CE-Certification vs FDA Strategy MedTech Startup Masterclass

Hello, and welcome everybody to medtech leading voices. Med. Tech startup master class ce certification versus fta strategy with 3 expert panel speakers today Ronald Baumans, Michelle Lott and Nika Mendeleev. Of course that doesn't advance the slide. So a couple of housekeeping notes as we get started 1. 1st of all. I'd like you to try the chat function. Just drop in what country you're joining us from? And say, if you're a startup, just just for the fun of it. you know. We like to know who's on the phone? There you go start using that chat function. I want you to use the Chat and Qa. Functions vigorously throughout this webinar. I want you to not be shy about asking questions. We'll try to get to all the questions those we can't get to. We'll follow up with.

Please participate in the polls and surveys. Yes, a recording slides will be sent via email tomorrow to all registrants. 766 people last time I checked. So that's a great thing. We are offering a certificate of attendance. Says you attended the 1 h, webinar and if you would like that, please please put your name as you would like it to appear on the certificate and your email address in the chat, and we happily send that to you. But please give us a couple of days, and don't nag me because we get them out as soon as we can, but it's a very manual process. Then make sure you're subscribed to Med Tech, leading Voice. And if you need to contact me for any reason, or don't feel comfortable using the chat. Use my email address. You could see it right there. Connect with me on Linkedin again, Shawn

moderator. quick in a round of introductions. I'm gonna let them say more about themselves. But Ronald is a co-founder of A. R. 2 R. 2 c. 2, and it's a a newly formed regulatory strategy group with Mika, and Michelle Lott. From Lean or IQ. What's interesting about this collaboration to me is that you know, these 3 experts are coming together from both sides of the pond to offer their particular strengths and insights into regulatory strategy, particularly for startups, so be sure to pay careful attention to what they say. and don't be afraid to reach out to any of them, because reaching out to any of them is being reaching out to all of them

with that in mind. Let's go ahead and get started. I'm gonna introduce Michelle to talk about the Us. Strategy.

Okay. thanks. Sean. so in this master class, we're gonna go through the ce certification process versus the FDA strategy. I'm gonna speak a little bit to the FDA strategy, and then Ronald's gonna hop in and talk about the kind of current state of the Ce certification. And then we're gonna keep both of our presentations rather brief, and hope to spend most of the time answering your questions. At the end. So let's get started. Shawn gave you an overview of me. I have been in that devices for over 1020 years. I did serve a 4 year term as a industry representative on a FDA. Good manufacturing practices. Advisory committee. Then I make a joke that I'm a Master Grief counselor, because you're here. You probably already know the pain on both sides of the pond with the FDA and the Mdr. On the other side of the pond.

This is my C-suite. They are currently asleep, but they might not stay that way. So I apologize for any extraneous noise. So let's get started.

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So 1 1 of the 1st unique things about the Us. Compared to the the methodology that the Mdr. Classifies and the Mdr. Uses like a rule based approach. The FDA uses a risk based approach that involves a level of different types of submissions based off of the risk structure of the product. So for S, for super low risk devices, the pathway to market in the Us. Might be a walking, the part in that it could be G at 5, 10 k. Exempt. It could also be Gmp exempt. Then the next kind of risk class, for, like low and moderate risks is more like running a marathon. This is for class 2 products. And and this is a 5, 10 K submission that's based off of a a predicate or substantial equivalence argument.

If you have kind of a a, maybe a a medium risk product. But there doesn't exist a regulation or a product code. That's a little bit more like running a marathon. The FDA calls that de novo, or of new. So for new and novel things that you don't anticipate being live sustaining, live, supporting. You go through this de novo process, and then you are most likely classified into this lower risk class to 5, 10 K product. whereas those life supporting and life sustaining products, it's more like running an iron man. In terms of these are going to be pre-market approval. They're gonna require standalone safety and efficacy data and a lot of animal and clinical trials as well.

So this is another unique thing about the Us. Market is the con, the combination of different controls and exemptions available for each class of device. And it's unique because you may have some exemptions. In the Us. For, for example, class one products, are usually exempt from design controls. However, not even self certified products in the EU are exempt from design controls. So what this means is, not only can the type of submission and the the level of information involved vary compared to the EU, but also the content of your quality management system.

