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eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226

  • 1.  eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226

    Posted 22-Mar-2022 12:51
    Dear RAPS experts,
    do you have any experience providing eIFU for products outside of the listed ones in article 3 of the EU regulation 2021/2226 (repealed 207/2012)?
    Which is the current position of NBs?
    Is it possible to provide eIFUs for devices outside the scope of this Regulation?
    Thank you in advance for your valuable support!
    Mauro

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    Mauro
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  • 2.  RE: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226

    Posted 22-Mar-2022 14:00
    Edited by Kevin Randall 22-Mar-2022 14:01
    The Commission's Directorate General for Health and Food Safety told me that if ever an eIFU is provided for medical devices in the Union, whether the eIFU is provided instead of paper (for qualifying Article 3 devices) or else in addition to paper (for any devices), then the applicable provisions of Regulation (EU) 2021/2226 always apply.  eIFU may not be provided outside the scope of that Regulation.  Indeed, that Regulation isn't limited in scope only to providing electronic IFU instead of paper IFU.  Rather, along with that scenario, it also contains certain provisions applicable to all medical devices (excluding EU MDR Annex XVI devices) whose IFU are provided in both electronic and paper format.  Be sure not to err regarding that scope.  This is in alignment with the longstanding precedent established by the sunsetting Regulation (EU) 207/2012.

    Also, remember to integrate your compliance approach with measures to meet the EU MDR's Annex I.23.1 / IVDR's Annex I.20.1 website provision (which has overlap with the eIFU's website-related provisions).

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------



  • 3.  RE: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226

    Posted 22-Mar-2022 14:38
    Remember also that EU MDR Annex I.23.1(f) reminds us that instructions for use may be provided to the user in electronic format only to the extent, and only under the conditions, set out in the eIFU Regulation...

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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------



  • 4.  RE: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226

    Posted 23-Mar-2022 05:45
    Thanks for your clear and complete answer Kevin.
    Much appreciated

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    Mauro
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  • 5.  RE: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226

    Posted 24-Apr-2023 14:20

    Kevin,

    Thank you for the insight on the eIFU regulation. To confirm, simply having a copy of the eIFU available on a website which is accessible in the EU would obligate a manufacturer to comply with relevant sections in (EU) 2021/2226, correct?

    I am reviewing a scenario in which an IFU with multiple translations would be added to a website for users to access. A paper copy of the IFU is already distributed with the device, so this would be an "in addition to" scenario, where (as I understand it), the "eIFU instead of paper IFU" requirements in (EU) 2021/2226 would not apply, though the likes of Article 9 would apply. But again, how I am reading this is that by simply adding that IFU to the website for users in the EU and elsewhere to download, this would obligate a manufacturer to ensure that they are compliant with the regulation.

    Thanks again.



    ------------------------------
    Thomas Saladin
    Regulatory Affairs Specialist
    Minnetonka MN
    United States
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  • 6.  RE: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226

    Posted 24-Apr-2023 15:17

    Hi Thomas,

    Yes, I definitely consider IFU placed on a website to be eIFU.

    And y
    es, excluding Annex XVI devices, my interpretation of the aforesaid Commission stance is that any eIFU provided in addition to paper IFU must comply with the applicable provisions of Regulation (EU) 2021/2226.  But this needs to be done in remembrance that only certain aspects of 2021/2226 apply to the "in addition to" scenario (I don't have those exact "in addition to" clauses off the top of my head).

    Best,
    Kevin



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



  • 7.  RE: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226

    This message was posted by a user wishing to remain anonymous
    Posted 14-Sep-2023 09:17
    This message was posted by a user wishing to remain anonymous

    Related to this discussion, if I provide a PDF copy of the medical device IFU on the company website (in addition to, and identical to, the paper IFU which is packaged with the device), the PDF copy is an eIFU and must comply with 2021/2226.  Since the company has a website, is it a requirement of the MDR 2017/745, Annex I, Section 23.1, to provide the PDF copy of the IFU on the company website? 




  • 8.  RE: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226

    Posted 15-Sep-2023 03:33

    Hello Anon

    Yes, article 23.1 of Reg (EU) 2017/745 requires that IFUs of medical devices are available on the company website (if such a website exists). Reg (EU) 2021/2226 describes the requirements for the provision of IFUs in electronic format (eIFU), in the case you describe the website has to meet the requirements of article 9 of Reg (EU) 2021/2226.

    Uploading a PDF to a website will not qualify as an eIFU system. IFU and eIFU are integral parts of a medical device and need to be provided accordingly in a validated and quality-controlled process.

    Best regards



    ------------------------------
    Hans Strobel
    www.dokspot.io
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  • 9.  RE: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226

    This message was posted by a user wishing to remain anonymous
    Posted 18-Sep-2023 13:54
    This message was posted by a user wishing to remain anonymous

    Thank you all for confirming that the PDF copy of the IFU on the manufacturer's website is indeed an eIFU which must be in compliance with applicable sections of EU 2021/2226.  One of the requirements of the EU 2021/2226, Article 9, is that we must comply with Article 7, Section (2) f, which states that all previous versions of the IFU shall be available on the website.  I interpret this requirement to mean that each obsolete version of the use instructions is available to the user.  Am I interpreting this requirement correctly?  It seems that this requirement introduces the risk of a user accessing an obsolete version of the use instructions.




