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 Respectfully, Chuck August-McDowell From: Pete Perkins <00000061f3f32d0c-dmarc-requ...@listserv.ieee.org> Sent: Friday, May 14, 2021 10:51 AM To: 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 www.researchgate.net<http://www.researchgate.net/Peter%20Perkins> search my name p.perk...@ieee.org<mailto:p.perk...@ieee.org> Entropy ain’t what it used to be From: Brian Ceresney <bceres...@delta-q.com<mailto:bceres...@delta-q.com>> Sent: Friday, May 14, 2021 10:40 AM To: Pete Perkins <peperkin...@cs.com<mailto:peperkin...@cs.com>>; EMC-PSTC@LISTSERV.IEEE.ORG<mailto: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 www.researchgate.net<http://www.researchgate.net/Peter%20Perkins> search my name p.perk...@ieee.org<mailto: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 - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. 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