Maximizing Structured Dialogue for MedTech

Hello, everyone, and welcome to maximizing structured dialogue from Medtech. How to achieve greater clarity and build stronger relationships with notified bodies. My name is Shawn Smith. I'm going to start with a few housekeeping announcements before I hand it over to Basil. Who's gonna be moderating today? So make sure that you use the question and question, answer button or the chat button to ask questions throughout the presentations. Your questions are welcome. We'll try to get to them, but if we don't we'll try to follow up afterward. This webinar will be recorded, and the deck and the recording will be made available tomorrow to all registrants.

So look in your email tomorrow, about 24 h after the fact. And that's when it should arrive. There will be one poll with 3 questions, and there will be a survey at the end of the webinar. This is the agenda here, and I am going to pass the baton to Dr. Agra, take it away.

Thank you so much, Sean, and it's very exciting to have this meeting today with all these speakers who are going to be helping us, understanding what is structured dialogue? What are the synergy between Europe and the Us. How to deal with that? What does it mean? What are the struggles? And I'm happy to have with us today. Here Marta Canelli, head of certification of Ibds from product Service. a notified body in Germany, and also Michelle Lott, who is the principal and founder of Leanraqa, a consultancy organization in the Us. Supporting on various manufacturers on European as well as on FDA submissions, and she will be presenting to us today a bit more about the FDA process. Next to both of them. We have also Alex LAN,

who was head of Ivd notified body at BSI and notified body in the Netherlands, and who was actually also involved in a lot of discussion on structural dialogue and other guidance documents in Europe. And finally, we have also Tom Petten, who is an Ivdr. And Ivd. International manager at Gmat, a notified body which is in France. And you see here a variety of notified bodies with a lot of expertise. And finally to myself, Basil Akra, CEO of Akra Team Consultancy Company in Germany. Today we're going to talk about an interesting topic, structured dialogue. A lot of people are talking about that. They want to know what it is. The wording is very confusing for a lot of people, because it's really

strange wording when you talk about structural dialogue. The birth of this wording came actually with Mdcg. 2022 14 when the European legislators started recognizing, we are having an issue with regulation implementation, and they recognize that we need to have measures. And they defined multiple points which are trying to address industry, expectations. notified bodies, challenges and system implementation challenges. And during that preparation they wrote that Mdcg. And they stated that there will be a recommendation on how notified bodies can speak to industry and help them early in the process. And I was actually surprised by listening to all of that, because a lot of people like feel structured dialogue is something completely new.

Now, looking to our speakers, I would like to give you a bit of history and give you a bit of understanding if this is really a new process, because, from my point of view, as a person who worked also for notified bodies. Structured dialogue is just a new naming, but it's a topic which was already done in the past, and I would look to Marta and ask, Marta, what is your view on this? What is structured dialogue? Can you help us just getting an understanding what it is? And what does it mean, from your point of view.

Sure. Thank you, Bazil. Thank you for the introduction. Thank you for setting up the

See the slide. Sorry we see your screen if you can keep the slide in front of us. Thank you so much.

Go.

Headmart.

Thank you. Yes, so structured. Dialogue as such a term is used, defined in Mdcg. 2022, 14. So this term is pretty recent, however, the discussion among notified body and manufacturer. As you were saying, it's it's not new, it's something that is already happening. But what structured dialogue and Mdcg. 2022, 14 did was maybe better formalizing the this pre discussion, this discussion that could happen before application. That was the maybe the main clarification. Also during the the conformity assessment process, the idea of Mdcg. 2,02214, when

presenting structure dialogue was to enhance the overall efficiency of the conformity assessment process. Now, the guidance per se doesn't give a lot of details on what can be addressed in during such a dialogue. The expectation, however, could be summarized is, we can discuss the what we cannot discuss, the how and yes, when it comes to challenges and to examples of what can be discussed. For example, if this is happening when the manufacturer is preparing to apply to a notified body, it could be the classification of the device, the coding that has been assigned to these devices, what conformity, assessment, pathway should be followed? Can

we apply sampling approaches, notified body, or we need to review each individual technical documentation file. What are the timelines? So what are the expected costs? But of course we could not confirm. The files are actually Ibdr. Or Nvr. Ready, we could not do a mock assessment. We cannot complete the gap analysis. Once more we can say what is expected, but not how it should be fulfilled. So yes, this conversation happened. They can happen before the manufacturer applies to a notified body, but they need to respect the independency of the notified bodies.

Sometimes.

Can I interrupt you shortly if I listen to you? And I'm looking to the past from my point of view, you know, as and now I'm a consultant helping manufacturers. And if I look to it, actually, manufacturer typically would not actually be interested in hearing what is the classification? What is actually the conformity assessment process. It might be very important at the beginning when you plan the project, but they are more interested in getting a feedback was, is my study, as it's planned, a clinical study sufficient to address the notified body expectation. So if I hear you well, those kind of discussion cannot happen at the beginning. They are actually no go.

and we are still actually not getting the supportive guidance which a notified body can give early in advance, and all what the notified body will tell me is actually just administrative information which will help me filing in my submission. Is it the interpretation correct?

Yeah, indeed, there are limitations still in the dialogue and link to the role of the modified body to conduct and maintain its independency. So, however. overall from what we could see, although there is some frustration sometimes for manufacturers when we cannot go till the end of the discussion, but they are still helpful in getting the process started.

