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

 <mailto:p.perk...@ieee.org> p.perk...@ieee.org

 

From: Nyffenegger, Dave <dave.nyffeneg...@bhemail.com> 
Sent: Tuesday, December 18, 2018 11:16 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
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:reganar...@gmail.com] 
Sent: Tuesday, December 18, 2018 1:44 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG <mailto:EMC-PSTC@LISTSERV.IEEE.ORG> 
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 
<emc-p...@ieee.org <mailto:emc-p...@ieee.org> >

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 <sdoug...@ieee.org <mailto:sdoug...@ieee.org> >
Mike Cantwell <mcantw...@ieee.org <mailto:mcantw...@ieee.org> > 

For policy questions, send mail to:
Jim Bacher <j.bac...@ieee.org <mailto:j.bac...@ieee.org> >
David Heald <dhe...@gmail.com <mailto:dhe...@gmail.com> > 

-
----------------------------------------------------------------

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 
<emc-p...@ieee.org <mailto:emc-p...@ieee.org> >

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 <sdoug...@ieee.org <mailto:sdoug...@ieee.org> >
Mike Cantwell <mcantw...@ieee.org <mailto:mcantw...@ieee.org> > 

For policy questions, send mail to:
Jim Bacher <j.bac...@ieee.org <mailto:j.bac...@ieee.org> >
David Heald <dhe...@gmail.com <mailto:dhe...@gmail.com> > 


-
----------------------------------------------------------------
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 
<emc-p...@ieee.org>

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 <sdoug...@ieee.org>
Mike Cantwell <mcantw...@ieee.org>

For policy questions, send mail to:
Jim Bacher:  <j.bac...@ieee.org>
David Heald: <dhe...@gmail.com>

Reply via email to