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Electronic IFU

  • 1.  Electronic IFU

    Posted 13-Jan-2021 17:08
    Hello,

    We would like to provide an electronic IFU for a product but need to understand the requirements for Canada and the US. Apart from general labeling requirements for medical devices as defined by Health Canada and the FDA, and those specified in IEC 606061, are there any other requirements that pertain to electronic IFUs? 

    Thanks in advance!

    ------------------------------
    Breanne Cuddington
    Regulatory Affairs Lead
    Kitchener ON
    Canada
    ------------------------------


  • 2.  RE: Electronic IFU

    Posted 13-Jan-2021 19:21
    Hi Breanne,

    For Canada, requirements can be found in Section 21(2) of the guidance document "Guidance for the Labelling of Medical Devices, not Including In Vitro Diagnostic Devices" found here:  https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-labelling-medical-devices-including-vitro-diagnostic-devices-appendices.html


    I hope this is helpful.

    Regards,

    ------------------------------
    Camille Thorpe, RAC
    Toronto, ON
    Canada
    ------------------------------

    Original Message


  • 3.  RE: Electronic IFU

    Posted 14-Jan-2021 03:15
    Hi Breanne

    The basic requirement is that the device is intended to be used by a healthcare professional exclusively. In addition, you must set up a process that ensures that users of the device get a printed IFU on request. 

    For eIFU implementation, a suggested starting point is to analyze the quality processes you have for the printed IFU. eIFU should be at least equally quality controlled.

    We have a white paper on eIFU which you can download for more details under this address: https://leadership.dokspot.io/2020-white-paper/

    Feel free to contact me if you have questions.

    Kind regards,

    Hans



    ------------------------------
    Hans Strobel
    CEO
    dokspot GmbH
    Zürich, Switzerland
    www.dokspot.io
    ------------------------------

    Original Message


  • 4.  RE: Electronic IFU

    Posted 14-Jan-2021 05:03
    Hello Breanne,

    Indeed Health Canada and United States have both recognised eIFUs and for quite some time.  As Camille indicated the guidance for Health Canada, they have also stated this is to be used for IFUs for professional use, not for direct patient use, e.g. OTC.  The FDA has accepted eIFUs for a long time with the guidance here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-and-fda-staff-acceptable-media-electronic-product-user-manuals.  There are a few regulatory agencies around the world recognising due to translation needs providing an eIFU is more sensible and available for users especially in such a connected world.  However, just ensure your quality system has all the controls, records, maintenance, and updates needed to maintain electronic IFUs, especially if you keep them in a public location like on the company website.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 5.  RE: Electronic IFU

    This message was posted by a user wishing to remain anonymous
    Posted 11-Jan-2022 21:34
    This message was posted by a user wishing to remain anonymous

    Hi!,

    Can you please kindly re send or add the new link to find the information available in the FDA website?
    Thanks
    Original Message


  • 6.  RE: Electronic IFU

    Posted 13-Jan-2022 03:09
    Hi, here below is our summary on eIFU regulations. Kind regards, Hans

    dokspot summary eIFU - International regulations and quality standards

    In general, regulations and for eIFU Systems for medical devices and/or IVD devices require:

    A that the device is intended to be used by healthcare professionals exclusively

    B a risk assessment

    C a process allowing that a printed IFU can be requested from the device manufacturer free of charge


    International eIFU regulations

    Country / Region

    Regulations on digital instructions (Link)

    Australia  

    Electronic Instructions for Use - eIFU

    Medical device patient information leaflets and implant cards

    Brasil

    Normative Instruction-IN N°4, OF June 15th, 2012

    European Union

    Commission Regulation 207/2012 (has been repealed, transition period until May 2024)


    Commission Regulation 2021/2226 (in force as of Jan 3, 2022)

    REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices (MDR) - Whereas (98),  Annex VI, Part B, 22., Chapter III, Article 23.1

    REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices (IVDR)  - Annex VI, Part B, 19.

    Chapter III, Article 20.1

    Turkey

    TIBBİ CİHAZLARIN ELEKTRONİK KULLANIM TALİMATLARI HAKKINDA TEBLİĞ BİRİNCİ BÖLÜM

    Saudi Arabia

    GUIDANCE O LABELLING REQUIREMENTS FOR MEDICAL DEVICES 

    USA

    FDA Blue Book Memorandum on electronic instructions for use

    Medical Device User Fee and Modernization Act of 2002 - see Section 206

    India

    MTAL - Acceptance of eIFU for Medical Device a Welcome Move: MTa

    Canada

    Guidance Document: Guidance for the Labelling of Medical Devices

    International quality standards 

    Standard

    Details / sections

    ISO13485 Third Edition 2016-03-01

    Sections 4.1.6 and 7.5.6

    21 CFR Part 11

    Requirements of the US legal system for compliance of computer systems with electronic records and signatures.

    GAMP Classification

    Requirements for computer systems used for the manufacturing, supply, and operation of medical devices.

    Important note

    This document lists regulations and quality standards to be considered for the implementation of a medical device eIFU system. Additional manufacturer and device specific requirements apply.  



    ------------------------------
    Hans Strobel
    www.dokspot.io
    ------------------------------

    Original Message


  • 7.  RE: Electronic IFU

    This message was posted by a user wishing to remain anonymous
    Posted 19-May-2022 11:09
    This message was posted by a user wishing to remain anonymous

    Hi,

    Thank you for the links. I just have a follow-up question.  I know FDA has approved electronic IFUs for a few years now but it also states that it is limited to those medical devices that will be strictly used by health professionals. We manufacture hearing aids and those devices go to the health care professionals first before they get dispensed to the end-user. Does this limitation apply to hearing aids as well?
    Original Message


  • 8.  RE: Electronic IFU

    Posted 19-May-2022 11:47
    Hi Anon,

    as far as I know this would be related to the intended user. If this is a professional user like a surgeon, etc. it could be allowed. However, the intended user of a hearing aid is a lay person - therefore, it would not be allowed.

    Hope this helps - All the Best

    Markus

    ------------------------------
    Markus Lantermann
    Head of Q&R Region International
    Mannheim
    Germany
    ------------------------------

    Original Message


  • 9.  RE: Electronic IFU

    Posted 20-May-2022 04:26
    Hello Anon

    The strict regulatory point of view is as Markus explains. For the time being, you have to provide paper IFUs for devices that are intended to be used by laypersons. This requirement can be met in different ways, it does not necessarily mean that you package each device with the IFU.

    From a device safety (and also customer service) perspective I would evaluate how an additional eIFU solution can improve your service to the customer. Keep in mind that eIFU website for patients has different requirements than eIFU websites for professionals.

    Best regards,

    Hans

    ------------------------------
    Hans Strobel
    www.dokspot.io
    ------------------------------

    Original Message


  • 10.  RE: Electronic IFU

    Posted 14-Jan-2021 09:56
    Hi Breanne,

    If you also ever intend to use eIFUs in the EU there is this EC Regulation 207/2012:
    https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:072:0028:0031:EN:PDF
    It includes a lot of requirements that may be helpful when deploying eIFUs in any country. 

    Lindsey

    ------------------------------
    Lindsey Folio RAC
    Regulatory Affairs Consultant
    Portland OR
    United States
    ------------------------------

    Original Message


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