The Radio and Telecommunications Terminal Equipment (R&TTE) Directive has shifted the burden of approving telecommunications and radio products for the European market. Rather than requiring a long and costly approval process involving certifying authorities, compliance is presumed when a manufacturer issues a declaration of conformity (DoC).
This shift improves access to the European market, broadens consumer choices, and speeds up technological competition and innovation. In general, the trade-off is faster and lower-cost product CE approval vs. increased manufacturer liability.
The directive, enacted by the European Union (EU) in April 2000, removed significant barriers that prevented wireless communications products from freely circulating within the EU. In addition to the normal cell and wireless phones, these systems include wireless LANs, alarm systems, remote-entry systems, meter readers, PDAs, video-game controllers, and keyboards. The opportunity represented by the EU market makes it imperative for manufacturers to understand the R&TTE Directive and how it applies to their products.
The goal for a manufacturer is to obtain the CE Marking by demonstrating compliance with the R&TTE Directive. Several routes are available to reach that goal:
- Standards: the simplest path, described in Annex III.
- Technical Construction File (TCF): used for more complex cases and nonharmonized standards; requires a notified body (NB), described in Annex IV.
- Full Quality Assurance: a manufacturer declares compliance based on having an accredited quality system, described in Annex V.
The standards and the TCF routes are akin to the EMC Directive process and discussed here since most products will fall within one route or the other. However, before choosing a route for compliance, the manufacturer first must understand the essential requirements of the directive:
- Frequency Spectrum: effective use to avoid harmful interference.
- Electrical Safety and Health: as in Low Voltage Directive 73/23/EEC.
- Electromagnetic Compatibility: as in the EMC Directive 89/336/EEC.
In addition to these essential requirements, the directive addresses other requirements, as shown in Figure 1, that may be applicable to certain communications equipment. These issues deal with aspects such as not causing harm to the network, privacy of data, avoidance of fraud, access to emergency services, and features for users with disabilities.
Routes to Compliance
The Standards Route
The standards route allows the manufacturer to test and evaluate the radio product to the essential radio test suites of harmonized standards for that particular type of device. A harmonized standard is one that has been published in the Official Journal of the European Communities (OJ). These typically have been produced either by the European Committee for Electrotechnical Standardization (CENELEC) or the European Telecommunications Standards Institute (ETSI).
ETSI documents that fall under the directive include a drawing similar to Figure 1 that shows the current status of the standards harmonization process. Dotted outlines signify that when the document was published the European Commission had not yet adopted essential requirements in those categories. Solid outline boxes represent either new harmonized standards or existing generic and product standards that will be replaced in the future. Harmonizing all of the relevant requirements is a continuing effort.
If a harmonized standard is not available, then the manufacturer must involve an NB to prescribe the necessary test suite. When an NB is consulted, the CE Marking on the product must include the assigned number of the NB. Complying with a harmonized standard does not ensure that a product meets the essential requirements of the directive, but it gives the manufacturer a presumption of conformity with the requirements.
In addition to standards being harmonized, frequency bands and device operation also must be harmonized among the member states. Although the R&TTE Directive has removed the barriers to trade, there still exist limitations in the frequency allocations and operation of devices within various member states. This mainly is due to history and the frequency bands already being used by other activities and services, such as the military.
When a frequency band is not harmonized, the manufacturer still applies the harmonized standard, assuming it exists; however, a separate process called notification is required. The manufacturer must provide written notification to the member state spectrum authority about the device. In addition, the equipment class identifier (ECI) or alert symbol is required to appear on the label of the device signifying that the frequency band in which the device operates is not harmonized. Most frequencies are harmonized, and as new technology is developed, these nonharmonized frequency allocation problems will diminish.
Once the device has been successfully tested, the manufacturer or authorized representative within the EU must prepare a DoC attesting that the product complies with the essential requirements and has the appropriate labeling.
The TCF Route
The TCF route to compliance is slightly more involved because it requires the submission of a complete technical package to an NB for review. This option typically is used when harmonized standards do not exist such as in marketing new technologies or when harmonized standards have been only partially applied.
It should be noted that the TCF route may be chosen even if harmonized standards exist for a product. Some manufacturers gain a level of confidence by submitting TCFs to NBs for review—a third-party independent assessment.
An NB’s role includes identifying test suites, reviewing the TCF, and issuing an opinion to the manufacturer. By mandate, the opinion of an NB to the manufacturer must be given within four weeks of receipt of the TCF.
At the end of four weeks or upon the receipt of the opinion from the NB, the manufacturer or authorized representative within the EU can label the product and place it on the market. The label will have the CE Marking and the NB’s number. If the device operates on a nonharmonized frequency band, then the ECI alert symbol also must be placed on the label.
