2024 MedTech Regulatory Global Pathways Virtual Summit

Hello and welcome everybody. My name is Sean Smith with MedTech Leading Voice. I'd like to welcome everyone that has registered for this exciting event today. And to introduce this exciting topic, which is 2024 MedTech regulatory global pathways. You know, this is a really, really interesting time in terms of medical devices. Last night as I was tossing and turning, trying to get to sleep, I was thinking about how like less, you know, not more than a hundred years ago, they were still doing bloodletting as a form of medicine, you know. And. The distance that we've come in terms of, you know, patient safety, efficacy, and in the realm of medical devices, even in my, you know, short 20-year career has really come a long way.

And so the efforts that are underway from a regulatory perspective to put a framework around, you know, proving that your device is safe, effective, and does what it's supposed to do. what it says it's going to do, you know, within reason, isn't asking too much. And so we're, we're, you know, balancing innovation and regulation. And a lot of you, a lot of the attendees on this call have to thread that needle. And so what you're going to get today is to hear from, you know, three experts and our, and our moderator, David Fillmore from Market Pathways about just how to do that in these individual markets. And we're going to start with Matt

Burton in the, in the UK, and then we're going to move to Herod Voss in Europe and Michelle Lott. And then in the last half hour, we're going to have a round table discussion with, with, with all four of them, really. So I'm going to go ahead and introduce Matt. I love Matt. He's got a unique perspective on, on the UK and Northern Ireland. Matt, why don't you introduce yourself? Sure. Thank you very much. So I feel really honored to be invited to speak today. I'm in fantastic company and I'd like to kick off my presentation by covering the UK and Northern Ireland. So if it's okay with you guys,

shall I go ahead and present? Let me introduce the other speakers first. And then we'll circle back and start the presentation quickly, introducing Herod Voss who almost needs no introduction, but there we go. Take it away. So thank you, Sean. It's great to be part of this excellent panel. I'm a CSO of QSERP Group, a consulting group, as many of you might know. But other than that, I speak a lot at conferences. I have worked long time in notified bodies in BSI, in DECRA, and worked in Europe to get that funny legislation, MDR and IVDR in place. And since it was well, already for publication, basically I stepped over and I'm now trying to help a lot of manufacturers

to come to terms with it. That period of transition takes so much longer than anyone ever anticipated, but it's still worth your while. And I hope to convince you of that in my brief presentation later today. And happy to join the crew and the Q&As. Next, I'd like to introduce our speaker from the U.S., FDA expert, Michele Lott. Hi, I'm Michele. I'm the principal and founder of Lean REQA. We help primarily startups and early stage companies, small to midsize companies, figure out the best regulatory and quality solutions to fit their needs. And to Herod's point earlier about he's been helping people

come to terms with the MDR, I call it grief counseling. regulatory brief counseling because there are a lot of feelings. People have all the feelings about what's going on in the regulatory environment these days. So we'll talk about those things too. And lastly, I'd like to introduce today's moderator, David Fillmore from Market Pathways. David and I work together at the Graysheet. So it's really nice to reconnect. After all these years when I envisioned this program, I immediately thought of him and I'm glad to have him. Hi, David. Say hello. Yeah. Thanks, John. I appreciate being here with all you guys. Yeah, I'm David Fillmore.

I'll introduce myself briefly and then maybe I'll get started with our, pass it back to Matt, or unless, John, you have more stuff. But I'm editor of Market Pathways, which is the publication we write about regulatory as well as reimbursement, other market policy issues impacting the medtech sector, about company experiences, dealing with a lot of the context of the issues we're talking about today in different forms. And I'm with the Medtech Strategist Group. So that's sort of the broader place to check us out. But I appreciate it. And yeah, yeah. Sean, I don't know if you want anything more to say or should we pass it back? I just want to say one last thing. Feel free to

use the chat function or the Q&A function. Let me know if there's any difficulty with them. Let's just like to start with having everybody say. Where they're dialing in from in the chat function, just drop the country right in there. And while we're doing that, I'm going to turn it over to Matt to get started. Go, Matt. Sure. Thank you very much, guys. So I'm just going to share my presentation with you. And hopefully you can see my screen. Are we all good? I'm not seeing it yet. Are you guys seeing it?

No, I'm not seeing it. We saw it in a practice mode. No, there we go. Sorry. Slight delay. Yeah. Are we good? Yep. Excellent. Right. Thank you so much. And as Sean has said, yeah, if you've got some comments or thoughts along the way, don't lose those. Throw them in the chat. Go free to the Q&A and throw them in there because we'll be glad to discuss them later. So first of all, as I said, I'm honored to speak today and I'm in great company. A quick short about myself. I'm a principal consultant and the strategic director. I'm a development director at IMED consultancy. I'm also responsible for our representative and

international services. At IMED, we're a UK-based consultancy. We're a team of full-time employed experts. And we operate by using niche experts as well to support our clients. We really value our growing network and our client base. About myself, I've been in the wider pharma, health tech and med tech industry for, well, it's over 25 years now. I think my experience is fair to say covers a lot. I've been in the pharma industry for a long time. I've been in the pharma industry for a long time. I've been in the pharma industry for a long time. I've been in the pharma industry for a long time. I've been in the pharma industry for a long time.