So if we look at how in the EU these types of submissions compare the just. The methodology of of compare creating an argument for a successful 5 10 k. Is based off of something called substantial equivalence, and it's a comparison to a predicate or an already legally marketed device that has an existing regulation and product code. Now, substantially equivalent doesn't mean it has to be identical. It just means that in terms of intended use and technology, it has to be similar enough that it's not raising new questions of safety and efficacy. But if you don't have enough similarities where you can make a substantially equivalent argument, and you don't fall into an existing regulation. That means that you were new and novel. But you're moderate risk. So you're you go for this de novo process in hopes of classification into a class to 5, 10 k. For for future products.

whereas, again, that that Pma pre-market approval has to have standalone scientific validity of safety and efficacy in terms of of length and kind of effort. You know, you're you're ranging 5, 1,500 plus pages, 1,500 for maybe a simpler type of product for 15 K, whereas you're in the range of about 4,000 pages for a de novo and Pmas, or the back, when, in the days we used to print these are the equivalent of 30 plus 3 inch ringers. Another unique thing about the way the FDA processes submissions compared to the EU notified bodies is that the FDA has clock days that they're in metrics, that they're measured internally on so 4 or 5 10 k. Those clock days are 90 days.

However roughly, the average 5, 10 k. Takes about 200 days. Once you go through your additional information, request, and responses with the agency, whereas De Novo's and Pmas, the clocks are 180 days for de novo average of 400 days. Pmas. The average is about 800 days for pre-market approval, generally 5, 10 K's and de novos don't have to have an inspection before you can. market. Your products. Pmas, require pre approval, inspection, and again, compare and contrast anything besides the self certified products in the EU are going to require the notified body for both your quality management system and your submission, technical file content.

The user fees is another area where it varies greatly from you from the EU. These are fixed for the type of pro submission that you have to do. And if you qualify as a small business, which means you're less than a hundred 1 million dollars in revenue a year. You also qualify for discount on these fees. It's important to note the terminology that goes with with each. So for 15 k. You could say, you have market clearance de novo market clearance are granted. And only can you say, FDA, approval if you've gone through the Pma process. So some advantages of going to the Us. Market 1st compared to the EU market.

So in the Us. The FDA is the only agency involved in reviewing and and approving or clearing products. So there overall is more consistency than the notified bodies we are up to. I believe, over 40, nearly 50 notified bodies. Now these are independent for profit organizations that are designated by different government bodies. But they are not government bodies in and of themselves, and each one of them has different interpretations. Also, once they provide a Ce mark for your product, they become the defenders and responsible for your technical documentation in front of the national competent authorities or the the equivalent of their in-country in FDA.

So the problem here is that each country in the European Union could have one, if not more competent authorities that these notified bodies must interface with. So you can see how the number of both. you know, pro agencies that are giving the approval for your product. And the number of government agencies that they have to answer to kind of grows exponentially from the the number and type of interactions that you could expect with the FDA. So what's happened recently with the Mdr. Is that we've seen a shift in go to market strategy, especially for startups that may have newer novel products.

It used to be that the Us. Had a reputation for requiring strenuous clinical studies, and the EU had a reputation of ease of entry, but with the advent of the Mdr. That these paradigms have totally shifted the the time and cost that it takes to to enter each. So if we look at those shifts in communication and budget we see that the FDA offers many types of free interactions. Pre, FDA, submission. These are great ways of getting FDA's input and feedback on your technology. They even have special programs to create. A facilitate faster access and more collaboration with the agency. And then they have also low fee programs for you to get written confirmation of your classification and regulation.

During the the review, with the FDA submission. Depending on your types. The fees here are fixed, and you are not going to come up at the end of a a submission review with an unexpected cost in terms of the actual agency fee. Whereas if we look at from the notified Body Review, there really is no such thing as a free pre review or interaction to find out where your notified body may stand on your particular technology or testing theories just the application form and the process of getting a a quote itself is extremely tedious, as that the notified bodies are still running at very limited capacity. And just the application process alone, I've heard from different notified bodies can take, you know, 6 to 9 months.

the fees here are not fixed. You can go up to, you know. They try to cap it at 3 rounds. I know a client that pulled out of a EU ce mark assessment early in the Mdr. Process. Because they had hit over a hundred $1,000 in notified body fees alone, and they didn't feel like there was any end in sight. So you just have to know that going in that there, there's not going to be a fixed time or goal time or cost. FDA also has the small business designation that can save you. 50 to 75, depending on the type of submission that you? You have. You're going for

in terms of other, that difference that I discussed about the pre-submission. This is a really powerful tool to be able to ask FDA specific questions related to your regulatory process and your technology. It gives you a snapshot of FDA's current thinking on your pro, on their product and current thinking could mean other things that that are under review, but might not be cleared yet, that so you don't have visibility to things in the pipeline that might be coming. It could be maybe guidance documents that are in draft or being discussed internally in in the FDA, that you also might not have visibility to

the FDA will will tell you more than you then is publicly available about your product. These are especially important if you have anything that is 1st of its kind or novel. And, best of all, again, they are free. Other types of pre-submissions that can are advantageous are the breakthrough. And these safer technologies program. With the FDA these are different types of pre-submissions where you make a case. Where in the breakthrough your product is more effective than more effective treatment of specifically life threatening or irreversibly debilitating diseases.

