Regulatory Open Forum

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  • 1.  eIFU Question

    Posted 17-Feb-2021 01:48
    Hi-
    What is the EU MDR requirement for CE Marking (EU MDR) for eIFU for OTS class IIa medical device. Is there anyway to use combination of Quick Reference Guide (QRG) and user manual with all pertinent information on QRG but make user manual electronic esp. if the user manual is in multiple language.
    I am interested in understanding the translation requirement for App (UI only), clinician portal & website for marketing. Do each of these need to be translated in all the languages the company intends to sell around the globe? Please suggest.

    Thanks,
    Ritam

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    Ritam Priya
    VP Quality & Regulatory

    Fremont CA
    United States
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  • 2.  RE: eIFU Question

    Posted 17-Feb-2021 07:14

    Hi Ritam,
    You could make the IFU available in electronic format as long as you also ensure that your customer is aware and knows how to request for a printed one if required. However, it is important to perform and document a risk assessment of providing the information in e-format instead of a printed to ensure all aspects accessibility ,availability of information to your users and the environment of the use has been considered. 
    The UI and the IFU's must comply to the language requirements of the various countries that you plan to sell in. So here translation may be necessary. The website for marketing may not come under the regulatory purview for translation but more of a business/marketing decision. 

    Hope this helps.

    Thanks,

    Ramya



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    Ramya Santhanam MS, BS, RAC
    Team Lead, Regulatory and Clinical Evaluations
    Bangalore
    India
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    Original Message


  • 3.  RE: eIFU Question

    Posted 18-Feb-2021 06:42
    Hello Ritam,

    If you read through the EU MDR there is more a reference to Information Supplied to the User such as in Annex I.  This would include IFUs, eIFUs, DFU, service manuals, operator manual, quick reference guides, installation guides, etc. etc.  And yes this does apply to any electronic interfaces such as computers, GUI, or Apps on smart devices.  It is up to you as the manufacturer to define all these as part of your Technical Documentation, identifying all information which is supplied to the user.  This should also be considered as part of the risk management process (and probably usability).  If you are talking about a company website, translation would be more marketing needs.  If you have any software GUI interface directly with the device such as computer screen or App, then yes, the expectation is these are translated.  I have made a previous comment in another thread where need to think about this from a practical perspective: if you sell an App where target market is home-use for patients in Germany, English is not the main language, so not only not complying with local requirements, you may not have many users.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: eIFU Question

    Posted 21-Mar-2021 00:39
    Ritam,

    No one mentioned Commission Regulation (EU) 207/2012--i.e. on electronic instructions for use of medical devices; see link below, in case it is helpful to you. 

    https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:072:0028:0031:en:PDF 

    When we converted to electronic labeling (under MDD) we had to have NB approval of our electronic labeling risk analysis.  Then the NB reviewed the reference to our elabeling on our product labels when they reviewed our product technical files.  This was a former company and they were prescription Class IIa & IIb devices though.  

    Kind regards,

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    Alyssa Thomas RAC
    Principal Consultant
    Beaverton OR
    United States
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    Original Message


  • 5.  RE: eIFU Question

    Posted 22-Mar-2021 05:02
    Dear all,

    many thanks for this valuable discussion and comments.

    May I ask you: Does anyone know about the current and finalized document from the Saudi FDA on eIFUs? We are aware of the draft document and about the publication of the SFDA on their website, but do only find the draft document of the guidance related to eIFUs.

    The link from SFDA is:

    https://www.regdesk.co/sfda-eifu/

    but there, the final document itself is unfortunately not available.

    Can anyone kindly help us with the final document or explain where to find it?

    Many thanks in advance.

    Kind regards from Germany,
    Folker

    Folker Spitzenberger, PhD, M.D.R.A.
    Professor for Regulatory Affairs for medical devices
    University of Applied Sciences Luebeck
    Germany

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    Folker Spitzenberger
    Prof. Dr,
    Berlin
    Germany
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    Original Message


  • 6.  RE: eIFU Question

    Posted 22-Mar-2021 10:00
    Hi Ritam,
    Alyssa is completely right, do not forget in the whole discussion the reference to the Commission Regulation 207/2012 as required per MDR, Annex I GSPR, requirement 23.1(f). It is stated in 207/2012 that IFU may be provided to the user in non-paper format to the extent, and only under the conditions set out in said Regulation. That means that manufacturers may provide instructions for use in electronic form instead of in paper form where those instructions relate to a specific group of devices defined in article 3.1 of that Regulation.

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    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs | Head of Training
    Arnhem
    Netherlands
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    Original Message


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