Critical Misconceptions About PMS, Vigilance & Reporting in the Device and IVD Lifecycle

Good morning. Good afternoon, or good evening, everyone. Alexia Lynch with the Akra team here. It is my pleasure to welcome you to our Webinar today, led in conjunction with medtech leading voice, we are going to be focusing on critical misconceptions about Pms. Vigilance and reporting in the device and ivd lifecycle. Our subject matter. Experts and speakers today are going to be Julia Hoyer, who is foreign Affairs, product specialist, auditor as well at Tusud Marta Carneelli, who is head of certification for Ivds again at Tusud and Milad Mazzetti, global Medical Devices technical manager with Sgs. Belgium. And we're also going to be listening to a colleague of mine, Muna Kebedi, who is senior regulatory consultant for medical devices at

Akra team. We have a few housekeeping notes for you all before we officially kick things off. Just Fyi. The recording of this session will be made available to you all as of tomorrow throughout the session. If you have questions for our speakers. Please use the Q. And a button that you have in the zoom window here, and we will take time at the end of the session to look at questions that you might have. You can use as well the chat for comments, or to request a certificate of attendance. We would just ask you to give us your email address and the name as you want it to appear on that certificate, and it will be delivered to you within 48 h.

So with no further ado, Muna, I'll hand things over to you for your presentation part, and then we will move into a panel with our notified body speakers. And right after that the Q. And a. Thank you so much. Everyone.

So thank you, everybody for attending. What a great turnout! It's a pleasure! And before I begin I would like to say, thank you again for our guests, for joining this webinar with us, to demystify at the critical misconceptions around vigilance, and reporting. So I will kick off with a short presentation, highlighting some critical issues which we will dive deeper into during the discussion right after the webinar. So let's move forward and start directly into looking at the agenda we will look at the Pms from a lifecycle perspective and have a short overview of the Pms system.

A short disclaimer here I will not be presenting normative and regulative references in detail or guidance documents. Those are a part of the slide deck, and you will receive this after the webinar. So, instead, we will dive directly into some misconceptions and look at recommendations on how to approach such cases. So forward to the 1st topic, the lifecycle approach the evolution of the lifecycle approach in the medical device sector reflects the need for understanding the true safety and performance of the device when applied in the real world. So, and the need also to be able to catch potential risks

before they occur, which is pivotal. Given the exponential growth in device, technology, and complexity in the past 20 years. In the medical device sector, and also Ivdr. Before 2,010. The approach was not too different from other industry sectors. It was focused on vigilance and reporting with minimal involvement of the risk management process and the emergence of the lifecycle approach. As we know it today for devices was established by 2,010 when the Ghtf. Introduced the concept of Kappa and risk management, including feedback after the Eumdr kicked in the modern approach which is highly data driven was solidified, and the focus on long term and real world evidence was introduced and it's still growing.

In addition, a predictive approach is required, and this urges us to identify serious incidents and public health threats before they occur. and to do something about it. So this really hits home the Pdca. In Qms. For clinical data. It had also become evident that pre-market data gathered in a controlled setting with little variability is not enough and lacks the necessary sample size, follow-up and real world experience. All in all this modern approach is not just one big challenge and a negative, but it ensures also that devices maintain a positive benefit risk ratio. and it provides manufacturers with valuable input for further developments. For example, for the next generation devices for variations, or it might even spark up new ideation.

It also provides the possibility of more flexible regulatory approaches supporting innovation. For example, also through conditional approvals, special regulatory approaches for AI devices and orphan devices will benefit from this as well. Please note, however. that the growing emphasis on post-market data for better evidence over time does not mean that a lack of data or poor quality data and pre-market is acceptable. So this is not an argument or a way out for not fulfilling pre-market requirements. In summary, what does the lifecycle approach need from us all? So as an agreement, it needs continuous interaction between all stakeholders. So not just between notified bodies, competent authorities, and manufacturers, but also those in the supply chain are now responsible for reporting complaints even stronger to legal manufacturers.