Thank you so much, Marta. Everyone who's listening to us. We have a poll which you can see the questions. So please answer those, because this will help us also understand your challenges and your situation, Sean, can we move to the next slide, please? So, looking to manufacturers that they are looking to their situation and the structure dialogue and their expectations. And what is happening there? We see a lot of companies, especially small companies, actually facing big challenges with Mdr. So the classification is one topic. The conformity assessments is another topic, then the biggest challenging topic for them is understanding

whether their strategy is actually sufficient to meet notified body expectations. This is how they call it. I know it's not the notified body expectation, but the low. But this is how they call it, they say notified bodies are setting on us expectation which cannot be fulfilled. Alex, I'm looking to you, and I'm looking to Tom. Can you contribute a bit more about this to tell us like, how can those manufacturers be supported? Starting with Alex, how they can get the help? Actually, if the notified body cannot talk to them.

Thank you for raising this, Basil. I think this is a particular topic which is good to cover for Ivd manufacturers, and since all of us are very much Ivd experts. I very much want to make use of of the opportunity to also coffered up the the challenge with knowing what requirements to meet is that some requirements are quite clear and explicit, and some are implicit. and if the requirements that are implicit, and the Mdr. And Ivr are full of it. A manufacturer need to make assumptions. Now, if a manufacturer comes to us as a notified body, and what that manufacturer ideally wants to do is check if their assumption is right.

And I think that is where the structured dialogue process could very much help. We can bounce back particular assumptions, making sure that manufacturers are on the right path, on other. In other situations we're not able to explicitly explain what is needed, because if that would be the case, we would also need to assume on our end. And if we are assuming on our end, we can also make mistakes. I mean, if we're giving a bad advice, let me put it this way. Then a manufacturer would then come back to us and say, Hey, Alex, we had that very nice conversation a year ago. You told me to do this, and now it's something else.

So that's that's a balance that we all need to walk. And I emphasize we because manufacture need to walk this balance and notified bodies need to do with the cells. But ultimately, most importantly, we need to hold hands to help each other. Go through the process. and let me just leave it here for for Tom to.

Yeah, thank, you.

You, Alex, for this. And before Tom, taking the word, I think you mentioned something which is key, which is actually, you know you. You don't want to be as well part of the plan of the manufacturer. They need to do it. and you need to actually assess at the end, and you cannot take that liability at the beginning by getting just a few information to tell them what is acceptable. What is not. This is why you try actually to to tell them what is the lowest, telling them, because at the end you can just assess the full documentation which allow you to conclude and say, if they are in compliance with with the Mdr. Or the Ibdr. But at the beginning, when they are having structured dialogue, you need to be also careful that you don't mislead them because you didn't get the full picture.

Thank you for this, Tom. Do you want to add some some topic.

Yeah, very, very quickly. It's it's you kind of took a part of my point. But overall, I think it's important to keep in mind that direct questions can be very easy to get the wrong answer to. So if you ask questions like, how many samples do I need to to test. It puts the notified body in a very, very difficult place, because we have to give a very hard answer to that and say, Well, we can't actually tell you the numbers of of samples. So what what I kind of like to to stress here is, think about your question and like, what? What do you? What are you trying to get out of your question? You're trying to get information that would help you with your conformity assessment.

So what the notified body can give you to help with. That is what our expectations are. So, for example, and I always talk about stability studies because I quite like them, and we would be an expectation that the stability study is going to support your device, for where it is being sold. So if you are in regulatory affairs, you should be able to infer quite a lot from that answer. And so and again, it's it's it's that. And again, to go back to the numbers. There's common specifications for high risk devices. So there are numbers in the common specifications for high risk devices. If your device is not a high risk device. There's an inference that can be made there as well. So again, it comes down to your, to your, to your questions. If you ask very direct questions.

and you might be disappointed.

So I was. I'm watching the chat and the Q. And A. And somebody just asked, Do product Demos fall within the purview of a structured dialogue.

They can. We like to be told a story, and everybody likes to be told a story. and personally I always loved when a manufacturer gave me a demonstration of their device, particularly if I wasn't familiar with the technology. So.

So I think this is a very good point, Michelle, that you you added from the chat, because at the end it's also key, not just to have a conversation, but to have an educational session because notified. Body reviewer need to also know about this upcoming submission, and this might be very helpful, so I don't think that notified bodies will be rejecting having an interaction early to learn more about the product, about the design, about the plans of the manufacturers, but they might not be able to contribute to changing that design early in the process, because it's not their job. They just going to tell you later on. If it's compliant or not, Marta, is it consistent in Europe? We hear a lot about actually the various processes, and the question before is like, how consistent are notified bodies. Can you tell us a bit more about

how you are making sure that those activities with the new definition of structured dialogue. Very fancy name is becoming at least consistent across the various notified bodies in the EU.

Yes, thank you. Bazilla. Yes, consistency and notified body consistency is a topic that comes up regularly. We are in different Member States. We have different authorities designating us. We are different companies, but we do do a lot to align our processes and our procedure through different means. We have specifically the code of conduct for notified bodies that participate to the Tmb. That are member of the Tmb. Association, that also include a section on structure, dialogue, and what could be covered and what could not be covered. We also have other means of cooperation and alignment via the notified Body Coordination group. So

there is a lot of I would say communication among notified bodies to align as much as possible their processes taking into account the condition I said before, so we are in different Member States and we have. We are different companies.

