Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi RAPS forum,

I work as an RA in a company that designs and manufactures IVD medical software.
The Service Team asked me if the customer facing training material must be translated into the different languages where we sell (mainly in USA and EMEA, but also LATAM and APAC).

I know that the labeling (labels, IFU, ..) must be translated into different languages, in particular this is required for EU member states. It is not clear to me if the customer training material should also be translated. I have not found any references on the IVDD/IVDR for example.

For your information, the training material is released in English, so for the US market we should meet the requirements I suppose.

Please could you help me clarify this point.

Thanks for your help!

Hello Anonymous Member,

I think the main driver is to make sure the user can use the device safe and effective. So, if english training means that the use does NOT understand how to use the device safe it is better to have it translated.

Hope this helps?

------------------------------
Stefan Duizer
QA/RA Consultant
Herwijnen
Netherlands
------------------------------

Original Message:
Sent: 21-Jun-2021 13:05
From: Anonymous Member
Subject: Translation of customer facing training material_mandatory?

This message was posted by a user wishing to remain anonymous

Hi RAPS forum,

I work as an RA in a company that designs and manufactures IVD medical software.
The Service Team asked me if the customer facing training material must be translated into the different languages where we sell (mainly in USA and EMEA, but also LATAM and APAC).

I know that the labeling (labels, IFU, ..) must be translated into different languages, in particular this is required for EU member states. It is not clear to me if the customer training material should also be translated. I have not found any references on the IVDD/IVDR for example.

For your information, the training material is released in English, so for the US market we should meet the requirements I suppose.

Please could you help me clarify this point.

Thanks for your help!

Hello,

I agree with Stefan, put all the regulations or regulatory requirements aside.  Ask the question about your business and product: if we provide training material only in English will all of our customers be able to use the device safely and according to intended use?  If you many user failures which can be attributed to mis-understanding of training materials, then that could be viewed as an issue.  I have seen regulatory agencies "pull that thread" during audits and end up writing something about design inputs not being appropriate ... they word it in a nice way to avoid saying, "Material should have been translated," which may not be against an audit criteria of a regulation, but design inputs would be.​

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 22-Jun-2021 02:21
From: Stefan Duizer
Subject: Translation of customer facing training material_mandatory?

Hello Anonymous Member,

I think the main driver is to make sure the user can use the device safe and effective. So, if english training means that the use does NOT understand how to use the device safe it is better to have it translated.

Hope this helps?

------------------------------
Stefan Duizer
QA/RA Consultant
Herwijnen
Netherlands

Original Message:
Sent: 21-Jun-2021 13:05
From: Anonymous Member
Subject: Translation of customer facing training material_mandatory?

This message was posted by a user wishing to remain anonymous

Hi RAPS forum,

I work as an RA in a company that designs and manufactures IVD medical software.
The Service Team asked me if the customer facing training material must be translated into the different languages where we sell (mainly in USA and EMEA, but also LATAM and APAC).

I know that the labeling (labels, IFU, ..) must be translated into different languages, in particular this is required for EU member states. It is not clear to me if the customer training material should also be translated. I have not found any references on the IVDD/IVDR for example.

For your information, the training material is released in English, so for the US market we should meet the requirements I suppose.

Please could you help me clarify this point.

Thanks for your help!