DIRECTIVE 2006/42/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 May 2006 on machinery ANNEX VII A 2 "The technical file does not have to be located in the territory of the Community, nor does it have to be permanently available in material form. However, it must be capable of being assembled and made available within a period of time commensurate with its complexity by the person designated in the EC declaration of conformity."
The LVD and EMC directive do not have formal requirements for a technical file from what I have seen. -Dave From: John Woodgate [mailto:[email protected]] Sent: Thursday, February 02, 2017 2:16 PM To: [email protected] Subject: Re: [PSES] Authorised Representative in EU Is the Blue Guide entirely consistent with the current LVD and EMCD, which have a lot of detail about the responsibilities of bodies in the supply chain? I think the point about the TF not needing to exist until it's asked for is not explicitly stated, but is a logical consequence of what is stated. With best wishes DESIGN IT IN! OOO - Own Opinions Only www.jmwa.demon.co.uk<http://www.jmwa.demon.co.uk/> J M Woodgate and Associates Rayleigh England Sylvae in aeternum manent. From: Nyffenegger, Dave [mailto:[email protected]] Sent: Thursday, February 2, 2017 6:35 PM To: [email protected] Subject: Re: [PSES] Authorised Representative in EU Yes it is a bit confusing as the term "authorized" is used for both the Manufacturer's representative with responsibility for the DoC and placing the product into the market as well as for the technical file. Review the Blue Guide. Yes, the manufacturer does not have to have an authorized representative within the EU. However the entity identified on the DoC as responsible for compiling the technical file must be located in the EU. The two could be but are not required to be the same. This is so that the EU authorities have someone with roots in the EU they can contact for the technical file. Note that the entity listed on the DoC as responsible for the technical file does not necessarily need to be the expert on its content and that the file does not necessarily have to exist as such until the time that it's requested by EU authorities. This is also explained in the Blue Guide I believe if not the directive itself. -Dave From: Kunde, Brian [mailto:[email protected]] Sent: Thursday, February 02, 2017 11:10 AM To: [email protected]<mailto:[email protected]> Subject: [PSES] Authorised Representative in EU A quick question. A manufacturer established outside the EU placing product on the market in the EU can but does not have to have an authorized representative within the EU.? Is this a correct statement? AND; The Machinery Directive requires the name and address of the person authorized to compile the technical file be established in the EU and listed on the EU DoC. But this person is not referred to as the "authorized representative", even though it may be the same person. This "person" appears to have no responsibilities other than compiling and making available the technical file to Authorities within the Member States. Is this also True? Confirm that the EMC and LVD directives do not require the person responsible for compiling the technical file to be within the EU.? So if true, the EU DoC from a manufacturer outside the EU declaring only to the EMC and LVD does not have to list any "person" from within the EU.? Is this true? It appears that sometimes these two responsibilities get confused. Or, maybe it has been confusing only to me. Thanks The Other Brian ________________________________ LECO Corporation Notice: This communication may contain confidential information intended for the named recipient(s) only. If you received this by mistake, please destroy it and notify us of the error. Thank you. - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]<mailto:[email protected]>> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe)<http://www.ieee-pses.org/list.html> List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]<mailto:[email protected]>> Mike Cantwell <[email protected]<mailto:[email protected]>> For policy questions, send mail to: Jim Bacher <[email protected]<mailto:[email protected]>> David Heald <[email protected]<mailto:[email protected]>> - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]<mailto:[email protected]>> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe)<http://www.ieee-pses.org/list.html> List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]<mailto:[email protected]>> Mike Cantwell <[email protected]<mailto:[email protected]>> For policy questions, send mail to: Jim Bacher <[email protected]<mailto:[email protected]>> David Heald <[email protected]<mailto:[email protected]>> - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]<mailto:[email protected]>> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe)<http://www.ieee-pses.org/list.html> List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]<mailto:[email protected]>> Mike Cantwell <[email protected]<mailto:[email protected]>> For policy questions, send mail to: Jim Bacher <[email protected]<mailto:[email protected]>> David Heald <[email protected]<mailto:[email protected]>> - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]>
