Using practical examples to demonstrate the approval requirements for products under the R&TTE Directive, this article focuses primarily on two routes to compliance: the standards route and the technical construction file (TCF) route. The final route—full quality assurance—is discussed briefly. The first two routes to compliance are quite similar to those under the Electromagnetic Compatibility (EMC) Directive. The third option, full quality assurance, is available only under the R&TTE Directive. For the first two routes, a decision flow diagram is given in Figure 1.

Throughout the article, comparisons are drawn with the now-familiar EMC Directive's (89/336/EEC) routes to compliance for nontransmitting products. These comparisons should assist in understanding compliance with the R&TTE Directive.

In addition to the routes to compliance for the radio aspects of a product, manufacturers must also demonstrate compliance with the essential requirements of the EMC Directive and of the Low Voltage Directive (LVD; 73/23/EEC). It is imperative to note that no voltage limits apply under the R&TTE Directive.

The prerequisite for all routes to compliance under the R&TTE Directive is internal production control, which is covered by Annex II of the directive. This annex establishes three main requirements: legal, product documentation, and manufacturing.

Legal Requirements. The annex highlights the need to draw up a Declaration of Conformity (DoC) and affix the CE mark. Either the manufacturer or an authorized representative established within the European Union (EU) must complete the DoC. Keep in mind that other directives may be applicable to a product type. Affixing the CE mark implies that the product meets the requirements of all applicable directives. Additional requirements state that product documentation (see section 3.2 of the directive) must be available to authorities for inspection for a minimum of 10 years after the last product has been manufactured. For cases in which neither the manufacturer nor an authorized representative is established within the EU, the person placing the product on the market is responsible for meeting the requirements of this annex.

Product Documentation. The technical documentation relating to the product must enable the conformity of the product to be assessed against the essential requirements of the directive. It must cover the design, the manufacture, and the operation of the product. Annex II states that the docu-mentation must include:

Manufacturing. The directive requires that "all necessary measures" be employed to ensure that all products manufactured comply with both the technical documentation and the requirements of the directive. This requirement implies that procedures should be in place to ensure that all products off the production line are identical to the original sample that complied with the requirements of the directive.

As a practical guide, this section uses typical products to illustrate the routes to compliance. The requirements addressed are in addition to those covered under internal production control discussed previously. For compliance with the standards route, a product manufacturer must have applied the appropriate harmonized standard. To fully understand how to use the standards route, a definition of harmonized standard is required. A standard is deemed to be harmonized once it has been published in the OJEC. A list of standards was recently published on February 14, 2001 (analogous to the EMC Directive).

Complying with a harmonized standard does not ensure that a product meets the essential requirements of the directive, but rather gives the manufacturer a "presumption of conformity" with the essential requirements.

Harmonized Frequency Band. Here, an example could be a global system for mobile communications (GSM) handset transmitter. This example exploits the fact that, for this application, the frequency band is harmonized across the EU.

The choice of standard under the R&TTE Directive lies with a manufacturer as long as all essential test suites related to the product are defined in the chosen standards. If this is not the case, a notified body must determine the test suites. If a notified body has been consulted, then its number (NB number) must appear on the finished product once testing has been successfully completed.

Testing under the R&TTE Directive no longer requires the involvement of an appropriately accredited test house. Manufacturers that are confident their measurements are accurate can declare compliance with the directive without third-party testing. However, notified bodies are concerned that manufacturers can label equipment with a notified body's number without the notified body having any control over the testing.

As with other EU directives, testing to harmonized standards offers a manufacturer a presumption of conformity with the essential requirements of the directive. It does not imply compliance with the standards or directives. Even equipment fully tested to harmonized standards could be removed from the EU market if, for example, the harmonized standard was determined to be deficient in a certain parameter. This is considered very unlikely, however.

Once testing has been successfully completed, a manufacturer (or authorized representative established within the EU) produces a DoC stating that the product meets the essential requirements of the R&TTE Directive. In addition, the manufacturer must apply both the notified body's number (if used) and the CE mark to the product. Labeling requirements are provided later in this article.

Nonharmonized Frequency Band. Short-range devices, which includes equipment such as radio local-area networks (RLANs), are examples of equipment operating on nonharmonized frequency bands, such as the 2.4–2.4835 GHz band. Although this is generally harmonized across the EU, there are some exceptions—notably France—where the entire band cannot be used owing to military allocations. In this case, the route to compliance is the same as that for harmonized frequency bands. However, a further process called notification is required, which is also described later. A notified body must be involved in specifying the essential test suites for equipment only if the tests are not fully specified in a published harmonized standard.

