Accents for Letters - National Languages in Medical Device Software

A

AliceW

#1
We are developing a touch screen monitor (medical device) for the user to enter variable data during use. We will enable the user to choose the touch screen version from a list of languages - do we need to provide a soft keyboard with all the accent variations in each language or can we just have the one letter available without accent? i.e. just a letter e and not e grave and acute?

Thanks Alice
 
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G

Gert Sorensen

#3
I don't think that you should consider your interface to be much different to your labelling. In the EU you need to supply IFU and labelling in the local language, in order to ensure that the users are able to fully understand the contents of these. Much the same goes for the interface (and your keyboard), you may not think that various local letters or accents matter, but they may be necessary in the local language that you want to supply.

I presume that your "soft keyboard" is a "virtual keyboard" on the touch screen? If so, it should not be much of a hassle to implement the necessary varieties that you need.

:bigwave:
 

Ronen E

Problem Solver
Staff member
Moderator
#4
In the EU you need to supply IFU and labelling in the local language, in order to ensure that the users are able to fully understand the contents of these.
I'm not sure this is actually a generic EU requirement. AFAIK, the MDD allows Member States to require that the textual information which must be made available to the user, be in their national language(s) or in another EC language, when a device reaches the final user. Is it actually required in each and every state that the information be provided in the local language for all types of devices, or that some of them allow, for instance, English only?

Ronen.
 
G

Gert Sorensen

#5
AFAIK, the MDD allows Member States to require that the textual information which must be made available to the user, be in their national language(s) or in another EC language, when a device reaches the final user. Is it actually required in each and every state that the information be provided in the local language for all types of devices, or that some of them allow, for instance, English only?

Ronen.
Last I looked into this, 23 of the 27 memberstates required IFU's in their local language. So, I believe that it is more or less the rule.

:bigwave:
 
A

AliceW

#6
Thanks for all your input. The instructions (IFU) will be in the full languages to meet national laws - the issue here is the soft keyboard for the user to enter variable patient information during monitoring e.g. medication administered or patient condition. QWERTY keyboards are not universal. As this is not 'instructions for use' but more of a usability issue maybe it falls outside the regualtions and we could provide a QWERTY soft keyboard only?
 
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