whereas in the step program you make a case that your devices are just reasonably expected to significantly improve the safety and availability of treatments. But these conditions are less serious than those that are eligible for the breakthrough. but both provide you with an expedited access pathway, a more informal way to engage with the agency in terms of different types of discussions, and the goal is that the FDA becomes your collaborator and partner and bringing these important technologies to market another advantage. Now this one's a a double edged sword on one hand, it's an advantage, because it takes a lot of the guesswork out of assembling as a submission for the agency. It has a ton of help tech help text

that help you identify the types of information that FDA is expecting. It links you to other FDA guidance documents. It has a completeness verification. So it takes a lot of the guest work out of not only the preparation process, but things that you're gonna be asked during the review process. It also interfaces directly with the internal templates that the FDA uses to evaluate the submission. So what are your secrets to success for the usage market. Well, 1st off monitor, those FDA guidance documents and updates and press releases. It publishes so that you know ahead of time what their current thinking could be

become compliant with a quality management system regulations the Qmsr. As soon as possible. The clock is ticking. We have about a year and a half left before you need to transition your quality management system. Ensure that you've selected the right regulatory pathway via the P. Pre submission confirmation via the pre-submission process with the FDA, and then make sure that you're using those pre submissions to understand the FDA's position and to leverage the breakthrough and the step as much as possible to benefit from that expedited pathway. So there are a lot of resources to help you navigate all of this on my website, and then let me know how I can be helpful.

Thank you, Michelle. I just posted a link to everybody to a presub cheat sheet which gives the estimated time links for each one of those different pathways. So make sure you check that out, and I'll also put up the Qmsr cheat sheet as well. Because I think that those are both useful. There were a number of questions about how long these pathways take. Can you give us an estimation like how much the submission for a high class device might cost for the FDA certification. That kind of thing. So we'll get to those in the in the questions and answer section, but I encourage everybody to use the

the QA. This is easier to keep track of. The questions there. But you know, if you've already submitted a question the other way, that's fine. I'm gonna go ahead and turn it over to Ronald at this point for his presentation on certification in the EU.

Yes, sir, Sean, thank you. And thank you, Michelle. Very good presentation. I'm going to share my slides now. and so they should be there now. Okay, so I'm going to tell. Talk about our startup and the importance of of an efficient regulatory and clinical strategy. And I think you. You need to understand that you. You need to have a good understanding of both strategies and what they can do for startup. But 1st something about myself. I've worked with medical devices since 1987.

and I've I've been in many different jobs. Who are very important for my career. I've worked 11 years as a senior inspector for the Dutch and authority where I was responsible for the Southern half of the Netherlands regarding manufacturing authorized representation, import distribution and use of medical devices for the whole chain and After 11 years. I want to do something else. And I started working for Emurgo, later, Emurgo by Ul, which is a global building organization. You may have heard of heard about them, and there I have done lots of about 200 projects for companies all over the world, with all sorts of

interesting products and and and challenges. Since 2022, I have my own strategic consulting organization, and I provide Prc. Services. and last year I was one of the co-founders of A. R. 2 c. 2, like a motto, Good pilot can land a plane in its own. An absent pilot knows how to fly around that ladder. So if you see me from seated at the warning. hmm! So if I start working with when I work with a startup. one of my 1st questions is always, What is your exit? Strategy? Because no starter remains the starter forever. And

there are different ways of appending that status. One is autonomous growth. I mean. Facebook, Google, they did that right. They started somewhere in a garage and and room and apple. And what have you or acquisition? And that happens much more often. And the 3rd version ending the attempt. Of course, that's that's not. That's not why you started. But it also happens. Now you need to understand. So let's focus on the on the top 2 of them. So if we talk about autonomous growth, it takes a lot of time and investment. And what means that you need to justify that long way around. Okay. position that usually creates a faster return on investor investment. But

