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  • 1.  EU Declaration of Conformity - Translations

    Posted 21-Feb-2020 12:44
    Hi Everyone-

    I have our DoC formatted for the English version and was wondering if you had any suggestions on going about formatting? Are you having a new signature for each language or creating a booklet of sorts and having one signature for all translations? We will be translating to about 24 languages so I would rather not have my director sign 24 times for each technical file :) 

    Thanks in advance!

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    Alena Newgren
    Regulatory Manager
    United States
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  • 2.  RE: EU Declaration of Conformity - Translations

    Posted 22-Feb-2020 05:10
    Hello Alena,

    I did similar to what you mention having a booklet or sorts; what we did is the official signature was on the English version only.  Then on each translated version we had the person who's signature appears on the original, their name, title, date also on the translated version - just in print.  Then on the translated version we had a small statement by the signature block stating, 'Official translated version of Declaration of Conformity, original version is English version.' Or whatever official language your official version is in.  Yep, completely understand would be alot to sign 24 Declaration of Conformity and then times the number of Product Family you have.  Then internally in our quality system we had all translated version of the original DofC assigned document identification numbers that were linked to the original.  Or simply at one company I worked the document identification was DofC number 3210-EN for English, 3210-DE for German, 3210-IT for Italian, etc.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: EU Declaration of Conformity - Translations

    Posted 24-Feb-2020 09:14
    Richard,

    Thank you for your reply, it was very helpful!

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    Alena Newgren
    Regulatory Affairs Manager
    United States
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    Original Message


  • 4.  RE: EU Declaration of Conformity - Translations

    Posted 25-Feb-2020 03:48
    HI Alena,

    Richard offered a great solution to your problem.
    Another viable way is to adapt an electronic signatures system.
    This will help you in a lot of different sections.

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    Spyros Drivelos
    Medical Devices Expert, RAC
    Agia Paraskevi, Athens
    Greece
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    Original Message


  • 5.  RE: EU Declaration of Conformity - Translations

    Posted 25-Feb-2020 09:10
    Hi Spyros,

    That is a great option. Unfortunately we currently only use electronic signatures for certain documents but we are transitioning over to that so we could use that in the future.

    Thanks,

    ------------------------------
    Alena Newgren
    Regulatory Affairs Manager
    United States
    ------------------------------

    Original Message


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