a full life cycle right from concept right through post-market phases. And I've been a consultant QARA, quality assurance regulator affairs, I think it's over 14 years. My focus has been on devices over the past decade. Okay. So I've told you about IMED, UK-based, and we cover all devices, all classes. We cover UK, EU, US and rest of world. Okay. I'm really excited to be here. I'm sure you are too. And join this presentation. I'm going to give you an overview of the UK market. Some of you know what's already coming and there may be a few nuggets. I hope there's a few nuggets you can take away as new learning. And if you don't find the time during this presentation,

the Q and A or the chat, you can always approach myself or any of the other guys after the fact as well. We'd encourage that. Okay. So the UK, it's not unlike many countries, actually. We have health needs, patients are waiting. We're in that post-pandemic phase. We're in a hangover phase, really. And patients are increasingly interested and kind of wanting to take ownership of their own self-care. They want access to tech and state of the art health is becoming a big issue. We're kind of living longer and people are more engaged. And I think the Internet and social media allows people to see what other things are out there.

And people want that for themselves as well. And the UK government has repeatedly indicated that medtech is a key driver for economic growth. And I'll talk more about that a little bit further on. And the government, actually, the UK government seem to be engaging well with trade associations, bodies and stakeholders. They're really listening. So medtech, it's generally a subsector of wider health tech in the UK, but it's the largest share and it has strong growth. The UK may be considered to be a small. Small country in some ways. And now we kind of have different rules as a result of our departure from the Union, European Union.

But the UK should not be underestimated and should be recognised as a significant commercial market. It's growing year on year. And this is craving for new tech, as I've said. And the government and regulators are looking towards any solution they can. The population data I've just thrown out there just to give a sense. I don't know if it's meaningful to you. And that's taken from census data 2021. Though, as with all things, I think I just want to set the scene. You can cherry pick data and points within my presentation. I've always endeavoured to present statistics in a way that are kind of representative, just finding a middle ground.

So some of the things I put out here, you could probably find some numbers that say different. That's fair enough. I've endeavoured, as I say, to present a fair picture. So medtech opportunity is not new. You knew. The MHA was a significant competent authority in the European Union, along with private notified bodies. BSI, for example, was a significant early notified body. But now we've departed from the union. We still find the UK is a big player with close links. So those last two points I've put there, Europe is as in a geographical context rather than a union member. But you can see we are still a significant size.

So really, this is interesting. I've kind of conflated medtech and health tech in the bullet points here, two and three. And that was kind of deliberate. I wanted to emphasise the wider opportunities so we can get focused on the niche medtech. But health tech in general, if I just want to sort of go a bit deeper into that. So health tech tends to be those tools, wearables. It can be data or apps. They're kind of intended for outside of hospital. Or care setting. That's health tech. Whereas medtech is all the good stuff that we know about the equipment, apparatus, devices and machines. Those diagnostics and software.

So they're intended to be inside hospital or in care settings. So I just want to just say the health care expenditure is massive. Medtech is a significant proportion of that. The MHA have a delivery plan. We've got to have a plan. And actually, that's a really useful document. If you're a bit sad and a bit of a geek like me. It's wonderful. It's worth a read. It's a 30-page document. And essentially, a very short summary. It aims to put patients first. And really looking for a positive outcome of Brexit. To try and deliver something a little bit different. And maybe even take the opportunity to sit back a little and see what's panning out in the rest of the world.

Particularly in the European Union with the incorporation and the rollout. And the adoption of the regulations and new regulations. And trying to see how can we avoid those mix-ups or those bottlenecks. But trying to be agile as well as a small country. So you can see some of that in that delivery plan. The intention mainly is to look for a point of difference in the UK to become an even greater place to develop manufacturing supply products. Crucially, they want the UK patient to have access to safe and new medical products. So the government also revealed their vision to a policy paper that was published actually last February.

So their policy paper, their strategy talks about how again Medtech is vital to the UK. They're looking to build the economy post-pandemic. And it presents their visions and aims. I want a Venn diagram. I like a Venn diagram. So I borrowed this one straight out of that paper. I've got links in all of my slides by the way. And it talks about engagement with stakeholders and what's happening. And it talks about their main priorities. They are resilience and continuity of supply. Innovation and dynamic planning. Specific markets. Enabling infrastructure, which is a crucial one that's struggling a bit at the moment.

And specific markets focus. There's lots of useful information there in that policy paper about how the government and MHA intend to get there. Okay, so I've just given some rolling examples. I mean, you may or may not find them interesting. I just want to show you there's this kind of stepwise new schemes, new plans coming out. There's this rolling way of trying to get manufacturers and manufacturers to get their hands on the market. And then there's this rolling way of trying to get manufacturers and stakeholders to be supported to invest and to fund it. Some are available to UK and some actually extended to non-UK manufacturers as well.

That IDAP pathway actually was a really useful one. So because regs are really complicated, what can the country do to kind of inform and engage so people aren't having to pay for that information that it's provided to them and they can apply for grants and funding? So while some areas of the UK are going through retraction. We see a global recession and post-pandemic world. We actually see the UK government putting money where their mouth is actually. And they're committed to MedTech, which is great news all round, to be fair. So the UK, probably people are wondering what are we going to do? How are we different?