Thank you so much. So I think this is key that notified bodies are working hard to ensure consistency. But there is an influence of the various Member States that might influence their decision, making on how to do things and their process, which need to be considered as well. Now, Tom, you mentioned in your talk you spoke a bit about actually give me the right question. Ask me the right question. And looking to to actually Key Point, that you added in the best practice, you say, prepare and submit supporting documentation, so can I come to you and send you the holistic technical documentation in advance and say, I want to have a meeting with you, Tom, and I want to discuss with you. Annex 2, part 1, 2, 3. Is it possible? Or how far can I go? And what do you mean with sharing information in advance?

And perhaps you can give us a bit of insight about the best practice. And what would you actually recommend? That would be the best way to discuss with the notified body.

Sure. Thank you for that comprehensive question. So I I'm gonna start. Just go to go back a small bit at the start, and I'll come around to it. But it's it's so the the I think, the sentence that I say most when I speak on webinars, or when I speak at conferences, notified bodies like to communicate with manufacturers, and I think the inverse is also true that manufacturers should like to communicate with notified bodies and open communication both ways is essential, and the both ways part of that is the most important thing. Be that in what's now called a structured dialogue, or be it in the process that we had before structured dialogues became a thing

notified. Bodies are handling it differently, and and not to go, not to go back on the team and be code of conduct practice document. But the last sentence in the structure dialogue section is, it says that structured dialogues may not be needed, which is true, they may not be be needed. So what what makes you have a good structure? Dialogue is like any communication meeting is defining the meeting before it happens. So what is the purpose of this meeting? And then, even if this is a regular standing meeting, and we have some manufacturers that you might who do this brilliantly. We have the set agenda. The meeting is every 2 weeks, but before the before the meeting happens, there's always a check in call saying, we're good for this agenda, or we want to add this point to the agenda. And it's just really important. And it it's we want to speak about. A bio compatibility issue with our product. So could we have a

compatibility expert on this. So again, it's it's the clear communication and getting the right team on the call be beforehand on both sides. So again, the kind of the one that kind of Springs to mind. It's kind of adjacent to your point, Brazil, but I'll I'll use it, and if you don't think I've answered the question you can come back to me is where we do see value. And structured dialogue specifically is not say for the the regular technical calls that we have currently in place, but it's at the start of the process, say, and at the end of the process. So at the end. you want to make a modification to a sampling plan by adding 2 devices and taking one off. So you want to have a specific structure dialogue about it. That kind of makes that sense sense. There you have 6 or 7 different Psur is coming in for your products. You want to know how you can consolidate the app, the

and the upload or the submission dates of these into a more kind of cohesive method. But the one that we're seeing kind of most of all is, say, when you want to transfer a notified body. so transfer of the notification.

Thank you so much, Tom. So if I, if I listen to all of you, is actually this kind of structured dialogue is, is is a kind of technical support which is not product related is much more on the process itself of interaction with notified bodies. So this is where you can get answers. but how can a startup? And I looked to the chat, there was a question stating, who can I benefit from these structured dialogue? Bass actually, is it actually the startup? Are those actually the midsize, bigger manufacturers? How can a startup actually get relevant answers? And the answer that they are looking for are not just actually related to this is how I submit. This is what I expect from you. They want to know a lot of.

They have questions which are challenging. Sometimes they. They have a verification plan. They are unsure on this. So can we say that this is not possible to be answered in a structured dialogue. So if they will send you a verification plan in advance, you will reject such a meeting because you will say I can't talk to you about it at this moment. Is it true to to state it as such. Tom, do you want to answer this question?

What do? What do they? Again? I'll I'll play the notified body role and you can play the small firm. What do they want to talk about their their, their plan, like is this.

Is it compliant, or is it sufficient panning.

Okay, we we we can't answer either of those. But again, for for a small firm I would be happy that they know they need to speak to a notified body early in the process I would encourage that. They do reach out and and speak to us because the other, the other sentence. They always say to to Smes or to to startups is. grow your regulatory team as you grow your your as you grow your company, because what will happen is you will develop a really, really good product that is technically sound. And it works. And it does what you what you say it does. But you haven't considered the Reg. And you're just going to get dragged the whole way back.

So again, there is definitely value in speaking to a notified body, and even if it's to come in and to find out oh, well, we didn't ask the questions in the right way, like I kind of alluded to earlier, there is still value in in understanding that you need a Qms. That you need 13, 4, 8, 5, that you need a good basis to build your, to build your your product on. So it's kind of a yes and and no. So while we can't answer directly, we can still help.

I think you answered very well, Tom, and thank you for this, because, and sorry for being so.

No, no, I love it.

Challenging with those questions, because I want to make it clear for the people to say what is allowed, what is not allowed. I'm looking to Michelle and watching her, to see her face looking to us and saying, What are they doing in the EU? They are totally crazy. We have that established in the Us. Since many years, and we have a process for this. We name it differently as well. We have a different naming and language for this. Michelle. Tell us a bit more about this. How does it work in the Us. Today? A lot of manufacturers come to me as like, if we have a question. We go to the Us. We ask them the question. We get the answers related to the U. From the Us. FDA. Through a standardized process which is running in the Us. Can you tell us a bit more about this process? And how far can I go with these questions? And what can I expect as an output.