It increases corporate accountability, not just with manufacturers, but also with notified bodies depending on the device class involved. It has an increased demand on competence and education, because manufacturers really need sufficient regulatory and clinical knowledge at hand and always available to them to remain agile because they need to react to the data quickly and implement necessary corrective actions in a timely manner. So let's have a quick look at what is the life cycle before we go further. Since this revolves around this terminology the term is not declared as such. In the Aumdr, however, in the Imrdf it is defined as covering all phases of the life of a medical device from the initial conception to final decommissioning. So the last medical device out

not sold, but the last medical device out. And where do we place post-market surveillance, vigilance, and reporting. In this life cycle and the pre-market phase, we have reporting requirements to abide by when conducting clinical investigations which include serious adverse events and device deficiencies in post-market phase. This refers to also post-market clinical, clinical follow-up studies. but it's mainly driven by serious incident reporting and also includes trained reporting. however, the data transfer between the pre-market and the post-market is more interesting in its role, I think, and the pre-market the manufacturer defines

it's in its design inputs, key aspects that will then affect the type of Pms data collected. the extent of data that's collected and it defines future reporting obligations as well, depending, depending on the risk class of the device and not to forget. Also, the 1st Pms plan should already be completed in the pre-market phase, as it's part of the Td for submission. The Pms data can and should affect research and development as well as design and development and manufacturing either as research input or mainly through capas and through risk management, because data from set indicators from the market can communicate the need for action

to the manufacturer even before the occurrence of significantly increased rates and severity of expected side effect happens which should be reported. Increased frequencies of certain complaints should then trigger investigations that may identify root causes which are embedded in the design and development, or in manufacturing, or even in the usability of the device which will affect an area of your technical documentation as well. So let's deep diver. And let's deep diver. Let's dive deeper into the role of the manufacturer. it's highlighted throughout the whole regulation as well as in the Mdg. Mdcg. Guidance documents that manufacturers play a leading role.

It is in their responsibility to ensure a systematic execution. whilst also ensuring compliance of documentation of, and of all activities and processes that are described in their quality management system. So on paper, these are clear tasks, all right. The question remains, how and how to do this effectively. not only with respect to compliance, but also with respect to resources, whether monetary or competence related, or time or otherwise. How do I, as a manufacturer, become and stay compliant, and harvest the benefits also of the gathered information for improvements and growth.

without at the same time overburdening my quality management system, causing possibly other issues. So let's look at a simple yet possibly fatal misconception that can impact the limits of such resources that we just talked about, if it's not correctly implemented in the organization's project and quality plan. So the misconception that post-market surveillance of the device ends when we stop placing it on the market. The post-approval requirements in the regulation state clearly that the data needs to be gathered throughout the entire lifetime of the device. So this brings us to looking at another definition. That's quite important, but not declared in the Umdr.

The overall lifetime of a device is the 1st device marketed on the and the last device out of the market. So this includes the shelf life of the device, plus the intended lifetime. which is calculated by the expected lifetime and the uncertainty factor. and this expected lifetime, also not defined in the Mdr. Has a definition in the Imrdf. which is the time period specified by the manufacturer. during which the medical device is expected to maintain safe and effective. expected to maintain safe and effective use as intended. So this means it's defined in the design input phase by the manufacturer.

during which you ensure that the device's intended purpose meets safety and predefined performance characteristics which are in line with the state of the art expectations, and this must be proven via pre and post-market activities. So therefore, end of certification does not mean end of Pms activities. because manufacturers are legally obliged to continue to make. For example, the Psur available to the competent authorities upon request, when the device has not yet been covered by the last Psur. So let's have a look at one. One more of the major sources of nonconformities that we have

is the fact that actions in the Pms plan are generally applicable to all my devices. Despite differences in intended purpose, basic udidi, or any changes made to the device groups. So this means the same data sources, same methodology and general assessment plan for all my data sets can be made in the plan. And this is one of the core causes for non-compliant Pms reports as well. It has a direct relation to that leading to rejections of those records by notified bodies. The Pms plan is the heart of the Pms system. This is where you not only set specific methodologies and identify sources, identify specific investigative questions that are tailored to the device and current risk and clinical knowledge, but also where you identify, who will execute these specific tasks, and where you identify whether you have the relevant and sufficient resources? Or do you need to acquire these?

When will these these tasks be executed. and in which frequency will they be executed? And when will they be reviewed? Because it's not the best idea to review the data only at the end of the year. as a regular meeting and review of this Pms plan and its execution will mitigate the risk of a bottleneck and any surprises that you might have at the end of the year, it will contribute to identifying risks in a timely manner. In addition, what additional information do I need for innovation for further improvement, and just to stay ahead on the market, and this will engage your top management surely, and you will need their support to execute

a good Pms plan, and to stay compliant and to have real use out of it. So let's have a quick look at some some common nonconformities that were identified this time by the competent authorities in the past 6 months at least 2 calls to manufacturers were published by competent authorities, one in October 2024 from the Dutch authority, Igg and another this month from Swiss Medic. Most of most of the Nonconformities identified were related to post-market surveillance plan. Even those related to the report were a direct result of the missing direction and clarity in the plan. So, for example, Swiss Medic assist

