Name: From Paper to Digital: Understanding New EU Rules on Electronic Instructions for Use
Uploaded: 2025-10-29T16:15:06.780Z
Duration: 1 h 14 min 45 s
Description: From Paper to Digital: Understanding New EU Rules on Electronic Instructions for Use

Transcript for "From Paper to Digital: Understanding New EU Rules on Electronic Instructions for Use": So we would wait one more minute. Actually, we can already start. I I think I started. So welcome to today's, keynotes on EIFU. So I'm I'm pleased to be today's speaker along with, my dear colleague, Andre. We will try to cover all the requirements, at least the most important ones for you regarding EIFU. As you see, we have on the right a panel which we you can answer, you can ask questions that you might have, and we do our best to answer those questions towards the end of the keynote. If not, we try our best to contact you directly and answer those personally so there's no problem. So if you have any questions, feel free to put them on the Q & A part, and we try to address them. So moving on, a little bit about myself. So my name is Kasra Ghods and I work here at NSF for more than three years now as a consultant. I have, I have gained a lot of experience in remediation projects as well as performing gap assessments, and I have, also had the pleasure to work with a few a few transition projects in the past, which is the reason why I'm included for today's keynotes. I have my my experience mostly lies in risk management, labeling, and usability. And, my background, I studied, in The UK, and later, I came to Germany, and I also studied in Germany. And at the moment, I'm located, along with Andre in beautiful city of Hamburg. Yeah. So I would hand it to Andre to also give an introduction for himself. Thank you, Kasra So good morning and good afternoon to everyone. So as my my dear colleague, Kasra Ghods, already mentioned, we are located in Hamburg, Germany, but the keynote today, the global keynote, is held worldwide, international wide. So that means we have also participants and listeners here today from different time zones. My name is Andre Molotki. I'm manager of medical device consulting, and I'm working at NSF team here in Hamburg, Germany as team lead in a position of a team lead of a team so called tech file factory, which is, responsible for the creation of technical documentation, meaning all subsets of it like risk management, PMS, clinical evaluation, and so on, for medical device manufacturers. I'm working in the field of medical devices since 2010. It's 2010. So I already, yeah, I was also working working in the industry. So, I'm working as a consultant for eight years and was always working in the field of regulatory affairs and quality management. Beside of that, I'm also speaker for, for NSF speaker for labeling, also for medical device regulation, and, for example, also technical documentation as well. For today's keynote, I only play a side role. Yeah. The main person of today's keynote is my colleague, Kasra Ghods. But before we move on to the main topic, EI view, I just wanted to give you a short impression on what or who NSF is for those who do not know. So let's follow-up. Oh, sorry. NSF has been founded in 1944. So last year, we were celebrating our eightieth birthday. The main mission of NSF, which has its headquarter in Ann Arbor in Michigan, is to improve human and planet health. So around the world, we are we have a team of 3,000 colleagues working in the field, of life sciences, food and and drugs, and also, for example, food and nutrition. We are split it in different departments, like I already said. And as a policy team is, for example, part of a life science department and, NSF team let me move a slide further. Is working in the field of medical devices in terms of quality management and regulatory affairs topics for medical device manufacturers and also in vital diagnostics. Yeah. Besides of that, you can see here also on this slide, the other already mentioned departments like food and nutrition, water, life sciences, where we were taking care of different different solutions for our clients worldwide. We are working at the moment we or last year, we have worked in 110 countries, which is a huge sum. Anyway, we are trying to deliver our services for all of the clients worldwide. So, let's move forward slide. There it is. As I already mentioned, so NSF team is working in the field of medical devices, and we are supporting our clients throughout the entire product life cycle, which is illustrated here on that slide. Yeah. We have several stages, as you probably know, for the development and marketing of your medical devices starting with, for example, questions in the future regulatory affairs like intended uses. Yeah. We are also supporting clients very frequently in design and development phases when it comes to first risk managements and so on, but also registration purpose. As mentioned, so I'm taking care of a team which is working in the field of medical and and, and they're which is working or responsible for the creation of technical documentation as a whole. Yeah. But also post market surveying phases, for example, as well are covered by us. Why I'm telling this? Sure. I want to promote our services a little bit, but the today's topic is also relevant or also related to the specific design stages, which you can see here as we recognize. So the EIF to regulation tackles different subsets out of it, which might be interesting for you because interesting questions might arise in the different phases, which we will have a look today. Okay. Before we jump