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  • 1.  Labeling: IVD Language Requirements for European, Middle Est and African Countries

    This message was posted by a user wishing to remain anonymous
    Posted 23-Jul-2020 10:29
    This message was posted by a user wishing to remain anonymous

    Hi

    For sales of IVDs in European, Middle East, and African countries can IFU's in the kits be in English with a QR system/code on the IFU that contains the other languages?

    Is it required to have specific languages only on the IFU with others accessible via a QR code?


    Thanks in advance for any comments


  • 2.  RE: Labeling: IVD Language Requirements for European, Middle Est and African Countries

    Posted 24-Jul-2020 08:30
    Hi,

    as far as I know, this really depends on the specific country. If we are talking about EU markets, the labeling and IFUs need to be in the adequate language of the member state. Providing them in english with a QR code referring to the local language is possible in some cases, depending on the users experience (e.g. lay users vs. HCPs). For other countries in ME and Africa you need to consult the local legislations.

    All the Best

    Markus

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    Markus Lantermann
    Head of Q&R Region International
    Mannheim
    Germany
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    Original Message


  • 3.  RE: Labeling: IVD Language Requirements for European, Middle Est and African Countries

    Posted 27-Jul-2020 02:29
    Hello,

    Most countries have their own country local language requirements, such as in Europe there are local laws for products (and medical devices) to be in the local language.  This is especially true for Over The Counter or lay-person use products.  Anyway, it would be awfully short-sighted of a company to sell a patient-use device in only English or their own local language.  It would be possible to have a QR Code pointing to a website location where the local language can be obtained, but remember depending on the customer, the type of product, and their accessibility to the internet, this should definitely be taken as a factor whether additional languages can be provided online.  There are a few Middle East countries that also require local language.  This is a difficult area to address from a regulatory perspective but always make sure you are looking at it from the user perspective.  It may be reflective of your company being customer-oriented or not.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Labeling: IVD Language Requirements for European, Middle Est and African Countries

    This message was posted by a user wishing to remain anonymous
    Posted 27-Jul-2020 09:31
    This message was posted by a user wishing to remain anonymous

    I agree with Markus. it differs from one country to another.  I have some experience with UAE, where the local authority accepts English only IFU for IVDs categorized under HCP-use.
    Original Message


  • 5.  RE: Labeling: IVD Language Requirements for European, Middle Est and African Countries

    Posted 28-Jul-2020 03:22
    Hi, 

    I agree with all comments. It largely depends on the specific countries regulation. From my experience in Africa you will require IFU in either of the following languages, English (which is accepted by majority of the countries), French, Arabic, Spanish, Portuguese. So your best bet is to group the countries as per language requirement for your label deployment. 
    Specifically, in Sub Sahara Africa, you will have the following language groups English, French, Spanish and Portuguese. North Africa most times aligns with Middle East (French and/or Arabic).

    All the best

    ------------------------------
    Emeka Chukwurah
    Regulatory Affairs Manager
    Ikeja
    Nigeria
    ------------------------------

    Original Message


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