30 cases and 20 had Nonconformities, 8 of which were based on the fact that the safety report was not prepared according to the Pms plan. The Dutch authority also similarly reported that the type of medic, the many manufacturers, did not tailor. The Pms plan to the type of medical device they were marketing and the plans applied were applied to multiple types of devices without any clear specification of which data they intended to collect for each type. So, in addition to that, it was identified that some manufacturers were not up to date with the lifecycle approach. and that they were still equating Pms to vigilance.

and the interaction with other Qms. Systems was not clear. The information was not specific, and the methodologies were lacking. Therefore it was apparent that manufacturers also could not have the appropriate signals to know when and how to act to triggers that were not set in the 1st place. and this goes together with main pitfalls, also seen in other manufacturers, which which also includes the absence of benefit, risk, analysis. The absence of similar device, comparisons and of literature reviews, and also the absence of compliant procedures which really drive the system, not just pms, procedures, but vigilance procedures, risk management and Kappa procedures.

and, as I mentioned earlier, the plan determines the fate of the records generated. It needs to be more comprehensive than what the Mdd. Had allowed. It needs to consider various data sources, both reactive and also proactive data sources. and a good tool to use a good place to start is the isotr. 24, one. 6. It's not only a detailed guidance for the Pms plan, but also provides some examples of data sources. It provides examples of data analysis methods, and also of some post-market surveillance plans depending on the type of device that is presented. So this is this is a good tool to have at hand

a very important aspect relevant to the current lifecycle approach is also that Pms data is not just vigilance and customer feedback. It needs to be planned in a way that critical, clinical, and technical information is monitored to identify and respond to potential risks quickly. and planning, therefore, needs to have the following pillars in mind, it's important to have intended purpose in mind, because the report must be able to compare the data to other devices with the same intended use. It's important to have clinical benefit in mind, because the report must be able to identify new benefits

and benefits not achieved as intended. It's important to have the clinical performance and safety in mind. because the report must be able to support or refute these safety and performance concerns and identify new signals, and last, but not least, the state of the art is important, because the report must be able to evaluate the data according to the state of the art, and these are not general parameters. They are specific to devices. and can also differ even within the same device group, or depending on the model or the size. So these are very important pillars to have in mind when creating the plan.

they will affect everything down downstream as well. So, in order to execute this, the organization will definitely need a competence team. Even small organizations need some kind of a competence base that interact with each other. and they have direct access to top management. You should avoid silos and also interact with external clinicians, and beyond that have people in your supply chain involved in your Pms. System, and this should be documented as well how they are involved, and that they have agreed to be involved in your Pms system. So remember this as a manufacturer. You are not only risking nonconformities, but you're missing out immensely on improvement.

A lack of indicators and thresholds might mean that critical information is missed, and you won't be able to prevent potential issues which can also lead to liability. And I think the big message here, all in all is that Pms is a team sport. and you need to involve different people from your organization outside of your organization in order to really maintain a strong Pms system throughout. so I would like to say, Thank you for your attention. I know I have promised some complimentary slides later on after the webinar, so I will not go into the regulatory parts here. And

yeah, so let's go directly to our panelists and have a little interesting and riveting discussion about the main details. Thank you. Okay. all right. Sorry. I was a little bit distracted by our presentations. So thank you very much for attending Miss Julia Hoyer and Marta Carneelli milad machet. Thank you very much, and we would like to kick off with

the panel. I will ask each of you to please share one thing that you'd like to emphasize as being important to consider, to avoid Pms to avoid in Pms and something that you've seen that manufacturers do continuously and repeatedly just share this. In short, just 1 1 core message, and I'll just ladies first.st I'll start with Julia.

Thank you very much. Thank you for the slides. They are very helpful. One thing I have learned, or when I did also Pms and risk management. In my former role at the manufacturer I learned the best way to make the reader who is the nexus notified body or competent authority give them the story of your device. Go back to your actual device and risk assessment and give the information holistically. What has happened or what does happen with your device nowadays, because the times are changing, what is actually the background of your device, and give the reader the information so that they can confidently understand what you are trying to give them for an information, and be precise, it does not mean being precise. It does not mean to be a very long text. It means rather

a holistic approach for all the areas you have actually perfectly touched in your presentation. What has changed in the literature? What has changed with my device on the market. What kind of information did I get and bring that together holistically, and draw your conclusion and write it down? Sometimes we see that the conclusion is not written down. So actually, you're sitting there with all the information. But you don't know. Now what is the is it? No good. Is it no bad, is it? No? Can I make my mind by myself? Or what is what is? What is the actual information the manufacturer wants to tell me. That is one of the the

yeah. The request may be, give the reader your story, and give you the reader the confidence to follow through your arguments? And why is it? Why did? Why is the risk profile? And why are your measures still okay, and based on all the experience you have gained so far, your device is in a safe shape. Thank you.

