The R&TTE Directive and Market Surveillance

Juha Junkkarinen and Frank Weisser
With an increasing number of market surveillance programs, up-to-date compliance is more critical than ever.

Who is checking on your product, Declaration of Conformity (DoC), and technical construction file (TCF)? There is an increasing chance it could be one of the European Union (EU) Market Surveillance Authorities (MSAs). This article focuses on products falling under the requirements of the Radio and Telecommunications Terminal Equipment (R&TTE) Directive.¹ This information, however, is applicable to almost everything requiring CE marking.

An informal questionnaire was sent to several of the authorities, and responses indicate that responsible parties (manufacturers, importers, etc.) are not doing a very good job of ensuring compliance with the essential requirements of the applicable directives. Thorough audits by the MSAs reveal errors in the original approval as well as problems resulting from changes in harmonized standards, interpretations, and product modifications after the product has already been introduced into the marketplace.

Manufacturers can insure their products against the risk and expense of fines and possible removal of product from the market through self-verification of complete and up-to-date compliance.

Although there is no direct requirement for MSAs to perform product examinations, it is implicit in Articles 6, 9, 12, and 14 of the R&TTE Directive. In the three years since the directive has been in force, the level of market surveillance in EU countries has varied from zero examinations to examinations of thousands of units per year. That is about to change. In September 2002, a new one-year campaign was started; each participating country will examine at least 100 units.

Products for examination are to be selected in an unbiased manner, and imports and local products are to be treated equally. The selection of products is partially random and partially based on other information: hints from competitors, consumer complaints, and information from agencies such as customs.² Be aware that negative findings from one examination have resulted in additional examinations of associated products and more problems for the offending party.

For most manufacturers or importers, the process for compliance with the directive is simple. The party responsible for placing the product on the market produces a TCF and a DoC and applies the CE mark, indicating compliance with the essential requirements of all applicable directives. If nonharmonized standards or nonharmonized frequency bands are used (Class 2 devices), the involvement of a notified body is required.

Additionally, for equipment using nonharmonized frequency bands, the spectrum management authorities must receive notification four weeks prior to the equipment being placed on the market. The process required by the R&TTE Directive, even for Class 2 devices, is faster and easier than previous approvals methods. The biggest change is the transfer of responsibility for compliance from notified bodies and approvals agencies to the manufacturers and importers.

Another effect of the R&TTE Directive is a change in the focus of the national authorities from premarket evaluation and approval to market surveillance, ensuring compliance by examination of products.

Some of the national authorities have been very active in checking products. Based on what they have found, the responsible parties have not been very responsible at all. Information provided in response to the surveillance questionnaire shows that, in some cases, only 20% of products examined are fully compliant. Most problems found have been relatively minor, and, fortunately for manufacturers, many of the examiners have taken the position that, for minor issues, educating the responsible parties is the appropriate action. This theory of proportionality is discussed in Electronic Communications Committee (ECC) report 15: "All actions should be proportional to the problem, and if the manufacturer appears to be co-operative, all unnecessary formal legal action should be avoided."

Not all of the problems found have been minor, however. In several cases, market surveillance has resulted in sales bans and fines. "When we find equipment clearly against the requirements on the market, we are obliged to confiscate all of them and prohibit the vendor from selling them."³

Results from the Examinations

Several MSAs have provided information on their activities. Some, however, do not have a program for examinations in place. In one case, the MSA said no statistically valid data were available because the controls program had been in operation for only a month. Others reported active programs that have examined thousands of products and will continue to do so.

In 2001, the Regulatory Body in Germany (RegTP) examined 2568 units to the R&TTE Directive and 16,252 units to the EMC Directive. A full 27% were found to be noncompliant and resulted in fines of €281,000 (~ $281,000 U.S.).

