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  • 1.  DoC and Translations

    Posted 03-Feb-2023 11:49
    Dear all, 

    Do you know if we can sign off our DoC under EU MDR with English version of IFU only and do the translations afterwards? Do we have to hold off on signing our DoC until translations are complete? Thanks

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    Tina Ariaee RAC
    Director, Regulatory Affairs

    Irvine CA
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  • 2.  RE: DoC and Translations

    Posted 03-Feb-2023 13:56
    Hi Tina,

    Article 19 of the EU MDR requires that conformity with the EU MDR's requirements shall be demonstrated via the applicable conformity assessment procedure before drawing up the EU declaration of conformity (DoC).  The fundamental intent of the DoC is to attest that conformity has already been demonstrated.  Declaring conformity before actually completing the conformity assessment process would be in violation of the EU MDR.  For example, it is not possible to have complete and compliant Annex II Technical Documentation if the IFU isn't yet translated into the languages accepted in the Member States where the subject device is envisaged to be sold.

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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 3.  RE: DoC and Translations

    Posted 06-Feb-2023 13:34
    Tina,
    If you absolutely need to draw up the DoC before the IFU translations are done, then an operational tactic which might, commensurate with risk, be worth considering, is to leverage Annex IV.10's 'date of issue' attribute by making the 'date of issue' a future date.  It is not uncommon that document effective dates are in the future.  I personally don't like such an approach; you would of course need to be sure that the IFU translations do in fact get completed properly by said effective date.  But in an operational pinch, that less-than-ideal approach could be something to consider.

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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 4.  RE: DoC and Translations

    Posted 03-Feb-2023 15:36
    Hi,
    Unless the translations are made available the declaration of conformity is not complete. Article 19- EU declaration of conformity states that "The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available.
    By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance with the requirements of this Regulation and all other Union legislation applicable to the device."
    Hope this helps.
    Thanks

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    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
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    Original Message


  • 5.  RE: DoC and Translations

    Posted 05-Feb-2023 10:30
    Just a comment Tina regarding translation of language for Instructions for Use (IFU) and in relation to issuing a Declaration of Conformity.  As already mentioned the Declaration of Conformity (DofC) is issued and maintained supporting the product is in conformance with all of the requirements of the regulation.  And this does include all of the internal documentation, specifications, statements, and claims which a company is making as well.  One way this can be addressed is clearly indicating in your Technical Documentation index/file those languages in which the company is conforming and by extension applies to the countries in which the company is selling/distributing (putting into service).  This way as you get new languages/new markets for your products, you update the Technical Documentation index/file with those languages which the labelling of the product/product family is in.  This also gives the flexibility to at least get in one or two countries at the beginning and also to introduce more countries as they are added to the marketing portfolio of your device.  So as an example, if there is only English language and Spanish language for the IFU, then countries like Ireland and Spain could be the markets where you can distribute product and the DofC is valid.  Also, using a methodology like this you do not have to update the DofC each time you add a new language, just update the Technical Documentation index/file - therefore the DofC shows the conformance at a higher level.

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


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