Yes Dirk,
Some organizations are finding that auditors are
starting their audits with a "Web search" using various search terms (e.g. company name, product name, part numbers, device DI, US MAUDE, etc .).
Such a search takes little time and these searches uncover a wealth of information on how a company is marketing their product, how their distributors and supply chain partners are marketing their products, and what claims and medical device "information" is being published (web content is publishing) to the clinical and the general population, as well as uncovering events and risks within the public domain.
One gage of what is important within regulation is the frequency of keywords or ideas. 2017/745 uses the word "Information" 371 times, more than risk (243), post-market (83), Economic Operators (71), or General Safety and performance (57). This would lead to the general paradigm that how and where manufacturers create, control, and publish information about our company or its devices is a critical component of our QMS systems and a key component of maintaining our Product Lifecycle Data Management.
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Michael Chellson
RAC
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Original Message:
Sent: 18-Feb-2021 12:30
From: Dirk Stynen
Subject: eIFU in addition to paper IFU
Good point, Michael.
I started as a consultant 20 years ago and being European I was not used to see promotional materials (including websites) as "labeling". I actually learned that from working with US based companies. I believe that FDA regulations paid more attention to this point than European authorities, notified bodies, etc... and rightly so. It was certainly normal in many companies to see promotional materials being created by marketing without consideration for what the regulatory documents said. Marketing usually being more optimist about the performance of the devices than Regulatory, it is not difficult to guess that there were "inconsistencies". Implementing a process of approval of marketing materials by Regulatory is one of the most challenging tasks I encountered as a QA/RA manager. Some changes are easier implemented than other ones :-)
Given the increasing importance of web based information, I would expect notified bodies to look more closely at the information that a manufacturer posts on the web. Having developed a commercially available eIFU web platform, I know that at least one major Notified Body has a checklist for their auditors to check eIFU solutions for compliance with 207/2012.
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Dirk Stynen PhD
President
Belgium
dirk.stynen@qarad.com
https://www.qarad.com/e-labeling-eifu
Original Message:
Sent: 18-Feb-2021 11:00
From: Michael Chellson
Subject: eIFU in addition to paper IFU
Dirk,
Let's take this up a notch and speak to "Website" content as labeling.
Information presented to the public pertaining to the specifications, use, safety, features, safety data, video materials, ALONG with eIFU & AdProm materials are labeling content and must be controlled and traceable to Clinical, Risk, and Design data in the Technical Documents.
Some MD mfg. have not considered website control as a critical element of labeling control much to their detriment during MDR evaluations.
Time well spent to review what information exists on the Internet pertaining to your devices and ensure those internet materials are accurate and represent data in technical documents, RM, and PMS.
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Michael Chellson
RAC
Original Message:
Sent: 18-Feb-2021 06:21
From: Dirk Stynen
Subject: eIFU in addition to paper IFU
I completely agree with Hans. When eIFU are posted on a website, the possibility that they will be consulted by the user for the use of the device must be taken into consideration. That implies that the entire process of creating and maintaining an eIFU platform is subject to the same level of control as paper IFU.
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Dirk Stynen PhD
President
Geel
Belgium
Original Message:
Sent: 18-Feb-2021 04:56
From: Hans Strobel
Subject: eIFU in addition to paper IFU
Hello Tiina
Our experience in implementing eIFU Systems with manufacturers and supporting them with notified body responses fully supports Kevin's interpretation.
I add a point that is more based on my insight in the subject than on eIFU regulations: The QA checks manufacturers implement for paper IFU, to ensure that the correct IFU version is used for the correct device, are extensive. Nevertheless, there are enough incident reports about failures in these processes. This is significant for a manufacturer because it concerns device labeling. eIFU fall also under device labeling and therefore a quality-controlled approach as described above is strongly advisable.
I hope this ads insight.
Kind regards
Hans
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Hans Strobel
CEO
dokspot GmbH
Zürich, Switzerland
www.dokspot.io
Original Message:
Sent: 17-Feb-2021 16:10
From: Kevin Randall
Subject: eIFU in addition to paper IFU
Further to the prior (August 2020) discussion and my posts and decision tree provided thereunder, my interpretation is that eIFU may for any device type be provided in addition to paper IFU. And in that case, such an approach is, by my interpretation, subject to the conditions imposed by the eIFU Regulation for providing eIFU in addition to paper. In other words, my interpretation is, to be safe, that this remains the case even for a device that is not an eIFU Regulation Article 3 device.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 17-Feb-2021 15:47
From: Kevin Randall
Subject: eIFU in addition to paper IFU
Hi Tiina, I'm thinking that my narrative explanations and decision tree in the prior discussion addressed the necessary principles to properly approach the "in addition to" scenario as distinguished from the either/or scenario. I'll look those over again to see. If they don't yet answer your current question, then I'll endeavor to circle back in this current thread to provide further narratives.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 17-Feb-2021 15:33
From: Tiina Tyni
Subject: eIFU in addition to paper IFU
Thanks Mark for sharing your experience clearly.
Kevin, I saw the thread prior to posting the question. Really good discussion and points, the decision tree was informative. However, I wasn't able to find the specific nugget of information I was still looking for, which is in addition to, rather than either...or scenario. If you have any advice or tips to share on the former, I'd be happy to read them.
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Tiina Tyni
Regulatory Consultant
Finland
Original Message:
Sent: 17-Feb-2021 12:47
From: Kevin Randall
Subject: eIFU in addition to paper IFU
I think you might of value the prior Forum discussion and responses involving this general topic at: https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=6e508864-48da-46ae-9a98-05b2e9a77bab&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer&SuccessMsg=Thank%20you%20for%20submitting%20your%20message.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 17-Feb-2021 07:28
From: Tiina Tyni
Subject: eIFU in addition to paper IFU
Hi,
lots of eIFU exchange going on here, but one thing or angle I wish to pursue after is that when Regulation (EU) 207/2012 is applied in providing an IFU on the manufacturer's website in addition to (not instead of) providing a paper IFU, are only those articles of 207/2012 which talk about "eIFU in addition to paper IFU" (e.g Article 9) applicable? The device in question does not fall under Article 3 of 207/2012.
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Tiina Tyni
Regulatory Consultant
Finland
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