into the specific topic, short disclaimer from our end. As usual, if you have seen our our keynotes in the past, this presentation is based on information available at the present time and has been compiled to the best of our knowledge. So this means, as my colleague, Kasra Ghods already, has mentioned in the beginning, we made lots of experience in the last month, yeah, working with clients together with clients, who wanted to fulfill the EIFU regulation in the European Union. Yeah. And there, lots of those questions came up. Yeah. It might be the case that we have different understandings to the EIFU regulation. Might be the case. We are presenting today ours, including our solutions. Kasra I think that's enough for a short introduction from our end. The stage is yours. Thank you very much, Andre. So starting with the agenda of today's keynotes. So the agenda falls into four category, four parts, actually. We have the scope, which we look into basic definition. What is the scope of the IFU and what are your options to deliver or omit IFU or EIFU altogether? Then we look into specific requirements and also common questions. And finally, we look into implementation, so, what can be done to implement electronic instruction for use. Starting with the first scope, the basic definitions, I would like to give you two definitions. So one, labeling comes from directly ISO 13485. You may know it as quality management system. So label instruction for use and any other information that is related to identification, technical description, intended purpose, and proper use of the medical device, but excluding shipping documents. So that's definition of labeling according to ISO thirteen forty five. We have a definition from MDR. Label means the written, printed, or graphic information appearing either on the device itself or on the packaging of the units or on the packaging of multiple devices. Yeah. So what's the take? Labeling information can appear on packaging and also on the device, and it is important that the intended use of the device is always represented on the labeling. That's the important thing. Now since this is an instruction for use, let's say, keynotes, We also have a definition for instruction for use, and that is information provided by the manufacturer to inform the user of the device's intended purpose and proper use of any precautions to be taken. Yeah. So that's the current definition that we have according to MDR for instruction for use. So you may ask yourself, we also mentioned, what are in which cases I can completely omit and not, let's say, publish an instruction for use. There are possibilities, and that falls into two conditions that must be met, at the same time. First of all, for class a, class one, and class two a devices, and it's very important that you don't have any, let's say, safety related messages within the instruction for use. Yeah. So that means that your risk management could not identify any, let's say, safety informations to begin with. And if that's the case, you can omit instructions for use altogether. Now going to the regulatory background, I would like to give you some perspective because we're going to talk about a lot of about, these actually two of the regulations here. So the first regulation that we had in place, regulation number two zero seven, that was repealed by the main framework that is currently in place for for the EIFU, and that is regulation two thousand twenty one two two six. So you may know that this regulation has been in place since 2021. However, we had recent amendments to this regulation, and we know it as regulation two thousand twenty five one, two, three, four. It's very easy to remember. And in today's keynote, I'm going to have put a heavy focus on what also has changed since then and also to put a main focus on what is what are the main requirements in terms of EIFU. Yeah. So starting with the scope and the most important part that has been changed. Initially, we had within the main framework that the regulation covered three categories of devices which were eligible for electronic instruction for use. So that was implantable and active devices, fixed installed medical devices under accessories, and devices with fitted or built in system visually displaying instruction for use. So we had these three categories. That has been changed and the scope has been expanded as you may already have heard, and that's the main focus of today and the reason why we have so many questions and regarding EIFU recently. So scope has been expanded, and currently, if your device is intended for professional users, you meet the first condition to, let's say, make a transition for electronic instruction for use. So it's not limited to the three categories that we had in the past but for professional users. However, there are more conditions and more requirements. We will get to it. But let's say this is the main scope that has changed. Previously, we had it that, the devices and the accessories, so we had two conditions that if had that had to be met in order to have, let's say, EIPU that has been changed and became a little bit more clear, I would just focus on the amendment in this case. And at the moment, it's the case that if it's reasonable foreseeable, that your device is intended for use by a professional user, then you are eligible for ER. If you and if it's the case that you see that it's foreseeable that it's also used by layperson, then you must provide paper IFU. You are not eligible to provide EIFU. So that's the, let's say, the main eligibility criteria for the scope of it. How