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
-
----------------------------------------------------------------
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>