Navigating the eIFU Regulation 2025/1234: Strategic Implementation Across Product Portfolios

Hello and welcome, everybody, to today's call on EIFU instructions. We have, a number of fabulous speakers today. Alexia, from… Alexia Lynch from Accra Team, who is the lead of training, community, and Engagement at Accra Team, is going to introduce everyone, and I'm going to disappear. Bye!

Thank you so much, Sean. Indeed, welcome, everyone. Thank you so much for joining us today, for this, webinar, on navigating the EIFU Regulation 2025-1234, Strategic Implementation Across Product Portfolios. As Sean said, I am Alexia Lynch, I am the Training and Community Engagement Lead with ACRA team. I'll be your moderator today on behalf of MedTech Leading Voice, with whom we are partnering to bring this webinar over to you. We're going to share some practical guidance on how med tech companies can prepare for expanded EIFU eligibility across professional use devices in the EU, with a focus on implementation challenges, regulatory expectations.

and system-wide opportunities. I have the pleasure of welcoming our subject matter experts, and we have quite a lineup of speakers. We've got Diane Legere. from DNV Product Assurance, she is Senior Clinical Auditor. Ardi Batman Gelich from Innovatum, Inc, he is the president of the corporation. Wuna Kabede, Senior Regulatory Consultant, and a dear colleague of mine with the ACRID team. Roger Peterson, Senior Manager, Global Legion, and part of the expanded regulatory Team with Arthrex. And, last but not least, Michael Kanya, the CEO of Medevo, before we start, a few quick housekeeping notes for you all to know how to interact with the Zoom platform today. First of all, know that the session is being recorded. The replay and any available slides will be sent to all registrants. If you'd like a certificate of attendance, please enter your full name and email address in the Zoom chat. And I'll say that again, because we always have a few delays.

Quince, who don't follow the instructions. We need your full name and email address in the Zoom chat, please, and we'll be more than happy to send you a certificate of attendance for the webinar. You can use the Zoom chat to say hello, interact, and share insights. And if you have any questions for our speakers, you can put those through the Q&A chat box in Zoom. And we will have a poll, pretty much halfway through our webinar today for you to answer. We do hope that you'll interact with that poll so that we know a bit more about who you are out there. Thanks so much, and I will hand it over to my lovely colleague, Muna, for a short presentation.

Alright, I think I am online. You can see my screen. Perfect. Good morning and good afternoon, everyone. My name is Mona Cabeta from Accra Team, and I'm happy to welcome you to this webinar on, navigating the EIFU Regulation 2025-1234. And today, we will explore the key changes and practical implications for manufacturers and stakeholders in the medical device sector. And before we dive in. A quick disclaimer, this presentation, is for educational purposes and not to replace the legal text of the legislation standards or guidance documents. So, here's our agenda for, for today.

is, for this portion of the webinar, which presents the regulatory background to set the stage, our agenda for this portion would be, to cover the development of the EIFU regulations, highlight what has changed and what remains constant, and highlight some implications for quality management systems and technical documentation. So, regulating the EIFU began already during the MDD era, where in 2012, the regulation 207 to 2012 set rules for the provision of EIFUs for certain devices. And when in, 2017, the EU MDR replaced, the directives.

The regulation, had introduced the regulation had introduced the rules under GSPR 2013, 23.1F, which allows IFUs to be provided electronically under certain conditions, which are set in the aforementioned regulation. And the regulation in 2021, was published, so Regulation 2021-2226, and enforced in 2022, replacing the old regulation in order to adapt the rules to the EUMDR and to the technological developments as well. The most recent development took place in June of this year. That is the regulation we are talking about today, 2012-1234, only amending the other regi- the older regulation. So, while the majority of the existing provisions remain, the amendments introduced are a highly significant

And this is mainly because the scope has been expanded now, encompassing all medical device manufacturers. And this marks a substantial shift in a number of aspects, not just a regulatory impact. In addition, the changes include other significant aspects, such as a requirement to link the AIFU internet address to Udemed, and revisions on how obsolete or historical versions are managed. And these updates also reflect, I suppose, the current zeitgeist, which align with today's technological landscape, and growing emphasis on digitalization and online integration with the regulatory frameworks available.

So the initiative to expand the scope stems from a concerted effort by the European Commission to modernize and streamline the medical device regulation. The survey conducted in 2024 Targeting healthcare professionals played a pivotal role in highlighting the sector's readiness and preference for digital solutions. So now, all medical devices and their accessories covered by the EUMDR, intended for professional users, are included. Including legacy devices and devices without a medical purpose, an intended medical purpose, listed in Annexes 16 of the EOMDR. With this, the Commission aims to, enhance the efficiency and accessibility of medical device information, which ultimately contributes then to improved patient safety and care outcomes.