Why are we not doing exactly the same? I think the government intends the UK to be a launchpad for new tech. And they're trying to put those systems and resources in place to allow that to happen. It's not all great news. It's not all great news. Because there are some big issues to circumvent. Industry's had a voice, particularly associations. I'm just going to cite CPI and ABHI for two. They're doing really well to discover and highlight the challenges and the problems by canvassing stakeholders and presenting those cases and making recommendations. And actually, I have it in good faith that the MHA and the government are listening because everybody wants the same thing.

So that's good news. Lots of other help emerging. In this case, the Health Tech Pathway Navigation Tool. It's generally aimed at SMEs who lack a deep history or understanding of NHS and its workings, which, let's face it, can be really complicated and does change. So this is intended for many stakeholders. And the NHS is a fantastic customer, if you can get there. Unfortunately, those forms are cumbersome. And if you can find somebody to help or find a tool like this to make it clear to you, there seems to be some great opportunity. There's actually a lot of pullback from the National Health Service.

And I'll talk about that in a minute. But there's actually more than ever a potential greater opportunity because it's been so complicated. Manufacturers have pulled away and it's actually leaving in many areas a greater market share. It's my personal view anyway. And, you know, it used to be the case that the bottom line is dictated by the cheaper, the better. But that's changing. There's a switch from focus from cost to overall value. And again, it's something I'll say. And again, there's something I'll summarise later on. So, you know, how do I get there? It's really important to consider the plan that the government and everyone's putting in place because it should inform our regulatory strategy.

The NHS has a plan, as everybody does. And they they would prefer patients not to be in hospital beds or queuing to see the doctor. So I guess everybody here that's attended today, what can we do? What can we do to demonstrate that we have got a solution to that problem? To provide some compelling case, if you like, to sell our products and actually with the patient at focus? How can we benefit the patient? What can we do to shorten those waiting times? Early diagnostics, predictive tools, AI, whatever else it is in there. I think there's a really strong point to try and sell. This is also taken from one of those papers.

It's a really good one. It's a really good one. I love this one because it presents an awful lot. I mean, we could focus on this. For me, I would really like to see this plan over time. I want to see it change. I mean, for an example, I expect that patient monitoring to increase significantly over time. We may see some new trends in areas moving in. But I mean, this is really interesting. This was going back to 2021 when the data was available. Things are moving fast. That could have already changed. But actually, people here today, you can be part of that. Change in bringing those new solutions and actually be directly responsible for that changing med tech spend.

Right. Here we go. Hopefully you guys are still with me. I hope so. Just going to talk very briefly about the UK regs. I'm sorry if you know this. Hopefully it will inform a few others. And do you know what? If there's anything I present that you feel is inaccurate or I'm missing something, please feel free to throw it out there. Put it in comments. Put it in Q&A. I'm not, you know, I like to be corrected because I'm a huge believer in sharing information freely amongst ourselves. It's complicated out there. Right. And I think really all of us want to be on the same page because we're trying to understand what's going on, what we're supposed to be doing.

And that's expensive if we get it wrong. So please feel free to correct me. We're all part of the same team. So the UK is currently trying to introduce or is partway through introducing the new three statutory regs. The new three statutory instruments. A statutory instrument, an SI, as it's referred, is the principal form in which delegated legislation is made in Great Britain. Okay. So we have the first, the transitional provisions. This is already fully applicable. It's a good one. This is what allows us to continue to recognize CE mark devices. We have the second, the post-market surveillance instrument.

That's expected to be laid down this year. Now, as far as I'm concerned, from my expectation, it's about two years. So it's about two years. So it's a bit late. I expected that at the start of the year. But it's coming and we'd rather get it right. So I'm watching with interest to see when that happens. And then we've got the final one, which is the full text. We're yet to see what this looks like. We don't expect the draft for quite some time yet. And I expect actually to have a rolling implementation. So I don't think it would be fair for it to go fully applicable. So the emitter of said core aspects will apply rather than the whole thing.

Okay. You still with me? This is kind of regsy. But the first one, the transitional timelines, that's enforced here are the dates in case somebody wanted to look at the slides. It gives you the links to that instrument as well and the applicability. I put this one together and I hope it's not misleading because what this says is, hey, you have this long. But that's not always true, much like the transition to the EU regulations. Really, it's not. It's not just about the transition to the EU regulations. Really, all it's doing is giving you time to make the change, not saying, hey, you don't have to do anything.

And these come with big caveats. I've indicated that. So if you change the intended use or claims or something significant like manufacturer or something happens in the meantime, then you lose that. But in some ways, this is the recognition of transitional timelines for devices on the UK market under those CE marks. I'm sure people will have questions about that, but you can find this, the MHRA, really clear, make an indication of what those caveats are. The second one, the strengthened PMS requirements. This one hasn't been laid down yet, so we're not quite sure when it will apply. But you can read the draft through the World Trade Organization, the WTO.

I've put a link in to that one as well. It's not much use to you at the moment, but in case after the fact, it could be helpful. The devil's in the details always, isn't it? Particularly in regulatory affairs. So we can have a look at the draft. And I don't want to assume that the draft is actually going to be the final version. But note the language in here. So there is a subtle difference. We're talking about the lifespan, actually. The lifespan in the UK market, actually, we expect it to require the manufacturer to keep the documents for longer. It's the shelf life. And note, I've added, if there is a shelf life, it's the shelf life.