you need to do something there. And if you want to sell in an acquisition you need to show value. So what's the value of a startup? Well, it's the assets and a promise assets of the most most startups. That's that's a past dwindling bank account, and some some very cheap laptops. Usually that that's it. And but the promise that's interesting. The promise is something of that's going to happen in the future. That's where investors will will pay money for. So what's the value of your startup? How do you? How do you do that. How do you measure that? So you have a promise, and the promise is the commercial potential of your product

multiplied by market access? No market. It doesn't matter how commercially interesting it is. If you don't have market access, it's 0 and vice versa. I mean beautiful market access. But no commercial potential. Still, almost is not there. So how do you demonstrate your commercial potential? You need to sell your product? Basically, that's it. Sell your product for real patients have physicians involved and in a competitive market. So against other alternatives, you need to do that. Now, if you do that, if you want to show commerce potential. If you do it in, the Us. Would do it there. And you do pretty good job. You manage to get. Maybe point 1% of of the market. Well.

will that be noticed? It's it's a bloody good result, because the Earth market is big. But if you go to a very small market in in, let's say, Europe like Ireland, Denmark, the Netherlands, and you have a 5% market share in terms of turnover. It's nothing, but it's those that you can push out other products. You can push out competitors. So demonstrating commercial potential is not about sense. It's about persons right? And that's what you need to aim for so market access is the other component. And that's the ability to demonstrate to authorities. The device is sufficiently safe and effective, otherwise they will not allow you to expose their citizens to your product, so

They each have their own. All these markets have their own specific level of scrutiny and in Europe. Mdr Ivr. They're currently the purpose specifically the toughest in the world. So while FDA is well, easier. Slightly there, well, not always, not everywhere. But there are some some ways to get it easier done in in the, in the Us. If you look at notified body certification notify bodies, the audit quality management system. They review technical documentation, and if they get it wrong, they face serious claims of or even prosecution. We've seen this with the pip breast impound. Place the notified body put involved in it is still struggling with court cases.

and it means that notified bodies will be perfectly fast. They just don't want to have another problem there. So yeah, they will be tough to fast. But that means if you go to Europe. if you'd make it there. You can make it anywhere, right? And to abuse another famous quote, we go to Europe, not because it's easy, but because it's difficult. and that's that's something that I want to to give you. And if you do that you can achieve a lot value. Add a lot value to the performance of your startup. So if you talk about regulatory strategy, you need to make sure that you understand what is your product. It's not the device, but something else is an Ivd.

whatever right? Then. if it is a medical device, what what is it? Is it just a single device or a multi-component device. Is it a system, a combination of devices, or or what? And how do you. man? How do you? How are you going to manage the certification? I've seen companies getting into all sorts of problems because they thought they wrong. although it is, it is a recruitment step. You need to do very, very early in your in your process. But it's a software involved right now, if you say, Well, well, that's not important for people to make it work well, a drug will be administered right? So think about the devices involved, and not only from a regulatory perspective, but also commercial.

that can be so commercial, commercially interesting aspects to that. Now, and only then you can. You can start thinking about route to compliance. You can start developing that. So what you need to do very early on in that process. and I think you need to do that well before your design freeze, because. after the design phrase, it's very difficult to change characteristics of your device if you think would be more efficient to do it slightly different. So start early on and make sure that she has bloody, good regulatory strategy discussion. Now, your clinical strategy. That's about demonstration of safety technical performance.

Of course, it's part of your regulatory strategy and for innovative devices in general, clinical investigations are necessary. And if you are going to do clinic investigation, what are you going to demonstrate? It's non-inferiority or superiority. Both have their pros and cons non inferiority. It's usually easier, faster. and it allows the product to stay what I call under the radar you're not exposing and not stowing all the benefits of your device. It's it's it's just you're just one of the other products superiority. Well, you can push existing technology into the market early today I had a call with the company, and they have something that could be very disruptive, and we had to warn them. Please make sure you stay under the radar, if you're just strong enough to have

to be so far as from beating up by this those larger corporations that you might be asset to. and that's something to keep in mind. So all there is is is a strategy. Now you can combine that your clinical strategy and your commercial potential because clinicians will be involved in investigation, and the hospitals involved can be potential customized. and the clinicians involved may turn into ambassadors of your technology so carefully select those. And if you want to start selling in, let's say. Denmark, don't do your study in Italy right? Do it in Denmark. We have to think all

