LSR is commonly answering questions regarding the requirements for radio products in Europe.
Written By: Thomas T. Smith
Thomas is the Vice-President of EMC Test Services at LSR. Tom has over 13 years of experience in EMC/RF Testing on a variety of products in the Industrial, Commercial and Medical Industry. Tom received a BS in Biomedical Engineering from the Milwaukee School of Engineering (MSOE) in 2000 and is an active member and contributor in IEEE.
LSR is commonly answering questions regarding the requirements for radio products in Europe. Obviously there are a variety of answers and requirements depending on each product; however the European Union (EU) has established a basic set of guidelines in the form of the 1999/5/EC R&TTE Directive.
The scope of this article is to discuss the current version of the R&TTE Directive and how it applies to the integration of an assessed radio module. This article in no way meant to steer the manufacturer or integrator of the radio module in one direction or another, but rather provide the manufacturer with information which can be used to make an informed decision.
For the purpose of this article, a few assumptions to consider are: 1). Discussion focus around using harmonised standards which minimizes the requirement for Statement of Opinions by a Notified Body. 2). Products being discussed contain a single radio module.
Most of the core discussions are relevant to all radio products however there may be additional requirements placed on the products as a result of any deviations.
The R&TTE Directive covers all radio equipment and all equipment intended to be connected to public telecommunications networks . It establishes a regulatory framework for the placing on the market, free movement, and putting into service.
Before discussing the specifics of the R&TTE Directive, basic definitions help to provide some context.
Telecommunication Terminal Equipment- a product enabling communication, or a relevant component thereof, which is intended to be connected directly or indirectly by any means whatsoever to interfaces of public telecommunication networks (that is to say, telecommunications networks used wholly or partly for the provision of publicly available telecommunications services). 
Radio equipment- a product or relevant component thereof, capable of communication by means of emission and/or reception of radio waves, utilizing the spectrum allocated to terrestrial/space radiocommunication. Radio waves are electromagnetic waves of frequencies from 9kHz to 3000GHz propagated in space without artificial guide. 
Technical Construction File (TCF)- a file describing the apparatus and which provides information and explanations how the applicable essential requirements have been implemented. 
REQUIREMENTS OF THE R&TTE DIRECTIVE
The R&TTE Directive, like other European Directives, does not contain test limits, those requirements are identified in one of 3 standard types (Generic, Product Family and Product Specific). The current revisions for the applicable standards can be found in the Official Journal of the European Union for the R&TTE Directive.
Article 3.1a and 3.1b of the R&TTE Directive dictates the essential requirements for Health/Safety and EMC respectively. Article 3.2 identifies the Radio Spectrum requirements.
APPROACH TO COMPLIANCE
In order to market and sell product in the European markets, manufacturers need to demonstrate compliance using a Declaration of Conformity. Unlike the United States, there is no certification process through a regulating body. Instead, manufacturers have the sole responsibility of ensuring their products are compliant to the applicable directives and standards.
This responsibility for manufacturers provides more flexibility; however it increases their risk as the system of “checks and balances” is minimized. Meeting the rules is the responsibility of the manufacturer or the company that brings the radio device on the market.
As a result, in the case of a module, there may be multiple companies responsible for ensuring the module compliance. If the module manufacturer declares compliance to the R&TTE Directive, they need to provide evidence that the radio equipment has been assessed by constructing a Declaration of Conformity (DoC) and TCF. However if another company then integrates that radio equipment into a product, the new product must also be compliant to the requirements of the R&TTE Directive.
Unlike the FCC, which has specific guidelines and requirements for Modular Approval, the European Union does not have rules in place specifically for modular approval. As a result, radio modules need to be assessed to the same compliance requirements as radios integrated in a product.