There is one. Plus the period the manufacturer expects the device to perform. And the period that is reasonably foreseeable, it may remain in use. OK. So we've got a little bit new language in here. We're not saying it's a much higher burden, but you might need to consider in your documentation. So manufacturers may need to actually consider whether you need to generate some more evidence in this case. If this goes ahead, you may require an evaluation of how the device is actually operating. used under real world conditions, you may actually need to address the instances where the end users ignore the shelf life, and they're specified by you yourselves. Okay, have a look, we need to kind

of drill down and see whether this is going to go ahead. And also a few watchouts. And I'm not necessarily saying that these are going to stay, but just some things to pay attention to. And you might need to just consider in your technical documentation. If a field safety corrective action is issued outside of Great Britain, you may be required to notify the MHRA if it's also on the device market here in GB, or to justify why it's not applicable to those devices here. For example, it may be back specific, may have happened in some other country in the European Union, but you have to inform them and tell them why it does not matter here. And the definition

of incident is more detailed. That sounds bad, but it's not. It's just a slight difference in terms. So you may have to cover this off. And CAPA resulting, from post market surveillance, you are going to be required to inform your UKRP and your UK approved body if that's applicable. More prescriptive on post market surveillance reporting, potentially, and product safety update. And there may be a slightly lower threshold for trigger and trend reporting. None of it's a big burden, but we just need to be aware if we're in different markets. Okay, let's move on quickly. So in terms of CE marking, well, this one's good,

but we need to know about this. If you have a CE mark device and you want to place it on the market in the UK, the government wants you to keep it here. And I think everybody wants to keep it where it is. So there's a simple registration fee, £240. You have to maintain the obligations under the EU regulations in order to continue to place on the UK market. We saw the transitional in the first statutory instrument. Note that the MHRA do not charge an annual renewal fee. They only require that if you make significant changes to your registration. If you are not located here, you need to appoint a UKRP to act on your behalf. Now, the UK responsible person's

important role. Please note that this is under transition at the moment due to Brexit. So there's quite a low burden. But new obligations are coming for this role. I think it's fair to say that a lot of stakeholders just talk about the UKRP. They don't talk about the UKRP. They don't talk about the European Union. And they ask what the UKRP is going to look like. And they don't talk about the UKRP. So it's important to not just talk about the UKRP. There are two people who are not directly involved in the situation. One is the one that's taking on the role as a Minister of Finance. The other one is being involved as a Minister of Finance working

on the matter. So I don't think there's a big difference in the Johnny and the other two people if you're talking about the UKRP of the UK. You don't need to have the UKRP as the EU representative. The UKRP is a bit of a bit too much. So I'm going to say it's not a huge difference. But I think the UKRP is going to be able to have the UKRP on the board. So if you are not staying in the UK at the moment, you're going to have to leave it and the commercial strategies. And there's a good reason, but as always, it depends on your supply chain model. Here's some of those new obligations. And we know what these look like

because they were in the response to consultation. They're not guaranteed to stick, but I think there's a big commitment to do it. So if you have already, or you're going to appoint a UKRP to represent you in the UK, make sure that they are physically located in the UK, i.e. not just a postbox, not a solicitor's office or something, because that may change and you may have a bit of a burden when you don't want it in a year or two's time. There's going to be a new requirement for the person qualified. They're referred to as a QP, the qualified person, which is prone to a mix up with medicines and pharma,

but it will be very similar, we think, to the Article 15 in the MDR. So a PRRC, it's going to be the UK equivalent. So UKRP will need to have that one or more. Liability. So there is a liability already for UKRP. As they are responsible for helping you to place it on the market, but under the new regs, it's expected the UKRP will become liable on the same basis as the manufacturer. Again, not new news, same as in Europe. There will be a requirement if you change your UKRP, one decides they don't want to represent you, to have a tripartite. So both UKRPs, incoming, outgoing, and yourselves, it's going to get a bit messy.

So if you're planning a change, do it before that requirement comes in. And the MHRA have said they're likely going to be liable for a change. So we're likely to ask for more information about devices, particularly at the point of registration. Okay. So if I don't have a CE mark, if you're wondering how you can access market for the first time, we've got UKCA marking, and that's been voluntary and available since January 2021. And it is based on the consolidated regulations. So the old directives, which is great. So it's a directive classification. For example, we don't have the class 1R, reusable.

Currently, we don't see the up classification of a lot of software devices as happened where the vast majority went from class 1 to a high risk class under MDR. So we're kind of behind the curve on that. So there is a window and a period of opportunity in the UK. But know that UKCA is not recognized in the EU. That could be a bit of a problem, but we'll talk about why you might be able to leverage that later. Okay. So we're not far away really. So hang with me and remember, keep putting stuff in the chat or in the QA if something has either bothered you, triggered you or given you some cause to raise some questions.

The UKRP is not required to be on the labeling. I discover this almost every day. You don't need to put your UKRP. You can, but you don't need to have it on your labeling with just CE marking. It's only when UKCA is applied. And there is, there is no particular symbol for the UKRP at the moment. So you would just put the details on there. It could be UK responsible person. And you can note that you can dual label. There's no issue with dual labeling UKCA and CE if they're applicable in the UK. So in order to get UKCA, you need a UK approved body specifically an EU notified body cannot do that for you.

