Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

Needed advice on the below query.

Once a manual is released in the English language and is translated  into the required languages, does it need to undergo translation for every other change or can such changes   be assessed under a QMS process   and only if the changes are critical from the performance /safety perspective , then they need to be translated ?

Good day Anon,

I am not sure understand the question ... if you make a change to a user manual, would you not need to translate the changes already?  If there is a user manual/instructions for use in English - the expectation is any other languages versions are equivalent.  When a change to text in a user manual/instructions for use is changed, there is not a determination whether the other language versions are impacted, this must be done.  Because even subtle changes to words can have different meanings when translated.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 11-Jan-2022 20:30
From: Anonymous Member
Subject: User manual translation

This message was posted by a user wishing to remain anonymous

Hello,

Needed advice on the below query.

Once a manual is released in the English language and is translated  into the required languages, does it need to undergo translation for every other change or can such changes   be assessed under a QMS process   and only if the changes are critical from the performance /safety perspective , then they need to be translated ?

Hi A, 

It depends. If you are talking about the IFU/User Manual for EU/Ce Mark, and translations for EU countries, the English (original) and translations need to be the same. 

However, if you are thinking non-EU markets, you could potentially have a specific IFU for each country as long as you comply with the targeted country's regulations. But in practice, having multiple IFUs gets very burdensome pretty quicly. 

I would recommend to have translations done for all changes affecting the English/official version. You can prioritize markets where it is most critical to have the updated version, but it should all be consistent in a reasonable timeframe (according to the risk assessment of the change). 

Having multiple IFU versions gets tricky to maintain (assessment of further updates and then update those including all the previous changes that werent done before, submissions, keeping a clean record in the design documentation, etc.), so I strongly recommend you keep an organized IFU/Manual/Label/Translations tracker and translate and update them for all changes.

I hope this helps, 

Daniela


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Daniela Mahan Soler Esq, RAC
Regulatory Affairs Manager
Munich
Germany
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Original Message:
Sent: 11-Jan-2022 20:30
From: Anonymous Member
Subject: User manual translation

This message was posted by a user wishing to remain anonymous

Hello,

Needed advice on the below query.

Once a manual is released in the English language and is translated  into the required languages, does it need to undergo translation for every other change or can such changes   be assessed under a QMS process   and only if the changes are critical from the performance /safety perspective , then they need to be translated ?

Good day,
I agree with the comments of my colleagues below. However, when your target market is located in a bilingual country, the translations could be requested for every change and/or adjustments made to the documents released originally in English .  

Kind regards,


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Eva Blaja
RA Documentation Specialist
Laval QC
Canada
------------------------------

Original Message:
Sent: 11-Jan-2022 20:30
From: Anonymous Member
Subject: User manual translation

This message was posted by a user wishing to remain anonymous

Hello,

Needed advice on the below query.

Once a manual is released in the English language and is translated  into the required languages, does it need to undergo translation for every other change or can such changes   be assessed under a QMS process   and only if the changes are critical from the performance /safety perspective , then they need to be translated ?

This message was posted by a user wishing to remain anonymous

thanks all, for your feedback
Original Message:
Sent: 13-Jan-2022 13:30
From: Eva Blaja
Subject: User manual translation

Good day,
I agree with the comments of my colleagues below. However, when your target market is located in a bilingual country, the translations could be requested for every change and/or adjustments made to the documents released originally in English .

Kind regards,


------------------------------
Eva Blaja
RA Documentation Specialist
Laval QC
Canada

Original Message:
Sent: 11-Jan-2022 20:30
From: Anonymous Member
Subject: User manual translation

This message was posted by a user wishing to remain anonymous

Hello,

Needed advice on the below query.

Once a manual is released in the English language and is translated  into the required languages, does it need to undergo translation for every other change or can such changes   be assessed under a QMS process   and only if the changes are critical from the performance /safety perspective , then they need to be translated ?

Good day,
I agree with the comments of my colleagues below. 
However, according to MDR 2017/745 -EU legislation , it is necessary not to forget the relationship of the IFU (given language mutation) and the identification of the UDI-DI code, including changes in the IFU.


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Evangelos Tavandzis
Lead Auditor, Consultant
Praha
Czech Republic
------------------------------

Original Message:
Sent: 11-Jan-2022 20:30
From: Anonymous Member
Subject: User manual translation

This message was posted by a user wishing to remain anonymous

Hello,

Needed advice on the below query.

Once a manual is released in the English language and is translated  into the required languages, does it need to undergo translation for every other change or can such changes   be assessed under a QMS process   and only if the changes are critical from the performance /safety perspective , then they need to be translated ?