Sure. So 1st off, we also have the East star that we can file like they're calling it prestar. And just even that document helps communicate some of those product detail features that that Tom was talking about like getting the right people at the table, you know, and and all of those things because they have drop downs. They've got help text. And it really helps you have a more effective a process to communicate with FDA. But he, the pre-submission, is actually a type of a queue submission. It's my personally my favorite, and I do them in probably 3 different pieces, as the company is going through their design and development to commercialization. And we've got more definition around what the product is the intended use. We started collecting data. So this guidance document from the FDA actually has a really handy appendix to

that outlines ask the questions like, here are all the topics that we can discuss, and more. And here are example questions that are going to help us, you know, effectively communicate. So. And you know where the FDA says, oh, we can answer this question instead of you know, Alex was mentioning the difference between the implicit and the explicit requirements that are really heavy in the under the Mdr. And all those guidance documents that the Commission put out. But in the Us. I would say that it's more explicit with expectation rather than implicit with expectation. So I also think it's a little easier to navigate. You know that the FDA has really equipped people with, I think, very

maybe not very clear guidance documents, but some that are definitely helpful to navigate this mission and others. So there's there's more written around what the FDA. It expects to see.

Thank you so much, Michelle. I think this is very useful and very helpful. What you are presenting to us, because I think in the past. Even the system in the U was allowing not all of these kind of questions, but a piece of that. So piece of that was done in the past. And today. from what I heard from Marta Tom, Alex. I can't get to a notified body and ask them, is actually my study design acceptable is my statistical calculation good enough to achieve ce marking? Because they will tell me. I can't tell you for this moment you need to get me the full protocol and report and file a submission, and then I can tell you, Badge, forget it, repeat it again, because it doesn't work so, which is hard to understand for a lot of industry, because they see actually the Us. Is willing to talk and able to talk, whereas notified. But they still have that limitation is my understanding correct, Marta. What I said, that what is allowed, what is not? Did I miss something? Or is it clear that you are not able to tell. If a study design is acceptable.

Yes, thank you. Covered it rather well and rather clearly. We do have the limitation. I mean, the FDA is a government agency. We are 3rd party assessor. So there is. This different leads us to have a strong, I would say, not control. But there is a need for us to remain absolutely independent. And there's such limitations on what we can say in the course of structured dialogue. Arena are still there.

Didn't know.

So I think.

I think that you know that if you have to think about the the thoroughness and the completeness, and who can answer what the the all you also get depending on what type of meeting, as a result of the pre-submission process you could have, you know, written feedback only. And then the FDA. Writes their answers to your questions in in great and very explicit detail. And so that that's also really helpful, because then you you have it kind of in their own words. And then, similarly, if you do have like a meeting meeting, they are, you know, will go back and forth with you on the notes for that meeting, so that you all agree and are on the same page with what what the FDA was trying to communicate.

So it's to some extent different. And I think Marta mentioned that this is like we have an authority versus a 3rd party who is impacted by various actually stakeholders who are connected to the system which do not allow them to do things like that. But from your experience, Michelle, is it. Actually, when you go to an FDA submission, most of the manufacturer nowadays they don't look just to one single location to place device on the market, they look to Europe, they look to the Us. And they try to find actually the most lean process to get their product on the market, and they might get actually to the Us 1st and get their question address and then plan to actually use the same data for Europe. Did you see from your experience actually, that more

more manufacturers now are going to the Us. 1st and then moving to Europe.

Yeah, I have seen a big shift in my business. And and I think right now not even the medical device companies that are based in Europe want to go to Europe 1st anymore. So I'm definitely seeing a lot of outside of the Us. Clients. Really, an influx coming in because they they want and need to commercialize their product. But it's just not viable for the startups or small companies right now.

Yeah.

So and then. So I'm also seeing that the governments, you know, if you had a ce mark in Europe, there were a lot of countries that would, you know, recognize it. But I think we're also seeing a shift of okay. People are going to start recognizing your 5, 10 K or your de novo decision. Letters in lieu of the Ce. Mark.

Thank you so much, Michelle, Alex. When Michelle was talking and Marta commenting, Marta commented, we are a 3rd party. We have one of the here attendees online. Who's asking, can we go to an authority in Europe and get the scientific advice? If notified bodies are not allowed? So can we go a higher level and get somewhere a scientific advice. Is it possible.

Yes, I mean, you can get scientific advice. There's a program with Ema. You can also get scientific advice from comp authorities dealing with clinical studies when it's that study is carried out in that particular Member State. There are challenges, though, I mean a lot of the knowledge resides with the notified bodies on medical devices in relation to the regulatory requirements, and ultimately a 3rd party will need to review the evidence in the end so ideally, and this is very much speaking from a manufacturer's perspective. I guess you'd rather have that discussion up front and not leading into those difficult discussions afterwards, when it lands on the desk of the notified body.

At this moment notified bodies are not allowed to give scientific advice to manufacturers regarding certification. There is a program where it is possible to get scientific advice from the Ema, and you can bring along your notified body and have that scientific advice there. mind you. there are different expectations to that, and not every person at the Ema may have the device knowledge. They certainly do have a lot of knowledge on drugs and biologicals. So.

Thank you so much.

I'm I'm just saying as it is, it is it is quite a challenging process.

