Thanks to all for your responses. They are very helpful.
Best regards,
Carl
On 5/14/2021 4:54 PM, Richard Nute wrote:
The symbol ISO 7000-3500 "Electronic instructions for use" is for
medical equipment. The related EU regulation is:
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
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
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
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
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
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
7 matches
Mail list logo