So, underlining this, additional changes also emphasize the importance of traceability and transparency. And hereby, the, they set retention periods which have not changed, they remain unchanged. And most notable is also the removal of .12 under Article 5 of the Regulation 2022-22. Where manufacturers are no longer required to have systems in place to inform users of EIFU updates or corrective actions for the downloaded EIFUs. And with the replacement of .13 under that same article, The amendment cements that All historical AIFUs do not need to be available on the website. Instead, obsolete versions may be made available upon request.

So, this is not only a load-off for manufacturers, but also makes a lot of sense from the risk perspective, and may provide more opportunities for mitigation. So, despite all the changes that are pretty significant, there are some constants which remain, mainly embedded within risk, which includes usability and risk consideration and security considerations as well. And risk management still plays a central role in EIFU management, and manufacturers must assess and document this assessment. They must assess the appropriateness of providing the EIFUs electronically instead of in paper form. And in this, certain elements such as knowledge and experience, environment, access and security, compatibility, as well as emergency situations must be considered.

And usability and human factors are also very critical. The EIFU must maintain or improve safety compared to the paper IFU just said. And the manufacturer must continue to obtain data from the field and collect and monitor the use of the EIFuse to verify and improve the system. Therefore, the risk assessment should also be updated based on post-market experience continuously. And, now turning to practical implications of, for the… of the AIFU for QMS and technical documentation. A few highlights are, the QMS must enable ongoing consistency in content.

and allow a timely access to paper IFUs free of charge to users. And this is embedded within the risk assessment timeframe, the time given in the risk assessment, or no later than 7 days. Which remains the same as in the old regulation. This guarantees that, access to instructions is never a barrier to safe use Of the device, even in emergency situations, and for users who cannot access electronic formats. The design and functioning of the EIFU system must be properly verified and validated with evidence maintained in the technical documentation. So, also version control should be embedded in the change management process to enable real-time updates as well, and maintain traceability.

To this end, manufacturers are expected to establish and maintain robust procedures that cover the entire lifecycle of the electronic instruction for use. The technical documentation must include evidence how these requirements are met and applied in the risk management system, in the usability files, as well as in the PMS plan and report. Even supplier documentation may be required, including records from, for example, translation services, platform providers, or technology solution partners, ensuring that every aspect of the EIFU's creation and maintenance is traceable and controlled. So, in summary, compliance with the new regulation requires a holistic approach.

And, most probably also a cross-functional team to apply efficient solutions. The EIFU system must guarantee that users can always access the most current and relevant instructions, regardless of their location and the device. So, this is just a short input and a summary before the more interesting part, which is the panel discussion, and I thank you for your attention. And, we'll end this short presentation at this point. Thank you very much.

Thank you so much, Muna. So, I see that we already have the poll up. I was going to say, indeed, we are going to run a very quick poll for the audience to enter a few details about who you are, where you come from, what your specific area of focus is with regards to this topic. That'll really help us understand a bit more about who is viewing the webinar today. Thank you so much for that. Muna, I'll let you also, interact with our speakers here so we can get things kicked off, while the audience goes through the pool. Thank you.

All right, thank you, Alexia. Yeah, I look forward to this discussion, and welcome fellow panelists and our speakers. I'm very happy to share this time with you as well. And to kick off the discussion, I would like to start asking each of you to please share one key concept For, for this topic, from your perspective. And I guess I will begin with, ladies first, and Leger, would you like to kick off? Let us know one key topic from your perspective.

Yeah, I feel like this is probably… everyone's gonna be, wishing they were first, because we probably all have a similar answer around, change management, and how this change in the regulations has really pushed forward the…

the need to be very strict with change management and how that's going to be addressed in your QMS system. Perfect. I will move on to Artie, would that be okay? Oh, absolutely, and she laid it out for me. Thank you, Diane.

I… I come from a background of about 25 years implementing labeling and artwork management systems. And I look at an EIFU system. In some cases, it is one system, but in many cases, there is the system that manages the back end. At the manufacturer location, with change control, etc. And also, then, there is the EIFU hosting, which can be done in-house, or it can be done with a service provider in a multi-tenant EIFU system. So I think it's really important from the label artwork management system perspective to, have version control, to have source control, if you're doing InDesign files to generate your PDFs, whatever you're doing,

A lot of companies manage those in folders or in areas that are not as controlled as they probably should be. So, a system that allows you to store that information, manage change control, link it with the catalog numbers, link it with the languages, and then push a button through an API to upload it to an EIFU system. That's what we're working on, that's what we would advocate for companies to try and achieve as a goal.

Thank you so much, Ardia, absolutely. I would love to move on to Roger.

Hey, thank you. So, I'd like to echo the change management process in support of EIFU to what I consider the most important aspect, and that is once the IFU is electronic, it becomes keenly relevant to the end user, okay? It promotes safe and effective use of that respective medical device, IVD, and with that, you know, consider, you know. largely, you know, devices that have been on the market, you know, they're in distribution, they might be in distribution for a year or two before they're actually consumed. And imagine, you know, being able to provide, you know, relevant, you know, up-to-date

instructional material, that promotes safe and effective views on demand. And that is the goal, behind EIFU.

