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
Original Message:
Sent: 9/29/2023 11:00:00 AM
From: Hans Strobel
Subject: RE: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226
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
Original Message:
Sent: 9/27/2023 10:56:00 PM
From: Anonymous Member
Subject: RE: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226
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?
Original Message:
Sent: 15-Sep-2023 03:32
From: Hans Strobel
Subject: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226
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
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Hans Strobel
www.dokspot.io
Original Message:
Sent: 13-Sep-2023 17:11
From: Anonymous Member
Subject: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226
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?
Original Message:
Sent: 24-Apr-2023 15:17
From: Kevin Randall
Subject: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226
Hi Thomas,
Yes, I definitely consider IFU placed on a website to be eIFU.
And yes, 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
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 24-Apr-2023 14:19
From: Thomas Saladin
Subject: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226
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.
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Thomas Saladin
Regulatory Affairs Specialist
Minnetonka MN
United States
Original Message:
Sent: 22-Mar-2022 13:59
From: Kevin Randall
Subject: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226
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.
Original Message:
Sent: 22-Mar-2022 12:51
From: Mauro Rinaldi
Subject: eIFU Electronic Instruction For Use in Europe under (EU) 2021/2226
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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