Yeah, wonderful. Thank you very much. yeah. The the red line through the story. Thank you very much for that. Input that I absolutely agree. I'll go over to Marta now from.

Thank you for this introduction. Very good overview of a post market surveillance. So as I think it's clear from the title and focus on in vitro diagnostics rather than medical devices, and however, we have separate the regulation a lot of points in common, and some. you see, the points raised by Yulia are valid also. For individual diagnostic. What I'd like to add to that is, see post market surveillance as an opportunity to gather additional information on the performance and the characteristic of your device when it is in customer hands, and ensure that the data that you collect, analyze, and concluded is then used and

feedback to your other processes, such as, for example, risk management. So the linkage between post market surveillance and the other processes within the manufacture quality management system is really an important point to ensure. It's a collection of data which is, for sure, a big effort to do and to assess, but also make the most out of it.

Wonderful. Thank you very much, Martha. Milan, may I give over to you.

Sure. Thank you for your presentation. As well. I hope everyone can hear me in terms of. I fully agree with what Martha and Julia mentioned about the link between the risk and Pms. Also what you mentioned in your presentation about what the competent authority found out about the mainly class. One devices. We actually see very similar cases where manufacturer have many variants and they haven't. We can't really extract the data per variant. We have no idea if these complaints are about this device or about other devices. So they just provide a very generic thing. Something we still see quite often is, we see Pms procedure. We see sop. But we don't actually see a Pms plan.

So clients just say, Oh, we are going to conduct surveys. They have. No, they don't provide us with any information. What's the details of that survey? What are the questions? Who are the cohorts? How many? What are the timelines? So basically, they provide very little information on what they're actually going to do. They make a very generic things. And that results in nonconformities. So even though they're committing to something. We don't actually know what they're committing to. Thanks.

Thank you very much. I really like that last comment. They're committing to something. But we don't know what they're committing to. That's something that happens and occurs often. Thank you very much, milad. So I would like to hand over another question, and I'll direct this to Marta. Now, if that's okay. And it goes a little bit more into the Ivd perspective. So I'm from the medical device sector myself. So maybe this is a bit of a self-centered question. I'm not sure but looking at the impact of the life cycle of a device, there are many nonconformities that can occur for medical devices, so I would love to hear your perspective from an Ivd device, you know, from the Ivdr. And are there any key differences

that there are between medical devices and Ivds in this respect, or, you know, specific examples. When Ivds have a lifetime that really exceeds their shelf life. Because when you think Ivd, you don't really think about that in the beginning. So I think that would be a really interesting point of view to hear from you, Marta. That'd be great.

Yes, so of course, one of the key differences be with the between Ibd and medical devices is the concept of indirect harm. So an Ibd. Will not cause harm directly to a patient, but an erroneous result can lead the physician to have to draw an incorrect conclusion and an incorrect treatment. So that's 1 of the difference that needs to be taken into account when establishing post-market surveillance and vigilance original supporting the other aspect you mentioned is lifetime. Traditionally, we think Lbds as reagents, it's the 1st thing that comes to mind, and reagents come with a shelf life. So once they expire they can no longer be used in a safe way. They cannot be used. Period, once they

they expire. So with the reagent part, we tend to focus more on the shelf life of that device. But we also have instruments. Software is becoming more and more common as Ibds, and there the concept of lifetime can be used. For example, a manufacturer can say, this instrument can be used for 3 years after its initial start of use. and not after that. After that the lifetime of that specific device is not is finished. The device can no longer be used so, but traditionally. For the majority of Ibds we talk about shelf life.

All right. Thank you. Thank you very much. I feel enlightened. I have to say So we talked a lot about the risk-based approach and and the feedback that is needed as well. So is the risk-based approach to creating an adequate Pms for a specific device limited to the risk classification. Maybe I can direct this back to you, Julia Yulia, sorry? Or are other product, specific criteria, such as materials used and intended purpose, target population, and so on. Important. And do they play a key role in determining the extent of the Pms system, and especially the plan as well.