Because the French Authority does not currently allow 2.4- GHz RLANs to be used across this nonharmonized band, the labeling and product information must reflect this. As with the harmonized standards route, the number of the notified body (if used) that specified which standards to apply must appear on the product along with the CE mark and equipment class identifier (ECI), sometimes known as the "alert" symbol.

The TCF route is primarily an approval route for new technologies. Currently, a new technology takes longer to reach the market because standards are developed retrospectively. Without appropriate standards, type approval is not generally issued. The European Commission (EC) sees this route as a barrier to the development of new and exciting technologies reaching the EU market.

As with the EMC Directive, the TCF route is for products where harmonized standards do not exist or where the standards have been tested to in part only. In these cases, an application must be made to a notified body. In addition, a manufacturer could choose to follow this route for a product that has relevant harmonized standards fully applied.

Applications can be made to multiple notified bodies; however, each notified body must be informed of all others where an application has been lodged. The notified bodies must review the documentation and issue an opinion within four weeks of receipt of the application.

A manufacturer (or representative) that receives an unfavorable opinion from a notified body (the notified body considers that the essential requirements of the directive have not been met) must inform all other notified bodies of this opinion. It is clear from the directive that it is not the responsibility of the notified bodies to communicate with each other, but rather it is up to a manufacturer to inform notified bodies of unfavorable opinions! Notified bodies must take into account previous opinions issued by other notified bodies regarding product compliance.

However, receiving an unfavorable opinion does not inhibit the sale of the product in the EU. It is just an opinion. For products on harmonized frequency bands, the product can still be sold. However, the national authority can invoke Article 9 of the directive (the safeguard clause), which permits the withdrawal of products from the market if the authority "reasonably" expects that the product could cause interference.

Declaration of Conformity. If a favorable opinion is received from a notified body and the equipment operates on a harmonized frequency band, then the manufacturer can produce a DoC and place the equipment on the market. The equipment must be labeled with the NB number and the CE mark.

If a favorable opinion is received from a NB and the equipment operates on a nonharmonized frequency band, then the manufacturer can produce a DoC and place the product on the market once the notification process has been completed. The equipment must be labeled with the notified body number, CE mark, and ECI (alert) symbol.

This section provides a brief overview of the requirement detailed in Annex V of the R&TTE Directive. Companies can demonstrate that their products comply with the R&TTE Directive by meeting the following requirements:

Table I details the labeling information required for the R&TTE Directive's routes to compliance. Affixing the CE mark to the product indicates that the equipment complies with all relevant CE marking directives, not necessarily just the R&TTE Directive (see Figure 2).

Figure 2. The CE mark.

The alert mark, as shown in Figure 3, affixed to the product indicates that because the product does not operate on a harmonized frequency band, it has restricted geographical areas of use across the EU. The alert mark applies to so-called Class 2 equipment (as opposed to Class 1 equipment that operates on a harmonized frequency band). Tables II and III provide the most recent lists of equipment specified in Class 1 and Class 2 categories. These lists are subject to change. An example of product labeling is depicted in Figure 4. The XXXX represents the number of the notified body. Other labeling requirements encompass the need for information to be supplied to end-users and to be provided on product packaging.

Figure 3. Equipment class identifier (alert mark).

Figure 4. The format of a harmonized frequency band product label (a) and a nonharmonized frequency band label (b), where XXXX is the number of the notified body (if used).

Member states must ensure that manufacturers (or those who are responsible for placing an apparatus on the market) provide user information on the intended use of the apparatus, together with the declaration of conformity to the essential requirements. For radio equipment, the geographical location where the equipment can, or cannot, be used must be easily identifiable both on the packaging and in the user instructions.

The R&TTE Directive states: "In the case of radio equipment using frequency bands whose use is not harmonized throughout the community, the manufacturer or his authorized representative established within the community or the person responsible for placing the equipment on the market shall notify the national authority responsible in the relevant member state for spectrum management of the intention to place such equipment on its national market."

This paragraph seems to imply that if a product operates on a nonharmonized frequency band, a manufacturer must notify every country's national authority (regardless of whether it fits in with frequency plans) prior to placing the product on that member state's market. This interpretation means the national authorities would be swamped with notification applications because all products using a nonharmonized frequency band would require notification.

