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  • 1.  (EU) 2021/2226 - Article 5

    This message was posted by a user wishing to remain anonymous
    Posted 24-May-2022 09:32
    This message was posted by a user wishing to remain anonymous

    Dear all,

    I am working to address one of the requirements in the eIFU regulation (EU) 2021/2226 and curious to see how other companies are working in compliance with the requirement. 

    Under article 5, section (13), the regulation states the following: all issued historical electronic versions of the instructions for use shall be available on the website.


    So, this means that we need to provide all previous versions of any IFU on the website. To avoid users from downloading the wrong versions, are companies providing current and previous versions on separate webpage i.e., a hyperlink that opens all previous versions of IFUs in a separate link. 
    Is it acceptable to provide a link to request prior versions and upon a request from any user, paper copies are shipped within a sepcific period? 


  • 2.  RE: (EU) 2021/2226 - Article 5

    Posted 24-May-2022 11:17
    Dear Colleague,

    you may find reasonable systems/examples here: Home | Johnson & Johnson Medical Devices Companies ( 
    Documents | Medicontur


    Peter Mikó M.D
    ArtPharm Ltd.

  • 3.  RE: (EU) 2021/2226 - Article 5

    This message was posted by a user wishing to remain anonymous
    Posted 24-May-2022 16:30
    This message was posted by a user wishing to remain anonymous

    Considering these eIFUs are specifically meant for use by professionals you can incorporate a watermark that is clearly visible on the document showing the IFU has been superseded.  You have to consider that some users may have older equipment and so not all new updates might be relevant to them. Therefore have a system where the equipment version/IFU version is very apparent. You could for instance choose a color code scheme on the margins of the IFU to differentiate or something more distinctive

  • 4.  RE: (EU) 2021/2226 - Article 5

    Posted 25-May-2022 03:21
    Edited by Richard Vincins 25-May-2022 03:26

    What that last poster said is correct and reasoning behind keeping the historical versions of electronic version of IFU (e-IFU) on the website.  If the company is providing software or equipment, the customer may have the last version or even previous versions of the equipment/software.  Therefore, configuration management is quite important to link up the correct IFU (and e-IFU) to the version of software or equipment which the customer may have.  As an example, an IVD instrument which has software version 1.8, there may also be version 2.0 and 2.2 in use as well.  Some of the software changes most likely would have updated the IFU, so this needs to be linked to the version of software.  And there may also be hardware changes to the equipment like new sensors or reader which needs to be clearly identified.  To answer the original question: it is the medical device manufacturers responsibility to ensure the versions of IFU are linked to the product being shipped and what would be available as electronic versions on the website (configuration management).

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

  • 5.  RE: (EU) 2021/2226 - Article 5

    Posted 25-May-2022 09:16
    Edited by Hans Strobel 25-May-2022 09:16

    You do not need to provide ALL previous versions of the IFU. The version requirement starts with the first electronically posted IFU (the first eIFU), this first electronic version (and all that follow) must remain available once there is an update of the regulatory content of the IFU. 

    Contact me if you want to see how we solve this in our eIFU solution for device manufacturers.

    Kind regards,


    Hans Strobel

  • 6.  RE: (EU) 2021/2226 - Article 5

    This message was posted by a user wishing to remain anonymous
    Posted 31-May-2022 09:08
    This message was posted by a user wishing to remain anonymous

    Hello everyone,
    I would like to post a follow-up question if I may. Does this requirement, to have previous revisions of IFUs available on the website, also apply to products that will not move forward under MDR?  
    Thank you.

  • 7.  RE: (EU) 2021/2226 - Article 5

    Posted 25-May-2022 12:06
    In addition to all the great feedback here, our company separates the current version of the eIFU from all the prior versions into two different pages of our website. After landing on the eIFU home screen, the user may decide if they want to see the latest version of brows the previous versions in two different pages.  

    Hope this helps

    Saleh Riazi
    Regulatory Consultant
    San Jose CA
    United States

  • 8.  RE: (EU) 2021/2226 - Article 5

    Posted 01-Jun-2022 08:16
    This is a common problem with standards. Look at the TechStreet web site for an example of their solution.

    The current standard is clearly marked, but historical versions are available.

    Dan O'Leary CQA, CQE
    Swanzey NH
    United States

  • 9.  RE: (EU) 2021/2226 - Article 5

    Posted 01-Jun-2022 11:31
    Oftentimes it will not be in the best interest of public health to force a user to request and await a prior version of an IFU that the user may need imminently.  Plus, such an approach may be an unsustainable operation for the manufacturer, thereby increasing the risk of delays.  Accordingly, I would generally avoid that approach.

    When it comes to assuring that users get/see the appropriate information (whether IFUs or other) on a website, a common best practice is to keep the potentially sensitive information on a separate page.  This can be achieved via a link to the current IFU, and a link to a separate webpage containing the prior versions of the IFU.

    For higher risk devices, it may be worthwhile to have a notification warning/advising the visitor when the visitor clicks the link for the prior versions stating something like, "Warning: You are about to access superseded versions of the instructions for use (IFU).  Be sure to always utilize the IFU corresponding to your product version.  If you are unsure which IFU corresponds to your product version, then you may contact technical support at #####."

    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
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