Yes, yes, you. You said it already in your in your question. Perfectly. It is not only the risk class, of course, inherent the the intended purpose, and the user group, or where at the body the devices is getting to use is within the risk class itself, and the less the less the risk class, the less the risk is from the from the regulation. But you might have low risk devices which you actually have newly invented. They are by themselves not not the most critical devices, but they are new to you, you as individual manufacturer, the individual device itself, the individual design. and you may approach new target population. So whenever something is from the profile of this product itself, it is not only the risk class itself, it is definitely, as you have said it, the actual design itself, new material, maybe design characteristics, manufacturing characteristics even, will determine your

follow up. And you're monitoring of your device. We call it usually post market surveillance. You can also call it monitoring. I'm monitoring my device throughout the use. And I'm accompanying my user groups. How they get along with my device, and how others giving me feedback on my device. Maybe I have something overlooked, or it was not clear. So this is all depending on, how familiar are you with the device itself? Did something change also changes is part of the Pms. Timeline. concept, how much do I need to engage in with the market and post market on my device to understand if that devices can be safely used.

Thank you.

Yeah, thank you so much. I think this is quite an important message that is really missed. I think so. I would love to open. Open this question to anybody else that would like to add anything to it, or maybe even from the Ivd perspective. Please just jump in.

I can add just some examples, if you don't mind, and sorry, Martha, for jumping in. For example, my background is orthopedics, and let's say, all hip replacements are class free. but we know that, like about 10 years ago, there were some emerging risk for metal on metal hip replacements, those metal on metal replacements still can be used for a specific cohort, but I would expect the manufacturer who do put them in the market do extra screening. Maybe they do some blood analysis or something every year, because we know there is a risk they need to control it, and if they don't control it and monitor it. There may be catastrophic.

Result again. There are people that I mean. If, for example, the cohort is younger children or pregnant ladies, or you know. older population. You do need to think about the impact. The novelty, as Julia said. If something is implantable, long term probably has a very different strategy to something that has got a transient use. If something is, you can actually see, partially implantable. You can see it is very different, maybe, to something that you don't see is inside you, but it's fully implantable. The procedures. There are lots of them. Let's say we have an epidural needle. It may be class 2 a. Because it's not supposed to touch the Cns, but it does happen so. Maybe that accidental damage again needs to be monitored. We can't just say, Oh, it's Class 2 a. So we don't need to do anything about that. So just some examples that maybe need to be considered.

Slide. Of course, the risk classification is is important, but it covers. It's linked to the intended purpose of that of that device. But there are other elements also. For example, the intended user. You may have a device that's perfect for professional use in hospital lab, for example, or it may be for the near patient testing, which is always a way of professional use, a type of professional use, but is not in the same environment, and that needs to be taken into account because it may have different. The user may have a different facility. May have different challenges. Let's think about a 90 day device. Who is from your patient testing to be using ambulance

as an emergency test for an emergency situation. The environment and condition of use of this device would not be the same as the device that is used in a regular, I would say hospital level. It's definitely an element intended user part of the population that needs to be taken into account.

So this this really brings me also to the thought that we're, you know, gathering all this information and specific information along the way and does the and and we're setting threshold values and indicators in the beginning. And we're gaining more experience and information from the Pms for our risk management system, and our Sota, and so on, and so forth. And I'm thinking, does the suitability of my threshold values that. I said in the beginning. Does that change? Do I still have the same threshold values after I don't know a couple of years of Pms and and experience? Or do these threshold values become lower or tighter over time. Yeah, I don't know. How does that resonate with you? You know, as as from the notified bodies perspective. So whoever wants to start. Please kick off, because I'd like to hear from all of you.

Yeah. So I really think that threshold value should evolve through the life of a device. At the beginning. You may not have sufficient data because the device might be new. You may not have similar devices of the previous generation, so you probably need to set the threshold value pretty low. But as you collect more information, you collect more data, you assess more data. You have more users of your device. Then you need to reconsider the threshold value. Are they appropriate? Sometimes if we find out that we have been extremely conservative, and that you can lower them, and sometimes it will be the other way around, and you will have to increase them

definitely. There is no size fits all, but I definitely expect that the values, the fashion values are assessed through the lifetime of the device.

So in agreement, I see so.

I mean, I can just add, I mean, I fully agree with Martha. I believe these threshold are made during the design phase and based on the risk management perform, then and then the risk value is based on the frequency that is assumed assumed then, and also the severity. But eventually, when we have the real data that's risk value changes the severity we actually have a based on real evidence. We know what the severities are, and what are the risk costs, so that for sure will impact. Then our threshold. Then sota as well. Obviously something that was acceptable 10 years ago doesn't mean it's not acceptable. Now, examples are these thermometers that we all maybe as a at least us in our generation, we have these mercury thermometers, but that maybe not really be used anymore, because of the, you know risk associated with it. Now, we have all these better user interface

wired versus wireless technology, all that some of those, maybe, have been accepted in the past, the risk associated with them. But now, based on the current Sota, I wouldn't think. Necessarily, they are accepted anymore. Just needs to be considered. So these values do change. That's the point.