Great. Last, but absolutely not least, I hope.

Yeah, thank you. I like the change management aspect, I like the automation aspect that, that you were talking about, and I would like to bring another perspective to that whole topic, because when I'm thinking about EIView. I'm absolutely not thinking about paper and PDFs. And I think that we should… take the, take a risk and look at, options that we have from the technology perspective, what EIFU can become in the future. Talking about content pieces out of the technical documentation, nice traceability, directly pushed to the user when the user needs it. So that is my, my take on EIView.

Wonderful. Thank you so much. So, I would, yeah, these are great inputs. So, I see a change control, version control. And technology coming together, and I, and automation, so I think this will probably take us through our, our discussion today. And I'd love to jump directly into the second question. Which is going to be directed to our notified body panelists, Diane and, Roger as well. So how does the, elimination of the obligations that we just talked about during the presentation, so Article, 512, the obligation to track and inform users who have downloaded and,

the EIFU, And, about up… so not to update them on the corrective actions and other updates on the IFU, and also the, change in Article 5.13. The requirement to make all historical versions of the EIFU available on the website, is no longer there, but rather providing obsolete versions upon request is allowed. So, from your perspective, Diane, maybe we can start from the notified body perspective. How does this, impact risk management files or post-market surveillance plans, and generally the manufacturer, from a notified body perspective, the expectations And maybe, Roger, you can, you know, elaborate a little bit more from your side and your perspective on the solutions and implementation on this. I'll start with Diane. Sure.

Okay, well, thank you for the question. I was gonna say, the prior legislation of having tracking users was a good example of… I don't know if you've heard the term regulatory lasagna, coined by Eric, and I'm not going to pronounce his name correctly, Volbrett at Axel Mares. But the layering did not necessarily fit when you think about the GDPR, and I always get those, those, initials wrong, but I think I got it right this time. But when you look at what, those requirements were, and trying to layer them, with the MDR, it was, very challenging. But this now, with the illumination, has created a different sort of,

issues with trying to track, because it kind of made sense, right? If you… if you were able to track them and you had an update, you were able to easily, easily, send them an update or a notification, so now, now we don't have that. So obviously EFU… EIFU brings, its own set of risks for… that need to be addressed in the risk management documents. It needs to be managed in your PMS plans, addressed there. Maybe specific PMCF activities could be used to address how are these being implemented in clinical practice. Because obviously it's not going to be the same across, across all. Yeah, really looking at how these EFI… oh my god, IFUs are addressed. I want to know how they're really being used in clinical practice, and that would require a very specific, PMCF activity that I want to see.

The other is really thinking about tracking the version control, so if you're having an on-site audit, and there is, maybe a new risk that was addressed, you need to be able to sort of temporarily show, you opened a CAPA based on this, even though now you've addressed it here, and you validated the change. So you really need to be able to show that, Sort of swim lane, if you will, of change.

Thank you. Not sure. Yeah, so, yeah, great response.

So… There's also the other, aspect, related to, you know, manufacturers that have already hosted, EIFU, okay? And with that, there's the utility of understanding who is accessing. a particular IFU in a particular language, okay? That's a metric. You know, post-market surveillance aspect, you know, understanding, you know, the use, of that particular IFU. With that, you know, one thing that we have done is we actually make it volunt… or we've enabled a voluntary, function Where an end user can subscribe. to an IFU, okay? And if they so do choose, they can, you know, access an IFU, you know, based on a notification that, by the way, you know, this IFU was updated, additional, indication, clarification, or critical warning, you know, to give them that insight, you know, that a change has occurred, is very important.

You know, for the end user to understand that. And that's a metric, you know, from a post-market surveillance perspective.

Perfect, yeah. Yeah, that's quite interesting, actually. It's, it's, it's a very, relevant topic for, for, tracking for PMS, and…

A question for Roger. It took significant technology to enable this notification concept, right? And because of GDPR, as Diane said. It couldn't be something that was done automatically. They always had to subscribe. So now that it's not a requirement, is it still a good function to have?

Yes, it is.

take that away.

It's good for two reasons. One, you're understanding where, you know, the IFU particularly is being accessed, okay? And in what language. Understanding, you know, the use, and… with that, you know, when you have an IFU that has obtained numerous hits, like, let's say in a particular language, maybe there's a nuance related to how it was translated. You know, that there's a particular, misunderstanding, or they just have to really concentrate on the content. that is, to us, a flag that we need to revisit, okay? Yeah.

Yeah, telemetry data is critical in terms of measuring use, identifying any issues that are kind of developing, patterns, etc. I agree with you.