is that that whole process? So what's your commercial potential? Well. physicians, 1st by patient, your reimbursement strategy. But, said, all of that is very important to build your merger potential, and it means that you need to have a study that impresses all these aspects. If you want to do it efficiently. Make sure your study design covers everything there. not market access. If you're not based in the EU, and you want to go to the EU, you need an authorized representative, you need an importer, you need a legal representative. If you want to do a clinical investigation and well, arc c. 2 can help with all those things. But there are also other companies that

provide similar services. Don't worry about that also. Very important in the perfections. That's something you need to understand. So if you have your your product, it it is allowed on the market. Just don't strove your device at physicians, and hope for the best, they will probably expose it to their most desperate patients. because that's that's where they start with. Instead, you should specify for the that 1st generation of users a sharp profile of that patient where they will be successful. And once they see that the product is successful, the device works. and that's what they what they expect, or even better, they will use it on other patients, and they will see, and and maybe even those desperations. And they know there are desperate patients, and and they know that they might not, they may not be successful.

So your perfect basin. That's also something you could then address in the study, and and you can refine, test, and refine that definition there. So what do you do you need to do for the Mdr. You need to have quality management system. You need to have your annex one general safety performance requirements. That's a huge checklist. There are 23 requirements. But actually, if you split them up in all the different levels. They are 197 annexes, 2 and 3. They provide guidance on how to build up the technical documentation. There's your structure for that. And then you must do all kinds of other things like your risk, management, clinical valuation, bio compatibility, evaluation, usability.

And what have you? Bms, bmc, F, you need all that. Course you can do it yourself. You can outsource everything or go vibrate. And what I mean with that is that you do most of the work. But you have experts guiding you, and that's something I would recommend, because then you can learn the most of it, and it's a very efficient way of quickly doing this. So in summary as a startup, you must have an exit strategy. You must know who you want to sell to. You must understand what I want to see as proof of concept, and who you want to sell to, who you want to sell your company to right misunderstand. What they want to see is proof of concept

define how you want to do your initial certification. Understand how how you become certified. Have a clinical strategy that supports those objectives. Convince your investors that this will all be worth waiting and paying for. and well, if that involves the EU, we can help with that. So, having said that. thank you very much, and I'm looking forward to your questions.

So the questions are rolling in, and I'm gonna go ahead and turn it over to Nika. Who is gonna give a short presentation before rolling into the panel. Discussion. So please continue to submit your questions. With the QA. Function. panelists. I've sent you a summary of the questions that were in the QA. In the QA. Because I can't access the I mean, I mean in the in the chat? So there are 5, 5 or 6 questions there. As as well as questions in the Qa. So with that, Nika, thank you.

Thank you, Shawn. Can you see my slides? Does it look? Can you see it looks okay. Okay. So thank you for the opportunity to speak to you this afternoon. Morning depends where you located. It was, by the way, not easy to find this time spot that suits us and our partners across the ocean. But it's all about all about partnership. So I'm want to to think about. I I have rather interesting question, do we really have to choose? So we we're presented with the Mda advantages. We've talked about certification. But I wanna talk to you few minutes about choices we have to make.

So 1st of all. few words about myself, I'm bi medical engineer. I'm from for about more than 2 years. I'm in the regulatory quality management field and the different roles. but my main, this is all for fun. My main main job starts afternoon with a lot of kids, cats and dogs. so yeah, I wanted to mention this globalization trend that. Kind of really, we are seeing for late last years. And it comes into the 1st of all, the both regulation system have the fundamental goal, the same goal to ensure that the devices, the rich and market, they are safe and efficient. And why don't they work together? One might wonder, why don't we have a global system? I guess we will, I guess in 5 years from now we will have global system.

Hopefully, everything will be digitalized and everything will work just the click of the button. But for now we still struggle. We know how much struggle it is for quality oratory professionals, as probably many of our listeners. Now we start this whole globalization started more than 10 years ago, I guess, with empty sub medical us single audit program that just brought together requirements from different countries. That was the 1st participants was United States, Canada, Brazil, Australia, and Japan. Basically, you just go through one audit procedure for your quality management system and it will be accepted by all those countries. Right now more countries are willing to participate.

more countries are participating, is as More countries are participating as observers at this moment. And yeah, we, this is very promising procedure to my opinion. Then we all know about Qms. FDA rule that will be effective. As we had mentioned in February 26, th that is very closely aligned. It is based basically on 13 Is013-45-2016. So the quality management requirements are already overlapping on both sides of the ocean. So these are already good news. More used to globalization, I think. What one can also

mentioned on one should keep in the mind that the European legislation, so meaning, if you are compliant, if your product is compliant with European, Mdr. Or Ipdair. The regulations in Europe you have an easy access to other markets, a lot of Asian markets, but also Canada, South Africa, Brazil, Brazil, they will. Simplify the registration procedure. And this also. The very very, very well. represented proof of of the useless of sorry usefulness of the European certification.

