Ha, ha, I have written many DoCs and DoIs with the two names for my current company. Fortunately we already had resident employees in the EU that could be used to meet the technical file requirement. But before I started writing the DoCs it was clear whomever created the prior DoCs had not a clue understanding the requirements and no EU resident/address was included.
It’s understandable that the signer of the DoC may not be in the EU as they are typically within the manufacturer’s organization responsible for the product compliance and/or manufacturing or company signatory if they are not an authorized rep. -Dave From: Regan Arndt [mailto:[email protected]] Sent: Wednesday, December 19, 2018 1:46 PM To: [email protected] Subject: Re: [PSES] MD clarification of the DoC Thanks Pete for that history lesson..... My confusion lies on the fact that 2 different people and addresses can be on the MDoC. One for the DoC as a whole and one for the compiler. If I understand you correctly, it seems that it will be easier for the EU courts to fine/imprison someone in the EU (person that 'compiles' the technical file) versus one outside the EU (i.e. one who can sign the MDoC (& ultimately is the responsible person). That's how I read it....don't know why the directive didn't just say the signer (responsible person) of the MDoC must be on EU soil. .......oh, btw, I have yet to see an example of a MDoC with 2 names and 2 addresses though.......despite seeing other multiple errors on these.... On Tue, Dec 18, 2018 at 11:34 PM Pete Perkins <[email protected]<mailto:[email protected]>> wrote: Regan, A little ancient history: When the CE marking system was set up it was apparent by the early reactions that the developers of the system never envisioned that anyone but a European would sign the MDoC and be legally responsible for the equipment safety. (I’ve always said they are looking for someone to arrest since there is legal criminal liability for signing the MDoC falsely.) Failing to set up the process the way they envisioned it, 2nd best is to have a European person available who can bear the responsibility; don’t be fooled that the Euro contact only has to provide the TF upon request. That being said, any European asked would not accept the responsibility lightly and want legal, contractual assurances that the non-European company would provide needed legal and financial support to defend them and the company. Getting this done has been left to the Directives and there is no uniform way applying it broadly to all Directives, MDoCs and products yet. (I’m surprised that the EU bureaucrats haven’t worked this out yet; they did it for the CE marking.) Moreover, non-Euro companies have been dragging their feet on meeting this requirement even when it is in a Directive, such as the MD you mentioned. This avoids the initial cost of setting up a contracted representative, any ongoing cost to maintain the representative and, minimizes the chances of being drawn into any expensive legal battle over challenges – either procedural or equipment incident related. It is so easy to sell over the internet and ship the CE marked unit to the Euro customer and have the payment flow to the manufacturer. Remember your mother’s mantra: be careful what you ask for; you might just get it. :>) br, Pete Peter E Perkins, PE Principal Product Safety & Regulatory Affairs Consultant PO Box 23427 Tigard, ORe 97281-3427 503/452-1201 IEEE Life Fellow [email protected]<mailto:[email protected]> From: Nyffenegger, Dave <[email protected]<mailto:[email protected]>> Sent: Tuesday, December 18, 2018 11:16 AM To: [email protected]<mailto:[email protected]> Subject: Re: [PSES] MD clarification of the DoC Regan, “So, a European must compile it but he can store it somewhere in i.e. Timbuktu......... strange.” I don’t take ‘compile” too literally, they are looking for a contact in the EU, one that can be easily contacted who can provide a copy of the technical file on request. How the person gets it or where they get it from is not of concern. This individual is distinctly different than one who signs the DoC and different than authorized representative, although it could be the same person as you have pointed out. The Blue Guide probably has some words on this, it’s been a while since I’ve looked at it. Technical file requirements vary across directives. -Dave From: Regan Arndt [mailto:[email protected]] Sent: Tuesday, December 18, 2018 1:44 PM To: [email protected]<mailto:[email protected]> Subject: [PSES] MD clarification of the DoC Hello folks. Hope you are all enjoying the festive season thus far! I was wondering if any of you knew the rationale behind requirement #2 in the Machinery Directive and why the other directives do not have this? (as you can see, this is over & above the authorized rep (#10) signing the DoC). Excerpt below: A. EC DECLARATION OF CONFORMITY OF THE MACHINERY 2. name and address of the person authorised to compile the technical file, who must be established in the Community; 10. the identity and signature of the person empowered to draw up the declaration on behalf of the manufacturer or his authorised representative. It's odd because in Annex VII, in section 2, it states: 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. So, a European must compile it but he can store it somewhere in i.e. Timbuktu......... strange. - ---------------------------------------------------------------- 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]<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]>