Following discussion within the Telecommunications Conformity Assessment and Market Surveillance (TCAM) Committee, the EC made the following proposal: Notification of equipment is required to be made to "relevant member states," i.e., member states in which the equipment cannot be allowed for use. Notification is not required for equipment covered by the following definition: Radio equipment using frequency bands whose use is not harmonized throughout the community is considered to be all radio equipment except those that:

This section addresses the process of transposing the directive into national laws and discusses the transitional requirements for products approved prior to April 8, 2000. As noted earlier, the directive was published on April 7, 1999, with a transitional period until April 8, 2000, to facilitate member states transposing the directive into their national laws. The directive in itself is not a law, but rather directs national governments to produce laws in accordance with the requirements of the directive. Those countries that do not transpose the directives into laws can be brought before the European Court.

A few member states did not meet the April 8, 2000, deadline; however, most countries implemented interim measures in accordance with the requirements of the directive. Greece was the only member state to miss the deadline. However, it has recently implemented interim measures.

Transitional Provisions. Transitional arrangements were introduced for one year following the implementation of the R&TTE Directive. On April 8, 2001, directives or provisions of directives were repealed, namely TTE Directive 98/13/EC, 89/336/EEC, and 73/23/EC. National type approval was also revoked.

Safety and EMC. Safety and EMC standards were published in the OJEC under the R&TTE Directive on April 7, 2000. The announcement stated: "In addition, standards published under Directives 73/23/EC and 89/336/EEC may be used to demonstrate compliance with Articles 3(1)(a) and 3(1)(b) of Directive 1999/5/EC." This means that even for battery-operated devices, for example, manufacturers can follow a route of "self-declaration" if the appropriate standard has been published under the Low Voltage Directive.

Equipment Approved under 98/13/EC or National Regimes. Equipment approved under the current approval process will enjoy free movement of goods throughout the EU for one year following the R&TTE Directive coming into force. Equipment placed on the market after April 7, 2001, must comply with the provisions and rules of the R&TTE Directive. This should not cause manufacturers any great concern because the standards used to demonstrate compliance with 98/13/EC or national type approval requirements are likely to be similar to those required under the R&TTE Directive.

Reassessment of Products. To continue marketing after April 7, 2001, those products that received a national approval before April 8, 2000, the R&TTE Directive requires reassessment. Theoretically, therefore, it could happen that under Annex III (standards route) of the R&TTE Directive, a notified body could prescribe essential radio tests that differ from the tests a manufacturer had done to obtain national approval. Likewise, it would be possible for a notified body to render a negative opinion on the technical file of a manufacturer under Annex IV (technical construction file route).

The commission sought an agreement among member states that reassessment of such products should be a purely administrative procedure, so that the notified bodies would not be able to insist on additional testing, even if deemed appropriate. The commission, therefore, would like national administrations to instruct notified bodies to accept radio test suites used to obtain national approvals as sufficient for compliance with the R&TTE Directive. The commission also asked that no negative opinions be given on TCFs that were based on a national approval.

Although administrations are likely to strongly recommend this course of action, notified bodies under the R&TTE Directive are commercial entities, and therefore they are not legally obliged to follow the commission's guidance. However, it is highly likely that most notified bodies will follow the prescribed guidelines.

The routes to compliance are similar to those of the well-established EMC Directive (89/336/EEC). The markings on products must consist of the CE mark, the NB number (if used), and the ECI in cases where equipment operates on a nonharmonized frequency band. Any geographical restrictions on the product's use must be clearly defined in its user's manual. In the short term, it appears that notification will be required for all equipment that has the ECI affixed.

The directive indicates that the longest route to compliance will be for products with no harmonized standard, operating on a nonharmonized frequency band. This process should take a maximum of four weeks. The directive does not preclude notification of equipment operating on a nonharmonized frequency band being done in parallel with a TCF assessment performed by a notified body.

In order to affix the CE mark to equipment, the provisions of the R&TTE Directive and all other applicable directives must be met. The transitional arrangements allow for products approved before April 8, 2000, to be manufactured and placed on the market up to April 7, 2001. Equipment that has been tested but not approved before April 8, 2000, can use standards published under the EMC Directive or Low Voltage Directive to give access to the standards route for these parameters. It is important to note that the application of technical information varies depending on each user's particular circumstances. Obtain competent technical advice before acting on the information presented in this article.