It has to be a UK approved body, UKAB. And note that the UK approved bodies cannot carry out conformity for the EU on your behalf. And our bodies are no longer called notified bodies because we left the union UK approved body versus EU notified body. The two differences in terms know that these guys can't necessarily automatically represent you or come and carry out conformity because some of them, they do not yet have their full scope of designation. So check and refer, and you can look on the UK government website. You can look on the UK government web page to find out who's designated against what,

for example, Scarlet's just popped up in the past couple of weeks. And I think their AI and software LNEG meds. Good to see have arrived. They're just building out their scope. And I think more will be coming later. Same for some of the other guys. So just do check, but you've suddenly got some more options. And I think it's fair to say there's a greater degree of capacity there too. Okay. So we're talking about opportunities in the UK. What, what, what can we do? I'm looking to, I'm looking to see what the response to consultation. I'm sorry, this is a really busy slide. You're probably reading all the words there,

but I want to summarize. So in this case, I think this could be a fantastic commercial strategy and an opportunity. If this remains, it remains the government's intention to introduce transitional arrangements for UKCA. So not just for CE marking, but for UKCA too. Okay. That's in the response to consultation. Again, the link there, you can Google and find it. You can find that document for yourself. What the government intends to do is establish a transition for UKCA. That's UKCA now, or that's UKCA prior to the new MDR regulations. And they intend to place an extra transitional arrangement for up to three years for devices and up to five in the case of IVD.

So if you get there, let's say just before new UK MDR, you can continue to leverage. The old directive and those requirements potentially up until a further three years or five years. And I've put the dates there, but they could change depending on when we roll into the new regulations, the UK regulations. If anyone has any other knowledge on this opportunity or has some updates or would wish to correct me again, throw them out there. I'm always happy to be corrected. Quickly, we're going to talk about Northern Ireland. We're just going to touch on it. It's a quick dip because, Northern Ireland has a unique status.

They're part of the United Kingdom, but essentially they're treated as Europe in a regulatory context. So distinct rules apply there and it's a bit of a muddle and it confuses people. And I feel sorry for those guys in that market. And I'm always looking to see if there's an opportunity there. The MHA are the competent authority for that market. Note that they have become a sovereign regulator for GB because they're not a competent authority necessarily under EU rules anymore. So there's difference in terms. And the MDR and IVDR were fully applicable in Northern Ireland as per Europe from the same dates.

In this case, UKNI CE marking is an indication if a UK notified body, a UK notified body undertakes the mandatory conformity assessment. People think that just because you place your device on the Northern Ireland market, you have to go UKNI. That's not true. It's only in the very rare, circumstances that you need that a UK notified body carries out the EU conformity assessment. In fact, I don't think any are designated to do that right now. Again, correct me if I'm wrong. I don't think anybody, any of those bodies are likely to go for it because it would be under the new EU regs. And I can't see the reason why with a lack of resource and the increased cost for such a small market why they would.

So it's almost like a rule that could be used, but just because you can, doesn't mean you have to. I'm not sure whether that's going to be done at all. Note that here's the crunch. CE UKNI mark devices will not be accepted in the EU market. So just for that tiny little niche market, which is a real struggle. Note that GB manufacturers, any of you out there that are looking, if you place your devices on the market in Northern Ireland, you do require an EU or a Northern Ireland based authorised representative. If you're placing devices on the EU market, which I, for most I speak to, they're already doing that.

Not a big deal. But if your model is just United Kingdom, so GB and Northern Ireland, you're going to need to do that. Talk to me if you need help. And then certain other devices, certain other devices need to be registered with the UK MHRA. And that can be done by UKRP or your EUANI, EUAR based in Northern Ireland. Okay, quickly, so the UK certificates of resale, export certificates, they're super cheap, super useful for accessing other world markets, not just unique to the UK, but people miss this trick. And those certificates are used as a bona fide document. Often they might need to be upstealed or legalised.

But what that says is that the devices are safe to be placed on Western markets. And therefore that's good enough in many regards. Now it's, you know, you do need to consider some other requirements like appointing, certain other local reps, and there are some other local requirements, but there's some missed opportunities here. I think a lot of people skip this because they're a bit confused or a bit scared. They don't know what it all means. If somebody could just unpick that for you and explain it to you, suddenly you've done a lot of the work. You just need to do a tiny little bit more, get the right people in place,

and suddenly you've got extra commercial opportunity. So in closing, the UK is a significant market with strong growth. We're the third largest, and the fifth largest for devices versus Europe. Remember geographical because we're not part of that regulatory requirement. There's a strong backing for our sector by government and MHRA. The National Health Service is the largest purchaser, and it's a single payer structure, which is epic. Once you're in, you're insured and sometimes for four years. There's a focus on value rather than cost. And if you can come up with a compelling proposition, you can get really good traction.