No, it's like we're trying to just to help people understand the current process and possibilities in the u versus us. And it's clear. And I saw some comments in the chats stating that U.S.A. Will never give you a clear yes, which is clear. Everyone will say it's not legally. Binding is actually based on what you are giving me for this moment of time. But if I go to Ema or I go to the expert panel, can I go with every device here because currently we are still talking about a limited number of manufacturers who got actually possibility to get the feedback. Can every manufacturer every startup.

Get that opportunity? And is it just limited to clinical, or can it go wider above clinical to get like? I mean, I saw authorities in the EU, saying, when a manufacturer asked them about their classification, they said, We can't tell you about that. We don't have a process. Speak to a consultant. We can't support you. So how can actually, someone who is have great idea want to get to the market, get some guidance without actually having a consultant involved in this process.

Yes.

So. Tom, do you want to comment on on the feedback of email which Alex mentioned to us? Is this something that will be reported as a notified body that the notified body have a clarity. What email or the expert panel told the manufacturer to be acceptable or not? Will they get that feedback.

I caught that one in the in the chat. Alex. Alex. Kind of kind of touched on it earlier. So there is the possibility to bring your notified body to the talks with email, which would, I would recommend. I can recommend things without going too far. I would be. I would wonder why you would not want to avail of that option if that option is available to you. But again, it's it it all comes down to to so if you go to the email website, you can find out the specifics on it. And then you need to incorporate that into your system and identify? Who do we want on this call? And what are we trying to achieve? From this call it literally, everything kind of comes back to that point, and if that's the point, I'm kind of going to hammer on this. So yes, you can bring a notified body with you if they're not there, or if you had, if you've had a call without them, you can still get a call with your notified body afterwards to go through it, and and it is important that

the accuracy of what is communicated from Ema is documented, I will say the expert panels on the Ibd side of Ema are the experts, the experts with the Ibds and they would have been they would have good experience. So they they they're quite knowledgeable. So it's it's a strong team on the Ivt side, so.

Thank you so much, Tom, because this is.

Or not.

Different as well. Ivds versus medical devices. Sean, you have a question or comment.

Yes. so it's interesting. The FDA pre-submission. Q sub process michelle has a course on that. I I sent you a link, Basil. I don't want to interrupt the screen by adding it to the chat, but if you add it to the chat, there's only a couple of days to register before that becomes a paid course. They'll have plenty of time to finish the course, but it really does go in depth into the pre-submission process, and so I recommend for anybody not familiar with that process, to take the free course. Similarly, I had a conversation with a notified body shall remain nameless. And I said, Would you, for example, take into consideration the FDA's approval of a clinical study, and the notified body

said to me, we would absolutely take into consideration, we would give great weight. Great weight was the quote to another competent authority from another region advice and input on a clinical study. So that is just an off the record remark that I felt like I would share.

This is very respectful, notified body, Sean, so.

Yeah, I would say so.

I think they were very respectful to the other authorities, and they it's good to know that. honestly speaking, you know, it's not about the authority. It's about the scientific validity of what you're doing. and if someone would tell you what you have done is scientifically valid, and I think FDA does such a stringent assessment which would allow you to say Yes, it makes sense. A notified body might not actually find more nonconformities connected to that study. So. Yes, if another, if someone reviewed the study in a good way, why not? Importance is the scientific validity of that document that will be presented as a notified body.

just to make sure that we are giving enough time for the next discussion. I would like to hear more about the values, and perhaps, Sean, if we can move to the next slide, and I recommend in parallel what Sean mentioned to even the European authorities. If we have some people also from European authority looking to to this event and this virtual discussion visit as well what Michelle is presenting in her session, because this might help you get ideas on how the structural dialogue can be framed for the future in a better way. Because I was like, you know, we are talking about theory. Manufacturers do not even have a notified body. Sometimes, when they have their question, they are not even established as a company. Some companies they have an idea they want to build it. They want to get the question answered. They don't know with whom to speak at the very early stage, and this might be very important to re evaluate the structural dialogue and to look to

when the process starts. It doesn't start always when I have a manufacturing company, and you need sometimes someone to get an answer from which is actually enabling you to have some certainty very early in the process from the idea, and not when you are already a manufacturer, and you have your notified body, so we should not forget that as well. Alex, I see you have prepared for us very nice presentation with showing some metrics. Perhaps you can tell us a bit more here about the benefit and values and what you you have in front of us here as a slide. Please.

Yes, thank you very much, Basil. Now, with respect to metrics or or benefit of structured dialogue. I don't have very clear metrics on that, and neither do any of the other notified bodies. I'm just guessing that it really has a benefit. That is without a question. If you apply structured dialogue properly. then you would get regulatory clarity. If you get regulatory clarity, manufacturers are able to make the right assumptions, prepare for the right things, focus on the right things, and they're able to move ahead. And I would say also, very much for startup companies and companies that perhaps do not have a final device.