So staying around that question, maybe this question is for you, Michael. Staying around that question, but the second part, for manufacturers who decide to keep all historical IFU versions available online. So, no longer give the option to provide the obsolete versions upon request, but those that decide to keep all those historical versions online What solutions or best practices can help ensure that users do not inadvertently refer or apply outdated IFUs, for example?

It's, honestly, it's really, really usability, how you are presenting, the data or the PDFs to the end user. And sometimes you have these use cases where you are maybe marketing disposable devices. So, what about maybe older versions, and you have something on stock? Then you have maybe the non-disposable devices, where then the updates are related to, to your current product, or maybe to a specific version of the product, and so on. So… there are a lot of use cases, and it's not so easy to say, okay, you simply have a current IQ, and then you have some older version, so you need to clearly communicate that.

this is… this is not always that easy, and what we… what we found in developing our solutions is that when you are addressing that to the user, clearly by user interface, that they are at a wrong version, or not at the current version that is available, this is a great choice to do so. to keep in mind user interface for the specific instruction for use I'm looking at, but also when you are browsing and searching for instruction for use, to have a clear… so the user can clear distinguish between this is the current IQ and this is maybe some history version, and also make that clear via red alert colors, when they are visiting, that if you.

Perfect, thank you so much. And talking about versions and version control, I think there are questions around that as well. And coming to my fourth question, RD, it would be great if I could address this, question to you. What are the most current and scalable solutions, let's say, available to ensure automated version control, real-time updates to users, and to ensure that the users always have the latest EIFU versions, basically. For the… and also, on top of that, for the relevant member state language where the device is placed on the market for, so…

I don't know.

Smart IF use QR codes. Absolutely, and I…

And I want to finish Michael's thought, because he's Spot on.

But, you know, there's two aspects to this. There is the presentation layer.

Yeah. Where a user goes into the website and scans or enters a reference number or maybe a GTIN or something to identify the product. And then at that point, through geolocation, often, the IFU system determines that this person's coming from a particular country, and their language is this, and etc, etc. So, that's on the presentation layer, and also it should be aware of what the latest version is, etc, but… Something's gotta feed that information into the EIFU site. And that's the job of the back-end systems. So you need systems in which you have a listing of all of the EIFUs.

version control, so you've got version 1 and version 2 of the IFU. And often with a version change on an EIFU, you're adding some catalog numbers that are now covered by that EIFU, or you're subtracting some catalog numbers that are no longer covered by that EIFU. And then that EIFU initially starts with an English language content, and then it goes through the translation company, and then all of the baby EIFUs come back for the various single or one or two languages. So now you've got you've got assets, a few assets, sitting in your backend systems. Now you've got to link them electronically in a very precise way to the catalog numbers that they cover, and the version of the catalog numbers that they cover, and all the languages.

and then all the countries that they support. So, you create this infrastructure in the back end to be able to make those associations and then you load them into the presentation layer, whether it's yours or a hosted solution, etc. And then, as Michael described, then the user gets that experience in a really pretty. and useful user interaction. So the back-end systems are really critical in being able to manage all of that information.

Yeah. And also, I suppose, all of that management and, electronic management, solution management should be documented somehow in your quality management system. And also be provided, as an audit trail when the notified body, comes along. So, how can… how would you, from, you know, from a manufacturer's, maybe, perspective, establish these effective change management processes that maintain the audit trails for the ERFU content modifications as well. And maybe after that, Diane can jump in and say maybe what she would expect as well.

Well, let me give you this up, there's that scary word, validation, right? Everything has to be validated and controlled, audit trail, Part 11 compliance, etc, etc. All of that has to be built in. And, you know, with any good GXP system, and this I would consider to be a GXP system, all of that has to happen. So, pass it on to you, Diane.

Yeah, you know, I was going to say these are… these are living documents. We expect them to be living documents. They've always been. I just feel like now they're kind of maybe multiplied, in a sense. But, You know, back to the… you hear notified bodies often say, tell the story. So when you need to make a change to your document, you need to clearly document why… what was the assessment that showed that this change was necessary? Then you need to do the change. Then you need to use that scary word, validate around how do you know the change that you made was actually serving its purpose? Did it do what you expected it to do? So when I…

when I review it, that's what I want to see. I want to see… I want to see that story. I want it to make sense. I want it to be clearly documented and, you know, link references, to… to it. And then also the knock-on. I want to see that whatever changes you made. On this document, there's all these other documents and processes that are affected by it. Show me that those were updated. As well. And then I want to know, what extra or additional risks do the EF… EIFU… God, I really struggle with that. make, and how have you… how have you addressed those? So again, tell me the story of how you're addressing this. Don't just go, okay, this is going to be…

when I look at my regulatory strategy, easier, because it's electronic, and I don't have to send it to the printing press, and every time I make a change. It brings its own other set of… Of, risks and issues, with it, and you need to show me you planned for that.

