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  • 1.  electronic IFUs

    Posted 10-Dec-2019 18:06
    ​Is there an EU regulation governing conditions in which medical device manufacturers may provide electronic IFUs (i.e., pdfs that can be downloaded from a medical device company website) for medical device users who are not medical professionals?

    EU 207/2012 only allows for eIFUs when "the devices and accessories are intended for exclusive use by professional users" and "the use by other persons is not reasonably foreseeable". We wish to provide eIFUs to users in addition to paper IFUs. We also wish to provide eIFUs in place of paper IFUs for certain stand-alone software accessories (apps).

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    Mark Mortellaro
    Sr. Principal Regulatory Scientist
    Germantown MD
    United States
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  • 2.  RE: electronic IFUs

    Posted 10-Dec-2019 20:30
    Perhaps this discussion will be helpful:

    https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=ae4e2cc4-aa36-4f0a-9bfe-4b65e43f1cdb&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer#bmae4e2cc4-aa36-4f0a-9bfe-4b65e43f1cdb

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 3.  RE: electronic IFUs

    Posted 11-Dec-2019 02:45
    The EU Commission Regulation 207/2012 on electronic instructions for use of medial devices is the Regulation concerning eIFUs. There is no other Regulation or Guidance available on this subject for the European Union. This is what we have to do with in the medical device arena for active implantable and medical devices.

    I presume that In 2012 they were not aware of the boom in developments of stand alone software and more specifically of apps, I gather this Regulation is kind of 'out of sync' with these developments. Also note that under the MDD (and also MDR) it is still possible to market class I and class IIa medical devices without an IFU at all under certain conditions. Does this provide opportunities for your devices?
    Be aware that this said Regulation is specifically connected to Directives AIMD 90/385/EC and MDD 93/42/EC and both Directives will become void as of May 27, 2020. This Regulation will not be (officially) applicable under the MDR.

    There is also a document from the IMDRF on principles of Labelling for MD and IVD (IMDRF/GRRP WG/N52 Final:2019) but it relates (obviously!) to applicable Regulatory requirements in the region where you want to market your medical device, so this also does not extent your possibilities.

    You cite from the Regulation yourself, so I presume you are aware of the do's and dont's regarding eIFUs.

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    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs
    Arnhem
    Netherlands
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    Original Message


  • 4.  RE: electronic IFUs

    Posted 11-Dec-2019 04:12
    Hello All

    Peter, thank you for your input. MDR states under point (98):

    Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the placing of medical devices on the market and the related aspects covered by this Regulation. Manufacturers' obligations as regards the making available of documentation regarding devices they placed on the market and manufacturers' and Member States' obligations as regards vigilance activities for devices placed on the market pursuant to those Directives should however continue to apply. While it should be left to Member States to decide how to organise vigilance activities, it is desirable for them to have the possibility of reporting incidents related to devices placed on the market pursuant to the Directives using the same tools as those for reporting on devices placed on the market pursuant to this Regulation. It is furthermore appropriate, in order to ensure a smooth transition from the old regime to the new regime, to provide that Commission Regulation (EU) No 207/2012 (1) and Commission Regulation (EU) No 722/2012 (2) should remain in force and continue to apply unless and until repealed by implementing acts adopted by the Commission pursuant to this Regulation.

    Wouldn't this indicate that 207/2012 remains valid under MDR? It is our experience that notified bodies to assume this as well.

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    Hans Strobel
    CEO & Co-Founder dokspot GmbH
    Zürich, Switzerland
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    Hans Strobel
    CEO & Co-Founder
    dokspot GmbH
    8044 Zürich
    Switzerland
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    Original Message


  • 5.  RE: electronic IFUs

    Posted 11-Dec-2019 04:30
    Hans, I stand corrected. Your reference to point (98) is part of the Recitals of the MDR​ and therefor not binding requirement; but triggered by your contribution I have checked the MDR and in Annex I (GSPR), clause 23.1(f) explicit reference is made to Regulation 207/2012. It is identified explicitly that eIFUs are only allowed to the extent, and only under the conditions, set out in this Regulation.
    Thank you for making me aware of this.

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    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs
    Arnhem
    Netherlands
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    Original Message


  • 6.  RE: electronic IFUs

    This message was posted by a user wishing to remain anonymous
    Posted 11-Dec-2019 09:31
    This message was posted by a user wishing to remain anonymous

    Hi - just to comment on Peters advice that Regulation 207/2012 wont be officially applicable under the MDR (unless i'm reading the comment wrong, in which case apologies) - within the MDR, Point (98) states,
    'in order to ensure a smooth transition from the old regime to the new regime, to provide that Commission Regulation (EU) No 207/2012 (1) and Commission Regulation (EU) No 722/2012 (2) should remain in force and continue to apply unless and until repealed by implementing acts adopted by the Commission pursuant to this Regulation.'

    Im not aware of any recent implementing acts that repeal the regulation, therefore as an aid to pursuing eIFU i would continue to use this while you transition to the MDR (if you haven't already), and until there's notification that the regulation isn't applicable anymore.
    Original Message


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