We have good time to leverage the market. We can leverage the existing old directives or the consolidated regs. You can exploit the UK actually many cases to generate real world data, to get some post-market data, which can support your EU initiatives. If you're in a queue, you're trying to maintain legacy status, you can generate under low burden here. And you might even just use the UK to do that for, if you don't have the cash to already take all of your products to Europe right now, to do that in the future by exploiting UK and NHS. The UK is angling itself to be perfect for niche novel disruptive technologies,

and you might find some commercial help, particularly in the digital AI space. You've got a growing choice and capacity for approved bodies for UKCA. Just talked about certificates. Pick your UK RP carefully because they're going to inform your regulatory strategy. Don't just pick a post box. Don't just pick somebody who's going to just sit there and register you. You need help. You need somebody to give you really strong advice. Particularly in the changing regulatory market, because you could make a mistake. And ensure that that regulatory intelligence you're getting, your extension of team,

informs your commercial strategy. Make sure that you're not going to be left high and dry. So that's going to conclude my presentation. Hopefully, if you've got any thoughts or comments, you can drop them in and I'm going to pass right back over to David. Before we go to David, I'm going to run the first poll question. I appreciate it if you can launch. Chime in on this. The question is, in which markets are your devices currently being sold? Awesome. While everybody's doing that, we're going to gear up Hurt's presentation. And David, what would you like to say? Well, yeah, I was just, while Hurt's maybe we could,

I mean, obviously there's a number of questions rolling in and some things that Matt maybe could get to. Individually after or in our conversation later, but there was a few, I don't know if you want to briefly that there was a few, a number of questions on location related to, you know, UK responsible person. Does that actually need to be based in the UK versus in some cases, just generally, or in some cases versus great Britain, when it comes to the Northern Ireland situation, is that something that's clear cut or is there, is there a more complicated answer to that question? But there was a number of.

Yeah. Yeah. Now it's a good question. The UK RP has to be based in the territory. And whilst there are numerous models out there that essentially, if you call your UK RP, you'll be through to somebody that's going to receive your call in another European union country. The intention of the UK RP is to give the MHRA immediate, good access to that representative person as if they were the manufacturer. So they should be located in the territory. That's going to become a legal requirement. It's coming. And, and really that's, that's the intention. And the same way that we've got some good guidance on where the PRRC should be based.

I think the UK representative, because we're in the territory, they should really be based in the UK. So do please check. And I think some of the UK RPs out there that have been taking the forwarding model and using legal offices are probably making amends and a change as well to set up a business here because there is a need. So just check in with them as well. Great. And I think we're going to go ahead and end the poll. Share the results. I think you're able to see the results. Yes. Yes, we can. Very, very interesting. And I'm going to stop sharing the results and we're going to move on. Great.

Well, why don't we head to her to talk about you and obviously all the calm and nothing much going on over there. I don't think. I don't think we can do that. We can talk more and answer some more questions after. Thanks. Excellent. We'll try to see if I can share my screen. And hopefully now you will be able to see it if someone can nod or agree. We can see it perfectly. Thank you. Very good. Very good. So, yeah, I'm so happy that Matt indicated UKCA is complex. So I can. I don't have to say any more about Europe. It's a little bit similar, but maybe it's easier. But there's something else happening in Europe that is making a lot of people.

Hit their anxiety buttons. A lot of people are uncertain and clear about what they have to do. So hopefully in the next couple of minutes, I can highlight a little bit of the thinking in Europe and what you should be doing to gain or continue to gain access to that market. And as we say in regulatory, there's never a dull day in regulatory. And that certainly is true for the European situation as well. Every day, something new and sometimes something surprising. Or as in the green room before we started, someone else. Why on earth should anyone still consider going to Europe? Well, hopefully in the next couple of slides, I'll show you how easy it is.

As for QSERV, I already mentioned briefly what I do, but we also see that on top of regulatory and quality affairs, our CRO is in the last few years starting to hit that new phase where in Europe we do more clinical trials, pre-CE marking, post-CE marking, and so on. And a lot of those trials, pre-CE marking, post-CE marking, PMCF surveys, registries, that is just kind of kicking in. Well, that was one of the key reasons why we needed to have this new set of legislation in the first place. And so with kind of a decade delay, that new emphasis of manufacturers trying to get more and more data is seeming to really now get started rather than being finished.

But it's getting started. So that's the good news. You can read this later on. Call me. conflict of interest slide I have to put it in but in detail what are we talking about when we talk about Europe and and basically there's only well two two Market ways at this moment to enter with your medical devices or IVDs into Europe and I say two because well of course we have the MDR replacing the old uh MDD and AIMD legislation that are expired and gone so it is MDR same for IVDR having replaced the IVD rather a directive sorry about the typo there um but basically the difference is if you are working and you never went to the Europe uh you're working on something

innovative or a new product that is entering actually it is a new product entering Europe you just fulfilled the new legislation and you're done it's clean and easy as that the real confusion starts for those people that already had products on the market and we call that Legacy products um where the situation is much more complex because keeping your products on the market as Matt already alluded to and keeping your CE Mark that is a very complex uh thing to do whilst you get ready for the new legislation so clear cut new products new legislation old products complex um but why would you want to do this

um you'd like to do this because well besides a couple of um of well we talked about Brexit before Switzerland exited from the MRA as well uh Australia is well more or less out but still we are talking about 27 countries 600 million people a large market in the world uh including then Iceland Liechtenstein Norway from the economic area Turkey with the customs union agreement and on top of that we have the benefit if we have a CE Mark that around 122 countries one way or another partially or fully recognized that CE Mark and we just learned also that for now at least the UK and Northern Ireland continue to recognize that also in this civil transition