Thank you, milad, for that. Maybe I'll stay with you on this one, and maybe go a little bit deeper into the into data and the level of detail that is required. For example, when you're devising a protocol for data analysis. So we need to already plan how we're going to not just collect, but also analyze the data once once we're there. and how important is number one, the implementation of statistical methods and application of standards like the 2416. And what major nonconformities do you encounter in this area related to the protocol for data analysis, or the plan on how to analyze data in your.

Just to begin with, I have to say that we don't necessarily expect manufacturer to follow the standard. 2, 4, 1, 6. There is a good standard. It's a recommendable standard, but if they don't follow it, it's not a nonconformity. We won't force them to use that standard. So is that being said level of details, such as objective and scope, data collection, responsibilities and data preparation. Statistical methods are all important. Doing a correct trend analysis. Seeing all the you know based on your complaint, handling and sales. That's important. Obviously, this is requirement of Annex 3 as well to have this threshold, to have these thresholds again. You need to have some statistical analysis to clarify. If these are, you know you're based on your decision making. You can't, just, you know. Say, oh, this is, you know, subjective

decision making. You have to have some sort of objective decision making. yeah, I mean, we do raise nonconformities when there's, you know, manufacturer states something, some numbers without any statistical calculations, without any justification, so that, commonly seen.

Wonderful. Thank you very much. Anybody else would like to add. Maybe.

Yeah, if you allow me, I agree with with Milan's, or we agree with Milan's explanation. The maybe 1 point. What we encountered also recently with the discussion with the competent authority that they really expect from the manufacturer. When you do, the statistics on like events or incidents happen in the market versus the actual devices sold on the market. We had the discussion because the manufacturer only deliver the users potential uses of a device in the market. So this gives, of course, context. But the European competent authorities really want to see how many devices were delivered into the market, and this is where they could

the threshold on, or where they find themselves. In comparing data. Of course it is very necessary to understand. for example, as Mila said, if he's from the orthopedic field there you have often the reusable surgical instruments, and you know that in the hospitals they can be there for ages, and of course, only because 1 GB breaks after 10 years of use doesn't make the manufacturer, or doesn't give the manufacturer the thought. So. It is, of course, very necessary to have that in mind to bring it next to your conclusion. But Europe will always ask for how many devices of that particular catalog number have you brought into the European market? And of course, complement that data with the uses you can consider based on when it has been delivered?

Thank you.

Yeah, thank you. So, going directly from from data to to vigilance. Maybe I can stay with you with this Julia. there is often a struggle with the interpretation of reporting criteria specifically regarding the terminologies might have led to or reasonably possible. And what can manufacturers do? Number one to also remove bias in the approach of determining this, and to standardize the assessment of incidents in the above mentioned aspect. So what is reasonably possible, what can a manufacturer actually do to make sure that this is interpreted in a way that is expected by the notified body and competent authorities.

Yes, thank you very much. I was. I also went to our team. Internally, we do have the regiment's team who's taking care of that. And they encounter this, this this question and discussion every day. Certainly. So. We align with them on, on, how do we? How we do we see that? And what kind of mechanism can be used to remove bias in the In. In the Nvcg guidance there is also a bit an explanation. What can be seen so how it can be seen. So if in complex situation, where you do not at that point in time when the reporting deadlines are approaching, and you are not 100% sure if you really, the device can be part of it, and but you cannot exclude it. You, if you cannot exclude it, then it is like, in case of doubt, you have to report, and it is, I know, or we know, that is a bit of a struggle because you have 15 days then only if that is

such an such an urgent case. And and then later, after 30 days, or whenever you find out your device has not been part of the actual root cause, then you still have to have to close the case, but give them more information. That is an administrative burden, we know, unfortunately. Still, it is the case, or or fortunately, you can see how, however, you want to have it in case of doubt. Still, you have to report it and but you can always also reach out to your knowledge, body, and clarify, but due to the amount of of cases in in Europe, and due to the demands of the 15 days, it might be the safer way to report and then clarify again, and then clarify again afterwards.