So it's not only also open your ways in our markets as well. but I have even better news for you. You don't really have to decide, because as this sense of this master class is to bring both the companies on the same table, and we truly happy to close this partnership, this cooperation between our 2 companies, and that means that doesn't matter who you address. We will help you to find the right way. And every company has its own way, and depending on devices depending on legislation, depending of your goals, depending on your investors, and so on. Then maybe one on the other way would be right for you

and the good news you can come to either of us, and we will guide you and support you for the whole way. So if you need FDA, we will gently hand you over to the trustful hands of Michel another way around. If you need support in the European area, we, with authorized representative with clinical strategy, regulatory strategy. getting in touch with notified body choosing the right notified body. It's very true that some notified body have waiting lines, but not all of them. There are some notified body. They have very short waiting times, and they're eager to work with small companies with startups. So we can help you to get in touch with those.

And yeah, so we we can help you to get them your innovation into the market. I I have one more slide about our company. We're really new on the market, and we get a lot of questions about our name. So we have the little cute guy from Star Wars, R. 2D. 2. And this was kind of inspiration for us to choose our name. R. 2 c. 2. Authorized representative and clinical strategy to 0. We do claim to create a new strategy. And you thinking about this important tasks because we we addresses task as a whole. We not only give you a stamp, but to be your tries to implement. Okay, we check that. They have documentation. You have certificate conformance. Okay, we'll approve you. And you damn it, and you're a client. No, we try our best to provide the whole service, to support you also with market access, to help you to develop

optimal, regulatory, and clinical strategy that will help your company to get in the market. So it's a bit unorthodox, I'm aware. So we still finding a way in the market, and will be really glad to get in touch with you if you have some questions or need some also some short consulting I just also want to take this opportunity to present our 2 other partners, so you can see myself and Ronald. We have also Leo and Zev. They are carry more responsibility for business development and market access. And together, I think we are very unique team. And yeah, we'll be happy to answer questions and we happy. You can also approach us offline. And yeah, thank you for the opportunity to speak to you today. And I guess we can. These are our contact details. And I think we are ready for next step. Thank you.

So let's go ahead and move to the Qa. Just to get things started. I wanted to ask a a provocatory question to Ronald. About predicates and equivalents, and the discussion that we are having offline about that. If if he could speak to that while we're finishing the 3rd poll question. I apologize. I forgot to launch the poll question. So you're gonna share results for them. There are 3 poll questions. There's 1 more coming. It was about half and half for the us versus the EU and you'd see the stages

of Ronald be with us.

Yes, yes. Yeah, I can. Yeah. Yeah. Equivalence. That's that's about the product the device which is similar in in clinical, intended purpose, risk class. and essential design and manufacturing characteristics. And that means it must be the same thing. And and it's it's it's a very narrow, definite definition. So you can't cannot use equivalents like. You have 2 implants and they they they're used in different parts of the body, but they are, but the rest are quite similar. No, they're not you. They don't have the the same intended purpose, so they cannot be compared.

Predicate. I've seen predicate devices. But okay, yeah, that's that's more or less looks a bit the same with some some using my free spirit. I can see some similarities. But when I and and yeah, it's, it's a different way of thinking. So at the moment you go to Europe and I recommend all documents to do a very careful search term soon for the word predicate. Remove it, because at the moment the note, the butter reviewer sees that they got an allergic reaction which is quite fatal not to not to them, but for your technical documentation. I saw a question pause it. That may have something

appeal to that. If if you have let's say access to to the to the Us. Mark like 5, 10 K. does it help for Mdr. Some level, because you may have done a lot. Look at the world already. You may have lot of underlying reports and test reports know things. But with regulations. What I use as a rule, is that if regulations are not 100% the same, please consider them 100% different. Avoid copying and pasting unless you're absolutely certain you can do that. basically, if if if it if there's a difference, you need to. You need to set up the whole technical documentation

from the from the from the start. Sorry for that. But that's yeah, that's that's how it works, because otherwise you may have the little errors, little things that slip in that you overlook. But the notable reviewer will not overlook that? And other questions.

Yeah. So then it says, Hi, Ronald, could you take on the pros and cons of conformity assessment via annex 9 versus annex. 11 for a class. 2. A device.

