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Guidance for Manufacturers on the Introduction of the R&TTE Directive |
The introduction of the Radio Equipment and Telecommunications Terminal Equipment (R&TTE) Directive in April 2000 will bring a sea change in the way manufacturers of radio equipment obtain conformity with the appropriate requirements. The Directive will allow manufacturers far greater flexibility in the way they are able to market their products in countries that are part of the European Union. From 8 April 2000 the current rigid type approval regime will be replaced with a system that gives a choice as to how manufacturers obtain conformity. The following is a brief overview of the RTTE Directive.
New approach directives
The R&TTE Directive is what is called a "New Approach" Directive.
New Approach directives aim to promote the European single market by removing barriers to the free circulation of goods. These Directives are proposed by the European Commission and adopted by the Council and the Parliament under a co-decision procedure.
New Approach directives are total harmonisation directives: their provisions supersede all corresponding national provisions. They are addressed to the Member States, which have an obligation to transpose them into their national legislation. National provisions, which transpose the directive, shall contain or be accompanied by a reference to the directive in question and must be communicated to the European Commission.
Directives under the New Approach to technical harmonisation and standardisation are based on the following principles:
Harmonisation is limited to essential requirements;
New Approach directives require products to bear the CE marking. Member States must presume that products bearing the CE marking comply with all the provisions of the applicable directives providing for its affixing. Accordingly, Member States may not prohibit, restrict or impede the placing on the market and putting into service in their territory of products bearing the CE marking, unless the provisions relating to CE marking are incorrectly applied.
As an exception, Member States may prohibit, restrict or impede the free movement of products bearing CE marking (in accordance with Art. 28 and 30 of the EC Treaty) because of a hazard that is not covered by the applicable directives.
Why the R&TTE Directive
There are a number of reasons why it was felt that a directive covering both radio equipment and telecommunications terminal equipment was necessary.
For the majority of radio products a national type approval was required for each Member State. There was only limited harmonisation of national approval regimes through CEPT/ERC Recommendations and Decisions such as Recommendation 01-06 on mutual acceptance of type testing results and Decision ERC/DEC/(97)10 on mutual recognition of conformity assessment procedures. Other ERC Recommendations and Decisions attempted to harmonise approval requirements by the adoption of ETSI standards in national type approval regulations. However, the poor record of adoption of these CEPT/ERC provisions by EU Member States severely limited their effectiveness.
For Telecommunications Terminal Equipment, European approvals under existing TTE Directive 98/13/EC provided harmonised one-stop access to the European market place. However, there were significant differences in national interpretation in implementations that impaired its effectiveness. In the UK it was only effective if CTRs existed. There were significant delays in adopting CTRs. The essential requirements of the TTE Directive were seen as disproportionate and to a large extent unnecessary. The conformity assessment regime of the TTE Directive was seen as over-burdensome and time consuming.
Under both the existing national and European approval regimes, the excessive costs and delays in approvals processes have lead to trade barriers and have held back innovation.
Aims of the Directive
The Directive aims to provide the European radio and TTE industry with a more deregulated environment than at present. The involvement of third parties in conformity assessment is not necessary in most cases. The person who places equipment on the market will, in general, be regarded as taking full responsibility for its conformity to essential requirements, and for properly informing users of its intended use. Only in the case of radio equipment for which harmonised standards are not available, or are not used, is it mandatory to consult a notified body.
The Directive replaces the national approval regimes for radio equipment and TTE and the requirements of the consolidated Telecommunications Terminal Equipment Directive (98/13/EC). The Directive also contains requirements on Health & Safety and Electromagnetic Compatibility (EMC) based on those in the Low Voltage Directive (LVD) (73/23/EEC) and the EMC Directive (89/336/EEC), disapplying those Directives for equipment within its scope. This means that manufacturers will only have to declare conformity to one directive to enable them to place their products on the market anywhere in the European Union.
The following essential requirements (Article 3.1 (a) and (b)) are applicable to all equipment within the scope of the Directive:
The following essential requirement (Article 3.2) is applicable to radio equipment:
The following essential requirements (Article 3.3 (a) to (f)) may be applied to equipment within the scope of the Directive if the Commission make a decision to apply them to certain classes of type of equipment:
It is likely that the Commission will apply the above Article 3.3 requirements vary sparingly and that for the vast majority of radio equipment no Article 3.3 requirements will be applied. Currently the Commission is only considering the application of Article 3.3(e) (access to emergency services) to marine radio equipment not within the scope of the Marine Equipment Directive and for radio equipment intended for use on inland waterways.