about options to deliver EIFU? Well, there could be other options that we might be not including here, but we put here what we believe are the main ones. As you can see, we have a website. Yeah. We have a built in display on the device. We have a portable electronic storage like a USB stick, or you might, provide electronic instruction for use within software or app. There is one important note here. We have four methods mentioned here, and regardless of which method you're going to use, for instance, if you're going to use software or app, you are still required by the regulation to have electronic, instruction for use available on your website as well as a manufacturer. So that's a really, really important take take that whichever the repair method you're going with, you must also provide the IFU on your website. Moving on to paper IFU availability. Previously, we headed that, for devices and accessories referred in article three one three one point a. This is referring to implantable, devices, essentially. And for those category, you must provide only paper out of use. So you wanna allow to provide electronic instruction for use, and that has been changed. At the moment, this requirement has been completely crossed out with the recent amendment that we had, meaning that if you are implantable medical device, an active implantable medical device, is a good news for you because you might be eligible for electronic instruction for use as well. How about paper IFU availability? So as you might be aware, you still are required to leave the option for the user to request for paper IFU, and you must have a system in place. A system, you mean, processes probably. That cover, that paper IFU can be provided to the user upon request and at no additional cost. So it should be free of charge, and it should be provided latest within seven calendar days. It's just something that you need to look into your risk assessment and identify. However, let's say maximum delivery date is seven days. So let's say if I'm the user and I put a request, I must receive the IFU within seven days, and it should be free of cost. Moving to part two. So now we go to the requirements. You understood the scope by now. And digging into the requirements, I would say the most important requirements comes to maintaining or improving level of safety. Yeah? So the regulation specifically requirements requires that within your risk assessments, you identify that you you have maintained or improved the level of safety when transitioning to EIFU. So so let's say I have a paper EIFU. I go to EIFU. I must provide that, I have maintained or improved level of safety. You may ask, okay. How can I do it? What does that mean even to begin with? Well, you must start with risk analysis and usability assessment in parallel, which come to the conclusion later that that's a benefit and risk ratio is not affected affected negatively. So that's the second step. And once you have that, then you can conclude that safety and performance will not be negatively affected. And then you're eligible. You're allowed to go ahead with transitioning to EIFU. That is a really, really important requirement. Speaking of risk assessments, I have put for you here what we believe are the main risk categories. This might be different from depending on the case to case, the device that you have and how the device is going to provide, how you're planning to provide the instruction for use. But let's say I have put it into four main categories, which you believe you must cover within your risk assessment, and that is to design development of the publication of EIFU. So there needs to be process to overlook that you upload the correct EIFU on your website. There's a version control. There is review. There are mechanisms in such to ensure that the correct EIFU is uploaded. The second category here I have written, printing, distribution, and handling of the paper based IFU. You may ask why do we still have a paper based IFU risk here. We still have this requirement because it's still a requirement, and it is still necessary for you to provide IFU, as remember, seven within seven days of fee of charge. Yeah. So still, we need to assess risk associated with that and especially what happens if I deliver, let's say, paper IFU and it takes more than seven days? What are the risks associated with that, and how would my user be would be affected? Yeah. So that needs to be taken into account. Then we have risk related to the EIFU platform. This can be the website, a hardware, or USB stick. You need to look into risk in that. So that covers cybersecurity. What happens if the server is out? Can someone access my IFU and tamper information? Is the design a bit intuitive and, is easy to navigate? And questions on also language accessibility. Finally, the for the final risk category, I have placed human, environmental, and medical emergency factors. So what happens if there is no Internet? What happens if there is lack of IT compatibility? And what happens if there are, let's say, emergency situations? Can the user deal with the device without an instruction for use available, and what are the cases in that case? Yeah. We're going to cover each of these in the coming slides, but just to give you an overlook of the risk categories. So labeling. It is required that you clearly indicate on the label that the instruction for use is in electronic form, and it can be shown on the packaging of each device or, where appropriate, on the sales packaging or on the device itself for fixed devices. And in case of software, we can have it within the