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:[email protected]> [email protected]
Entropy ain’t what it used to be
From: Charlie Blackham <[email protected]>
Sent: Friday, May 14, 2021 1:17 AM
To: [email protected]
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 <[email protected] <mailto:[email protected]> >
Sent: 13 May 2021 20:36
To: [email protected] <mailto:[email protected]>
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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