The implementation of the RTTE Directive will allow manufacturers the choice of four routes to conformity. The following diagram indicates what routes are available depending on the type of equipment.
Diagram 1: Routes to compliance.
| Conformity assessment procedure | ||||
| Internal production control (Annex II) |
Internal production control + radio test suites (Annex III) |
Technical construction file (Annex IV) |
Full quality assurance (Annex V) |
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| Equipment | ||||
| Wired terminal equipment |  |
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| Receiving parts of radio equipment | |
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| Radio equipment for which a harmonised standard has been applied | |
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| Radio equipment for which a harmonised standard has not been applied | |
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The routes, which are specified inn Annex II to IV of the Directive, are as follows:
Internal Production Control (Annex II)
Following this route the manufacturer assesses their product directly against the essential requirements of the Directive, puts together the technical documentation listed at page 4 and declares that the equipment complies with the essential requirements. This route is only available to non-radio telecommunications terminal equipment and receiving parts of radio equipment.
Internal Production Control Plus Specific Apparatus Tests (Annex III)
Following this route the manufacturer applies an applicable harmonised standard, if this harmonised standard does not contain the essential radio test suites the manufacturer needs to have these identified by a Notified Body. It is then the responsibility of the manufacturer to have the identified essential radio test suites carried out and to put together the technical documentation listed at page 4 and to declare that the equipment complies with the essential requirements. This route is not available for non-radio telecommunications terminal equipment.
Technical Construction File (TCF) (Annex IV)
Following this route the manufacturer presents a technical construction file to a Notified Body. The file must contain the results of the essential radio test suite agreed with the Notified Body and the technical documentation listed at page 4. The Notified Body then has four weeks to issue an opinion. After the manufacturer has received this opinion or after four weeks he is free to place the equipment on the market.
Full Quality Assurance (Annex V)
Following this route the manufacturer must operate an approved quality system for design, manufacture and final product inspection and test which has been assessed by a Notified Body.
As an alternative to the above routes the manufacturer has the choice of using:
The important thing to remember with any of the above routes is that it is the manufacturer’s responsibility to ensure his product complies with the Directive and declare accordingly. Where Notified Bodies are used they have no power to prevent a product being placed on the market. Even with the TCF route the Notified Body only issues an opinion, it is the manufacturer who makes the final decision as to whether it complies or not.
The conformity assessment procedures are applicable for every Member State of the EU. Separate procedures are not required to gain access the different Member States market. The R&TTE Directive will give considerable freedom to manufacturers to assess their products against the requirements of the Directive taking into account the intended use and environment of their equipment. It should speed up the manufacture, conformity assessment, product to market cycle considerably.
The technical documentation must enable the conformity of the product with the essential requirements to be assessed. It must cover the design, manufacture and operation of the product, in particular:
Notified bodies are requires for three tasks under the conformity assessment procedures of the Directivce:
There is no requirement for manufacturers to use a Notified Body in their own country or in the country where they intend to market their products.
When reviewing technical construction files, Notified Bodies may need to assess products for compliance with all the essential requirements of the Directive not just the radio aspects. For instance they may need to have expertise in health and safety requirements and potentially all the additional essential requirements.
A Notified Body cannot be a designer, manufacturer, supplier, installer of radio equipment, a network operator, a service provider, or the authorised representative of any such parties. This criterion will mean that the Notified Bodies will be impartial and conditions will be in place to ensure that staff tasked with evaluating equipment will do so in a fair and impartial manner. It is also a condition that a Notified Body will have the staff and facilities available to carry out the evaluation process in an efficient and comprehensive way. Finally the Notified Body is bound to observe professional secrecy with regard to all information gained in carrying out the evaluation process.
Details of Notified Bodies appointed in the UK appear at the end of this document.
It is important to be aware that the responsibility for ensuring that the requirements of the Directive are met lies with the manufacturer or in the case of equipment manufactured outside the EU, the company or persons within the EU that have placed the equipment on the EU market.
