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]> Sent: 13 May 2021 20:36 To: [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 - ---------------------------------------------------------------- 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 <[email protected]<mailto:[email protected]>> 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)<http://www.ieee-pses.org/list.html> List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]<mailto:[email protected]>> Mike Cantwell <[email protected]<mailto:[email protected]>> For policy questions, send mail to: Jim Bacher <[email protected]<mailto:[email protected]>> David Heald <[email protected]<mailto:[email protected]>> - ---------------------------------------------------------------- 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 <[email protected]> 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 <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]>