Perfect. So I'm… I'm gonna jump to a 12th question that I had, actually, because now, right now, we're talking about risk, and I'll stay with you, Diane, on this, and I have a question for Roger right after. So what would be the major risk assessment elements, specific to EIFU delivery that are often missed by manufacturers or inadequately assessed or misunderstood?

Yeah, that's probably a good question for some of my panel here, but I will just tell you that for me, I'm looking at accessibility, I'm looking at your security, and how you're going to ensure that the IFU is not tampered with. I'm going to make sure that the version control that we've talked about quite a bit here already, and then again, just making sure all GSPR23.4 that's relevant to your.

my view is still relevant. So the rest, I think, if anyone else can add to my, to my answer, that'd be great.

from a very high-level technical perspective, like, when you have the accessibility of the IPO needs to be assured, how are you managing that if your server goes down? What is your backup server?

Right.

Is there any gay or redundancy in your landscape, and so on? So I think this is things that, when someone starts thinking about, oh, let's move to EIView, they are not thinking about that.

Yes. Absolutely, and sorry to jump in on that. That is key, you know, the failover, redundancy of hosting an IFU, EIFU, making sure that, you know, in the true sense, it's persistently accessible. But for the end user. It's critical from an IT perspective.

And just because it's something that happened last week, we had a major AWS outage last week, and… a bunch of systems weren't accessible over the internet, worldwide, so… This can also happen, and those things happen, sadly, but it's not about these major outages that we have from huge providers. You need to start with your own systems to keep them alive.

Yeah, perfect, and so, talking about systems and online systems, that is a big topic, and has been since UMDR kicked off. and functionality. I'll go back to question 7, and I would love to stay with you, Michael, on this one. What, solutions can manufacturers implement to, ensure that the internet address, for example, where their AIFUs are hosted, remains continuously up-to-date on Utimed, so real-time updates. from a QAMIS perspective, so if that, if you want to jump in afterwards, perfect, and… or, you know, automated solutions that can support and maintain accuracy and compliance.

Yeah, I think this is… this is a brilliant question, because, you are changing things on your website, or on your EIFU platform, and so on, and how to ensure that, because you want to point the people to the right, address, and which is also registered, on the UDAMAT. So, what we think is a best practice here is to, maintain an evergreen linkage to the products that you have on your site. So, it doesn't matter how many times you are uploading a new revision of a specific document for that product, it needs to stay evergreen. So, never expire. It should be, always the same URL and everything. So this is something, where when you are implementing or coding something on your own, you need to have that in your design inputs to develop that, because this link that you are registering in Udamet, it should be, never be changed.

for this specific product, when you are taking, for instance, the product code as a URL slug, but everything inside of these addresses needs to be untouched. for eternity.

I love that answer. I'm gonna tell you, I try to think about, as a clinician, so my background is in critical care, and when I try to think of how I would incorporate IFUs, because I'm gonna be honest. I don't remember using one when in my, like, almost 20 years of clinical practice, I don't remember really using one, so… to… I don't really understand how we're going to ensure users, clinical users, are aware of this, so that's sort of a question from me. And then also what Michael's saying, I need it to be the same. I'm… I'm busy. I haven't peed for 8 hours, and I need to be able to go onto that site and navigate it easily, and it needs to look… it needs to look like I think it's going to look. So I love that answer, Michael.

Perfect.

Yeah, the other element, if I could just add, is remember the linkage on the label that's on the box?

Yeah, yeah.

Right? Roger and I are… Yeah.

Right? Yeah.

Because it, you know, that… if your product, and we have customers that have 10-year shelf lives. So, all of that needs to be static, on the label, and evergreen, as Michael said. It's super critical.

Yeah, and to add to that, Artie, you allude to, you know, the URL and how it is concatenated as far as linking specifically to an IFU. And there's two really Use cases. One is where you have a generic URL to a hosted service, and you train the end user to use a key code, you know, catalog item number, or a UDIDI to access that IFU, okay? probably the most preferred method, but there, you know, depends on, you know, a manufacturer's portfolio. You know, maybe you're a medical device manufacturer, and you only have 25 to 100 items, in your portfolio, you may choose to, you know, your URL includes the key code, okay? But there, too, you need to maintain that, you know, constantly, within your QMS, have processes in place to ensure that, from a design assurance perspective, that that's always on the label.

Is key.

Yeah, and to add to that, Roger, if I could add to that very quickly, it's also part of the website design, that if a company makes a decision to go with the URL and then the key code of that particular product, that if that product is no longer on there, that you don't get a page not found, but you get… you know, a search bar that… into which you can put the new key code, and then continue from that point on. It's a little thing, but it keeps it evergreen.

Exactly. And to that point, you know, ensuring that it… you alluded to earlier, when you add additional, let's say, a line extension for a particular product, you add those key codes to your website, okay? So that you don't have a situation where an end user types in the key code, nothing found. You know, you always maintain that traceability of, okay. the portfolio is, you know, evolving over time, and that you maintain that to ensure, you know, that it's, you know, the IFU is accessible.

