Brian, This is another method that needs to be on the list of accepted paths
to show compliance, in my opinion.
Of course, the acceptance for any such methods need to come from
the Euro Commission, meeting Euro legal requirements and having the buy-in of
all the interested parties – such as the Customs Officers who are charged with
either clearing or refusing entry to CE marked items and are looking for
further justification (MDoC in particular).
I see this as a long slog to get anywhere unless some very
influential group that the EU folks admire takes it on with a passion. Do you
know anyone at the WTO?
I guess, if your company is gutsy enough you can try it and see
how it goes; sometimes changes are made in fact and later the paperwork catches
up.
:>) br, Pete
Peter E Perkins, PE
Principal Product Safety & Regulatory Affairs Consultant
PO Box 1067
Albany, ORe 97321-0413
503/452-1201
IEEE Life Fellow
IEEE PSES 2020 Distinguished Lecturer
<http://www.researchgate.net/Peter%20Perkins> www.researchgate.net search my
name
<mailto:p.perk...@ieee.org> p.perk...@ieee.org
Entropy ain’t what it used to be
From: Brian Ceresney <bceres...@delta-q.com>
Sent: Friday, May 14, 2021 10:40 AM
To: Pete Perkins <peperkin...@cs.com>; EMC-PSTC@LISTSERV.IEEE.ORG
Subject: RE: [PSES] EU DoC on Thumb Drive?
Hello All,
Apologies for “hijacking the thread”, but we’ve been considering the
now-ubiquitous(post pandemic) QR Code as a method of delivering information
about the product – user manual, declarations for the EU, MC documentation,
etc. A small accessible code label could really help make information
accessible to the customer, using the cell phone.
Does this also still fall under the “not-yet” category?
Best Regards,
Brian C.
From: Pete Perkins <00000061f3f32d0c-dmarc-requ...@listserv.ieee.org
<mailto:00000061f3f32d0c-dmarc-requ...@listserv.ieee.org> >
Sent: Friday, May 14, 2021 10:34 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG <mailto:EMC-PSTC@LISTSERV.IEEE.ORG>
Subject: Re: [PSES] EU DoC on Thumb Drive?
CAUTION: This email originated from outside of the organization. Do not click
links or open attachments unless you recognize the sender and know the content
is safe.
Carl et al,
This question has been asked before and the official answer
seems to still be ‘not yet’.
Some folks in the IEEE PSES TAC/ITE interest group have been
working to put together a draft proposal that would allow digital documentation
(thumb drive or even website) to meet the requirements. As noted, there are
many interests in this way outside our usual working circle. Nothing has
developed from this yet; maybe sometime in the future.
Keep your hopes up though; pie in the sky is what keeps us going
some time.
:>) br, Pete
Peter E Perkins, PE
Principal Product Safety & Regulatory Affairs Consultant
PO Box 1067
Albany, ORe 97321-0413
503/452-1201
IEEE Life Fellow
IEEE PSES 2020 Distinguished Lecturer
<http://www.researchgate.net/Peter%20Perkins> www.researchgate.net search my
name
<mailto:p.perk...@ieee.org> p.perk...@ieee.org
Entropy ain’t what it used to be
From: Charlie Blackham <char...@sulisconsultants.com
<mailto:char...@sulisconsultants.com> >
Sent: Friday, May 14, 2021 1:17 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG <mailto:EMC-PSTC@LISTSERV.IEEE.ORG>
Subject: Re: [PSES] EU DoC on Thumb Drive?
Carl
A number of other Directives such as RED and Machinery also require DoC to be
provided with equipment
In the absence of Guidance that says you can provide it electronically it is
best to work on the basis that you must not – Customs / Market enforcement will
expect to be able to find the DoC if they inspect the product, and if it’s not
in print format they won’t be able to as they’re not going to load up a CD or
USB stick, and you will be considered to be shipping “non-compliant” product
Best regards
Charlie
Charlie Blackham
Sulis Consultants Ltd
Tel: +44 (0)7946 624317
Web: https://sulisconsultants.com/
Registered in England and Wales, number 05466247
From: Carl Newton <emcl...@gmail.com <mailto:emcl...@gmail.com> >
Sent: 13 May 2021 20:36
To: EMC-PSTC@LISTSERV.IEEE.ORG <mailto:EMC-PSTC@LISTSERV.IEEE.ORG>
Subject: [PSES] EU DoC on Thumb Drive?
Group,
I've not been able to find anything that suggests that the EU DoC can be
provided with the product electronically for a medical device. I sent an
inquiry to the commission and received no response. The MDD and MDR require
that the DoC is shipped with each product and I have a customer that would
like to include it on a thumb drive document package that will ship with the
device rather than a paper hard-copy.
Do any of you have experience with this question that you can share?
Thanks in advance,
Carl
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