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  • 1.  GMDN & CND codes

    This message was posted by a user wishing to remain anonymous
    Posted 20-Nov-2019 14:44
    This message was posted by a user wishing to remain anonymous

    Apologies in advance if this has already been covered here.

    On the basis MDCG will map Italian CND (Classificazione Nazionale dei Dispositivi medici) codes to GMDN codes for ease of use by manufacturers and other entities utilizing Eudamed, does this mean the CND will reflect existing GMDN codes?  E.g. if I have a product, 'device A' with a GMDN code of 1234, will the CND code also be 1234?

    If not, is the CND database available to search to establish the CND code for 'device A'.

    Many thanks


  • 2.  RE: GMDN & CND codes

    Posted 21-Nov-2019 12:02
      |   view attached
    I have just gone through the exercise of re-classifying our CE Mark products per CND codes (attached) and they are distinctly different from the GMDN codes. I have yet to find a "mapping" of the two, I had to do a keyword search in the CND document (attached). My take was that once Eudamed v2 is up and running, when we get access (or our Authorized Representative or "local user administrator") we will be able to enter a GMDN code and the system will show the applicable CND code. But we'll see.

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    Maureen Dawson RAC
    Regulatory Affairs Associate
    San Diego CA
    United States
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    Attachment(s)

    pdf
    CND Codes.pdf   1.23 MB 1 version