Sorry, I interrupted somebody. I think it may have been Michael.

No, but this was perfect addition to that, so…

Would you, would you like to continue, Michael, a little bit? Because this, I think this is quite an important…

It was just…

You're learning so much from the technical.

the idea about this 404, or search bar, when there is a missing link. So, from the technical perspective, of course, it's possible to have a mapping of links, so if you decide to change something, you can forward the users and so on, but Think about how large your portfolio is, and if you want to maintain, additionally, this new dimension. of mapping for forward URLs and so on, this will be a mess, and also for the QM to maintain the documentation for that.

Yeah, and I can imagine, What implications this might have, maybe, also for all of you, if the manufacturer is, having a hybrid portfolio for both paper and electronic IFUs, so during the transition period, is there any implications on that, or is that something simple to manage, or would you think that there's no impact? I cannot have… I can't wrap my head around that one.

there might be a very huge impact, because imagine if it's not QM controlled, and you have something like, well, we stopped printing that, but there is no online iView or the other way around, so I think that this is something that needs to be really, really good in a change process.

Right, absolutely. Yeah, good point, Michael. The other thing, too, is, there might be some utility, actually, in having a printed IFU. particularly depending on the device type, okay? What comes to mind is medical electrical equipment, okay? You have a surgical technician and a IT professional setting up a device, and sometimes it's… there's some utility in that. That's the first thing they see, is some high-level instruction on how do they set it up, okay? How do they, you know, configure a particular device. But then… you know, the… as far as expanded instructions, you know, of use and etc, you can enable, on that printed construct a QR code that they can scan.

And then that leads them to, okay, this is the IFU for how do you use it? You know, to build that hierarchy for a particular device. You know, some of those considerations, and maintain that in a very robust QMS process.

If… if I could add to that, So the hybrid is not as much of a problem on the website, right? You scan for a country code and a reference number, and it either shows up or doesn't show up. Where it's much more of a burden is in the packaging of the product, or in sending it to your distributor or end user. That's where it becomes really important, and I saw a question in the chat just popped up that said, who's got a list of what countries accept EIFUs and what countries don't? So, that also factors into it. And what you need is, again, from my perspective, systems that say, I'm packaging this, and if you package for a certain destination, for a certain country, then having an awareness of whether EIFU is supported for the product, or EIFU is supported for where it's going.

is going to be critical in terms of adding that additional single-sheet EIFU, or IFU replacement. So it's in the back end that that's really, really critical.

Yeah.

already implemented, basically, in the packaging process, and manufacturing process of the product, and I guess it starts with the order number, and knowing where everything is gonna go. Yeah, so, Well, that… that was really great, this discussion. I love it. I'm gonna put, you know, move a little bit to a bit of a different focus. So the manufacturer has now the option to, to, implement electronic IFU or paper IFU. So, I'll go back to Artie and Roger for this one. So, how should manufacturers maybe approach the optional nature of this EIFU adoption from a regulatory strategy perspective, and what would determine, like, a go, no-go decision per device? So, what's your experience in this?

And of course, Michael and Diana as well, you could… you may jump in. I think this is for everyone.

I defer to the maestro, Mr. Peterson, on that.

Okay, so.

Yeah.

Yeah, well, and thank you, Artie. So, what comes to mind, go versus no-go, I mean, in general, you know, the idea of providing EIFU is advantageous, from an end-user perspective to ensure, you know, relevant information, and then also from a manufacturer's perspective, the cost of maintaining a paper IFU. But what comes to mind, really is, products that are in the field, okay, that have a paper IFU versus, okay, the most relevant, information that's provided digitally or electronically. And then the other use case, is really,

which comes near and dear to my heart, really, is the transition in certification. And you're moving from an MDD-certified device to an EUMDR-certified device, okay? And with that, you likely have additional content to meet very specific general safety performance requirements under EUMDR in an electronic IFU versus a paper IFU. FU that's in a… carton or box. And then what has to happen is that assessment of the inventory, okay, that you have in your control. Do I rework that inventory, okay? to ensure that the EIFU is represented with the ISO 15223-1 graphical symbol.

see electronic instructions for use, or do I simply, you know, control where that product is distributed, you know, and not move it into the European market for obvious reasons? So those are some of the considerations, really, you know, that we're experiencing, is, you know, that transition. And, you know, going from, you know, an MDD-certified device to an EUMDR, That's… that's… that's very important, you know, to understand what you have in your control, that might require re… rework, actually.

In the manufacturing process, keep in mind there's bill of materials, and my God help us, we've gone through a bazillion bomb changes because of these kinds of things, so you have to remove all the IFUs. And then it, like, for those of you who sterilize product, it has an impact on sterilization, because all that paper's no longer in the box. So, there are a lot of implications, but it is a huge money saver with massive ROI that can be established very quickly.

