The R&TTE Directive - A Brief Summary

The following brief summary applies to the R&TTE Directive in its base form as no amendments have been made.

Article 1 - Scope and Aim

Article 1(1) states the scope as creating a regulatory framework for radio equipment and telecommunications terminal equipment.

Article 1(2) includes within the scope of the Directive the following types of apparatus if it is incorporated either integrally or as an accessory, but without prejudice to the Directives relevant to the apparatus:

• Medical devices as defined by Article 1 of Directive 93/42/EEC.
• Active Implantable Medical Devices as defined by Article 1 of Directive 90/385/EEC.

Article 1(3) includes apparatus which is a component or separate technical unit of a vehicle covered by Directive 72/245/EEC or of a two or three wheeled vehicle covered by Directive 92/61/EEC, but without prejudice to the two Directives.

Article 1(4) deals with equipment excluded from the scope of the Directive, listed in Annex I, which includes:

• Radio equipment used by radio amateurs, unless available commercially (i.e. not home constructed). Note that kits to be assembled by radio amateurs and commercial equipment modified by and to used by radio amateurs are not regarded as commercially available equipment.
• Marine equipment covered by Directive 96/98/EC.
• Cabling and Wiring.
• Receive only radio equipment for sound and television broadcasting services.
• Products, appliances and components to be used in the field of civil aviation, covered by Council Regulation No. 3922/91.
• Air-traffic management equipment and systems within the meaning of Article 1 of Directive 93/65/EEC.

Article 1(5) excludes apparatus concerned with public security, defence, State security and the activities of the State in the area of criminal law.

Article 2 - Definitions

Article 2 lists definitions for 'apparatus', 'telecommunications terminal equipment', 'radio equipment', 'radio waves', 'interface', 'equipment class', 'technical construction file', 'harmonised standard' and 'harmful interference'.

Article 3 - Essential Requirements

Article 3(1) states that essential requirements covering safety as defined in Directive 73/23/EEC (with no lower voltage limit applying) and electromagnetic compatibility as defined in Directive 89/336/EEC are applicable to all apparatus covered by the R&TTE Directive.

Article 3(2) covers the construction of apparatus to prevent harmful interference by effective use of the radio spectrum.

Article 3(3) covers the construction of equipment in order that:

1. It interworks with networks and apparatus throughout the Community.
2. It does not harm the network nor degrade the service nor misuse resources.
3. It incorporates safeguards to protect data and user privacy.
4. It incorporates fraud avoidance measures.
5. It supports access to emergency services.
6. It supports features for disabled users.

Article 4 - Notification and Publication of Interface Specifications

This article covers the definition of interfaces used by Member States, the need to communicate this information to the Commission, and the need for operators of public telecommunications networks to produce technical specifications of the interfaces in order that terminal equipment may be designed to fully utilise the services provided. Reference is made to Directive 98/34/EC which has the following function - taken from the Website of the European Commission -

"The 98/34/EC Directive (formerly 83/189/EEC) sets up a procedure which imposes an obligation upon the Member States to notify to the Commission and to each other all the draft technical regulations concerning products and soon Information Society Services before they are adopted in national law. Such procedure aims at providing transparency and control with regard to those regulations. Since they could create unjustified barriers between Member States, their notification in the draft form and subsequent evaluation of their content in the course of the procedure help to diminish this risk."

Article 5 - Harmonised Standards

Article 5(1) deals with the presumption of compliance if the apparatus meets the requirements of the harmonised standards.

Article 5(2) deals with the situation where the committee must be notified if conformance to a standard is found to be insufficient to meet the essential requirements of the Directive.

Article 5(3) covers the process of dealing with shortcomings in the harmonised standards.

Article 6 - Placing on the Market

Article 6(1) requires Member States to place apparatus on the market only when compliant with the relevant essential requirements and when installed and used as intended.

Article 6(2) covers the overlap situation where apparatus has been placed on the market prior to the introduction of the essential protection requirements for that apparatus. Reference is made to the Advisory Committee procedure (Article 14) to determine a reasonable transition period for compliance with the essential requirements.

Article 6(3) requires manufacturers to adequately inform the user of the intended use of the apparatus and provide a declaration of conformity. For radio equipment, the user must be advised of any restrictions of use in e.g. certain geographical areas or of restrictions imposed in any of the Member States. For telecommunications equipment, the relevant interfaces that the equipment is intended to connect must be identified.

