Regulatory Open Forum

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  • 1.  User Manual Translation Costs

    Posted 23-Jan-2023 12:15

    Anonymous

     

    We are a U.S.-based, medium-size medical device company with a line of IVD products.  We sell our products internationally.  Regulations mandate and distributors request that we make our user manuals available in a variety of languages.  We understand translating our user manuals into Spanish, French and German (from English) but now we are expected to translate our manuals into Greek, Swedish, Hungarian and Portuguese to name a few.   Are you sharing these costs with economic operators or are you covering these costs yourself?  We appreciate your responses. 

     

     

    Deborah Van Noy

    Regulatory Affairs Associate

    ELITechGroup Inc.

    370 West 1700 South

    Logan, Utah 84321

    Tel:  435-752-6011 x1417

     



  • 2.  RE: User Manual Translation Costs

    Posted 24-Jan-2023 03:13
    Hello,

    It is difficult to share these costs with economic operators as it is a legal requirement to have those translations available under the MDR.
    The way you can proceed is that you have a minimal user manual translated, so that all risks are clearly under control and for the extended (full) manual you can refer to the English one, if the product is used by professional users (and they accept it).
    If the product is intended for lay users this will not be possible

    ------------------------------
    Franky Dubois
    QA/RA Manager
    Gent
    Belgium
    ------------------------------

    Original Message


  • 3.  RE: User Manual Translation Costs

    This message was posted by a user wishing to remain anonymous
    Posted 24-Jan-2023 09:26
    This message was posted by a user wishing to remain anonymous

    I imagine if you tried to share costs with distributors some would advocate for cheap translation services or tools that might not meet your standards for quality and safety.
    Original Message


  • 4.  RE: User Manual Translation Costs

    Posted 26-Jan-2023 14:33

    Dear Annon...

     

    We cover these as a cost of doing business.  You cannot, under MDR, take the cheap way out as there are requirements for the translation company.  They have to be an approved vendor, and we insure they are certified to ISO 17100.

     

    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


  • 5.  RE: User Manual Translation Costs

    This message was posted by a user wishing to remain anonymous
    Posted 25-Jan-2023 09:04
    This message was posted by a user wishing to remain anonymous

    t is very important to understand that the liability related to the user's manual rests solely with the manufacturer.

    It may be possible to share the costs, but the content of the manual should be fully controlled by the manufacturer.
    Therefore, the agreement should include the cost of updates or the like.

    Once our EU representative told us that a manufacturer went bankrupt because of an incident caused by an error in the user manual.
    The error was caused by their distributor who translated the manual.


    Original Message


  • 6.  RE: User Manual Translation Costs

    Posted 25-Jan-2023 10:31
    Hi Deborah,

    Shop around ... there are technical translation companies, medical device translation companies, and translation companies.  There are positives and negatives with different companies, but primarily seeing if they have the expertise in IVD products and translating manuals.  Indeed as others have indicated there is a liability with translation and even one word (I have seen) can result in significant issues and a recall.  There is a "standard" cost per page/pages out there, but it would be better to shop around and give examples of your technical manual to confirm they can actually do the work.

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

    Original Message


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