In one case, a manufacturer "forgot" to include an EMI suppression ferrite on a modem cable. The product's original test report included in the TCF indicated that the ferrite had been added to pass EN 55022 Class B. Testing done as part of the examination of the product determined that without the ferrite the product was 10 dB over the limit. The manufacturer was ordered to pay a fine of €3000 as well as €2000 for the test.

As in this case, many administrations will charge the cost of testing and obtaining the sample to the responsible party if a noncompliance is found. More significantly, a Europeanwide sales ban was placed on this product. The costs of the testing and fines are minimal compared with the costs of removing the product from the market and the loss of sales during rework.

The RegTP recently released data from the examination of 100 products (16 telecom, 15 combinations of telecom and radio, 69 radio) completed in October 2002. Incorrect user information continues to be the most common problem. Only 34 out of 84 combination and radio products were compliant with user information requirements. A missing or incomplete DoC is the next most common problem, affecting 39 of the 100 products examined. In March 2003, the RegTP selected another 100 products for examination.

In 2001, the Finnish Communications Regulatory Authority (FICORA, Finland) made inspections at 475 retail locations and at 12 exhibitions. Through October 2002, FICORA had visited 504 retail locations and 7 exhibitions, examining about 800 different products. Only 20% were found to be fully compliant. Most problems were considered minor, including documentation issues such as the purpose of use. The purpose must be written in both Finnish and Swedish. Another documentation issue that arose included failing to list the countries where the equipment is meant to be used. A more serious deficiency, the lack of a DoC to the R&TTE Directive, characterized 170 of the products.

Audits performed by consultants on behalf of manufacturers have found similar problems:

Avoiding Problems

Including a copy of the DoC, or a link to where the DoC can be read, in the user documentation with the product is a primary way to demonstrate that the unit in question is in compliance with the directive. Although this is not mandatory, having the DoC available can streamline market examinations. If there is no DoC or if it cannot be located by the authorities in a reasonable amount of time, the item in question will be declared noncompliant and removed from the market.

Avoid the most common problems by having policies and procedures in place. Such procedures result in each product, its TCF, its DoC, and the harmonized standards used being checked at least annually. The audit should be an exhaustive examination of the product and all of the documentation in the TCF. Make a note of any differences between the product and the description in the TCF; evaluate the impact of all engineering change orders processed since the last review. As part of the audit, be sure to check the latest list of harmonized standards published in the Official Journal of the European Communities. Schedule any testing to new requirements far enough in advance to allow time to make any changes that may be required. Some of the changes in standards are relaxations of limits; this is an opportunity to evaluate the design for possible cost reductions.

Engineering change control and quality procedures should result in an evaluation of the impact on compliance of any change to the product or its documentation. The evaluation of changes should be done prior to implementation to ensure continued compliance. All changes to a product, user documentation, labels, and packaging need to be evaluated and documented. The TCF must be maintained so that it accurately reflects the product. Some changes will require retesting, but many will not. The only way to know is to perform a sound engineering analysis of the impact of each proposed change. Problems resulting from changes can be avoided by having all modifications reviewed by a staff engineer or regulatory consultant familiar with the directive, the applicable harmonized standards, and the product.

It is essential that a date code, serial number, or other form of traceability to the date of manufacture is included on the equipment. Items that are manufactured, imported into the EU, on the shelf at retail establishments, or installed prior to the date requiring a change in standards do not need to be retested or modified to meet the new requirements. Keep a copy of the TCF describing all versions of a product that may be in the supply chain.

The TCF

A TCF should contain all of the detail required to determine that the product is in compliance with the essential requirements of the directive. The following list includes the usual items needed, although some are not applicable to all types of equipment.

A TCF should contain only the required information. At best, any extraneous material will result in confusion and delays during an examination, and it could result in a rejection of the TCF and product. The form and format of the TCF are not defined in the directive and subsequent official opinions. Paper files and electronic versions on CD have been accepted. Surveillance authorities have indicated a preference for write-only media for electronic TCFs. Adding a table of contents and a list of revisions can facilitate an official examination and an internal audit.

