MDR translation requirements

#1
Hello,

I was not able to find an existing thread for this topic, so I thought I would create a new one.

We are currently trying to set up a new translation procedure for our product, since outsourcing costs for translation services are going crazy. We have lots of text involved in our product since it is a software and are translating it to all EU languages, therefore a HUGE amount of translational work - not just the label and leaflet.

In order to bring down costs, we are trying to employ translators internally and set up a procedure to cover translations that way. I would assume that in this procedure you have to cover selection criteria for this translators (e.g. test translations, appropriate CV) as well as criteria for validating of the translations (proof reading?). Would anyone know of any MDD/MDR requirements or required standards for such a procedure or could share with me best practices of keeping translations internally (or at least outsourcing to freelancers instead of a company)?

Thanks a lot!


PS: to add: I am aware of IEC 82079-1 which says:

1601978089096.png

but this is very vague except for the native speaker aspects. No mentioning of persons doing validations etc.
 
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yodon

Staff member
Super Moderator
#2
Can't answer your question but want to mention that native speakers don't necessarily qualify someone to translate. As your post points out, they need to know product-specific terminology and need to be able to communicate that to the intended audience. Native speakers not familiar with the medical device world can incorporate less-than-appropriate idioms in their translations. (And this is why whomever does the translation validation also needs those qualifications.)
 

Mark Meer

Trusted Information Resource
#3
Normally, we have a declaration document by an independent party signed to show that the translated text was independently reviewed. Something like a "Certificate of Translation Accuracy".

The declaration includes the individual's qualifications for review, and reference to the translated documents.
Something like:
"I, ____, am a medical professional familiar with the _____ device and its intended use, and am a native (language) speaker also fluent in English. I have reviewed the original text of document XZY-123, and its (language) translation, and attest that the translated text reflects the content, meaning, and style of the original text and constitutes a correct and true translation of the original document."
 
#4
Thank you both for your answers!

for the validation/review part - which requirements would you see to cover this position? applicable standards (as stated above) only define qualifications needed for the translator. My Q-logic tells me that the validator of the translation needs to be on the same level though?
 
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