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

 

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 <chu...@meyersound.com> 
Sent: Friday, May 14, 2021 11:42 AM
To: EMC-PSTC@LISTSERV.IEEE.ORG
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 < <mailto:00000061f3f32d0c-dmarc-requ...@listserv.ieee.org> 
00000061f3f32d0c-dmarc-requ...@listserv.ieee.org> 
Sent: Friday, May 14, 2021 10:51 AM
To:  <mailto:EMC-PSTC@LISTSERV.IEEE.ORG> EMC-PSTC@LISTSERV.IEEE.ORG
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

 <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 < <mailto:bceres...@delta-q.com> bceres...@delta-q.com> 
Sent: Friday, May 14, 2021 10:40 AM
To: Pete Perkins < <mailto:peperkin...@cs.com> peperkin...@cs.com>;  
<mailto:EMC-PSTC@LISTSERV.IEEE.ORG> 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 < <mailto:00000061f3f32d0c-dmarc-requ...@listserv.ieee.org> 
00000061f3f32d0c-dmarc-requ...@listserv.ieee.org> 
Sent: Friday, May 14, 2021 10:34 AM
To:  <mailto:EMC-PSTC@LISTSERV.IEEE.ORG> 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 < <mailto:char...@sulisconsultants.com> 
char...@sulisconsultants.com> 
Sent: Friday, May 14, 2021 1:17 AM
To:  <mailto:EMC-PSTC@LISTSERV.IEEE.ORG> 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/> https://sulisconsultants.com/ 

Registered in England and Wales, number 05466247

 

From: Carl Newton < <mailto:emcl...@gmail.com> emcl...@gmail.com> 
Sent: 13 May 2021 20:36
To:  <mailto:EMC-PSTC@LISTSERV.IEEE.ORG> 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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