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  • 1.  Languages requirements

    This message was posted by a user wishing to remain anonymous
    Posted 03-Jul-2019 16:13
    This message was posted by a user wishing to remain anonymous

    Hello RAPS community

    Does somebody know if language exemption is possible for Norway for IFU/labeling´of medical devices? E.g. Using English instead of Norwegian.

    Thank you!


  • 2.  RE: Languages requirements

    Posted 04-Jul-2019 00:16
    Yes, there is a provision for exemption, in some circumstances. Here's an English language explanation:
    https://legemiddelverket.no/Documents/Medisinsk%20utstyr/Language%20requirement.pdf
    ​

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    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
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    Original Message


  • 3.  RE: Languages requirements

    Posted 04-Jul-2019 09:57
    You will need to request the exemption from the local Competent Authority in this case Norway.  There is not an "automatic" exemption just because it is professional use - some countries have formal process for doing this.  It sometimes takes a while.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Languages requirements

    Posted 08-Jul-2019 17:24
    ​Since Norway is not part of the EU, the MDD requirement does not apply.  They are an EFTA country and they may have their own national law to require Norwegian, but it has been my experience that customers will ask for English product in writing and there has never been an issue.

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    Al Van Houdt RAC
    Sr. Mgr. Regulatory Affairs & Compliance
    Snoqualmie WA
    United States
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    Original Message


  • 5.  RE: Languages requirements

    Posted 09-Jul-2019 02:20
    Norwegian is very similar to Danish - especially written language. In fact, I very often see instructons and texts like Table of Content marked DK/N, meaning: this is intended for users in both Denmark and Norway. Most professionals in both Norway and Denmark are used to English instructions etc. but to avoid misunderstandings I always read the Danish version if available. 
    And Al is correct: Norway is not a part of the EU, so the language reuirements for EU are not relevant for Norway. But I will suggest that you talk to your Norwegian distributor or other relevant partner. They will know what to do

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    Dorthe Wallin
    Regulatory Compliance Officer
    Denmark
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    Original Message


  • 6.  RE: Languages requirements

    Posted 09-Jul-2019 03:29

    Hello,

    See the below link for the Norwegian language requirements. This said that Norwegian is required except in few cases where exemption could be demanded. And there is also a clear document referenced in the bottom right part of this page.

    https://legemiddelverket.no/english/medical-devices


    Note: And I would not say that MDD does not apply in Norway. In fact they have like other countries in EFTA and Switzerland included the MDD in their localregulations "With reference to the EEA Agreement, Norway has the same rights and obligations as other EU Member States with regard to requirements for medical devices."

    Maud



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    Maud Giorgi
    QMS & RA Manager
    Lausanne
    Switzerland
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    Original Message


  • 7.  RE: Languages requirements

    This message was posted by a user wishing to remain anonymous
    Posted 09-Jul-2019 12:34
    This message was posted by a user wishing to remain anonymous

    All these comments are very useful. Thank you so much.
    Original Message


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