Where a company is marketing a product manufactured outside the EU and has no involvement in importation, it is the responsibility of the wholesaler/importer to ensure that the requirements of the Directive are met.
It is also the responsibility of the manufacturer to ensure that the equipment being marketed has the CE marking affixed and has adequate information and instructions containing the equipment’s intended use, a declaration of conformity and, for radio equipment, details of the countries the where product is to be marketed. In the case of telecommunications terminal equipment, information should be provided identifying the interfaces of the public telecommunications networks to which the equipment is intended to be connected.
For radio equipment using frequency bands whose use is not harmonised throughout the Community, manufacturers must notify the Member States at lease four weeks in advance of their intention to place the product on their national market.
The following interpretation of when and to whom notification should be given is based on an interpretation developed at a meeting of the Telecommunication Conformity Assessment and Market Surveillance Committee (TCAM) on 13/14 October 1999.
Notification under Article 6.4 of directive 99/5/EC is required for equipment covered by the following definition: Radio equipment that uses frequency bands whose use is not harmonised throughout the Community. This is considered to be all radio equipment except those:
a) which do not transmit; or
b) which can only transmit under the control of a network; or
c) which use a frequency band which is allocated to the same radio interface in every Member State in the following way:
Notification of radio equipment which uses frequency bands whose use is not harmonised throughout the Community should be made to relevant Member States.
At the same TCAM meeting, it was agreed that the information to be notified should include all items on the following list if the notification is to be considered complete and proper:
For equipment placed on the UK market these notifications should be sent to the RA. We will scrutinise all notifications received and in the vast majority of cases an acknowledgement to the manufacturer of receipt of the notification will be all that is necessary. RA have developed a proforma and guidance notes on notifications (Document RA 368) which is available on our website. However, we do not insist on the use of this proforma, provided the above information is received in a clear and understandable format the information may be presented in other ways. Notifications may be e-mails to RA at a dedicated e-mail address, notifications@ra.gsi.gov.uk, or sent by post. All notifications will be acknowledged on receipt. Please see RA 368 for further details.
The notification procedure is not intended to be used as any form of approval process by spectrum management authorities and RA will not use it in this way.
It must be stressed that manufacturers should not rely on the notification procedure to identify countries where equipment can and cannot be legally used or licensed. Administrations have no obligation under the Directive to respond to a notification. A lack of response does not mean all is OK. It is the suppliers’ responsibility to ensure they meet the relevant requirements before placing products on the market.
The Directive requires Member States to implement it in National Law no later than 12 Months after it entered into force (i.e. 12 months after the Directive is published in the OJ, by 8 April 2000). In the UK this will be achieved by the introduction of the Radio Equipment and Telecommunications Terminal Equipment Regulations 2000 SI 2000:1730 which will enter into force on 8 April 2000.
These Regulations take the form of a Statutory Instrument (SI) (i.e. Secondary legislation) made under The European Communities Act 1972. They will repeal Telecommunications Terminal Equipment Regulations SI 1992/2423. They will also will disapply Sections 22 and 84 of the Telecommunications Act 1984, the Electromagnetic Compatibility Regulations SI 1992/2372 and the Electrical Equipment (Safety) Regulations SI 1994/2372 for equipment within the scope of the Directive.
The text of the Regulations follows that of the RTTE Directive wherever possible and appropriate. This approach has been taken in recognition that the text of the Directive might be open to interpretation in more than one way. A European committee - the Telecommunication Conformity Assessment and Market Surveillance Committee (TCAM) - assists the Commission in the application of this Directive. Differences in interpretation will be aired in TCAM and may result in a common understanding at a European level. Should this occur, the UK may issue or amend Guidance on the interpretation of the Directive text, but it is expected that the Regulations will remain unaltered.
The Directive does not change the licensing/licence exemption regimes in place nationally for radio equipment, which will continue to be the mechanism for giving authority to use radio equipment. In fact, Article 7.2 of the Directive specifically allows Member States to restrict the putting into service of radio equipment for reasons related to the effective and appropriate use of the radio spectrum, avoidance of harmful interference or matters relating to public health.