Annex 9 is about your quality management system. So it looks at the quality management system and it singles and it it selects a few of your devices as a is it? Was it best if you can, if you can. If your call to management system is searchable results in good quality products of which the quality, the performance assessment implementation is correct. But that's annex 9. If you have only one product like starter, then the sampling is very simple. Then it's just that one product, and you're not benefiting from the the main thing in for next 9 on exten is about product verification, and that very much that very often works very well. If you have

huge installations and you're only selling one or 2 products right then you're looking at the the single products. And that helps it's it's completely different process. If you are working as a startup and you want to sell your company. there must be some growth in it. I strong strongly recommend. Go for Annex 9, because that allows for a lot of growth in your in your product. An extent is, it's really an old run out. I think less than 1% of the product will have Annex connect 11 to an extent it's it's it's a very rare thing, and especially class to a go products. 9. It's it's you're making your life a lot easier. And you're creating a future for your company and your

your devices.

There are a lot of questions here. But one of them that was answered in our path to Market Summit more extensively, and I'll include the link to that. Is what about Uk legislation? You've got it.

Yeah. And and and then I think he's got a question. No, the Uk, that's in Uk, you have Uk Ca marking, and they want to promote that. However, with other products, the British Government has said, Well, okay, well, we're not going to make it mandatory if you want to. Apply Ukca marking. That's fine. But we also accept ce marking that, actually marking that it for medical devices, they keep it the same. and for now they are opening up their market for Uk. Ca, of course. Yeah, you can go there and but you can. You can also use ce, and they also want to have open the door for FDA.

Approve products. And I think, what have you? that's last step. They're still thinking about it, because it has a lot of consequences. If you have different devices, I mean, there's no FDA stamp on the product. So you have products without a stamp in the Uk. So what does it mean? They can come and come from anywhere. They may even be ce mark devices without ce on it? so they have. They have a little problem there. If they want to accept us products. But of so for for that perspective. The Uk is still not still working on, on developing this and and and developing the the full understanding. For now

I think, just focus on on ce, if you want to go to Europe, forget about Uk, Ca, that's not going to fly for for the Us for the Uk. because they okay, they don't have to know different body or the body capacity to do it and it will add costs. And so the patient will have to pay for it. and for now nobody is, is is preparing for it, and we have seen what happens in the in the EU, but even their companies and notable bodies try to prepare as good as possible. And they still are this huge gap in capacity. That's posing a lot of problems in implementing Mdr Ivr. So I don't think. See this happen in the UK.

However ambitious they are, but no reality is within them. And and that's the current government. I think there is a slightly more realistic people there. less unique unicorns and and more realism. So let's hope for that.

2 questions from the same user. For Michelle, one is, gonna be fairly easy to answer. We plan to submit our Us. FDA application by March 2024. I'm not sure if they mean 2025, or 2024. Do we need to consider Qmsr.

Well in the Us. This is a different of other distinction between the Us. And Europe. When you put your product application in, there is no expectation that you have a full quality management system until you go into commercialization. And very technically, if you go in in 2025 and you get cleared in 2025 and you commercialize in 2025, you need to be compliant very technically with the Qsr. But then, right on the heels of that. You're gonna have to be in compliant with the Qmsr. In February of 2026, you know, and then given that the the average 5 10 K. Review. Time is 200 days. It I feel like it would behoove you to go into compliance with Qmsr. Because you're not out of compliance with Qsr. By being in compliance with Qmsr. But you are out of compliance with Qmsr. If you're only compliant with Qsr.

so it will take you less time and less rework in your quality management system to just move towards the Qmsr.

Thank you. And the same user asked usability. Studies are studies done in Europe acceptable to the Us. FDA and I'm gonna flip that question to Ronald in in the reverse, which is studies done in the Us. Acceptable in Europe.

So I will tell you this. If you are planning on doing any type of study, be it usability, or clinical or animal I would get the buy in from the FDA Pride. Well, even if you're gonna do it in the Us. Those all those studies are so particular and so expensive that you need to get. Put those protocols through the FDA in a pre-submission, get their feedback, get their buy in, they for some studies they will let you use a certain portion of them. O Us. But they will require a validation from a Us. Population. And this could be because there could be socio economic differences ethnicity differences, language differences. That's the big one. Usability is a good bit to do with instructions for use and your instructions for use. They want to see that you have a native English speaking population, that you have tested the the product on.

So those are some considerations from Co. Using those in the Us.

Interesting question for Nika in the.

Ronald have a vice versa.

