Dave, As with you, I have helped many companies write their MDoC or MDoInc;
I typically get called in toward the end of a design project and am asked what
needs to be done to get CE marking on the product, and am engaged almost right
away with a project that is on a fast track. The MDoC is always done on the
American company’s letterhead and is signed by the designated person who has
the authority to commit the company (not allowed to ask the janitor to sign).
I carefully explain to the signer that they bear personal liability under EU
law. I also develop a document that lists all of the technical documents
supporting the MDoC (the list of TF documents) which is signed off by the
project manager or higher (which provides confidence to the MDoC signing
manager that the details have been carefully taken care of and are organized
for retrieval down line). The American signer of the MDoC understands that
they are at arms-length to EU law until they appear on EU soil (I always
recommend careful introspection into these issues before planning a Riviera
holiday :>). Hence, the EU desire for an EU Authorized Rep.
The inclusion of the EU AR on the same document is a company
decision, in my opinion, and should not be done lightly. Some companies
consider adding a distributor or some other contact without consideration of
the issues or consequences. When I have the opportunity I do point out these
issues and encourage the development of a contractual relationship with the AR
before their name is added to the MDoC. Because this has not been considered
the additional time/effort involved usually interferes with the product
introduction schedule and the need for the MDoC immediately.
Of course, there is always room for improvement next time.
:>) 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:[email protected]> [email protected]
From: Nyffenegger, Dave <[email protected]>
Sent: Wednesday, December 19, 2018 11:18 AM
To: [email protected]
Subject: Re: [PSES] MD clarification of the DoC
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] <mailto:[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
<mailto:[email protected]> [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] <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]>
