Regulatory Open Forum

 View Only

  • 1.  European regulation for in vitro medical device (2017/746)

    This message was posted by a user wishing to remain anonymous
    Posted 05-May-2021 08:26
    This message was posted by a user wishing to remain anonymous

    Hello all,
    I have a question regarding the European regulation 2017/746 (IVDR) is it possible for a software considered as an in vitro diagnostic medical device to have in its destination two different types of users, that is professional and layperson and where can I find the justification for yes or no?
    Thank you very much for your answers
    Have a nice day


  • 2.  RE: European regulation for in vitro medical device (2017/746)

    Posted 06-May-2021 02:05
    Hello anon, I don't see why this couldn't be possible under the IVDR. You would most likely need to compartmentalise functionality for the different types of users, which necessitates design choices that need to be accounted for in risk management, usability and all those things.

    ------------------------------
    Erik Vollebregt
    Partner
    Amsterdam
    Netherlands
    ------------------------------

    Original Message


  • 3.  RE: European regulation for in vitro medical device (2017/746)

    Posted 06-May-2021 02:08
    Hello Anon,

    It may be possible, but it would make your regulatory strategy and placing on the European market quite challenging.  There are significant details which would need to be considered such as if the software is the same, if the same why it would have two different intended users, how the results are being used by the user, etc.  You probably will not find anything that specific in the EU IVDR regulation about finding a justification, this would be something needed to be determined by your organisation.  There would be much information needed around risk management, claims, performance evaluation, intended purpose, which would need to be documented, supported, justified, and stated in your technical documentation.  Then depending on the product, review and acceptance by a Notified Body.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    Oriel STAT A MATRIX - ENTERPRISE
    ------------------------------

    Original Message


  • 4.  RE: European regulation for in vitro medical device (2017/746)

    Posted 06-May-2021 03:12
    Richard, if it helps this is quite common in the ivd sector whenever a condition can be monitored at home, like diabetes. patients will monitor themselves at home, but their outpatient clinic/doctors office will have and use the same software as the patient.

    ------------------------------
    Kevin Painter
    Mentor, Medical Device Regulatory Compliance
    Poland and United Kingdom
    ------------------------------

    Original Message


  • 5.  RE: European regulation for in vitro medical device (2017/746)

    This message was posted by a user wishing to remain anonymous
    Posted 06-May-2021 15:13
    This message was posted by a user wishing to remain anonymous

    It would logically be the least skilled user that the device would consider for risk, even if both professionals and non-professionals are expected to use an IVD software device. It may matter if the software is embedded in the device as opposed to being SaMD, as the total device risk would determine classification. But there should not be any obstacle to having intended users at more than one skill level.
    Original Message


  • 6.  RE: European regulation for in vitro medical device (2017/746)

    Posted 07-May-2021 13:05

    Hi Anon,

    It shouldn't be a problem but you need to carefully define risks for both users.

    Usability study will need to be done for both user types.

    If you have specific concerns for use and functionality, you may have two log-in accounts, for professional and lay person.

    ------------------------------
    Reyhan MUTLU
    San Jose CA
    United States
    ------------------------------

    Original Message


Related Content