Agreed. And you bring up another good point, Artie, regarding, you know, the size of that IFU. Under MDD, for instance, that IFU may have only had maybe 6 or 7 languages. As you know, under EUMDR, national provisions, decrees within the member states of the European Union, for instance, intend to enforce language requirements. So that IFU, all of a sudden, you know, you've got, you know, maybe 20 languages in total, okay? Up to, you know, the 23, representing the European Union. And so, with that, you know, to go from a paper 7-language IFU to a 20-page is sometimes not feasible, okay? So it's almost forcing the, or leveraging, really, the utility of EIFU availability.

We saw even manufacturers getting problems that during the packaging validation.

the huge eye fuse were damaging the sterile barrier.

And, there you have it.

Yep.

Yeah, I was just gonna add… I was just gonna add that, my expectation is, is that the manufacturer knows their users and is in control in that knowledge. So, where's your device used? So, what about devices that are used in the field? Where if you use just not, maybe, practical, there's no accessibility to it, or… Wartime, or, you know, conflict, or… where I live in the middle of nowhere, you know, when the EMS comes out. So, just also, really considering all of your users and how your device is used is important, for, for my review.

Yeah, I absolutely agree, Diane, on that as well, to, you know, consider all of the areas, and not only that, but also maybe the type of professional users that are using it, who's your audience, is not always the same type of professional user. I think maybe, Roger, Michael. So, talk a little bit more, on this topic. So, I think it's question 16. When you're assessing usability, for example, of your AOA, or evaluating the user-related risks, what does that mean, you know, for the design level?

Right. That's a good point, and Michael actually, you know, mentioned it early in this presentation today, or webinar, where this is headed, okay? EIFU. And with that, we need to look at the user lens, okay? What that means is the particular user that needs that information in a particular IFU, they may need not… they may not need all of it, but let's say you're a sterilization technician, okay? And you have a non-sterile device that needs to be processed, okay? You're laser-focused on, I want sterility information, I want to know how to sterilize this, okay? Imagine in the future where we can

Provide that specifically you know, on demand, to that particular user, based on their need, okay? You know, digitally. And, you know, to have that topic content delivered Directly to that particular user, in any point in time.

Padre, I can really relate to that, and also, Diane, your story about your past, as you were working in the field. And, I mean, what is the reality? You are not using iFuse for maybe a decade, or I don't know how long, but when you want to use it, you really need to. And in that special case, imagine the user opening your EIView portal, and then you have, like, this PDF format. With a lot of languages, and the user goes, like, pinch and zoom, and pinch and zoom, it's really not good. We need to make sure that the user gets this information, as Roger said that, on point. And that's why, I am a strong advocate of non-paper or non-PDF-based IFUs for the future.

Right, yeah. Yeah, and that is.

Yeah, no, that's a good point.

Yeah.

Yeah, I was gonna say, if you're… you're right, if I opened one, I needed it emergently, I needed to get to the point that I needed quickly, and so I don't want to have to… Scroll through so that being able to put a search term in. And get what I need immediately is super important. And, I mean, to be honest, IFUs were always created more for legal purposes than the user. And so I see this as a great opportunity to really look at what do our users need? How can… how can this be a tool that's… Actually helpful when used.

Yeah, I don't disagree, and I think, Michael, it is the future, and Roger's working on projects like that, but even today, as a short-term solution, many companies have single-language IFUs, so it really is just… one or two pages specifically for that language, or for those sets of languages. So, there is an intermediate, but I do agree that the future is probably fully digital.

That's true.

Yeah, so, talk, you know, it's, it's important, we were talking about, you know, the digital aspect and the paper I fuse, or PDF IFuse, but I see in the regulation as well, maybe, Diane, you can, you can address this as well, that, it's required to see what foreseeable medical emergency situations would require the availability of information in paper form. And from a clinical, maybe, perspective as well, and in your experience, what type of devices or situations are typically involved in these scenarios? And, what do manufacturers often overlook and… or underestimate in their risk assessment to this… to this respect? So…

Yeah, so I alluded to it earlier, around when you think about, services that go into the field, anything that would be in, you know, when you call EMS, and anything that's sort of housed in there, so… you know, DFib, ECG monitoring, anything, anything like that that is, used in the field would, be challenging to think that you could always access, an electronic anything, to be honest. So, anything like that, You know, talking about, sort of, emerging Michael's point, I… it reminded me when I was working with Greg Brompton and Royal Brompton, sorry, in London, and I was working on an ECMO machine, so an extra, like, heart-lung machine, but… but in the unit.