period up to way to 2030. and most of these recognitions will be in the Middle East and Northern Africa and Latin America and Asia Pacific where either a fully based review based on CE marking or at least it gives you some leverage to to go easier into that country so as such well CE marking is one thing for Europe big market but the global coverage uh is is is worth your efforts I would say but it's more complex than it was before it takes more time takes much more money and takes much more preparation but if you do it right it's easy and you can do it I'm sure of that so explaining a little bit of these troubles why are we in the

situation in Europe and let me go back to this slide basically on on when uh the initiation of this legislation and mind you this was in 2007 uh was done with now a transition period for IVDR up to 2030 so so about 25 years um just about that time the uh originator of who can initiate new or revised law had changed and the European Commission was for the first time allowed to do that and they immediately grabbed a chance and started doing into that that led to a lot of different perspectives like not only on the health care situation but also on what's happening here with with that uh well some even said at the time

um hostile takeover by now we're used to it but that led us to have a fierce debates about what really matters to the healthcare situation and that led to very complex legislation and vague legislation in a way um and we'll see some of that so it went up from from a directive to regulations as you saw meaning that also the governance is partially done centrally in Europe meaning loss of power to member states and so also there are a lot of uh an ease was in the system and gradually we're starting to see member states adjusting to that new role and I I guess the worst scare is over yes we get new extensions in a sense but the players

seem to finally really be happy with their current role and power revised balance of power and so by now everyone is moving towards well let's get it done let's get everyone certified let's get these products rolling making sure that uh Europe continuously sees all these beautiful basic as well as innovative products on the market uh key and that's what you've seen and lots of early on negotiations have been around is that we needed to include a new legal framework where not only the manufacturer is mentioned in the law but also responsibilities for for importers distributors the authorized representative and

PRC as Matt already alluded to much more detail nothing specific for medical devices but that's just a general European framework that has changed and if we look at the objectives of the law nobody could object to this right but products should be safe and sound it is to lower the barrier of trades in Europe and get your products in approved in one place allowed in everywhere and then of course after 25 years we needed to have a little bit of an update to state of heart trouble starts here like these words are nice but they're not in the law what you find in the law is sufficient clinical data without a definition and nobody can tell you what sufficient is and so people start

arguing saying well if I run a clinical trial with 500 patients and these and these endpoints is that going to be good enough well we can't tell you we can only tell you when you when we review the data right and so go back to your CEO ask for so many millions to run this study on the chance that it might be good enough and that level of unclarity also hints into the toxicity the biocomp and so on and because you have to really get it right you have to do well more than enough I would say more than just enough and that really raises the cost so a lot of the cost rise uh double triple five times ten times even what we've seen compared to early uh mdd applications not only for notify

body costs they spent more time reviewing auditing and so on but really the cost of preparing getting all the validations getting all the products in place um that really is where the driver of cost is and so that depends on your product or classification and so on but also what you did before and when you lost it your validations and how much clinical data you have so there's no sense telling me how much different it is because it really depends on many other cases um so if you if you're new to this and you've never read these laws before and some people might have that it's it's just easy to get the well this is the example

of mdr ifdr is the same read the first five pages to whereas that really is kind of the executive summary uh then you go through the articles nothing specific about that it's just what we had before the articles of medical device legislation including what previously was in the guidance it's now basically all put into the law and then we have the house in the annexes in similar type of order um the fun starts when you start comparing what's in the articles and what's in the guidances in the annexes that is not the same and so then you start thinking about what to do well follow the articles the rest is just an explanation of how you might be able to do it but the articles

basically are leading here main themes in the mdr and the ivdr and for this slide in orange is you see some of the elements of the avdr um as I mentioned before clinical evidence or performance performance evaluation for ivd is really one of the key drivers of uh what is changed a second change is post-market surveillance where like like a third or half of your energy is not going to be on getting your product on the market but on keeping your product in the market and that has to be a continuous process staggered approach high risk low risk and so on stays but the emphasis much more than before on high-risk devices

and as such we we do continue to see the same classification as we had before for medical devices aimd is now all class three and for ivds we moved from a list to class abcd d being the highest um still in Europe we need to get through another public assessment for everything but class one or class a devices and for medical devices most of the manufacturers were aware of this for ivd for the majority of manufacturers this is new never done before and they they started off having no clue what to do meanwhile we're in this for seven years and I guess the majority of manufacturers now have much more understanding of what it takes and what is needed um as it was before in Europe we we have

this funny system that you get your market approval by the notify body you get your CE mark and then you still have to go through a health technology assessment uh individual countries are not as simple as it would be in the UK for instance or in in the US um health technology assessment every country per se different different reimbursement systems and so on and so forth and so forth and systems and that is the good news uh new legislation is being worked out to get European HTA in place rather than the current diverse fields that we currently have system-wise a few changes have been made lots of push and notify bodies they were heavily criticized by all stakeholders

including the authorities Commission manufacturers everyone was was unhappy with them I think that is a thing of the past largely they are they are now really seen as well that they they will help us all get there um and so in that sense also there's more trust and that means that also they can slowly start talking with manufacturers in in guided discussion um still pretty strict but a little bit more uh upfront discussion on on your strategies and and what is good enough what is sufficient clinical data and so on so we're slowly getting back to that that good and balanced uh discussion uh improved transparency is one of the intentions