app, let's say, in the display. It's possible to have the instruction for use. So the first step, how can we indicate that the instruction for use electronic? The easy solution for that is ISO fifteen two two three one. We have as you might have noticed, this is the same. So the middle is the same at least for the paper IFU. And in addition to that, we have an EIFU indicator. Just to correct myself here, there's no need to have EIFU indicator on three side, but you have to choose one. And the EIFU indicator in the next slide, I will give you examples of what it is. But before I give you these examples, I want you to I wanted to to to trigger one also question which we will answer later. There's a requirement which ask manufacturers shall provide information how to access instruction for use in electronic form. I'm not answering this here. We're gonna focus on the label, but just bear this question in mind because we're going to answer it later. So with the symbol itself, what is best way to for me as the manufacturer to provide this symbol for the user so it's intuitive and, it's compliant, let's say. Let's say as NSF, I have give examples here, nsf.org, and I will enter this. It's the main website of NSF. Disclaimer, we don't have any instruction for use, but this is just example for you. Let's say I enter nsf.org, and it takes me 10 to 20 clicks maybe to reach my instruction for use. That is obviously not good usability. In our opinion, you can go one step further and provide it in nsf.org/ifu. So you open it, and it brings you a platform where you can look now for the article number. Basically, less clicks for you to find instruction for use, and that is better usability. Now if you are a small to medium sized company and you don't have many products in place, we had even a better solution. However, you must remember that you need to maintain these links. There are retention periods for this which we get into. Yeah? And the third solution and the best solution in my opinion, however, it comes at the cost, to provide the article number that you have specific to the product. However, this means that for each product, you must have different labels in place. It's much better usability, but it comes at the cost. So now moving on to how to access the IFU itself. Yeah. For the user, in order to access the instruction for use, the regulation asked that on a minimum, they should be able to access instruction for use using the basic UUIDI and or UUIDI. Yeah. So bear this in mind. There needs to be a way on the website for the user to insert the UDIDI or basic UDIDI and find the the IEP that they have. However, there can be other indicators such as article number or any indicator that you might, that the user know that they can look for and then that they have access to the instruction for use. And then the the way that they can you can provide this, to aid the user is, for example, to use hyperlinks and to use this information on how to access the EIFU on a leaflet. Leaflet is its own topic we will get into. However, this is these are all solutions that you can have. But just bear in mind, basic UDIDI and UDRDI should be a way for the user to find, instruction for use electronic instruction for use. Speaking of retention periods, and we mean retention periods, by how long you need to maintain a URL link, how how long this link needs to be maintained for the user. Now we have to, let's say, retention periods depending if your product has expiry dates or does not have an expiry date. And, for products with a defined expiry date, that is ten years after the last device has been placed on the market and at least two years after the end of the expiry date of the last produced device. That's why I put this dot dot dot in my graph because it could be that the expiry date of my product is five years, then we need to add that and take it into account. For products that are without expiry dates, for example, implantable devices, that is a fixed fifteen years. So you need to make sure that you maintain this link. Even if the company disappears altogether, you still need to provide this electronic instruction for use to the user for these retention periods. How about website archiving? So previously, we had a requirement that all historical all issued historical version of the instruction for use shall be available on the website. This requirement currently has been crossed out and has been replaced with this statement, which is an interesting one. So let's just read it together. Still, you are required to have all issued electronic versions on the website available, including data publication. However, something interesting has been added here. Shall be available on the website or as regards versions that are obsolete, be made available upon request. What is our take from this statement? It basically means that you no longer need to provide all historical version of the EIFU on your website. However, our recommendation is to, on a minimal, to have the latest version of your instruction for use, which must be identical with the electronic instruction for use available on the website with the date of publication. However, for us, those versions that are obsolete, you must have them locally available as a manufacturer in case if the man if a user asked that, can I have version 2.0, then you must provide them in paper formats? Yeah. So that you need to archive it locally, but there's no need to have everything on the website, which is great news. Another requirement that has been crossed out, but I get to it, I would recommend to keep. So effective systems and