That is very much of added value, because the more clarity they have. the more and better and accurate information they can give back to their investors. Now. there is a thing we need to be mindful of, though, and is where this structured dialogue is happening. And if you look at the Nscg guidance that is currently under consultation. There's basically a drop off between pre-application and application pre-application. A notified body can discuss, not to the same extent particular information regarding technical or clinical. However, after an application has been filed with a notified body, and it doesn't mean necessarily an actual technical doshe submitted. But just an application to start with a conformity assessment.

clinical, technical, and regulatory information can be shared, and also can be. You can have a dialogue on. I think. What is also very important is that a structured dialogue is really structured, meaning you not only get the right experts involved, but you also document the outcome of the meeting that can be, for instance, in meeting minutes that are vetted by the notified body. There can also, for instance, be an opportunity to create a short report where every question is answered, and that's basically given back to the manufacturer. Also being mindful that such a report will include a disclaimer that anything that is assessed now does not provide a guarantee for compliance in the future, because regulations may change.

but this is the best, you know also from a manufacture standpoint you can get last thing with this. I think there is also differences in the type of structured dialogue that a manufacturer would want. for instance, startups, and also small and medium sized enterprises. They may have many more questions on the process, on how to prepare for a conformity assessment as opposed to perhaps very large organizations that have gone multiple times through conformity, assessment process with the notified body. and they would have, you know, a different interest to set up a structured dialogue. And I think within a notified body there should be a flexibility to organize all of that.

That's it. Basically.

Okay, thank you. Thank you, Alex. I I think this is very useful, because what you literally stated in your presentation here, talk to us throughout the process, communicate with us as notified bodies. Make sure that you are. If you have a question, talk to us. If we can't answer it. We will tell you. If we can help you. We'll let you know, because this is how we can support and build the relationship and ensure also trust and continuous communication. And I think, Marta, Tom yourself kept saying that and this is a different actually approach than when the Mdr. And Ivdr were in place, because at the beginning the communication was going down because notified bodies were not even were not even available or able to communicate on such a high level. And now you are structuring the conversation.

and you are recommending to manufacturers. Come and talk to us, regardless in which state you are. We might have some limitation, but where we can help you, we are willing to help you if we are gmed. If we are, we are BSI or other notified bodies. We will help where it is possible for us to help, but we cannot do actually what the FDA does. It is much more detailed feedback. We are not allowed yet to do this. If we will be allowed, we are willing to do this in the future. So this is the key message that I'm hearing out of what we are discussing. Sean, can I ask you to move to the next slide? So, looking to all of that, looking to those situations

can can. Can you give us a bit of like information about what we can expect? Because people are talking about actually, potentially new regulation or amendments. And all these amendments that potentially will come into place. will we have something similar to FDA in the future? Will this change the future regulatory frame that we have an opportunity in the future to have a possibility to get written feedback from a notified body very early in the phase, Tom, do you want to contribute on that.

Yeah, sure. Who knows Brazil to be? To be perfectly honest, we do know that changes are coming. But when we consider what we have heard in relation to the variety and the extent of the changes versus what we have been told is coming. It's a broad spectrum. There's a lot of room in there. There's a couple of things where where the notified bodies and I think industry in general would really really welcome change and electronic Ifus and Medsap coming in to align to the Mdr and the idea that they would be 2 things that we think could be incorporated very, very easy. That would be a huge benefit to everybody. But then a couple of the other changes. We're we're a little more hesitant on, I think the best answer I heard given.

and to this came from the European patients Forum, where where? The lady again I have to look up the person's name. But the request was that to request data driven change, that the changes actually come from the data behind everything, which is what's important. because, realistically, if we look at them. How the Mdr numbers have have improved over the years we do see quite a lot of improvement, particularly in the last, say 12 to 18 months, and we see devices getting on the market quicker, and we see and stability. And so we are requested to be more stable, and we are requesting more change, and those 2 things are not compatible. So I would urge everybody to keep that in mind, and say that the changes should come in in a structured way. And this should be based on data that is going to be of benefit.

Thank you. Thank you, Tom.

That there is a learning curve on the side of manufacturers, but also on the side of notified bodies. And as long as we're able to process this more quickly. Compliant. Then I think it's all for the greater good.

Yeah. And Alex, there's also the implementation curve that is often forgotten about when the change comes in getting that into 50 nbs on the on the Mdr side getting it applied, and then we want consistency as well. So again, any changes that come in like I said, it will take, it will take time for them to see the benefit of so.

Experience was was a positive experience. Was such a structured dialogue where your customers felt out of the structural dialogue. Actually, they are seeing a positive impact.

Yeah, I I don't have any customers that have pursued this this particular type of dialogue with their notified body. But again, I think it's the the hesitancy of you know. We're going to jump in that puddle or not with taking on the Mdr. But one thing I did want to mention that I saw a couple of things in the the Q. And a. And in the chat was just talking about, you know, time and cost. So for FDA a pre-sub, for now is still free and and they take between 60 and 75 days, and they're pretty on the money for that turnaround time, too. I think that for the Us. That the FDA is going to start charging a fee for the pre-submission

and then there it's it doesn't have metrics on it right now. It doesn't have a cost on it right now, but it does have metrics for performance, whereas there's another 5 13 G, which is different type of queue submission. You ask different types of questions, and it has a a pretty high fee for a startup company, and then. but it doesn't have any metrics. So several of the ones that I've seen, you know, took 10 months to get a pretty basic response from. So there's some different dynamics that are afoot. As far as what is the future gonna look like for these queue submission processes.

Thank you so much, Michelle, Martha, do you want to comment on? Perhaps I mean Ivds, we are still seeing manufacturer are very hesitant to move to Ivdr. So we have, like big players who are Ivdr certified. But does this structure dialogue help them actually in moving their legacy devices in getting actually the certainty that they are looking for. Can you share with us, like the last comment from that point of view on your positive or negative experience with implementation of the structural dialogue.