The Wireless Telegraphy Act 1949 requires that no radio equipment is installed or used in the UK except under the authority of a licence granted by or otherwise exempted by regulations made by the Secretary of State
Member States have the authority to prohibit the placing on the market or withdraw radio equipment from its market if it considers the equipment has caused or is likely to cause harmful interference (Article 9.5).
Any application of article 9.5 will have to be justified to the Commission. At present in the UK a small number of products are already banned from the UK market by the application of orders under section 7 of the Wireless Telegraph Act1967 (i.e. illegal CBs, videosenders & Cordless Telephones). We are currently reviewing the need to keep restrictions on these devices in place in the light of the R&TTE Directive. We have no plans to introduce restrictions on any other equipment types for the foreseeable future.
Article 4.1 of the Directive requires Member States to notify the Commission of interfaces they have regulated. The European Commission have given the following interpretation of interface regulations:
Interface Regulations are high level descriptions of how the spectrum should be used. They typically consist of the spectrum allocation table, together with requirements related to intentional transmissions in allocated frequency bands. They should not prescribe technical interpretations of the essential requirements of the Directive.
Harmonised Standards can give a presumption of conformity with the requirements of the Directive, also where equipment operates in non-harmonised frequencies. This may be achieved through appropriate parameterisation and is the responsibility of ETSI. It is in the interest of industry to maximise the use of harmonised standards and national authorities, through their Membership in ETSI and the ERC-ETSI MoU have due influence in the drafting of harmonised standards;
The current set of approval specifications constitutes a safe but voluntary set of specifications on which manufacturer can base the construction of products;
National restrictions on the putting into service of equipment should not impose additional requirements on equipment. No technical requirements should be imposed on equipment, which has already been assessed under the Directive to operate in conformity with the notified Interface Regulation and which meets the essential requirements of the Directive, other then those directly related to spectrum assignment and avoidance of health hazards.
In the UK these notified interface regulations will be in the form of documents called "UK Radio Interface Requirements".
Interface Requirements provide the link between the R&TTE Directive and licensing/exemption of radio equipment under the Wireless Telegraphy Act 1949. Under the previous type approval regime it was the practice to quote a particular MPT or ETSI standard in the type approval clause of licences and licence exemption regulations. This had two purposes: the first was to define the characteristics of equipment that may be used and the second was to define the performance parameters that must be met by the equipment. However, under the R&TTE Directive compliance is now with the Directive and this allows a number of routes to compliance only one of which requires the use of standards (harmonised standards). Therefore from 8 April 2000 of licences and licence exemption regulations can no longer make reference to compliance with a particular standard as this would imply that equipment had to meet that standard where the Directive allows other compliance routes.
Interface Requirements are limited to a high level description of spectrum use (frequency range, channel spacing, output power, where appropriate a technology to be used, licensing regime). A group set up by the EU Commission to advise on aspects of implementation of the R&TTE Directive has proposed the following basic elements for defining radio interfaces:
Equipment that has been designed to operate in conformity with the notified Interface Requirements and complies with the essential requirements is allowed to be put into service provided that the user has obtained an appropriate authorisation to use the spectrum.
It may not be possible to specify all the parameters usually contained within an equipment standard in an Interface Requirements document (for example receiver parameters). However, such parameters could be included on a ‘for information’ basis. This would specify the basis on which our planning, assignment, licensing and charging regimes will be based.
Equipment that complies with current type approval standards is likely to be RTTE compliant. Because of this there is strong likelihood that equipment that is compliant before 8 April 2000 will remain so under the new regime.
At a meeting of TCAM on 16/17 December1999, the Commission proposed a Decision defining two equipment classes and assigning an equipment class identifier to one of these classes as follows:
1. Radio Equipment and Telecommunications Terminal Equipment which can be placed on the market and be put into service without restrictions will constitute a class. This class will be referred to as "Class 1". An Equipment Class Identifier is not assigned for this class of equipment.
2. Radio Equipment for which Member States apply restrictions on the putting into service as foreseen in article 7.2 of Directive 1999/5/EC or for which Member States apply restrictions on the placing on the market as foreseen by article 9.5 of Directive 1999/5/EC will constitute a class. This class will be referred to as "Class 2". The following Equipment Class Identifier is assigned to equipment within this class:
3. The Commission will publish and maintain, in consultation with the TCAM, an indicative and non-exhaustive list of equipment or sorts of equipment falling within the above classes on the website containing information on Directive 1999/5/EC (http://forum.europa.eu.int/dg3/tcam).