procedures shall be in place to ensure that the the device users having download instruction for use from the website can be informed in case of updates, corrective actions with regards with regards to those instruction for use. Yeah. You no longer need to have the system in place. This requirement has been crossed out from the main regulation by the amendments. So you no longer need to have it coming. You no longer need to keep track of everyone who's download the instruction for use. However, in case you have updates that are related to safety reasons, you must inform the user. Yeah. So we have a separate requirement. I put a bot here. And with that in mind, our recommendation is that as a good practice, please have a way of, let's say, informing your users so it's still a good mechanism to have it, let's say, subscribe for updates or register to receive update mechanism to let your those users know if there has been any change with regard to your instruction for use. Now doing a bit of a speed run with the requirements for websites, and these are all website requirements. The instruction for use shall be provided in a commonly used format. So I'm talking about the requirement a. So a good example, PDF format is accessible by everyone by everyone and is pretty accepted. Item b, it shall be protected against unauthorized access and tampering. Yeah. For this requirement, as a state of the art solution, we can give you the standard that has been mentioned here, ISO IEC or IEC, twenty seven zero zero one twenty twenty two version. Yeah? However, this can be a little bit of overkill, especially if you're a small size company and you don't have the resources to do so. Then our recommendation is to try to address the requirements specific. You don't have to address the entire standard. Yeah? Let's say state of the art, perfect solution would be to comply with the standard, but I we believe it's too much. Yeah? Item c, it shall be provided in such way that server downtime and display errors are reduced as far as possible. Again, we have a solution. So ISOIEC twenty seven zero three one twenty twenty five, and that is not limited for medical devices. Yeah. This is for if you're an enterprise and you have, let's say, a website in place, then you can also benefit from this. It's about readiness for business continuity, yeah, for server downtime and so on and so on. Now, again, if you're a small size company and you cannot comply with this, there are other solutions you might be able to address this directly looking at specific requirements that can address this. If you had EIFU in the past and you were leveraging this already, you may also use PMS data to see, for instance, what was the server downtime in the past, if there had been any errors. Maybe you can provide a rationale on how you can address these requirements, and that might be sufficient. Item d, it shall require it shall fulfill requirements regarding regulation twenty thousand sixteen six seven nine. So that's general data protection regulation. You must already have this in place. And the way you show compliance for this is to draw itself declared, and you must draw a declaration of conformity. Of course, you must fulfill the requirements to, have a declaration of conformity, but that's the way to do it in terms of technical documentation proof. And finally, we have it that the, internal address should be available for the retention periods, and that we already covered. Now if you're a hardware, you need to take into account knowledge and experience of the user. So let's say if you didn't have EIFU in the past and now you have it, that's obviously, the change in the user interface, and you might require, let's say, usability evaluation. For safety and backup mechanisms, you need to make sure there are backup features in place. In case the device shutdowns and you restart the device, the EIQ is in place. If you update the device, the EIQ is still in place. You must assess this is the again, risk management impacts caused by temporary unavailability. Yeah. What's the case for that? You must assess the website compatibility so it can be shown from every device, maybe older version of iPhone or Android or specific browsers so you can maybe have an in house testing for that to address this requirement. You must ensure this is the final item, item e, performance of safeguard to ensure that the content is protected from tampering. This is directly cybersecurity for software as medical device. Yeah. This is its own topic, and if you have a software, you should have this already covered, hopefully. Moving to the next item. What about PMS obligations? Do I have any? At the moment, the requirement is that it's expected that you consider PMS into your risk assessment, and this needs to be continuous. So if you have vigilance and PMS procedures in place, you need to make sure that EIFU is covered. If you don't have complaint calls for that, you can maybe add them, before you go online with your EIFU and make sure that there is mechanisms in place to keep track of, let's say, PMS complaint also related to EIFU. Language requirements, it's exactly same as paper IFU at the moment. For instance, in Germany, you need to have German and English and other languages for UK English. And if you're wondering where I can find this information, you can refer to this document I have put a snapshot of. Yeah. It's a European Commission document. How about EUDAMED?? So with regard to EUDAMED, you are required to update EUDAMED information regarding your EIP URL and have it linked to the device. Yeah? And some of you