Article 6(4) covers the cases where radio frequency band usage is not harmonised throughout the community. Manufacturers must alert the national authority of the Member State(s) of the intention to place the equipment on the market. The notification must be given at least four weeks in advance and must provide information on the radio characteristics and the identification of the Notified Body used. (Such equipment has to carry an 'Alert Mark' which identifies it has using non-harmonised parts of the radio spectrum).

Article 7 - Putting into Service and Right to Connect

Under Article 7, Member States must allow apparatus compliant with the essential requirements to be placed on the market. Member States can apply restrictions to radio equipment but only under the following circumstances:

• Where the radio spectrum is used ineffectively or inappropriately.
• Where there is harmful interference
• Where there are issues relating to public health.

Member States must ensure operators of public telecommunications networks allow connection of terminal equipment compliant with the essential requirements. Refusal to allow connection of equipment declared compliant can be made if such apparatus:

• Causes damage or harm to a network or to the functioning of the network.
• Causes harmful interference.
• Causes harmful radio interference.

In such cases, the Member State must notify the Commission and other Member States as a review of the harmonised standards relating to that piece of apparatus may be required.

An operator may disconnect apparatus immediately and notify the national authority in cases of emergency.

Article 8 - Free Movement of Apparatus

This article mandates Member States to allow CE Marked apparatus to be freely placed on the market except in the circumstances covered by Articles 6(4), 7(2) and 9(5). Member States shall allow the use of limited quantities of non-compliant apparatus to be used for demonstration purposes provided that it is clearly marked as non-compliant and will be made compliant prior to placing on the market.

Apparatus subject to more one Directive for CE Marking must carry information on the Directives which have been applied and to which the apparatus conforms. Directives invoking transitional provisions which have been used by the manufacturer should not be listed in the Declaration of Conformity.

Article 9 - Safeguards

Article 9(1) deals with the immediate withdrawal from the market, restrictions of movement and prevention of placing on the market, apparatus found to be non-compliant with the protection requirements of the Directive.

Under Article 9(2), the Member State involved must notify the Commission of its actions and the reason for the action. Non-compliance could be due for example to:

1. Incorrect application of the harmonised standards of Article 5(1).
2. Shortcomings in the harmonised standards of Article 5(1).
3. Failure to meet the essential requirements of Article 3 through failure to meet the requirements of the harmonised standards of Article 5(1).

Article 9(3) covers the response of the Commission to the non-compliance of (1) above reported by the Member State. This is essentially to judge whether the action is justified and notify the other Member States accordingly.

Article 9(4) covers the response of the Commission if a problem is found with the harmonised standards as in (2) above. If in their judgment the action is justified, then the Committee will be notified following the procedure of Article 5(2).

Article 9(5) deals with the situations where radio equipment can be prohibited from sale or use within a Member State if it is deemed that the radio equipment has caused or is likely to cause harmful interference which includes interference to planned services or nationally allocated frequency bands. In such cases, the Commission must be informed of the measures taken.

Article 9(6) covers the response of the Commission to such measures taken by a Member State. Measures which are justified are notified to the other Member States and measures which are unjustified are requested to be withdrawn by the Member State concerned.

Article 9(7) covers the recording of cases notified to the Commission by the Member States.

Article 10 - Conformity Assessment Procedures

Article 10(1) is a basic statement - Article 10 procedures demonstrate compliance with the essential requirements (Article 3).

Article 10(2) gives the option of using Directives 73/23/EEC (Safety/Low Voltage) and 89/336/EEC (EMC) to demonstrate compliance with the essential requirements directly. The provision is that the apparatus falls within the scope of these Directives.

Article 10(3) gives an alternative to 10(2) for telecommunications terminal equipment which does not make use of the radio frequency spectrum and the receiving parts of radio equipment. For these pieces of equipment the procedures of Annexes II, IV or V must be followed. Note that Annex II is self-certification using harmonised standards but Annexes IV or V require the services of a Notified Body.

Article 10(4) covers the use of harmonised standards for the conformance of radio equipment other than receive only equipment (i.e. not within the scope of Article 10(3)). For such apparatus, the procedures of Annexes III, IV or V must be followed. Note that Annex III is self-certification using harmonised standards but Annexes IV or V require the services of a Notified Body.