Definitely, I see structure dialogue as a positive option for for small companies, for or for companies that maybe are not small but never had to interact with a notified body before, because, compared to the medical devices, the Ivdr. Was much. much larger shock to the system than the Mdr. Was for for the manufacturer there is a really a lot more that is being asked so, especially a lot more devices that need to be certified by a notified body so definitely for those manufacturers that have are interacting. For with a notified body for the 1st time or

the beginning of the Ivdr journey, having the possibility to discuss even staff, as the classification of the device is helpful, and we have seen positive positive feedback and positive experience on that. Of course, it's always very important to plan what you would like to ask to the notified body. Yeah, come with a question in mind, provide the question even in advance to the notified body, so the proper expert can be selected to participate to the structured dialogue.

Thank you so much, Marta. So let me let me take it from this point of view, and I share with you my positive experience, regardless what you name it, structural dialogue, or dialogue or talking. I think I highly recommend to everyone. Speak to each other because communication is key, and if you start communicating, you create trouble. So I think positively I had it with the various notified bodies as well as authorities. When you talk to each other, you will find solutions regardless where the limitations are. You need to have the conversation, and you will hear actually what are the expectation and the trust, and the relationship is key in the holistic process. And this is important to achieve success

and also to get some certainty about your move from legacy device to a new Mdr. Or Ivr. Certified devices to address changes that you are dealing with. As Tom was mentioning, or to deal with a completely new manufacturing site or new manufacturer establishment. You might have fundamental basic questions which are key for you, and at least you will get some of the answers that you are looking for, and the other ones that you would need, you might be required to check with a consultant or another expert who might help you, and this will be actually key to prepare and make sure that you are moving in the right direction. Now, I'm looking for the questions from the audience. And, Sean, if you can help us on

picking some of these questions, this will be very useful.

Okay. not sure. I understand this question. But Eiu and Md. South.

Oh, sorry that was that was to me. So there! There was a request in just to Re to repeat the 2 potential changes that would be up.

Oh!

So so electronic, I haveus and incorporating the Mdr and Ivdr into into emptysap. So the single audit program.

Thank you, Tom, for answering this, and meanwhile I've picked another question, and I saw it, which is potentially very helpful to be addressed should the notified body be provided, the pre application before reaching out to Ema for consultation, or it can be done at the same time. So the pre-application for the conformity assessment process? Or can I actually select you as a notified body and say, I want to go to Ema to talk to them? And I would like you to be with me joining that meeting. Is it possible? Can any one of you want to answer this question, Marta? Alex, Tom.

It's the 1st time I hear this question. I mean, if it's possible from the Ema to join a notify body, I wouldn't see why not? But I think, after you have that meeting, the requestion still remains. What are then the next steps you're going to take? Let's say the the topic is very scientific, and does not relate to any particular device. It may be that, you know a notified body not be involved for the next couple of years or so so, and a lot of things can happen and can change in that amount of time. So it. it depends a little bit, and I'm not that familiar with the process for an Ema, whether that is possible.

But good question.

Let's take it from a different point of view, because I'm seeing this question repeating multiple time, we have here the second question, perhaps Marta and Tom can help as well on this is saying, is structured dialogue possible prior to the manufacturer and notified body being actually in an alignment or an agreement. Because, let's say, I'm a manufacturer, and I didn't decide whether I gonna take Gmat or BSI. Can I speak to you and have a kind of structured dialogue. Before I select you as a notified body.

Yes.

For sure I would, I would, I would say, like if you view it from a purely manufacturing point of view, and view us as a critical supplier like, if you're going to get a critical supplier in for our raw material, are you going to go with the 1st one that you speak to. Maybe maybe you are, but you'll have done your due diligence on. Why, you select that one, and it's the same for us. So myself and Martin speak on these panels the whole time. We're genuinely, fairly friendly outside of them, and but business. But business.

Even outside of them.

Even even outside of them. But business is business, and you, as a manufacturer, need to make the best call for your business. So I would also caveat it with, do you really want to spend your time having the same conversation with 3 or 4 or 5 nbs. Over and over again? So.

Yeah.

Maybe you do. But is there? Is there a lot of value to it?

That's very good. Got here. So I heard you all of you this the 1st time during that conversation, that all of you at the same time. Yes. So which means actually, you can have an early conversation keeping in mind. It has limitation, and they will not talk to you about aspect which will tell you which study design would be possible that you do shopping around. So it's not intended for shopping, but for selection of the most suitable let's say, a a partner in the in the chain to ensure the conformity assessment process is running in line with your expectation as well, because you will be for the notified body actually as as a customer, and the notified body will be for you something

critical in the holistic process, and therefore you have the right to have that conversation in advance, and to select the right notified body for your organization.

Yeah, want to make one side note on that. Obviously, our primary process is conformity assessment. So the more time we're going to be spending on having structured dialogue the less time we're able to spend on all the other processes meaning certification. So I'm just setting the expectation also with the audience. That structured dialogue is very much a process that will enhance the transparency and enhance clarity. But it's it's not going to be our primary business. So if you want to set up a structured dialogue, then, you know, come with a very good plan. Come with very good questions. and then we'll certainly will oblige.