  • 10.  RE: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226

    Posted 18-Sep-2023 14:00

    I interpret it the same way and I have the same concerns.  Accordingly, the previous versions need to be clearly marked and/or segregated on the website so as to maximize the users' abilities to know when they are looking at a previous version.



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



  • 11.  RE: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226

    Posted 18-Sep-2023 14:20

    Only previous eIFU versions have to remain available, so if you start with eIFU now, there is no need to upload previous versions of the IFU. And yes, once there are previous versions they must be clearly marked as such and be available on your website.



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    Hans Strobel
    www.dokspot.io
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  • 12.  RE: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226

    This message was posted by a user wishing to remain anonymous
    Posted 28-Sep-2023 09:04
    This message was posted by a user wishing to remain anonymous

    Hi Hans,

    "Uploading a PDF to a website will not qualify as an eIFU system."

    Why not?




  • 13.  RE: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226

    Posted 29-Sep-2023 11:00
    Edited by Hans Strobel 29-Sep-2023 12:22
    Hello Anon
    Several reasons:
    1. Providing a paper IFU with a medical device is very clear and straightforward for the medical device user. Apart from finding the right languages and the required information, there is no question that the document provided with the device actually belongs to the device. If this is to be replaced with searching the electronic version of a document on a company website and then selecting the document from a list, then there are a number of steps that can not be controlled. The risk that the medical device user selects the wrong document is too high.
    2. The process of packaging a paper IFU with a medical device is a validated, quality-controlled, and documented QA process with defined roles and responsibilities. For eIFU - which is part of your device labeling - an equivalent process must be defined.
    In my view, there is too little understanding about this in the industry and this could be one of the reasons for the reluctance of the EU medical device authority to broaden the use of eIFU.
    Best,
    Hans
    Hans Strobel
    www.dokspot.com






  • 14.  RE: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226

    Posted 02-Oct-2023 04:35
    Hello, All,
    My experience is that you must qualify the system for publishing an maintain e-IFUs and eIFU accessibility, considering in the risk analysis risks such as: 
    - User not familiar with eIFU
    - eIFU is not consistent with paper IFU
    - User not aware of revision of the IFU due to safety reasons, or updates/corrective actions with regards to IFU
    - No computer or no internet available to access eIFU
    - Lack of knowledge and experience of the intended user of the hardware and software needed to display the instructions for use in digital form
    - Access to website not easy to get
    - Website is not sufficiently protected against hardware and software intrusion
    - IFU is provided in a non-commonly used format
    - Downtime and display error
    - IFU not available in the user language
    - Upload of language other than indicated
    - Website does not fulfill privacy requirements
    - Internet address is unstable or not accessible
    - Internet address is not directly accessible
    - The website does not show all previous versions of the IFU issued in digital form and their date of publication
    - No safety, back-up, redundant mechanisms in place in the event of a hardware or software failure
    - Foreseeable medical emergencies (as applicable)
    - Evaluation of the time within which the instruction for use shall be provided in paper form at the user's request is not within 7 calendar days
    - methodology to get the request from the user of the paper IFU not validated
    - The link to the eIFU service is changed or erased
    - Upload of IFU not belonging to the device in question
    - Failure to update the eIFU service with latest version of the IFU
    - eIFU Service is not available anymore
    - eIFU Service is not available

    Once you assessed all these risks and found new ones, you might understand that a commercial website is not the right place for eIFU and you will look for professionals doing this service. I can suggest Qarad.

    Mauro










  • 15.  RE: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226

    Posted 15-Sep-2023 09:10

    Hello Anon,

    A disseminated PDF copy of the IFU is an eIFU pursuant to Regulation 2021-2226's definition.

    Regarding the MDR's  Annex I, Section 23.1 requirement for placement of the IFU on the manufacturer's website if the manufacturer has a website, the MDR doesn't prescribe any particular electronic format for the IFU placed on the website.  However, Regulation 2021/2226 does give an important parameter for the format of the eIFU on the website.  Specifically, it must be in "a commonly used format that can be read with freely available software".  Accordingly, yes, PDF format is generally acceptable. But there could be other file formats that might work too as long as it meets the aforesaid formatting parameter.



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



  • 16.  RE: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226

    Posted 15-Sep-2023 10:36

    Hi Kevin,

    while I generally agree, one small thing that is strange in Regulation 2021/2226:

    Article 9 limits (as far as I can see) the availability of certain requirements for eIFU that are provided in addition to the IFU in paper form to Article 7(2), points (b)(protected against unauthorised access), (d)(fulfil the requirements of Regulation (EU) 2016/679), (e)(internet address stable and directly accessible during the archiving periods i.e. 10/15 years) and (f)(availability of previous versions).

    Article 7(2)(a) that requires the eIFU to be in "a commonly used format that can be read with freely available software" is left out in this case (although it would make perfect sense to include that requirement and I would not advise to do otherwise).

    Another case where I am not sure whether this is just an oversight by the regulators or has some deeper meaning.

    Best regards

    Christoph



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    Christoph Kiesselbach
    Reutlingen
    Germany
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