Article 10(5) covers the case where harmonised standards have not been used or have only been used in part for the conformity assessment of radio equipment out with the scope of Article 10(3), i.e. radio transmission equipment. In this case, the procedures of Annexes IV or V must be followed and that the services of a Notified Body are required.

Article 10(6) covers the language used for the conformity assessment procedures.

Article 11 - Notified Bodies and Surveillance Authorities

This Article deals with the notification to the Commission of the Notified Bodies appointed in the Member State and the surveillance authorities appointed. The names and identification numbers of the Notified Bodies are published in the OJ as is a list of the surveillance authorities.

Article 12 - CE Marking

This Article covers the CE Marking requirements which are summarised as follows:

1. Compliant apparatus shall bear the CE mark according to Annex VII of the Directive.
2. Where the apparatus is radio equipment, the identification number of the Notified Body shall be added to the CE Marking. The class identifier shall be included if assigned to the apparatus.
3. There shall be no marking likely to cause deceit as to the status of the CE Marking. The Member State must take action against any person incorrectly applying the CE Marking.
4. There shall be equipment identification in the form of type, batch and/or serial numbers. The name of the manufacturer or agent shall also be included.

Article 13 - Constitution of the Committee

There is a committee appointed to assist the Commission which is composed of representatives of the Member States. It is known as the Telecommunication Conformity Assessment and Market Surveillance Committee (TCAM).

Article 14 - Advisory Committee Procedure

This Article, as its title suggests, is concerned purely with the roles and responsibilities of the technical committee and the relationship between the Commission and the committee. Attention is drawn particularly to the following Articles of the Directive:

• Article 5 - relating to shortcomings of the harmonised standards.
• Article 6(2) - relating to the involvement of the committee in assessing the application of essential requirements to a particular class of radio equipment.
• Article 7(4) - relating to the involvement of the committee where compliant equipment causes damage to a network or causes serious radio interference.
• Article 9(4) - relating to the involvement of the committee where shortcomings in the harmonised standards are discovered.
• Annex VII(5) - relating to the class identifier assigned to the equipment.

Article 15 - Regulatory Committee Procedure

This Article is as its title suggests - the basic procedure to be adopted by the committee.

Article 16 - Transitional provisions, Third Countries

This Article deals with difficulties with placing apparatus on the market in third countries.

Article 17 - Review and Reporting

This Article covers the requirement for the Commission to revue the operation of the Directive and the work of the technical committee and report to the Parliament on a periodic basis. The reporting periods are after the first 18 months and thereafter every three years. The report contents are summarised as follows:

• Progress on producing harmonised standards.
• Problems with the implementation of such standards.
• The activities of the committee.
• Assess progress in achieving an open market and regulatory framework which provides a coherent system at Community level, allows for convergence of the telecommunications and information technology sectors and enables harmonisation of regulatory measures.
• Revue whether the essential requirements are still necessary for all classes of apparatus.

Article 18 - Transitional Provisions

Article 18(1) states that standards published in the OJ under the Low Voltage Directive 73/23/EEC and the EMC Directive 89/336/EEC can be used to demonstrate presumption of conformity to this Directive. Common Technical Regulations, published in the OJ under the Telecommunications Terminal Equipment Directive 98/13/EC can also be used. These standards are presumably as a substitute for harmonised standards listed in the OJ specifically under this Directive.

Article 18(2) states that the substitute method of Article 18(1), using Directive 98/13/EC, can be followed for a period of not exceeding two years from the date this Directive came into force.

Article 18(3) deals with a specific case where telecommunications terminal equipment must not cause deterioration of voice telephony within the framework of Directive 98/10/EC. This requirement may continue for up to 30 months after the date of transposition of this Directive into National legislation and is in addition to the safety requirements of Article 3(1).

Article 19 - Transposition

This Article sets the date for the implementation of the Directive in the legislation of the Member States to be not later than 7 April 2000.

Article 20 - Repeal of Existing Directives

1. Directive 98/13/EC is repealed from 8 April 2000 at the end of the period for transposition of this Directive into national law.
2. The R&TTE Directive is not a specific Directive within the meaning of Article 2(2) of the EMC Directive 89/336/EEC (as amended). The R&TTE Directive refers to the EMC Directive for the protection requirements of Article 4 and Annex III, and the conformity assessment procedure of Article 10(1), Article 10(2) and Annex I. In all other instances, the EMC Directive does not apply to apparatus within the scope of the R&TTE Directive. This is effective from 8 April 2000.
3. The provisions of the Low Voltage Directive 73/23/EEC do not apply to apparatus within the scope of the R&TTE Directive with the exception of the safety requirements of Article 2 and Annex I and the conformity assessment procedures of Annex III, Section B and Annex IV. This is effective from 8 April 2000.