At that point in time time I could not have known that, but now I can, I'm sure, after the investigation. My device was not participating, or as it was not a root cause for the event. and indeed exactly the same reasoning would apply to individual diagnostics. So in doubt if you cannot exclude device, your device, report to the authority, competent authority of the Member State where the issue occurred and the incident occurred, and also to the notified body. If a notified body is overseeing this this device.

and then, if additional investigation shows later on that your device was not involved. You actually have the opportunity to file a final report where you indicate that it's the final report indicated that the event is not a report from event, because your device is not involved in the incident.

Yeah, thank you very much for this very important message. I think this this cannot be. repeated. It's it's a common question and insecurity, I think, amongst many manufacturers. So just for an overall question. I'll I'll I'll direct this to you, Martha. So have you seen from a notified bodies perspective any over engineering, for example, of the Pms system or the internal requirements. They're either meeting the regulatory requirements and completely overburdening their Qms. Or because of this over engineering, they are missing important aspects of their Qms. And creating pitfalls for themselves. So there's a lot of discussion about how to keep your Qms and your Pms lean so that it's actually effective and not just overburden impact

with actions and activities that you are never going to actually complete. So please everyone starting with Marta, give us give us some input on that.

Thank you for. The question directive was, didn't go through a recast. As for medical devices, so it was, if you like. Still, the older Directive, published in 1998. So the concept of post market surveillance was not, was not covered here. The Ibdr is therefore a huge change for Ibd manufacturers. The idea also includes a lot of instruction. I would say, of what needs to go, for example, in to be included in the post market surveillance plan. And yeah, what is the minimum content? So

if you follow what is in the, you can create a plan. But then you need to execute it. You need to assess the data, draw conclusions on those data which is sometimes missing. And as I was saying earlier on the connection, so it's nice to have this Psur or Pmsr report with all this data, and hopefully the conclusion. But then you have to ensure those data are transferred back, or the conclusion from those data is are transferred back to your risk management, to your capital process, to the overall design and manufacturing improvement. That's where I see the risk for post-market surveillance. It's mandatory exercise, but we don't use the data

to the extent we could.

Thank you very much, Marta. I appreciate it. And from our Md side, can anybody, maybe input on that as well? Some experience from your side? Thank you.

You unmuted yourself already I see you.

No, no, I'm waiting for you. I just wanted to say, actually, go@firstst You go ahead. You go ahead. Okay. In that case, I mean, personally, from our side, we haven't seen a lot of manufacturer going for over engineered ways. The only thing we commonly see is that we raise nonconformity, because we sometimes just need a justification or clarification, let's say, on lack of Pmcf justification for that. And manufacturer comes back and provide us with this amazing clinical investigation plan that they're going to do on 300 patients. And they're never going to do so. That sort of things we sometimes, you know they do have good data. We don't expect them to do that clinical investigation. We just

justification because I don't want to make a conclusion on their behalf. They all want justification for them to make that decision. but they come up with this plan overall. I never see this as a negative thing, so if they have over engineered. Actually, that gives me more competence to the manufacturer, and probably I can make that recommendation for certification easier. That's my opinion. Julia. Audience.

Then, when you ask about over engineering, you can maybe have that. What you actually in your slides, what you have pointed out that sometimes you may have devices which are slow movers or very state of the art devices, or very conventional traditional devices, where it's not not much so much to not much invention, or in anything new. So but this the manufacturer, maybe out of the entire brand new Mdr. Head. set a very short timeline for doing their reports, and so on. Maybe that is a a good point to reconsider. Do I really need to do that like every year? Or maybe my frequencies even too tight. for a device which is more or less a slow mover, and I can grant myself 2 years instead of one year. It is as as we discussed in the panel also already.

Maybe sometimes it's also good to revisit your actual Pms planning and make it more reasonable after the 1st year, second year, 3rd year, to the actual situation you encounter with the respective devices for some of the devices you might need to have a shorter time, and for somebody really can give a larger time in between until you make your next report. So this will not overburden your personnel, and not overburden your your system, then.

All right. I think I can safely say that we have had a very riveting discussion, and thank you very much for for having answers to all the questions, and for joining I will be quiet now, and let Alexia do the speaking and thank you very much. Yeah, thanks a lot.

Thank you to the 4 of you. Really, those were very, very interesting questions, and of course, answers provided very enlightening. So thank you so much. We do have a little bit of time left to go through some of the questions that the audience has sent. If within the audience you have more questions. Please go ahead and enter those now. We likely won't have time to go through all of them. But we will do our best to still address those questions in writing post live session. So there are quite a number of questions actually related to software as medical devices. But very quickly. There was an interesting question about. Is it required to report the incident report that I'm sorry. Is it required to report an incident that happened outside of the European Union.

But I can comment on that one.

Edge.

