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]> 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] > > > > *From:* Nyffenegger, Dave <[email protected]> > *Sent:* Tuesday, December 18, 2018 11:16 AM > *To:* [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] <[email protected]>] > *Sent:* Tuesday, December 18, 2018 1:44 PM > *To:* [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 representativ* > e. > > > > 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]> > > 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]> > Mike Cantwell <[email protected]> > > For policy questions, send mail to: > Jim Bacher <[email protected]> > David Heald <[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) <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]> > Mike Cantwell <[email protected]> > > For policy questions, send mail to: > Jim Bacher <[email protected]> > David Heald <[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) <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]> > Mike Cantwell <[email protected]> > > For policy questions, send mail to: > Jim Bacher <[email protected]> > David Heald <[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]>