Oh, right? Right? Yeah, Ronald. Tell us about.

Yeah.

Europe, accepting clinical data from the Us.

Yeah, well, usability data and clinical data. Of course, if you have a non-european population, you need to justify that, you can extrapolate those data for Europe and and that can be done. You can do all kind of studies anywhere in the world as long as you can justify extrapolation for the European population. Having said that, you must meet certain standards. So for reusability studies, you have the the 6 to what is it. (623) 662-3666, standard for usability studies and for clinical investigations. Iso 1, 4, 1, 5, 5 about to study ethics. Those are just essentials that you need to comply with. If you don't have that you have a problem

and so that's that's something to keep in mind. At the moment you start doing usability or clinical studies, you will probably get the some some experts involved. Just ask them if there are any issues, if you want to use them in Europe, the the data, and that's to keep that in mind and or vice versa. So at at the moment you do that be very efficient. And just say, Yeah, we want it for both markets. That's that's what I reck would recommend, and if they are good experts they know exactly what you ever what they should be doing. Then then.

Fantastic moving to Nika this question. In the past, Saudi FDA accepted us, FDA, to facilitate faster market access in Nika's presentation. We can see that Eumdr has a similar effect for the Saudi market. Is that the same for Ivr devices? I'm gonna venture to guess? Yes, but I'm gonna.

Yeah, I think it's it's really hard to be very detail without knowing the specific cases. I think they do have based on predation based on the race class. But it's definitely the same. The same. Mdr and Ivdr are considered the same level of legislation. So that's opens the door in the same way.

Thank you very much. question for any or all of you, how realistic is changing the notified body in the middle of the Mdr. Certification due to extremely slow and disappointing process. Is it worth considering.

I? Yeah, if I may, if I'm already there, I just want my my thoughts on that. It's a lot of communication issues where people communicating with people. So I would suggest, really, we can gladly look together into this. I encourage this person to get in touch with us. Personally, I will love to speak about it. It's very often the case that auditors are expecting something. That they don't communicate, maybe very well, or they have. They don't that the clients don't understand that manufacturer don't really understand what they want from them. And then, they don't provide it. And so it's goes too slow. But it can be definitely as as Michelle also mentioned, some notified body overloaded. So technically, it's possible

we need to see into this important is that there are no unclosed issues, no couples, no open audit findings. That can prevent that might be tricky. But technically, if you will clean, and then just want to switch your notified body from this cycle. This is very manageable. but you need to see that each case what exactly happened. There. Is there something we can fix? Is there something that they just didn't receive the answer they were looking for? Because we had cases like this. speaker, don't.

They have to. Report it. If you're gonna withdraw from an active review with a notified body, they have that notified body has to report it to the competent authority that you withdrew that application. Then you have to explain to the next notified body why you withdrew, and it can't just be because I didn't like where it was going. I didn't like the information request I was getting, and so then you could make a bigger mess for yourself right.

sounds like like.

Yeah, that's yeah. It's all about.

Yeah.

Yeah, it's all about communication. I I I like to be in the process of selecting the notified body, because then then I can really guide a company through it, and that usually helps to smooth out a lot of things. But I've been called in with not a process that got stuck, and it sometimes come down to to well, to what Nick Nika said, some somewhere, that is problem in the communication. and people get stir dug in into into what they think is is right. And yeah. takes a bit of time. But in general notified bodies don't like it if someone starts complaining, and So if you, if if you can use, would

the the exact right amount of pressure, and exactly the right people. You can also make them move. But that's a very delicate process. And I would say, don't don't try it at home.

But again, it's doable. You might need a number out extra out in your cycle, but it's still doable. But 1st try to resolve communication issues. And maybe you just don't understand what they want from you, or they don't understand what you expect from them. So this communication is really critical, and we're happy to support.

Fantastic. So there are a lot more questions we're gonna have to follow up individually. In. So I wanna thank everybody for their time. I wanna thank the speakers, especially today, for coming and sharing their knowledge and expertise on these subjects. And I encourage everybody to complete the survey and to reach out to the speakers directly. To let them know what you think, because you know what it's a lot of fun to do these things, but sometimes it's it's like talking into, you know, an an empty box. So don't be shy about sharing your feedback. With the speakers, connect with them on Linkedin. Do what you need to do. You people know how to do this. I wanna thank you again. And I hope everybody has a a great weekend. Thank you.

Thank you so much, Shawn, for hosting us. Thank you. Guys.

Okay, thank you. Bye, bye.

Bye, bye.