepage -“Does article 12.4 of the Directive oblige manufacturers to include their name as part of the marking?” The position of the Commission is: The name of the manufacturer, the type, the batch and/or the serial numbers need to be put on the equipment. 2.2.6 Additional marking European or national approval regulations previously covered the equipment that is now covered by the RTTED. The transitional regime of the RTTE Directive ended on 8 April 2001. Before that date it was possible to place items of equipment on the market that were of a type previously approved according to Directive 98/13/EC or national regulations. Since that date all items of equipment placed on the market must comply with 1999/5/EC. For further information, refer to: http://europa.eu.int/comm/enterprise/rtte/tcam3.htm#conclusion 2.3 DOCUMENTATION 2.3.1 Declaration of conformity (DoC) |
| information shall be sufficient
to identify interfaces of the public telecommunications networks to which
the equipment is intended to be connected. For all apparatus such information
shall be prominently displayed.” The DoC is one single document issued by the manufacturer or the person responsible for placing the apparatus on the market. It is recommended that it is drawn up in accordance with EN 45014, but at least it must be signed and dated. The language used is at the choice of the manufacturer. This article can be complied with in two ways, cf. TCAM 6 (00) 30: • A copy of the DoC shall be part of the User Manual, or otherwise
provided together with the apparatus “Hereby, [name of manufacturer], declares that this [type of equipment] is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC.” For the text of this statement in the 11 official languages of the Community, see: http://europa.eu.int/comm/enterprise/rtte/tacm5.htm#tcam5_3 Question Q35 on the Commissions R&TTE homepage - “During the
negotiations on the Directive, provisions were introduced, which allow manufacturers
to continue to use some of the conformity assessment procedures of the EMC
and LVD Directives. Should manufacturers using these procedures claim compliance
with the R&TTE Directive in their declarations of conformity or they
could alternatively declare compliance to the LVD and EMC Directives for
electrical safety resp. EMC aspects?” 2.3.2 Information to the user According to Article 6(3) of the R&TTE
directive it is required that: |
| Question Q4 on the Commissions
R&TTE homepage –“How should article 6.3 be interpreted for harmonised
equipment?”
The position of the Commission
is: This also apply for receive only equipment. • Where it concerns telecommunications terminal
equipment it is required to identify interfaces of the public telecommunications
networks to which the equipment is intended to be connected. Equipment that cannot operate in the Community is permitted to be placed on the market and freely move in it, provided the user is properly informed (that the equipment is not intended to be used in the Community) and the equipment meets the essential requirements when used for its intended purpose (ie. not switched on). The equipment should be properly marked according to the RTTE Directive. Member States can invoke Article 9.5 of the Directive if there is a high likelihood of harmful interference. For further information on this issue refer to http://europa.eu.int/comm/enterprise/rtte/tcam3.htm#possibility and for Article 9.5 see http://europa.eu.int/comm/enterprise/rtte/dir99-5.htm#Article 9(5) .
A manufacturer or other entity selling radio equipment over the Internet to EU consumers is placing that product on the EU market, so the RTTE Directive does apply to Internet sales. However liability is not covered, as it is beyond the scope of the Directive. This is because the buyer does not know if he is buying from a company inside or outside the Community. For further information on sales over the Internet
see http://europa.eu.int/comm/enterprise/rtte/tcam5.htm#tcam5_5 . |
| 2.4 PROPORTIONATE ACTIONS See results of Questionnaire ADCO12(02)06 3 TECHNICAL COMPLIANCE See: http://europa.eu.int/comm/enterprise/rtte/tcam3.htm#manufacturers Recital 35 of the RTTE Directive gives this
guidance on liabilities: |
| • Manufacturers are liable
for damage caused by defective apparatus according to the provisions of Council
Directive 85/374/EC • 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 [also] liable according to [Council Directive 85/374/EC] • The manufacturer, his authorised representative or the person responsible for placing the apparatus on the Community market is liable according to the rules of the law of contractual or non-contractual liability in the Member States The question of personal liability of the person signing the declaration
of conformity needs to be examined in the context of the rules set-up by
Directive 85/374/EEC. This Directive establishes the general principal that
the producer is liable for damages. Article 7 of said Directive enumerates
a limited set of cases where a manufacturer can waive his responsibility.
Article 7 a) in particular foresees the case where he hasn't placed the product
on the market. Article 8.1 indicates however that the responsibility of the
manufacturer is not reduced when the damage is caused jointly by a defect
of the product and intervention by a third party. 4.1.3 Responsibility for providing documentation Annex II.3 of the RTTE Directive states that « Where neither
the manufacturer nor his authorised representative is established within
the Community, the obligation to keep the technical documentation available
is the responsibility of the person who places the product on the Community
market. ». 4.2 INSTALLED SYSTEMS |
| assessment has been carried
out. The RTTE Directive does not specify what the "appropriate conformity assessment" procedure for installations is, unless these are sold as a complete product. For fixed installations that are built on site, it is considered that there are no requirements for the CE marking of the installation per se or for a Declaration of Conformity under the RTTE Directive (although the person who puts the installation into service is responsible for its conformity to the essential requirements of the Directive). This
issue was covered by an Ad Hoc Group on Installations, as discussed in document
TCAM13(03)42. |
|
This is not applicable to products covered by Directives relating to toys, low voltage equipment, civil explosives and refrigeration appliances, since these Directives only cover placing on the market. Further, this is not applicable to recreational craft build for own use, provided that it is not subsequently placed on the Community market during a period of five years, or to craft designed before 1950. As an exception, construction products manufactured for own use should be considered as being placed on the market (see footnote 30). |