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  • 1.  Software information in IFU - MDR

    This message was posted by a user wishing to remain anonymous
    Posted 01-Aug-2023 09:06
    This message was posted by a user wishing to remain anonymous

    We have software modules integrated in our device . What information does the IFU need to contain with respect to the software function, as all the software upgrades are managed by the service personnel and are part of the service manual. This came up as a query during the MDR audit.

    thanks



  • 2.  RE: Software information in IFU - MDR

    Posted 01-Aug-2023 11:49

    Hi Anon,

    could you maybe provide more context? Does your device have an IFU for the user that describes the medical functions and a separate service manual? Then I would assume that you could both formally consider as "IFU" in the sense of Annex I that are just adressed at different types of users.

    Best regards, Christoph



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    Christoph Kiesselbach
    Reutlingen
    Germany
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    Original Message


  • 3.  RE: Software information in IFU - MDR

    Posted 01-Aug-2023 13:47

    Pursuant to point (ab) of section 23.4 of EU MDR Annex I, the IFU with respect to the device's software function(s) must contain minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorized access, necessary to run the software as intended.

    But in addition, the IFU with respect to the device's software function(s) must also contain whatever other particulars from section 23.4 that are relevant to those software aspects.  For example, with respect to software patches, updates, and the like, the IFU would need to contain corresponding attention to point (k) (i.e., information needed to verify whether the software patches or updates are properly installed).  Similarly, points (h) and (i) of section 23. 4 could also require IFU attention regarding instructions to the user for software patches, updates, etc.

    Ultimately, the EU MDR allows us wide liberty and flexibility regarding the medium, format, content, legibility, and location of device software instructions for use (see section 23.1 of Annex I).  Therefore, the parameters you choose for those just need to be appropriate to the particular device, its intended purpose, and the technical knowledge, experience, education or training of the intended user(s).  Be sure to include software human factors / usability considerations here too.

    In practice regarding IFU for device software, my clients typically embed the post-installation operating IFU within the software (thus constituting eIFU and thus triggering the corresponding legislative requirements for eIFU) rather than providing the software IFU in paper format.  Instructions regarding software installation, updates, patches, etc., could also be provided digitally as well; either via software update reminders coming from within the software application, or via other electronic means.  And paper instructions are of course allowed also.



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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 4.  RE: Software information in IFU - MDR

    Posted 02-Aug-2023 02:03

    Good day Anon,

    A bit more information is probably needed to address specifically your question, though Kevin has provided a good overview of requirements needed for labelling.  A couple points wanted to add to the information: changes to software contained in the medical device may need to be communicated to the user through release notes or updates when changes are made.  While the software updates may be made by a Field Service Engineer (FSE) or similar, the users may still need to be made aware of changes to the software application(s), system, or module(s) contained in the device.  The other comment is if the device does have servicing performed where an FSE updates the software, there is also typically a Service Manual or similar describing how this is performed as well.  A Service Manual should exist for how servicing is completed for the device and would also be considered labelling.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


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