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  • 1.  Electronic Labeling/Marketing Materials

    This message was posted by a user wishing to remain anonymous
    Posted 10-Nov-2021 22:53
    This message was posted by a user wishing to remain anonymous

    Hello,

    We are a class II medical device manufacturer in the US (and IIa in EU) and want to eliminate the use of paper IFU and Installation instructions provided with our products.  What are the requirements as its related to providing customers with electronic IFU's, brochures, and installation guides?  Is this possible?

    Which regulations drive the use of electronic marketing materials?

    Which symbols are required to uPostse electronic marketing materials?


  • 2.  RE: Electronic Labeling/Marketing Materials

    Posted 11-Nov-2021 01:52

    Dear Anon

    You may look into the Commission Regulation (EU) No 207/2012 of March 9, 2012. Here is the Link: Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devicesText with EEA relevance (europa.eu).

    Presently a new draft of this regulation is in preparation. You can find this text here: COMMISSION IMPLEMENTING REGULATION (EU) …/... laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices - Publications Office of the EU (europa.eu).

    Regards



    ------------------------------
    Oscar Banz
    RA & VIG Manager
    Grenchen
    Switzerland
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    Original Message


  • 3.  RE: Electronic Labeling/Marketing Materials

    Posted 11-Nov-2021 04:52
    Hey
    There are wonderful threads in this forum on this issue :)
    Here are the links:
    Electronic IFU's | Regulatory Open Forum (raps.org)
    eIFU | Regulatory Open Forum (raps.org)
    eIFU Globally | Regulatory Open Forum (raps.org)
    eIFU Verification and Validation | Regulatory Open Forum (raps.org)

    ENJOY :)

    ------------------------------
    Ella Sheiman
    Haifa
    Israel
    ------------------------------

    Original Message


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