The following initial list of subclasses are proposed for class 1:
Terminal equipment attached to fixed networks and non-transmitting radio equipment:
Class 1.1 ISDN (ISDN Basic Rate, ISDN Primary Rate, ISDN U, Broadband ISDN ATM)
Class 1.2 PSTN (Analogue single line, Analogue multi-line (with/without DDI), equipment attached to Centrex interfaces or Virtual Private Networks)
Class 1.3 Leased lines (2w and 4w analogue (baseband), 2w and 4w analogue (voiceband), Digital, SDH, optical)
Class 1.4 Wired data equipment (X.21, X.25, ethernet, token ring, token bus, TCP/IP, frame relay)
Class 1.5 Wired interactive broadcast equipment (unswitched vision/sound, switched vision/sound)
Class 1.6 Telex (single line equipment, multiple line equipment)
Class 1.7 Receive-only radio equipment
Class 1.8 Other terminal equipment attached to fixed networks
Radio equipment, which only transmits under control of a network:
Class 1.9 GSM handsets, including GSM 900, GSM 1800, GSM 1900 (and when it appears GSM 450)
Class 1.10 TFTS equipment
Class 1.11 Land Mobile earth stations in the 1,5/1,6 GHz bands
Class 1.12 Land Mobile earth stations operating in the Ku-band
Class 1.13 TETRA end-user equipment (non-DMO)
Class 1.14 Satellite Personal Communication earth stations operating in the 1,6/2,4 GHz bands
Class 1.15 Satellite Personal Communication earth stations operating in the 1,9/2,1 GHz bands
Class 1.16 Low data rate Land Mobile earth stations in the 1,5/1,6 GHz bands
Class 1.17 Other Radio equipment , which only transmits under the control of a network
Radio transmitters, technically harmonised in the Community for which Member States don’t constrain their putting into service:
Class 1.8 DECT equipment
The following initial list of subclasses are proposed for class 2:
Class 2.0 Other
Class 2.1 VSATs in the C-band
Class 2.2 VSATs in the Ku-band
Class 2.3 Satellite News Gathering earth stations in the Ku-band
Class 2.4 TETRA Direct Mode of Operation
Class 2.5 TETRAPOL
Class 2.6 Private Mobile Radio
Class 2.7 Short Range Devices
Class 2.8 Microwave links
Class 2.9 Fixed radio links
Class 2.10 Broadcast transmitters
Class 2.11 Maritime radio equipment
Class 2.12 Infrastructure equipment (e.g. base stations)
Class 2.13 Radio equipment, operating in amateur radio band
For a period of one year after the Directive is implemented (i.e. until 7 April 2001) manufacturers have the choice of complying with the R&TTE Directive or the requirements of the Directive 98/13/EC (if applicable) or the national rules in force before 8 April 2000.
This means that individual products approved under the old regime may continue to be placed on the market during the transitional period. During the transitional period of 8 April 2000 to 7 April 2001, notified bodies appointed under Directive 98/13/EC can continue to act in support of approvals given before that period, for example by continuing arrangements for production control, but cannot grant further approvals. Also, no new national approvals under sections 22 and 84 of the Telecommunications Act 1984 will be granted during the transitional period (the same is true for EMC Type Examination certificates issued under the EMC Regulations).
From 8 April 2001, all items of apparatus placed on the market must meet the requirements of the R&TTE Directive.
For further information on the R&TTE Directive and on UK Radio Interface Requirements please visit our website at: www.radio.gov.uk
The Agency publishes a range of information leaflets, guidance notes and technical specifications dealing with most aspects of radio use. If you require a publication, please contact:
Information and Library Service
Radiocommunications Agency
Wyndham House
189 Marsh Wall
London E14 9SX
Telephone: 020 7211 0502/0505
Facsimile: 020 7211 0507
e-mail: library@ra.gsi.gov.uk
or visit our website at: www.radio.gov.uk
Leaflet RA0, available from the above address, lists current publications.
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| April 2000 |  |
