The symbol ISO 7000-3500 "Electronic instructions for use" is for
medical equipment. The related EU regulation is:
https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:072:0028:0031:EN:PDF
<https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:072:0028:0031:EN:PDF>
This regulation specifies, among other requirements, “exclusive use by
professional users” and requires a risk assessment.
If your equipment is not medical equipment, you cannot (or should not)
use the symbol.
I know of no regulation that prohibits electronic instructions, but
standards and regulations specify statements which are traditionally
printed on paper and which must accompany the equipment.
Stay safe, and best regards,
Rich
*From:*Chuck August-McDowell <[email protected]>
*Sent:* Friday, May 14, 2021 11:42 AM
*To:* [email protected]
*Subject:* Re: [PSES] EU DoC on Thumb Drive?
Seconding Brian’s motion to allow the QR Code as an approved method to
provide DoC information.
We recently Include Symbol ISO 7000-3500 "Electronic instructions for
use" and the QR Code in the Symbol table in the basic safety
information provided on paper with each product.
Currently provide paper DoC also.
Symbol ISO 7000-3500 Function/description :
To indicate on product or product packaging that relevant information
for use of the product is available in electronic form rather than, or
in addition to, printed paper form.
Link https://www.iso.org/obp/ui#iso:grs:7000:3500
<https://www.iso.org/obp/ui#iso:grs:7000:3500>
Respectfully,
Chuck August-McDowell
*From:*Pete Perkins <[email protected]
<mailto:[email protected]>>
*Sent:* Friday, May 14, 2021 10:51 AM
*To:* [email protected] <mailto:[email protected]>
*Subject:* Re: [PSES] EU DoC on Thumb Drive?
[EXTERNAL EMAIL]
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
www.researchgate.net
<http://www.researchgate.net/Peter%20Perkins>search my name
[email protected] <mailto:[email protected]>
Entropy ain’t what it used to be
*From:*Brian Ceresney <[email protected]
<mailto:[email protected]>>
*Sent:* Friday, May 14, 2021 10:40 AM
*To:* Pete Perkins <[email protected] <mailto:[email protected]>>;
[email protected] <mailto:[email protected]>
*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 <[email protected]
<mailto:[email protected]>>
*Sent:* Friday, May 14, 2021 10:34 AM
*To:* [email protected] <mailto:[email protected]>
*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
www.researchgate.net
<http://www.researchgate.net/Peter%20Perkins>search my name
[email protected] <mailto:[email protected]>
Entropy ain’t what it used to be
*From:*Charlie Blackham <[email protected]
<mailto:[email protected]>>
*Sent:* Friday, May 14, 2021 1:17 AM
*To:* [email protected] <mailto:[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/* <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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