might be wondering, from when do I need to comply with EUDAMED and what is the deadline. And there are some uncertainty issues regarding EUDAMED itself, so let's cover that. As a reminder, this is the current timeline for EUDAMED. And if you have noticed, we are at '3 already, and, it is expected that, other modules become public. At the moment, none of the modules are national law. None of them are mandatory to have. However, we have national laws in place. For example, Germany required that the first three modules, which are at the moment voluntarily to be, complied with, to be fulfilled with. Yeah. So you need to check for each state what is the national law for that. But once the official journal releases, let's say, that specific modules are now functional, which we're expecting, for example, post market as well, then you must also comply to those as well. We're waiting for the timeline to see what happens. And once the journal is released, you have six months until it becomes the law. Then then I'm taking over that one. Yes, please. Kasra, during the project we had kind of a best FAQ, yeah, with frequent ask ask questions which which we received in the last month. So let's move through that four questions we can see here. So the first one. So in in the regulation, there is a definition of a so called medical emergency. Kasra, can you tell us what what has it to be with the with with the medical emergency? What is it all about? So that's the interesting part. At the moment, we don't have the exact definition of what is medical emergency. However, the requirement specifically asks you that if you have medical emergency, then you must provide that specific information on leaflets. So, again, we're going back to paper. How can we do this? You look into your instruction for use. You take specific sections, and you have you will have this in a leaflet to address that this is a medical emergency. Now we have clients that ask, is this medical emergency? And they had a class one device. It's very unlikely that you have medical emergencies in place. Good example of medical emergency would be, for example, for devices such as ventilators, that if they shut down, that's very, very high risk and will lead to a medical emergency situation. And the way you can make sure that you don't have it, it should be covered in your risk assessment to begin with. And if you have those scenarios, then you must address it. So to answer this question, again, it's your risk assessments to begin with, and if there is, then Leaflet can address that. Thank you. Next one. So, was it too fast? Maybe. No. Does this constitute a significant change? Maybe maybe as kind of a reminder for everyone here. So the ISO thirteen four eight five says or tells us that we need to evaluate changes related to our devices, related to our systems. We need to evaluate the significance. So what we are talking about here, is it significant or is it is it is it not? Kasra, do you have any idea? Yeah. So for that, again, we would like to refer to MDCG guidance. Even though this MDCG guidance is for legacy devices, it's still our only reference point for change, let's say, enable, for example. And if you refer to, the annex, you will see that we have specific figures. I'm not going to follow exact flow of this, but we will share the slides also so you can look later. But, essentially, what our final take is that EIFU transition in nature is not significant change because if you follow the flow that we have here and it takes you to part b, it asks if does the change affect safety or performance negatively? Yeah. And if you remember, that was one of our main main requirements on top. And if that cannot be met, you cannot go ahead with the AI issue transition anyway. So this is a good way that you can show to notify body that we are going ahead with the IFU transition, and in fact, it's not a significant change based on this. Yeah. Maybe before we go to the next slide to add, we had that conversation also with global players in the past, which had thousands of articles available. Yeah. So why it's so important? Yeah. When you're discussing this for all different IPs we have available, that can be a a huge amount of changes you need to to trigger here. And so you need to have a practical solution available in order to fulfill that question at this instance. Okay. Next one. So this is also may maybe we can relate it also to one of the questions of one of one of our participants here. Yeah. So we have also received, questions related to technical solutions. Yeah. So if you, for example, can can use, bar codes or QR codes as well for the EIFU for for transferring the website in there or putting the website in there. But all in all, Casper, is there any pragmatic solution how we could handle the label itself or instruction for use when it comes to EIFU? Yeah. So our temporary solution, it might be the case that you're already selling your product and to recall everything and to reapply label, that can be difficult. Yeah. So one solution that we have at the moment is to use stickers. Yeah. For example, let's say this is a sticker that I'm going to use. However, there are risks to using stickers. It can be peeled off, and, in our opinion, it can be reset before more. So, ideally, you would change the label altogether, but if that's an option, also from a logistical point, then we can use stickers. So let's say we apply this sticker, and we have this, beautiful label of ours. It's NSF. It's just an example for you on how it can look on, let's say, a label. So we have the nsf.org/ifu, and then we have