Hello
There are two things to consider. (1) Will the software be used safely if the text on the interface is not easily understood by the user? (2) Will it be allowed by local laws?
Under both MDD and IVDR, each country may make its own requirements for local language labeling, including software user interfaces, labels, and instructions for use. A few countries have recently revised their language rules. The labeling working group at MedTech Europe has compiled a handy list that is nearly up to date and includes pointers to many of the relevant member states' legislation and/or websites, and is in most cases relevant to IVDR as well as MDR: "Language implications of MDR for labelling of Medical Devices"
https://www.swiss-medtech.ch/sites/default/files/2020-11/Language%20implications%20of%20MDR%20for%20labelling.pdf------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States
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Original Message:
Sent: 21-Mar-2021 06:12
From: Anonymous Member
Subject: Language requirements for the software User Interface - IVDR
This message was posted by a user wishing to remain anonymous
Hi all,
are there language requirements for the software User Interface in the IVDR? I am working on software that will soon be CE marked according to IVDR, I am already aware of the language requirements for labeling (= the user manual must be in the language accepted in the Member State where the device is planned to be sold).
I was wondering if there are any requirements for the user interface, or if English can be accepted by the different member states.
Thanks for your help!