The file should be physically located in the EU. For non-EU manufacturers, it could be held by the importer, a distributor, a sales representative, or an approvals consultant in the EU.

The TCF often contains all of the design information for a product. Maintaining control of the file and releasing the information to the minimum extent required by law can be important in maintaining a competitive advantage. The party holding the file should be aware of the importance of the information contained within it and the regulations regarding official access to the file.

Telecom Standards and Interface Specifications

Interoperability of the equipment with the network is the responsibility of the manufacturer; testing to the interface specifications is not essential for compliance with the directive. This does not mean that testing to telecom standards and interface specifications is unnecessary. Equipment that does not operate as intended can result in a variety of problems for the responsible party. Problems might include customer dissatisfaction and return of product, actions based on consumer protection and antifraud regulations, and, in cases in which degradation of network performance results, network operator disconnection of the equipment that is causing harm to the network.

For the manufacturer's protection, interface testing should go beyond the minimal requirements for protection of the network from harm. Testing should adequately demonstrate proper operation with the intended network. Verify that the product is compatible with interface specifications published in accordance with the requirements of the R&TTE Directive. Article 4 requires the following: "The specifications shall be in sufficient detail to permit the design of telecommunications terminal equipment capable of utilizing all services provided through the corresponding interface."

In addition to the interface specifications, technical bases for regulations (TBRs), common technical regulations (CTRs), and European Telecommunications Standards Institute (ETSI) standards are very useful in developing an interface verification test suite. As previously stated, although the DoC should not mention nonharmonized standards, the results of these tests are important and should be included in the design files. They can also be included in the TCF.

What to Do If Not Compliant

First of all, don't panic. Even with the best of intentions, mistakes can happen. The unit selected for testing may have been a defective unit. Test methods and procedures can influence results. And, with this directive, differences in interpretation abound. Whether the problem found by an examiner is clearly a deficiency, a defective unit, a difference in test methods, or just a difference of opinion, a little cooperation goes a long way in reducing the impact of any noncompliance finding.

Negotiate a plan of action to resolve the issues. A plan may include proposed changes to the product, the user information, the labels, etc. Additional testing may be appropriate if the results differ between the examined unit and those tested for the reports in the TCF. The selection of the test laboratory, the units to be tested, and methods to be used should be agreeable to both parties.

Having a TCF which, in your opinion, shows compliance with the technical, regulatory, and administrative requirements will help resolve issues; it at least shows a good effort and intent to be in compliance with the directive.

Conclusion

The MSAs are on the job, and the number of units being checked is increasing each year. Within the year, each EU country will have a market surveillance program in place and operating. Every product will not be examined. If yours is selected, will it be found compliant or will it be removed from the market? The cost of compliance is much lower than the costs of a sales ban, confiscation of equipment, test fees, and fines that can result from being noncompliant. The time to verify compliance is before products are selected for examination.

References

1. Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity (commonly referred to as the R&TTE Directive).

2. ECC Report 15, "Market Surveillance, Radio Equipment Inspection, Spectrum Monitoring, and the Enforcement Aspects of These Activities," Messolonghi, September 2002.

3. Personal communication in response to surveillance questionnaire, from Yrjo Hamalainen, FICORA.

Juha Junkkarinen, of Juha Junkkarinen Inc. (Forest Grove, OR), is a regulatory and design consultant with 23 years of experience in equipment design, test, project management, and approvals including product safety, EMC, NEBS, and telecom in North America, Europe, and Asia. He can be reached at 503-260-4364, via e-mail at juha@regulatory4u.com, or on-line at www.regulatory4u.com.

Dipl.-Ing. Frank Weisser, of Ingenieurbüro für Telekommunikation Oberursel-Germany, has 30 years of experience in EDP and telecom. He also manages the office of Patton & Associates (www.patton-assoc.com) in Frankfurt, Germany. He can be reached via e-mail at frank_weisser@compuserve. com or www.frankweisser.com.