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.
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