And the bridge pulled off. And I was training, and my senior person totally disagreed with how I should manage this, and we were literally discussing this while blood's flowing everywhere, and having an electronic version, we could just go in and bridge fell off. Something, some term that would be appropriate that you know, in our usability training, we… or testing, we thought about, and we could have not drained the blood bank, we could have served that patient better. So, you know, having that in paper format would be challenging. I know that was part of your question. We would never go there. But back to a prior discussion on… that would have been exceptionally useful. That would bring IFU to

the four in clinical practice. If you will, where it has extreme usefulness. Back to the… to the… just to summarize for your prior question, is anywhere where you just don't have accessibility, and you have, devices that are used in the field.

Okay, thank you very much. I think, it's about time for us to conclude. I would love to hear more about this, really, especially, you know, regarding the trends that we anticipate in the future.

Sure.

I'm not really the tech head, I'd say. So, regulatory and clinical, and very much, very much stuck with the human biology part of things, but this has been really interesting for me. Thank you so much. I'm sure our, you know, listeners have got way more interesting questions as well. inspired by this as well, I hope, and I'll give over to Alexi Lynch. Thank you very much, all of you.

And indeed, indeed, thank you all, because this has been a very, very interesting and dynamic conversation. I know that I've already taken a lot out of it, thank you. Indeed, we have questions that have come through the Q&A box. We have too many to take in the short 5 minutes that we have here, but we'll do our best to perhaps reply to those that are left unaddressed. in the live setting, over a PDF post-webinar. We'll do our best with that. But to look real quick at, some of the questions that we have here, and this… I'm going to make you repeat a little bit of some of the content you've already gone through, but we had a number of questions that, if I bring them together, basically look at, when a company does want to move into EIFUs, does that company need to get approval from the notified body before implementation? And is that move from traditional to electronic IFUs considered a significant change?

Can we just clarify that? Because we had a number of questions come through focusing on that single point.

Yeah, that's a really good question. A priori approval, no. I mean, it's still GSPR23.4, all those, requirements still need to be met. If you have any changes when you go… any significant changes that you're adding, then in all, unless you're just Replicating your IFU, I would say no for significant change. If you're adding anything, which my guess is you probably are, that I would say, check with your notified body, there probably is a significant change. And I don't know if anyone else has this experience already, or thoughts?

One thing that I… this is Roger, that's helpful from a notified body conformity assessment perspective is, within your technical documentation, to have a checklist of the languages and the intent that you're going to provide that IFU digitally, you know, or, you know, electronically, and list the languages, because they like to see that. That is our experience.

Perfect, thank you so much. Moving on, just to touch on GSPR23.1, if you only… the question here from our participant is, if you want to only provide a paper copy of an IFU with the device, but your company does have a website, is it mandatory for you to provide the EIFU instead?

Oh, this is… those are two… those are two, things. I mean, we have the EIQ, and, then, this is referring to the GSPRs, where it says that You… if you have a website, and you have an iView, then please make it also available there. And, I think that the majority idea about that is that you need to also present that on your website then. I heard also voices from a couple of people that say, okay, we don't read that like that, and I think it's, at the end of the day, then, the decision of unified body.

Our clients all have their, IFUs, on their website for this reason, so…

This is what I can say from the field.

Okay. Thank you so much. One that I found interesting, is who within the organization is the best, or most likely the best, department to handle EIFUs, IFUs, artwork, symbols, and copy generation. I know it's a little loaded, but Roger, would you want to take that one?

Sure, and the first thought that comes to mind is it is a collaborative effort, okay? It is IT, it is regulatory, it is your labeling, content, functional area, all working harmoniously together, to ensure, you know, accurate information is, you know, generated, you know, and you're following strict change and release control processes to ensure, you know, that, that IFU, represents its intended… its intended use, yeah.

Yeah, your post-market, your risk management, your clinical…

Yeah, I think no one's left out of this party. Nope.

And we're getting some hand clapping there, so I think that the audience agrees with us here. Very last one, and I'll go real quick because we're running out of time. If a manufacturer uses an external service provider for its EIFU system, are there any documents that should be made available from the said service provider?

Validation? Yes. Yeah.

Yeah.

So…

We're probably not going to have time to go through that exhaustive list, but I would, I guess, say that we got a yes right there, a very strong yes from Roger. Yeah. So, for that participant, I think the thing to keep in mind is to make sure that the service provider does know exactly what should be provided, because in principle, they should know. With that, we have hit time. Thank you so much, everyone. This has been a very, very, interesting conversation. I hope that the audience has, enjoyed it as much as I have, and Sean as well. We were chatting on the side, saying, this is so great, we love it! And it's always fantastic when even the hosts take so much out of the conversation.

So thank you so much for sharing your knowledge and time with us today.

Dude.

For the participants, remember to send us… well, we will send you, I'm sorry, the certificates of attendance for those that, have complied to putting their name and email in the chat box. Thank you so much to our speakers. Thank you so much, Sean and MedTech Leading Voice, for hosting this webinar with us at Accra Team as well. And, I want to wish you all a very good rest of the day, or evening. Thanks again.

Thank you, everyone.

Bye-bye.

Bye.

Aye.