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Compliance with the EU Radio and Telephone Terminal Equipment directive (R&TTE) is compulsory for radio devices. The responsibility for compliance is placed clearly on the manufacturer of the device. When integrating a radio module into a completed product, the integrator then becomes the “manufacturer” of the radio device. The underlying basis for this is that the integration of the two products can affect final compliance with the directive.
Technical reports from ETSI, ETSI TR102 070 parts 1 and part 2, give guidance related to the integration of radio modules into final product, already assessed for EMC, and the application of harmonized standards. These documents, together with the directive, form the basis of guidance notes developed by R&TTE notified bodies for the assessment of product to the directive.
In all cases, assessments must be made for compliance with R&TTE directive article 3.1(a), and 3.1(b). These articles cover Safety and EMC, respectively.
According to a quote in the guidance document;
“Assessed radio modules installed in equipment in conformance with the manufacturer's installation instructions require no further evaluation under Article 3.2 of the R&TTE Directive and do not require further involvement of an R&TTE Directive Notified Body for the final product. In all other cases, or if the manufacturer of the final product is in doubt then the equipment integrating the radio module must be assessed against Article 3.2 of the R&TTE Directive.”
ETSI Technical Report ETSI TR102 070-2, describes several applications of the above with different product configurations.
When the integration of a particular module does require assessment by a notified body, the technical documentation for the radio module will need to be reviewed by the NB, if not available, the NB may request this information from the radio module manufacturer. The NB may be unable to issue an opinion without this information. The integrator should ensure that the module manufacturer is willing to provide this information to the NB; however, the final Technical Construction File is not required to include the radio module manufacturer’s proprietary information. Furthermore, the final product integrator is cautioned to ensure that they know the build status of the integrated module.
The R&TTE guidance document also covers technical documentation, notification to national authorities, and marking requirements.
The full guidance document can be downloaded here http://www.rtteca.com/TGN01Rev4.pdf
Be sure to visit http://www.celectronics.com/europe.htm for more information related to EU regulatory compliance.
UPDATE: part II available covering EMC considerations -