So for serious incidents, you are required to report to the Member States where the incident occurred. So if it happens outside the European Union. You don't have to report it to any competent authority and not to the notified body. The exception is, if you end up issuing a field safety corrective action. In that case you would report the field safety corrective action to the main authorities to actually all the Member States where this particular device is sold, and also to your notified body.

Okay, thank you so much for the clarification there, Marta. Another question that we have is, Do Pms requirements still apply to a manufacturer if they cease to trade as a legal medical device manufacturer, for example, after voluntary withdrawal from medical devices or from bankruptcy, etc. Who wants to go ahead first, st Yulia, you're muted. I will call on you.

Thank you. So if the manufacturer legally does not even more exist, nobody can take over this this job. So by the mechanism, this will fall back to the competent authorities surveillance of those products because there's no one, no one can be grabbed anymore. And if that company is out of that business as a, as a, as a registered trade company, then there is no one to grab. So this is the fallback mechanisms, for to the competent authorities.

Makes sense. Thank you. Moving forward for the Pms plan. Do you recommend to group based on basic Udi di, or similar intended purpose. Mla, do you want to go ahead with that one.

Sure. The guidance doesn't really provide that much information. In Sgs. We have our own guidance that we provided to our manufacturers. We do say it's either based on Mda Mdn code, plus same intended use or can be based on the I believe we say it's based on if it's used in the same procedure. So, for example, let's say, a hip implant can be grouped together with some of the instruments, a reamer that can be used together with it for that procedure, whereas the hip implant can't be submitted together with shoulder implant because there are different intended purposes. So just because they're the same. Mda, Mdn code doesn't mean that you can group it. And also, just because, you know, there are different. Mda, Mdn code doesn't mean that you can't group it. But at least this is only for Sgs side. I like to see actually what TV does.

Julia, do you want to step into? Give us a bit of the two-suit perspective, or Marta.

Yeah, I, of course. Yeah. So there's there's a sort of flexibility in that, certainly. Then also for the for the Ps. Us, the guidance talks about leading devices. What we encountered is, there is not always one fits all, and mechanism, but what we encountered is when there's too many devices covered in report. It makes it very hard to go through all of that, and to really find the answers you're looking for. So it is. It is. It is a good approach to either have it in the system. But when this system approach, typically in an orthopedic language that considers not only the implants, but also the instruments. If that is too volume, if there's a too high volume, and then the pages going on and going on and going on, it will very. It will be very difficult for the body to find the answers he's actually looking for for the high risk devices where he's maybe where he needs to come in

every year, and maybe for the low risk devices he never needs to come in. That is, I think, a very good point where we need to find all our way through the years. What is a reasonable approach? What is maybe too much and too burdensome. But you can definitely go by the basic Udi. You can also bundle that that is also very helpful, and also explained it. So it is a bit of an individual thing, but it is, from our point of view, not necessary to have for each and every device. Of course, a report which it creates a lot of paper, and, on the other hand, if you budget too much, it will be too too inconsistent in the entire document, and errors and inconsistency will appear.

and the the revenue will not find the answers he's looking for. So that is also the the other side of the extreme. But yeah, this, I think we we need to to see how it, how it's ongoing through the years, and with more experience, we know what is the best practice.

Perfect. Thank you so much, Marta. Any further comments. Just from an Ivd standpoint or.

I would say the same would apply for Ibd. You have flexibility, and it's your device. You know it best. So decide on the approach and explain the approach to your notified body.

Perfect With this we will wrap up. We have reached time. We do have a number of questions that are left unaddressed once more to the audience. We will make sure that we provide answers, but in written form those will come to you in the next few days, so please give us a little moment with while we process through those. I would like, of course, to thank the 3 of you again, Marta Carneelli from Tusud, Yulia, Hoya from Tusud as well, and milad Masjidi from Sgs. Belgium, of course, would like to thank my delightful colleague, Amuna Kevedi, as well for her participation in this program. If you need certificates, and you have entered your details in the chat, we will send those through within 2 business days. Thank you so much. Everyone for participating. And before we end just a quick note that Acro team we're running an inaugural. I'm sorry in-person program on June 24th and 25 called the quality accelerator. It will focus on quality management systems.

how to optimize those, how to make everything more lean. It will be 100% practical. So get your hands ready to get dirty and do some work with us. If you need any information on that, please come, find me or any of our speakers today, and we will let you know more. And with that once more you will get the recording as well for this session tomorrow. Thank you again so much, everyone. You have a very pleasant rest of your day or evening, and thank you once more to our speakers. Bye-bye.

Thank you.