a leaflet here. So we talked about leaflets in, some of the requirements specifically for medical emergency, but we believe leaflet is a really great way to also provide further information to the user. So what that can be, for example, statement that the IFU are electronic, how to access the EIFU and provide QR code, viewing requirements if they need specific software or application to view the EIFU, which hopefully not, Device identification, for example, you can maybe show refer to your device and say, hey. This is my UDI, DI, and this this is my basic UDI DI. Yeah. So the user can then use that number to put you on the website. Information on how to request a paper IFU, so email address, phone number, and then they can request paper IFU. And you must also state clearly that it is provided at no additional cost within the time frame of maximum seven days. Yeah. Language availability options on the website. If you have different language availability options. Ideally, if you're providing a leaflet, you must also transfer the leaflet for that local language as well. Yeah? Medical emergency information, we already covered. Versioning and update information, for instance, if they can sign up somewhere and they would receive updates and how you manage versioning, maybe some information that you can provide. And also, as a tip, you can also let them know that it is recommended to save on download by a few locally, yeah, just as a risk control measure for the future, yeah, in case if there is no Internet. And finally, we have the disclaimers. Any specific, company disclaimer that you might want to add, this can be added also within the leaflets. Yeah. So that's a general solution at the moment that we would recommend in terms of labeling for your product. Moving on to the next question. Yeah. Right. So next, last, and very important question for the finance guys. So, the cost of EIF implementation, we made also experience in the past. So and we had lots of discussion, Kasra. Yeah. Do you have any any advantages and disadvantages for our for our listeners today? Yeah. So, of course, short term, there's going to be regulatory cost. There is cost to building that platform whether it's online or offline. There is relabeling, and there's training and regulatory effort. Yeah? However, long term, there is definitely sustainability initiative to it. You are saving printing costs, and it's much easier for you to update IFUs and release changes. So these are the pros and cons, let's say. Our take is that short term, of course, there's going to be negatives to it. There's cost and effort. However, long term, it's much beneficial for manufacturers. Yeah. Now moving to our final part, fourth part, and the implementation. Yeah? What are the steps for that? First of all, you must understand what is your case. Are you already live with the AI field? Do you think that with the requirements that we mentioned, you are fulfilling everything? If you're unsure, perhaps the best way to do and to proceed with this is to perform a gap assessment and follow-up by the gap assessment. You can do a remediation to harden, let's say, specific website and hosting requirements, as well as make sure that your supply chain is ready and you can deliver paper IFU within seven days. At the moment, unfortunately, the case is that a lot of manufacturers, they have a PDF online uploaded, and and they believe that they are using EIFU and they're compliant with EIFU regulation. Unfortunately, that's not the case, and, that's why we would like to raise awareness to let you know that these requirements exist, and you must consider that. Yeah. Case two is that you have only paper today. So you're at ground zero. It's still fine because now we have a regulation in place. We have an amendment in place, and we know how to build it from scratch. Yeah. So we need to build specific processes regarding labeling and packaging and logistics and risk assessment, and everything needs to cover what is related to EIFU. Yeah. So speaking of the gap assessment, it's something that also NSF provides, and it's something that, we really enjoy doing, and we are really good at it, I would say. So our labeling gap assessment falls into different tabs, let's say. And, the main one, of course, MDR. We have all the articles regarding MDR covered there. We have, let's say, we cover standards related to symbols and information that needs to be supplied and also processing of critical or semi critical legal devices. So it's not limited to EIFU. However, focusing on EIFU, I just want to give an idea of what we do and what we can do for you. So our gap assessment includes a close look to the requirements and looking for exact proof of verification and validation for those requirements. Yeah. So first of all, we were looking for objective evidence to see if that requirement can be fulfilled. If you find any gaps, then we would address that, and that would be followed by corrective action and remediation, so to speak. And we would cover you in all the steps we can. Second of all is a risk analysis. Yeah. So we mentioned all the risk categories that you saw. We have templates in place, and depending on your case, we can provide you with a specific template. And we we can also create risk analysis risk assessment documents for you specifically tailored to your needs of the device, and that's something that we definitely are happy to help you with. Now it's not only limited to these. We are also happy to train your staff and also to help you to build an online platform or if it's software and medical device, to fulfill those