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Notified bodies provide compliance services related to the operation of the directive. For R&TTE, three different roles are set out in Annexes 3, 4 & 5 of the directive, respectively:
The manufacturer generally has a choice over when to engage the services of a notified body and the scope of any notified body involvement. The notified bodies are appointed by the administrations of the member states.
When must I employ a notified body?You are obliged to involve a notified body in the case of radio equipment which transmits and for which all aspects of its compliance with the essential requirements of the directive are not covered by harmonised standards. TOPWhen can I proceed without a notified body?In the case of telecommunications terminal equipment that is not radio equipment or radio receiving equipment, it is always possible to proceed without involving a notified body. In the case of radio equipment which transmits, you can proceed without a notified body only if all aspects of compliance with the essential requirements of the directive are covered by harmonised standards. In practice, this covers most types of common equipment but may be difficult in the case of innovative products. TOPCan I choose to involve a notified body anyway?There is always the option to involve a notified body on a voluntary basis. TOPWhat are the advantages of using a notified body?Even when a notified body is involved, ultimate responsibility for compliance rests with the manufacturer (or his authorised representative). This is the case whether the notified body involvement is mandatory or at the choice of the manufacturer. The administrations of the member states are required to ensure that the notified bodies have the necessary technical competence and adequate insurance. This is the main advantage of using a notified body. However, a positive notified body opinion does not have equivalent status to a presumption of compliance arising from full conformity with a harmonised standard. TOPWhat information does a notified body require in a TCF?The information required falls into two broad categories: information which clearly identifies the product or products concerned and information which demonstrates technical compliance. The identification should show clearly what the product is called, its intended use, how it looks and the key physical attributes that fix performance in relation to the technical requirements. So, for example, it may include, user information, design and assembly drawings, photographs of internal and external features, parts lists, circuit diagrams and schematics together with any explanation or description necessary to understand them. The technical information will usually include an explanation of the compliance strategy, that is to say, whether harmonised standards have been applied, the test results obtained and, where any other approach has been taken, why and how it relates to compliance with the essential requirements. An example of the latter might be a theoretical calculation of RF exposure to demonstrate compliance with Article 3.1(a) of the directive. A copy of the Declaration of Conformity must also be included. Finally, it must be clear whether the notified body is expected to give an opinion relating to the whole of the directive or only in relation to particular essential requirements. You may submit your information to more than one notified body but if you do so then you must inform all the notified bodies concerned of the others' involvement. TOPWhat can I expect from a notified body?Within four weeks of a submission, a notified body should indicate whether or not, on the basis of the information supplied, the requirements of the
directive have been met. There is no prescribed format for an opinion but the R&TTE Compliance Association has issued guidance on the matter: TOPAre there things a notified body must not do?A notified body cannot act as agent of the manufacturer and so cannot issue or sign the declaration of conformity on the manufacturer's behalf. The notified body should not issue certificates or other documents that confuse their regulatory role which is restricted to the issuing of an opinion. The notified body must be independent and so must not be directly involved in testing, design or development of the products concerned. If the notified body is part of a larger organisation where such activities do take place, then care needs to be exercised to ensure the independence of the notified body. TOPIs there a notified body near me?Details of notified bodies in each country can be found in the NANDO database by following the appropriate country link and selecting "99/5/EC Radio
and telecommunications terminal equipment" in the drop-down menu on the respective country page. TOP© 2008 Cartman dot ORG Limited |
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