Hi Joe,
As I understand it, there is a difference between an authorised representative and an importer. An authorised representative has to be in the EU, and would normally work on behalf of the manufacturer, and in this case may also sign the D of C. Effectively the AR is the manufacturer, but you don't have to have an authorised representative in the EU. Paragraph 3.3 of the New Approach guide (http://europa.eu.int/comm/enterprise/n wapproach/legislation/guide/document/chap03.pdf) talks about the responsibilities of the importer or person responsible for placing the product on the market. The way it is worded, the importer in the EU must be able to provide the documents to the surveillance authority on demand. One point though, if you go this route the importer has to be listed as a point of contact in the User documentation. This approach is fine if you only have one dealer or importer in the EU. If you have more than one, then there you have to change the contact information for each importer. I personally think the authorised representative route, is better because you now have a single point of contact and one technical file , regardless of how many distributors you have. I don't think the EU surveillance organisations like DTI care whether you have the documents in hard copy or soft copy, but I think the point is that they have to be available on demand, so effectively the technical file is in the EU. I would just put them on a CD and send it to the importer/distributor, or put them on a secure website, and they can print them off when needed. Regards Doug Joe Finlayson <jfinlayson@tel To: "'[email protected]'" <[email protected]>, ica.com> [email protected] cc: [email protected] 04/29/03 12:57 Subject: RE: D of C again PM Doug, I agree with the D of C, but where does it state that the technical file must also be held by the representative in the EU? Maybe I missed that one. I am speaking with regards to the EMCD and LVD. It's not a big deal if it is required, although it would be easier to keep the files in a central location and minimize copying. Thx, Joe ************************************* Joe Finlayson Manager, Compliance Engineering Telica, Inc. 734 Forest Street, Bldg. G, Suite 100 Marlboro, MA 01752 Tel: (508) 804-8212 Fax: (508) 480-0922 Email: [email protected] From: [email protected] [mailto:[email protected]] Sent: Tuesday, April 29, 2003 11:19 AM To: [email protected] Cc: [email protected] Subject: Re: D of C again And the answer is........................ The D of C must be signed by the responsible person designated by the manufacturer. The signatory does not have to be located in the EU. The manufacturer must designate a representative in the EU who will hold the certificate and the technical file. This could be an agent, distributor. A copy of the D of C that states the directives complied with must be placed in the user manual. Note, this does not have to be signed, but it must state where the signed original can be obtained. i.e. the EU representative's contact details. Doug Beckwith (OOPO) [email protected] Sent by: To: [email protected] owner-emc-pstc@majordom cc: o.ieee.org Subject: D of C again 04/29/03 09:13 AM Please respond to Lfresearch Hi folks, I've been asked by a US manufacturer who's signature if any should appear on the D of C, and should they be located on European soil. Is there a clear consensus? Thanks, Derek N. Walton Owner L F Research EMC Design and Test Facility Poplar Grove, Illinois, USA www.lfresearch.com This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
