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  • 1.  EU MDR Translation Requirements

    This message was posted by a user wishing to remain anonymous
    Posted 14-Aug-2023 15:22
    This message was posted by a user wishing to remain anonymous

    Hi everyone,

    I have a question regarding translation requirements per the EU MDR 2017/745. Is there a requirement regarding providing evidence of translation validation of translations regarding labels/IFUs? We utilize an ISO 13485, ISO 9001, ISO 17100 and ISO 18587 compliant supplier to perform our translation services, however we are unsure how to provide "evidence" of translation validation.

    I know an option would be to outsource a third-party to reverse-translate our translated documentation to verify it is correct, however maintaining this for all EU countries would be costly. Does anyone have any guidance on how to fulfill this requirement (if translation validation is, in fact, a requirement)?

    Thank you!



  • 2.  RE: EU MDR Translation Requirements

    Posted 15-Aug-2023 06:53

    Hello,

    If you are using translation agency they should be able to provide you certificate for the translation. This should be sufficient as evidence. 

    It is not required in the UK, however as far as I know from my EU colleagues they require certified translation. 

    Have a good day,

    Olga 



    ------------------------------
    Olga Peycheva
    Regulatory and Study Start Up Specialist
    Solutions OP Ltd
    olga.peycheva@solutionsop.co.uk
    United Kingdom
    ------------------------------

    Original Message


  • 3.  RE: EU MDR Translation Requirements

    Posted 16-Aug-2023 09:57

    We have our supplier of the translations due a reverse translation.  The cost for that is minimal compared to having someone else do it.  By having this done, we can provide evidence to our long-time distributers/importers that while they may have personally translated it differently, it is adequate.  We also require their certification with each translation.

     

    Regards,

     

     

    D. Michelle Williams, CESCO

    VP – Operations

     

    Action Products, Inc.

    www.actionproducts.com

    301.797.1414 X1022

     

    https://www.linkedin.com/in/dmwilliamsvpopapiwvu88

     

     

    Action-MMD-Ribbon_Logo_5in_cmyk

     




    Original Message


  • 4.  RE: EU MDR Translation Requirements

    Posted 15-Aug-2023 06:55

    Hello Anon,

    There is no specific requirements for validation of translation activities and this could be done a number of different ways.  I would say the more important aspect is ensuring there is a defined process within the quality system for how translation occurs.  This is an area where verification and validation of translation can be quite a grey area.  As an example, a validation of translation may be doing a back-translation for every item or doing a back-translation for a sample of labelling ensuring the process is working correctly.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 5.  RE: EU MDR Translation Requirements

    Posted 15-Aug-2023 09:59

    Hi Anon

    It is my understanding that revision (verification) of the translation is required per ISO 17100.  So we ask our certified translator to provide a signed certification for each translation to certify that it was carried out in accordance with the standard.  So far we haven't had any issues with this approach (knock on wood).

      



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    Lauren Kamer RAC
    Sr. Director of Regulatory Affairs
    United States
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    Original Message


  • 6.  RE: EU MDR Translation Requirements

    Posted 16-Aug-2023 03:12
      |   view attached

    Hi Anon, 

    As other contributors have mentioned, it's a grey area - a written internal procedure on the subject and a sort of demonstration of good practice have worked for us with both UK and EU Notified Bodies. A Translation Certificate from Contractors would be adequate for external translations. Also, we have used Internal Competent Speakers (sample form attached - can be modified to suit), which was accepted by the auditors in the past.

    I hope it helps.



    ------------------------------
    Abi Bamigbade
    Head of Quality and Regulatory Affairs
    Kays Medical Ltd, UK.
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    Original Message


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