Article 21 - Entry into Force

This Directive came into force on 7 April 1999.

Article 22 - Addresses

This does not require any comment.

Annex I - Equipment Not Covered by this Directive

Refer to Article 1(4) of this Directive

Annex II - Conformity Assessment Procedure of Article 10(3)

This Annex deals with the procedure of self declaration using internal production control. There is no requirement for the services of a Notified Body following this procedure. The procedure is summarised as follows:

1. The manufacturer (or Agent) must affix the CE marking to the product and prepare a declaration of conformity (DOC)
2. The manufacturer (or Agent) must produce technical documentation for the product which is retained for at least 10 years after the last product is placed on the market.
3. Where the manufacturer (or Agent) is not established within the Community, the person placing the product on the market must keep the documentation and make it available to members of the community.
4. The technical documentation must contain as a minimum:
   1. A general description of the product.
   2. Conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits etc.
   3. Any explanations required to aid understanding of the schemes and drawings above.
   4. A list of the standards used for conformity assessment and explanations of the solutions used where no standards have been applied.
   5. Results of design calculations and examinations.
   6. Test Reports.
5. The manufacturer (or Agent) must keep a copy of the DOC with the documentation.
6. The manufacturer must ensure that all products retain conformity with the technical documentation and with the relevant Directives.

Annex III - Conformity Assessment Procedure of Article 10(4)

This Annex deals with the procedure of self-declaration using internal production control but with specific apparatus tests for radio apparatus. The services of a Notified Body are required except if the product is covered by harmonised standards.

Annex II also applies to this Annex. The manufacturer must arrange for all the radio testing to be carried out either by himself or by an external facility. The manufacturer must appoint a Notified Body to identify the tests except where a harmonised standard defines them. The manufacturer must declare that all the tests have been performed and fix the notified body's identification mark to the product.

Annex IV - Conformity Assessment Procedure of Article 10(5)

This Annex deals with the procedure of conformity assessment using a Technical Construction File (TCF). The services of a Notified Body are required for this procedure. Certification applies only to the product and any changes must be referred to the Notified Body for a decision as to whether retest is required.

Annex III (and also Annex II) applies to this Annex plus the following additional requirements:

1. The technical documentation provided by the manufacturer, Agent or Importer, in addition to the DOC for the radio test suites, must form a TCF.
2. The TCF must be presented to a Notified Body. Where more than one Notified Bodies are involved, all must be informed of the other recipients of the file.
3. The Notified Body has four weeks to review the file and advise the manufacturer and other Notified Bodies if there are issues preventing the placement on the market of the apparatus. If there are no issues, the Notified Body issues a certificate to the manufacturer. If the Notified Body does not advise the manufacturer within the period, the apparatus may be placed on the market,
4. The manufacturer must keep the TCF for at least ten years after the last piece of apparatus has been placed on the market.

Annex V - Conformity Assessment Procedure of Article 10

This Annex deals with conformity assessment using full quality assurance. To invoke this Annex, a manufacturer must operate a quality control procedure similar to ISO9000. The services of a Notified Body are required to vet the companies procedures and manufacturing plants and also the testing agencies identified by the manufacturer. The surveillance by the notified Body should be carried out at regular intervals with no advance warning to ensure consistency and continuance of the quality procedure. The Notified Body must be kept informed of any planned changes to the manufacturer's quality system.

The advantage of this procedure is that, once the surveillance has taken place, the manufacturer has full control over the self-certification of the apparatus and any changes that may be made during the production cycle. The manufacturer can decide whether changes require re-test or not without referring the matter to the Notified Body. For details of the Annex, refer to the text of the Directive.

Annex VI - Minimum Criteria for Designating Notified Bodies

Refer to the text of the Directive

Annex VII - CE Marking Requirements

This Annex gives details of the shape and form of the CE Mark and the condition under which it is to be affixed to the relevant apparatus.

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Page last updated 29 October 2007