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  • 1.  IVDR - Symbols Used in an EU only IFU

    This message was posted by a user wishing to remain anonymous
    Posted 23-Sep-2020 08:58
    This message was posted by a user wishing to remain anonymous

    Symbols are used from an EN recognized standard  in an IFU for an IVD intended to satisfy IVDR requirements, do they need to be defined and translated for each market in the EU the product is sold?  Or is the symbol sufficient since it comes from and EN standard?

    The product is only intended to be sold in the EU

    Thanks


  • 2.  RE: IVDR - Symbols Used in an EU only IFU

    Posted 23-Sep-2020 09:28
    Annex I, point 20.1.

    (h) Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognised symbols, taking into account the intended users. Any symbol or identification colour used shall conform to the harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols and colours shall be described in the documentation supplied with the device.

    Some day some of the European Norms may be harmonised, and some relevant Common Standards may be published.

    Also consider if your users are likely to understand the meaning well enough.



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    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
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  • 3.  RE: IVDR - Symbols Used in an EU only IFU

    Posted 24-Sep-2020 02:41
    Hi Anon,

    If you use symbols according to harmonized standards (which do not exist yet), there is no requirement for translation.
    You can also use other symbols, but you have to explain their meaning.

    A common practice from the manufacturers is to repeat in the IFU some translated warnings or other critical information, which are already included in the symbols.
    In my opinion, anything critical must be clearly stated on the label, because most of the end users (even professionals) do not read the IFU, or read only the basics.

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    Spyros Drivelos
    Medical Devices Expert, RAC
    Agia Paraskevi, Athens
    Greece
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  • 4.  RE: IVDR - Symbols Used in an EU only IFU

    Posted 24-Sep-2020 04:29
    Hello,

    Theoretically if you use symbols from an internationally recognised standard like ISO 15223 according to the Annex I as Anne cited there should be no reason for translation.  But welcome to the real world.  First there is no harmonised standard and would not plan on any for a long time.  Second even the "updated" ISO 15223 has not been published with the so-called new symbols for the EU MDR/EU IVDR.  Lastly, who are your customers?  Do they know what the symbols mean?  Some are intuitive and have been around a long time, but there are some new symbols even people in the industry are not completely aware.  We recommend strongly in the IFU to have a glossary of symbols used with the "official" wording from the standard (the glossary helps satisfy other requirements such as in the United States).  As you can imagine having the text in the IFU would need to ensure translated to local language as appropriate.  This is actually quite easy, usually little space, just make a table with the symbol on the left, then in 1 column on the right have the description of the symbol: Caution / Precaución / Vorsicht / Attenzione etc.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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