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A Declaration of Conformity is a common requirement in European Directives. However, the details vary from directive to directive. The information here relates specifically to the R&TTE Directive.
Who is responsible?The declaration must be drawn up by either:
The meaning of "manufacturer" and "authorised representative" is not specifically defined in the R&TTED but the generally understood meanings apply. In addition, anybody who brands products for supply under their own name (whether or not they actually made them) or who modifies products with or without re-branding may become the "manufacturer" for the purposes of the directive. Where products are not manufactured or placed on the market, then the person who puts the product into service will usually be considered the manufacturer. Exceptionally, where none of these parties has taken responsibility, the importer or supplier may be considered the manufacturer for the purposes of enforcing the directive. An authorised representative in the Community must be designated by the manufacturer and must therefore be able to demonstrate some legal / commercial arrangement with the manufacturer. The authorised representative may be an individual or a company. A manufacturer outside the Community is not obliged to appoint an authorised representative. A distributor or other commercial representative does not automatically become the authorised representative. In all cases, the person signing the declaration must be in a position to know on behalf of the manufacturer that the product complies with the requirements of the directive based on the design, manufacture, testing and production control of the products concerned. The responsibility is that of the manufacturer (or authorised representative) not of the person signing. The signatory must therefore be in a position to bind the manufacturer or the authorised representative in legal obligations. TOPWho cannot be responsible?Where a manufacturer or authorised representative engages the technical services of a third party to verify compliance with the directive, that third party cannot sign the declaration unless the third party is established in the European Community and accepts under formal agreement the role of authorised representative for the manufacturer. In particular, notified bodies appointed under the directive cannot issue a declaration on behalf of the manufacturer: the role of the notified body is limited to giving a formal opinion which the manufacturer or authorised representative may take into account when issuing the declaration. TOPWhat is the minimum content?There is no minimum content, or indeed, any particular content for a declaration set out in the R&TTED! However, it is clear that in order to fulfil its purpose it must include at least:
What about additional recommended content?The authorities in the various Member States will usually expect to see more than the minimum content above. Typically, in addition to the above, this is likely to include:
TOPIs there any official guidance or applicable standard concerning content?The European Commission's "Guide to the implementation of directives based on the New Approach and the Global Approach" contains information about DoC,
particularly in section 5.4. EN ISO/IEC 17050-1:2004 " Conformity assessment. Supplier's declaration of conformity. Part 1: General requirements" replaces an earlier
standard (EN 45014) which is still widely quoted in the literature. The new standard can be purchased as a PDF at: TOPWhat language should the declaration be in?If a notified body is involved, the declaration must be in a language acceptable to the notified body because it forms part of the documentation which must be submitted to and assessed by the notified body. Otherwise it should be in an official language of the Member State where the manufacturer, his authorised representative or the person placing the product on the EU market is located – but see also "Where should the declaration be kept?" below. TOPWhere should the declaration be kept?The original declaration must be kept with the technical documentation that is compiled under the relevant conformity assessment procedure. All the conformity assessment procedures require this irrespective of whether or not a notified body is involved. The declaration must also be supplied to the user as part of the information accompanying the product. There is some doubt about whether this means a paper copy of the original declaration or a translation into the language(s) of the user documentation. A compromise agreed in TCAM allows a copy of the original declaration to be made available, without translation, together with an informal statement in the languages of the Community. A suggested text for the informal statement is: Hereby, [name of manufacturer], declares that this [type of equipment] is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. Versions of this statement in all the EU languages are available from the European Commission R&TTE website at: The full original (untranslated) declaration may be supplied in hard copy as part of the user information or, for example, by reference to a web address from the user information. Where a URL is given, it is preferable to give the specific page address where the declaration can be found. TOP© 2008 Cartman dot ORG Limited |
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