Software Translation under MDR requirements

JoCam

Trusted Information Resource
#1
Hi All,

We are about to submit a new medical device for CE mark under the MDR and I have a question that relates to the new requirements for translation.

The device is a control unit that informs the healthcare provider via a display and a software application of both it's status and that of the user, e.g. calibrating, hi, low, patient movement. This allows the healthcare provider when remote from the patient to step treatment up. Obviously, due to the remoteness, it does not enable the healthcare provider to step treatment down, this can only be done whilst with the patient for their needs to be assessed.

I understand that we will need to translate the labeling and IFU's, and possibly the software application, into the languages of the member states we wish to market the device, but will we also need to translate the information that is displayed on the control unit?

Thank you,

Jo
 
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shimonv

Trusted Information Resource
#2
Hi Jo,
I am not aware of MDR translation policy, so it makes sense to follow the current MDD practices.
One positive point is that your product is intended to be used by healthcare provider; not home use.
If the information that is displayed on the control unit includes Warnings you might want to implement translations up front.
Otherwise, I believe you should be able to gradually complete the translations of the UI information as you introduce the product to the different member states. You only need to show that you have a translation process in place.

Shimon
 

kreid

Involved In Discussions
#3
I used to think that it could be managed using a risk analysis, so if your users were all degree educated surgeons, it is likely that they can all speak English and so a GUI in English would not present a risk in terms of mistakes being made by the user working in an unfamiliar language. But after a recent contract in Sweden I was told that it is EU law to translate the GUI and other labelling into the member state language.
I cannot find anything that exactly says this in the EU MDR 2017/745.
 

JoCam

Trusted Information Resource
#5
Thank you for your responses.

It is definitely a new requirement under the MDR to translate information provided by manufacturers into the language of the member states to which the device is being introduced, and I am all set to do this for the product labels and IFU's. What I am not sure about is whether the information displayed on the control unit itself (software/firmware controlled) will need to cover all languages. For instance, in the same manner as you can change the language on a mobile phone.

This exercise will obviously involve a last minute change to the device and possibly further verification/validation, not to mention additional cost.
 

yodon

Staff member
Super Moderator
#6
We've been involved (in the past - so MDD) in doing translations for the information displayed by the software. We typically farm out the translation activity to a qualified translator (be careful about informal translations as they may introduce idioms inappropriate for a medical device). The translation services typically have someone on staff that can validate the translation. Implementing on the software is pretty simple, using indexed tables. Validation should absolutely be done to ensure that all the translations are readily readable on the display (we've had in the past strings that, when translated, went well beyond our display space).
 
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