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  • 1.  REGULATION (EU) 2021/2226 – electronic IFUs

    This message was posted by a user wishing to remain anonymous
    Posted 30-Mar-2023 07:35
    This message was posted by a user wishing to remain anonymous

    We are a manufacturer of a Class IIa device that is packaged with a paper IFU.  We have a company website that includes a link to the current IFU revision, only.  Are we required to post all historical revisions that have been available on the website?  …and post them for the 10 and 15 years, as specified in Article 5(9), (10)?  I've never seen multiple e-IFU revisions posted on other manufacturers' sites.  Thanks in advance!!!<o:p></o:p>

    <o:p> </o:p>

    REGULATION (EU) 2021/2226 Article 1 reads:<o:p></o:p>

    It [this Regulation] also establishes certain requirements concerning contents of and websites for instructions for use that are provided in electronic form in addition to instructions for use in paper form.<o:p></o:p>

    <o:p> </o:p>

    Article 9 reads:<o:p></o:p>

    Instructions for use in electronic form, which are provided in addition to complete instructions for use in paper form, shall be consistent with the content of the instructions for use in paper form.<o:p></o:p>

    Where such instructions for use are provided through a website, this website shall fulfil the requirements set out in Article 7(2), points (b), (d), (e) and (f).<o:p></o:p>

    <o:p> </o:p>

    Article 7(2)(f) reads:<o:p></o:p>

    all previous versions of the instructions for use issued in electronic form as referred to in Article 5, point (13), and their date of publication shall be available on the website.<o:p></o:p>



  • 2.  RE: REGULATION (EU) 2021/2226 – electronic IFUs

    Posted 31-Mar-2023 04:03
    Edited by Hans Strobel 31-Mar-2023 04:09

    Hello Fellow RAPS Member

    The answer is yes. For the EU previous IFU versions that have been available electronically have to stay available per the new (2021/2226) and previous (207/2012) EU eIFU regulations (as quoted correctly in your question).

    There is room for interpretation of what a 'new version' means. We recommend defining it as a change in the regulatory content of the IFU (= new version, the current version must stay available) and treating any format changes (visual, language additions, correction of spelling, etc.) as the same version (replacing the current version).

    Many eIFU websites comply with this requirement, which is among the key topics checked by notified bodies when they review eIFU systems.

    Kind regards

    Hans



    ------------------------------
    Hans Strobel
    www.dokspot.io
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    Original Message


  • 3.  RE: REGULATION (EU) 2021/2226 – electronic IFUs

    This message was posted by a user wishing to remain anonymous
    Posted 31-Mar-2023 08:25
    This message was posted by a user wishing to remain anonymous

    1) Do we know why in EU there is a requirement to post previous revisions of the IFUs on the website?
    2) We see even big MedTech companies also post the previous revisions of the IFUs on the Website in USA even though there is no such requirement by FDA. Any thought why they are doing this?


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  • 4.  RE: REGULATION (EU) 2021/2226 – electronic IFUs

    This message was posted by a user wishing to remain anonymous
    Posted 31-Mar-2023 09:20
    This message was posted by a user wishing to remain anonymous

    My apologies to the Forum.  I posted this question without researching previous posts beforehand.  I now see that this topic has been covered in several previous posts.  My question is answered by those posts, but I still have not seen any medical device website with multiple e-IFU revisions.

    Also, the information provided by this Forum has been invaluable in my regulatory effort.  I appreciate all those who take the time to provide guidance.  I believe your input has advanced the entire regulatory compliance effort.  I trust the information here more than any other source.

    Anon


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  • 5.  RE: REGULATION (EU) 2021/2226 – electronic IFUs

    This message was posted by a user wishing to remain anonymous
    Posted 03-Apr-2023 08:02
    This message was posted by a user wishing to remain anonymous

    I haven't searched today, but a year ago I saw that Depuy had this format on their website - showing the archive copies. I remember using it as an example to show a colleague. 


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