Regulatory Open Forum

 View Only

  • 1.  Hybrid paper/electronic IFU Management

    Posted 29-Nov-2021 21:29
    Hi Regulateers,

    Looking at implementing eIFUs but since they're not accepted in all of our current markets, we'll still need to maintain a paper copy provided in the device packaging. 

    What are best practices out there on a hybrid approach?  For example, is your paper IFU identical to your eIFU or do you maintain separate paper vs electronic where the paper would only contain languages for countries who don't accept eIFU?   If yes, does your paper version contain a pointer to your eIFU website for the countries that do accept electronic or do you communicate this via an alternate method on the package labelling?

    Also, do you use a 3rd party eIFU hosting service?  Is it worth the $$ vs doing it yourself?  

    Thanks in advance!

    Tina

    ------------------------------
    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Airport Oaks
    New Zealand
    ------------------------------


  • 2.  RE: Hybrid paper/electronic IFU Management

    Posted 30-Nov-2021 05:14
    Edited by Hans Strobel 30-Nov-2021 05:23
    Hello Tina

    dokspot is a 3rd party eIFU hosting service, hope it is ok that I respond (I am a regulator). Maybe you will also get independent feedback or confirmation of my response.

    Per the EU eIFU regulation the following applies if you provide eIFU in addition to paper IFU:

    • the electronic IFU shall be consistent with the content of the paper IFU
    • If provided via an eIFU website:
      • the website shall be protected against hardware and software intrusion
      • the website shall fulfil the requirements of data protection (GDPR)
      • all previous versions of the instructions for use were issued in shall be available on the website

    You also need to set up minimum QA processes, mainly a work instruction or SOP.

    The $$ question depends on how much IT, QA, and RA resources (time and investments) you want to make and if building the know-how on how to develop and run an eIFU software is in the companies business and strategic focus. 

    Kind regards,

    Hans

    ------------------------------
    Hans Strobel
    www.dokspot.io
    ------------------------------

    Original Message


  • 3.  RE: Hybrid paper/electronic IFU Management

    Posted 30-Nov-2021 13:39
    Greetings Hans,

    Thanks for the info - all responses are 100% welcome!

    Regarding the requirement that the eIFU shall be consistent with the paper - could the eIFU contain different languages (e.g. those required for countries outside EU) than the paper version so long as the content is identical?

    Tina


    ------------------------------
    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Airport Oaks
    New Zealand
    ------------------------------

    Original Message


  • 4.  RE: Hybrid paper/electronic IFU Management

    Posted 01-Dec-2021 11:50
    Hi Tina,
    In a Hybrid configuration (having both eIFU and paper IFU) for the same device configuration, the paper and eIFU should be identical in their information. Yes, you can have different languages in both eIFU and paper IFU as long as the base IFU (usually English) matches the translated languages in the eIFU or paper  IFU.

    Thanks
    Shiven

    ------------------------------
    [Shiven]
    [Regulatory Affairs]
    [San Francisco] [CA]
    ------------------------------

    Original Message


Related Content