Thank you so much, Alex. 1 1 question which is asked regularly, how much does it cost? Will you charge the manufacturer for such a structured dialogue. I see Tom smiling. Oh, marvellous! Smiling Alex, hesitant to smile. But perhaps, Tom, you can. You can talk.

Yeah of. Of. Of course, we're gonna charge loads. And it's it's it's going to. It's gonna cost loads. But in reality, the answer is. and I hate this answer. I hate giving this answer to somebody from a notified body, but for Gmed. It depends where you are in the process. So if it is a structured dialogue which we don't call structure dialogue, if it's a normal technical call within the process of your review, where you need a sterilization expert and a bio comp expert and a clinical person on the on the call. You can expect to be charged the normal. The normal call rate that you would get it also depends on

notified bodies often have different different services that are, say, covered under your annual application fee. If you have an annual application fee, or if you have a tiered service, where, if you pay more, you get priority in queues. So if if you're part of that. Maybe it's in included. But I can say for Gmail if it's pre application. If you're coming to have a conversation with us for the 1st time, and you don't have a contract with us. There is no charge for for that.

Thank you, Tom. Mark BSI's parts. Alec, go ahead. Do you want to go ahead?

So for BSI, it's part of the process. So if a manufacturer has signed up with BSI, then we're able to provide the structure dialogue. Obviously. it's going to cost some money, but it is just on an hourly basis, and for the amount of time that we need to prepare and actually conduct. which in all fairness is not going to be much. But you know that's that's me just talking. I think it also depends a little bit in pre-applications. Some manufacturer would like to have new manufacturers. New clients want to have a conversation with us upfront. and there's no real, you know, a contract set up.

It. It could even be done for free. But the conversation will also be quite minimal. That that's all I'm saying.

Thank you so much, Alex. Marta, are you aligned with your colleagues, or will will be charged? What a defense! Tell us.

It depends. It depends the favorite word in regulatory. It depends whether there is already a contract in place or whether it's there is. There is no contract in place generally, if there is no contract in place, and we really want to have a well structured dialogue, then there would be if he charged to take into account the time needed for the preparation for the discussion. Different is if it is within the discussion, once the contract is set, and then it's I would say, regular communication among the notified body and the manufacturer.

Thank you, Marta, for this, Michelle you mentioned FDA doesn't charge, but is thinking about charging. What we are talking about. Is it the same like in Europe. You can decide between a Ferrari or a structured dialogue, or is it actually in the Us. Actually cheaper? How does it does it run in the Us. Perhaps you can share with us some insight, and I'm joking. It doesn't cost you like a Ferrari to have a structured dialogue, but perhaps you can tell us a bit more about the Us. Structure.

Yeah, sure. So part of the reason why I anticipate that they're gonna add a fee is that. And and this is a big difference between notified bodies and the Us. As well is that they? sorry I'm losing my train of thought here.

Will charge a fee versus hourly rate.

Yes, exactly like the 513 GI mentioned earlier, which is a different type of pre-submission. They they charge. I think it's about $5,800 this year. So it's still like, even if they added a fee to the pre-submission, I don't think it would come close to the the cost, to have ongoing discussions with a notified body at hourly rate.

Yeah, thank you so much, Michelle. So I think I think what we are getting out of this. it's by the end of service. So what we we FDA, is a governmental organization who can decide on a fee rate, whereas notified bodies they have to charge for the service because they are using resources.

And there are for profit patient.

And they they need to. They need to. Actually, they want to support. But they cannot support, free of charge, because no one is paying them salaries they will need to actually pay their resources is why, it's fair to say for this time that you are using. You will be charged for it. So I think it's it's business. Wise makes sense, and it's important to structure it. And this is going back to what Alex, Tom Marta were saying, structure it and raise the right questions. And it's not about the break. It's about actually having the conversation to get the value for that money that you are paying, and, like Alex Marta as well as Tom said, it depends where you are in the process, and they need to protect also from unnecessary number of questions coming to them. This is why they want to have a process which is structured to such a level, to say.

if you are applying, and you want to talk to us. We might have it in the whole package. If you want to talk to us in advance, we want to avoid actually spending a lot of time for conversation which are actually not leading to any potential future conformity assessment. So I think all of that makes sense. But what we learned today, and what we got from all of that discussion. Talk to each other, communicate. You have the willingness. There is actually an ability to have such a dialogue, you can structure it, and you might have some costs, but that cost will be actually value. Add to your holistic

process planning, and I think Alex, Tom, and Marta and Michelle shared with us a lot of feedback about the differences between Europe and the Us. And the fact that communication is key for everyone, and I would like to thank you for listening to us, and I think a lot of you might have a lot of additional questions. I would like to thank the speaker. Thanks, Sean, as well for organizing it, and I will leave the last word with you, Sean, to tell us about the upcoming events, and how people will get access to the recording and additional information that were presented today.

I've got to run to the other meeting. But thanks for having me again. And it's always good to to talk to you guys and with you guys.

And I would like to point out that everyone who showed up here today showed up here for free, and they gave you their time, and that's a lot of money right there on the screen. And so I would like to thank all of you for doing that, and for generously donating your time. Next week we have us market access with Edward Doherty and Yoner Institute, and so and I will include details for Michelle's course in the follow up email that goes to everyone. If there are more questions we will try to follow up with you. Thank you all for your time and attention. Please complete the survey afterwards. Bye-bye.

Thank you. Thank you.

I.