However the assessment does not necessarily equate into more testing. In general, the aim should be to avoid repeat assessment of the module in the final product where this can be justified on the basis of technical analysis and information provided by the module manufacturer . However, in many cases, it will not have been practical to perform a meaningful assessment of the requirements on the module alone, and a complete assessment is required after integration . This should be made clear in the information concerning the installation and intended purpose of the module provided by the module manufacturer, in accordance with Article 6 of 1999/5/EC .
A final product integrating an assessed radio module with an integral antenna, or supplied with a specific antenna and installed in conformance with the radio module manufacturer’s installation instructions, requires no further evaluation under Article 3.2 of the R&TTE Directive and does not require further involvement of an R&TTE Directive Notified Body for the final product. 
The above statement assumes that the integrator is able to leverage all existing data from Article 3.1a, 3.b and 3.2. Module manufacturers may not be able to fully assess the module to all requirements for Article 3.1a and 3.1b; therefore, the module integrators need to review the DoC carefully, and if possible, request supporting documentation from the manufacturer in order make an informed decision. The supporting documentation may include test reports, DoC, and installation guidelines.
At this point, the integrator is responsible for 1) evaluating the data to ensure proper assessment by the module manufacturer 2) evaluating the relevancy of leveraging the existing data into their own product declaration.
A specific example where an integrator may attempt to leverage existing compliance documents would be if a module has been assessed to the R&TTE Directive with an integrated antenna, but the integrator wants to use an external antenna. The module manufacturer’s documentation does not indicate that the module was assessed with an external antenna. At this point, it would not be appropriate for the integrator to leverage the existing assessment for compliance, as there is no test data to support the new antenna. Instead, the integrator would most likely need to perform an assessment that would include testing for Article 3.1a, 3.1b and 3.2 with the new antenna.
ETSI has provided two technical report documents (ETSI TR 102 070-1 and ETSI TR 102 070-2) that help define and guide manufacturers on the EMC requirements based on their type of integration.
All assessments need to be fully supported by the TCF and DoC, “he or his authorized representative established within the Community must keep it for a period ending at least 10 years after the last product has been manufactured at the disposal of the relevant nation al authorities of any Member State for inspection purposes” .
As stated previously, the intent of this article is not to steer integrators or manufacturers in one direction but rather to emphasize the important of understanding the various approaches and responsibilities the manufacturers face when going to market in Europe. Manufacturers have the sole responsibility of identifying and ensuring their products are compliant to the applicable directives and standards. Therefore special attention is required for proper assessment that provides adequate supporting documentation while limiting cost and time to market.
If a manufacturer is unsure of the proper approach it is acceptable for them to work with a Notified Body in order to gain confidence in the approach. However the Notified Body’s Statement of Opinion does not alleviate the responsibility of the manufacturer when placing the end product into the European market.
LSR has an accredited test facility, and has provided guidance in design services and European conformity assessment for over 30 years. LSR is recognized as a Conformity Assessment Body in accordance with the US-EU MRA, and as such can provide Notified Body services to any of our customers for both the EMC (2004/108/EC) and R&TTE (1995/5/EC) Directives
ABOUT THE AUTHOR
Thomas T. Smith is the Manager of EMC Test Services at LSR and has over 12 years of experience in compliance testing related to EMC and Wireless Products. Tom holds a bachelor’s degree in Biomedical Engineering, and is an active member of IEEE. Mr. Smith can be reached at firstname.lastname@example.org or 262-421-4986.
ETSI, "What is the R&TTE Directive," 2011. [Online]. Available: http://www.etsi.org/WebSite/Technologies/RTTEquestionsanswers.aspx. [Accessed 6 June 2012].
European Commission, "Directive 1999/5/EC," 9 March 1999. [Online]. Available: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1999:091:001…. [Accessed 2 May 2012].
R&TTE Compliance Association, "Technical Guidance Note on Requirements for a Final Product that Integrates an R&TTE Directive Assessed Module," 27 December 2011. [Online]. Available: http://www.rtteca.com/TGN01Rev5.pdf. [Accessed 12 May 2012].