requirements. We have in house experts for all of those topics, and we're more than happy to help you with those as well. Now I will hand it to Andre to give you a little bit more information about our services. We are we are done with the with the main part of our presentation of the keynote presentation. So if if anyone else has still some question left or the last question and, the last two questions, Casper, in the chat, the last two haven't been answered yet. Maybe you can have a look at this. But for everyone else, you can also still send us further questions. Just a short reminder related to our services, We have also service flyers available for some of our our services like post market clinical follow-up. Yeah. You can simply, also afterwards, once you've received received the slides and you're interested in, you can simply scan the the the the QR code you can see here and get further information. That also relates to other services like we are offering, like consultancy self support or the tech five factory support and creation of technical documentation or clinical services when it comes to clinical innovation, creation, for example. If you're interested, have a look at these ones. Yeah. Those are our recent flyers available. Further, just to give an update, so we have also online events, online seminars, in the next month available for PMS risk management, economic actors, and Asia Pacific requirements. And, also, we are promoting here on the right hand side, you can see there are also barcodes available for our next key keynote. So if you enjoyed what you were here, listening today to yeah. Please, you can you can definitely also join the other keynotes from our end as well. We'll be happy about that. Last but not least, if you like, follow us on social media. We are also available on on LinkedIn. We have a website available. Or give us just a call. And on the first slides, also afterwards, yeah, once we are done with the keynote for today and you still have questions available and you just want to chat with us, want to have a short call with us, you have our contact information on our introduct, on that, in our introduction slides available, yeah, also via QR code. Simply scan it. Give us a call. Write us an email, whatever. Kasra and myself, we will be glad to answer your questions afterwards as well and to get into contact with you. Okay. Yeah. I think I also I also can answer some of the questions that have been posted already. I appreciate the time is over, but, yeah, we do our best to answer some of the questions, just before we close down. So one question about the language, on your domain. So which EIF you you should place for, let's say, specific language. Our recommendation is that, ideally, if you have different languages provided for your instruction for use, you would have a platform in which, once clicked, you have a list of different languages of EIU queue that can be accessed. And we will recommend if you have that link, then provide this link, within u.net. There's no need to put specifically, let's say, English, EIFU, or other languages. But the best is to give an overview. And the best way to give an overview with all the languages that are available, you can do that. If it's the case that none is available, then, English is sufficient, I would say, since it's good on it. Let me check also other questions. Yep. There was another question related to an EIFO symbol coming from the ice, from a database ISO 7,000. Symbol was is named 3,500. Meanwhile, I looked it up. All the symbols coming from this database basically can be used. Yeah. So they are they are kind of best practice. They definitely can be used. But in this specific case, we have an EI fuels indicator listed in the ISO fifteen two two three dash one, which is widely spread on the medical device industry. So we would recommend using this symbol instead of the other. Anything else left? Yep. Maybe about registration in other countries that, EIFU is not covered. Yeah? This is something that you need to do country by country. This is something something that we also looked in the past. Some countries have specific, requirement. But to our understanding, meaning of the countries have similar rule about professional user and lay user regarding instructional use. We can answer for in general case, but this is something you need to do individually for each country, and that is something that we have done in the past. And, also, I want to point out all the information we have discussed today are related to European regulation. Yeah. Also, when it comes to the delivery of, the paper version of the iFuel of seven days, yeah, we we we talked about it. This is meant within the European Union, because the regulation is valid in the European Union. Very important to understand and to know. And as my colleague said, for all other countries, if you want to ensure you're fulfilling country specific requirements, you need to look it up. Unfortunately, we cannot cover everything for today. But what we can say is in lots of different countries, there are also information available related to electronic IFUs. But Yep. Ours are very far progressed in the European Union. Yep. I agree. Okay. I think then we are so far done. I hope you did not forget any questions. If yes, as I said, you have feel free to count to contact us and reach out later on to us so that we can, discuss your specific questions if available. We're we're happy today to to give you that keynote. I hope you are also, and we hope to see you one time again. Thank you very much for your time and attention.