In the event that an unfavorable opinion is received from an NB, it is the manufacturer’s responsibility to notify all other NBs of the opinion. Even if an NB does not issue a favorable opinion, the manufacturer still may decide to sell the product that operates on a harmonized frequency band in the EU.
The NB’s opinion is just that—an opinion. National authorities, however, may decide to have the product withdrawn from the market if they reasonably expect that the product could cause interference.
Quality-Assurance Route
The last route to compliance, full quality assurance, is more complex and not as popular as the other routes. This approach requires that the manufacturer have an accredited quality system. This tacitly demonstrates that the manufacturer has the necessary procedures and systems in place to ensure compliance with the R&TTE Directive. Currently, only a few NBs are approved to check, approve, and monitor quality-assurance systems.
The following points summarize the requirements that a manufacturer must fulfill to achieve compliance via the full quality-assurance route, as detailed in Annex V:
- Operate an approved quality system covering design, manufacture, and final product inspection and test.
- Allow an NB inspection to ensure that the quality system is sufficient and products will meet the essential requirements of the directive.
- Permit regular audits by an NB for continued compliance.
- Make all quality documentation, technical locations, and documents available to the NB for inspection.
- Allow unscheduled NB audit visits.
- Produce and retain technical documents referred to in section 3.2 of the directive and allow continued assessment of these documents by an NB.
- Apply the relevant markings to products placed on the market.
Quality system approvals require that each NB make available relevant information concerning the approval, including references to products issued and withdrawn, to all other NBs. Once compliance is achieved, manufacturers can produce a DoC and place a product on the market only if the equipment operates on a harmonized frequency band.
If the device operates on a nonharmonized frequency band, the manufacturer must wait until the notification process has been completed. The equipment must be labeled with the NB number, CE Marking, and ECI alert symbol if using a nonharmonized frequency band.
Although the full quality-assurance route is available, few manufacturers probably will use it. In his article on the R&TTE Directive, Martin Green, director of Technology International, commented, “There is no reason why manufacturers should use this route, unless they have already established a similar route under the old legislation….it would seem a somewhat complex and unnecessary method to achieve certification.”1
Table 1 summarizes the routes to compliance along with the requirements for using an NB and the marking of the product.
Table 1. Summary of R&TTE Directive Routes to Compliance
Legal Requirements
No matter which route to compliance the manufacturer or representative chooses, each requires that the procedures of Annex II covering internal production control be met. This annex sets forth the legal requirements, production technical documentation, and manufacturing control.
Legal requirements mandate that the manufacturer declares compliance with the directive via a written DoC and placement of the CE Marking on the product. Additionally, it is required that the manufacturer must keep all technical documentation for a period of 10 years from the time the product was last manufactured.
These requirements can be met by the manufacturer or an authorized representative established within the EU. If neither the manufacturer nor the representative is in the EU, then the person placing the product on the EU market is responsible for complying with the requirements of the annex.
Product Technical Documentation
The product’s technical documentation is used to assess the conformity of the product with the essential requirements of the directive. The documentation must cover the design, manufacture, and operation of the device. Following is a list of items that must be included:
- Product description.
- Conceptual design and manufacturing drawings such as schematics and subassembly drawings.
- A description and explanation of the drawings, schematics, and operation of the product.
- A list of all standards that were applied, in full or in part, to show compliance. If standards were not used or do not exist, then a description and explanation of the solutions used to meet the essential requirements of the directive must be included.
- Results of design calculations and examinations.
- Test reports.
- A copy of the DoC.
Manufacturing
The manufacturer must ensure that all measures have been taken to continue producing products that meet the technical documentation as described and that the product continues to comply with the requirements of the directive.
Notifying Authorities
Not all of Europe uses the frequency spectrum in the same way. For mainly historical reasons, the communications bands have variations in usage across the EU. If a manufacturer makes a product that operates on a portion of the spectrum that is not harmonized, then the manufacturer is obligated to notify the intended market’s authorities that they will sell transmitting products in their country. This notification process must be done four weeks prior to placement on the market. The process is relatively straightforward.
References
- Green, M., “Radio and Telecommunication Terminal Equipment—Is This True Deregulation for the Radio and Telecoms Industries?,” T&E Update, Washington Laboratories, Issue 10, June, 2000.
About the Author
Greg Snyder is the chief EMC engineer at Washington Laboratories. He has a B.S. in electronic engineering technology from Capitol College and more than 15 years of experience in EMC testing and compliance. Washington Laboratories, 7560 Lindbergh Dr., Gaithersburg, MD 20879, 800-839-1649, e-mail: [email protected]
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May 2003