The short answer is yes. Software interfaces, user interfaces, screens, etc., are often considered part of labelling and definitely considered part of information supplied to the user. Therefore, this should be in the local Member State language, especially if the user interface is used by a lay-person. For answers to question 1 - that might be possible without knowing what the device is, however I would recommend against doing that course of action. For question, you have to request exemption from each Competent Authority, there is not a "blanket" exemption type of approach. And if you even get a response from a Competent Authority, most of the time it is local language.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 13-Jun-2019 14:02
From: Anonymous Member
Subject: software user interface language requirement
This message was posted by a user wishing to remain anonymous
In the IVDR, the regulation doesn't specifically call out software user interface, but rather provide a general statement of "…… in the languages accepted in the Member States where the device is envisaged to be sold."
My question is: Does the text on the software user interface need to be translated into official Union language?
If the translation of the user interface cannot be completed on time before commercialization, 1) can we provide translation in the IFU w/ screenshots and keep the English text on the display? 2) what are the possible pathways to obtain language exemption for the software user interface from each member state?
Thank you for your help in advance!!