Sam, The assumption in the approval of a product for sale in the EU is that, if a manufacturer affixes a CE mark to a product and issues the DoC then, he is effectively saying to the authorities that he takes responsibility for the compliance of the product, including the conformity assessment procedures used. It is acceptable for a manufacturer to issue a DoC with another company's name on it - when that company is selling the product, for example where the product is badged with the seller's name, as long as the actual manufacturer's name appears on the DoC.
If a new manufacturer wants to take over complete responsibility for the certification of a product, then it is presumed that he has control over manufacturing and the actual manufacturer, if not a part of the company (such as being an approved subcontractor), may not change the design of the product without the approval of the new manufacturer. In other words the new manufacturer becomes the design authority and controls the design of the product. This is easy for self certification because the compliance documentation is simply passed across to the new manufacturer. The new manufacturer then issues a new DoC. However, if a third party has been used in the assessment procedure then this produces complications for the new manufacturer. This is particularly the case where the QA system used by the original manufacturer has been assessed by a notified body. The product approval and the approval of the QA system is completely dependent on the assessment by the notified body. This is not transferable. So if a notified body has been involved in any assessment via an assessment of the QA system, e.g. Annex V procedures of the R&TTED, then the new manufacturer will have to go through the same process again. If the new manufacturer leaves compliance responsibility with the original manufacturer and is simply treated as an approved subcontractor then the notified body may be willing to accept the original certification and the original manufacturer issues the DoC with the new manufacturer named as a supplier of the product. Confused? It is all really quite logical and the only thing the EU really want to know is where to place the blame when something goes wrong. Regards Martin Green Technology International (Europe) Ltd. Tel.: (44) 1793 783137 Fax: (44) 1793 782310 -----Original Message----- From: Wismer, Sam [SMTP:[email protected]] Sent: 12 September 2000 14:40 To: EMC Forum (E-mail); martin Subject: RTTE Radio Verification Group, Interesting discussion on FCC Verification of OEM ITE equipment. I have another twist that includes radio and the EU. Company A has a 2.4GHz radio device that they have self declared to the RTTE Directive in accordance with Annex V of the directive. Company B, with no internationally recognized quality system in place and has not been assessed by a Notified Body, wishes to OEM the radio device and to assume the existing approvals. In effect appear to the world as the manufacturer. In the USA that can be done via a Grantee change with the FCC. With that, company B assumes the FCC approval that company A has obtained and now enjoys it's own FCC identity. This allows company B to file permissive change applications with no involvement by Company A. This also used to be the case in the EU before the RTTE Directive. However, is it still possible between company A, that used Annex V to declare compliance, and company B who wishes to assume that approval even if company B does not have the quality system in place that is required by Annex V, which the approval is declared to? ~~~~~~~~~~~~~~~~~~~~~ Sam Wismer RF Approvals Engineer LXE, Inc. (770) 447-4224 Ext. 3654 Visit Our Website at: http://www.lxe.com ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: [email protected] Michael Garretson: [email protected] For policy questions, send mail to: Richard Nute: [email protected] ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: [email protected] Michael Garretson: [email protected] For policy questions, send mail to: Richard Nute: [email protected]