of the law a utima database I'll show that in a minute and that's not really coming off the ground that seems to be very complex to build after 10 years of building software they still are not ready to roll it out and what we do see is much more interaction between the member states the commission and all governance stakeholders in an improved coordination also on vigilance on post-market surveillance and even on approving your clinical trials so so slowly the players are really getting in place uh and are more comfortable in their role and are more trusted to do uh what it takes them to their

their role and in that perspective if a lot of the energy is is now back on the table we can just go ahead and get things done as a manufacturer basically it's not that difficult what you need to do is is get your validations in place uh link it to the the safety and performance requirements you put everything in your technical file think of it if you're a US based think of it as building a DMA and then you're pretty close to what you need to do the more complex thing and I'll show that in the next slide is NX3 continue to build your technical documentation throughout your post market surveillance and then you say it's good enough in your declaration of conformity and

the notifiable body will come and inspect you and they will update your reflections on the quality system and if we look at the next slide and I hope that Sean will share these slides afterwards with you there's a couple of boxes here where there's some specific asks on top of ISO 1345 in the old legislation that you need to put in your quality system the white processes while vigilance Kappa PMS PMCF as mentioned before there are some updates much more precise prescriptions and everything green is staying as it was or is just following ISO 1345 so that quality system is not that complex but it

asks for some attention to detail um that post-market phase that's really critical because that is where a lot of the uncertainty still is how to link everything together every year have your updates post-market clinical follow ups a summary of safety and clinical performance or SCP is that's called for the IVD um making sure that everything talks the same language that you have a feedback loop to your risk management that your claims are consistent with your marketing material Etc Etc and that continuous loop and making sure everything always aligns even if there's trouble even if there's vigilance cases and so on on a continuous basis that is

where the majority of manufacturers at this moment are are still working to get their processes uh fine-tuned um luckily with with more and more knowledge also inside the notify body the auditors they have seen good systems working systems and of course that helps also to to post the right question during your audits um so that that that it's clear what is good enough and and where you still need to improve your systems let's move on also I I saw quite some names on on people knowledgeable even though different bodies are calling into this like where are we with the implementation and for that I borrowed a few slides from the European Commission that they

shared last week in a conference in Brussels um given actually by Paul pisco as flora couldn't make it and I'll just quickly go through to give you that highlight of why are we still thinking that things are not good in Europe and and to some extent that is true um obviously we have a simple system in place where there's three parts of the Commission responsible with all the member states on the Central medical device coordination group with 13 parties working um on like over a hundred work items to get further guidance and new legislations and so on and so on in place pretty complex uh legal system to try and work out

um confuse you all with guidance whilst you're in the midst of your submission or even guidance that comes out your submission is being reviewed and you get questions why you didn't fulfill the guidance that wasn't there when you submitted your dossier well these are the things that we're working through um and we'll get there but be sure that there's more coming um a couple of slides on medical devices and then we'll have similar slides with a more or less similar picture for the medical devices uh of the last few years the. number of submissions to the Net-A-File bodies have increased rapidly. We need to get to 25,000.

These are the polls from half a year ago. So meanwhile, it will be higher than 13,177, but we're far from the 25,000 that are anticipated. And only in the orange, only a smaller percentage, around 4,000, have actually been certified. So we're on our way. You can see the J-curve. We're getting there. More complex is for combination products, where you see there's only a small percentage having been certified. And even the more complex with animal tissue, human tissue, or the substances, you can see that, well, some of them are coming into the Net-A-File body, only a few, and hardly any have been certified so far. So if you're in that era, then really

should push and have loads of debates with your Net-A-File body, because then time is running out. Timelines are hard to maintain. This actually is a surprising slide. If you look at why the first reviews from Net-A-File bodies are negative, and they turn you away. And these include things like, well, they don't have the scope, which is just public in the public domain. They can't review because they're not allowed to review your product. And so applications are far from complete, so far from complete that they can't even get started. And so really, in preparation, you should make sure that you get it right,

basically, first time, and do the same thing during the reviews. Basically, sometimes we get calls from customers, and they start calling us, well, we are at the third round of review with our Net-A-File body, and they don't agree with our position on a certain thing. Well, did you answer the question the first time? No. Did you answer the second time? We told them we disagreed with the question. Well, that's not a way. You would never do that to the FDA. You wouldn't do that in China. You wouldn't do that in Japan. Why do you think you can do that with a Net-A-File body? But take them seriously, and it's easy to get through. Slide for your reference later on,

completeness of submissions to support that. The first review typically turns away most of these submissions because there's so much wrong and faulty in them. Timelines then. Time to reach your certificate from the start of where the Net-A-File body actually starts reviewing. Six to seven months, not too bad for a number of Net-A-File bodies, including some of the larger Net-A-File bodies, but longer, up to two years for some of the others, if that is the QMS. If that is the technical files that need to be reviewed as well, think of 13 to 18 months, and in some cases, longer, and especially for these complex combination products and so on and so on.

Meanwhile, you must have seen that the timelines have been extended. If you are in legacy frame, if you are already having a certificate, you must have seen that the timelines have been extended. If you are in legacy frame, you must have seen that the timelines have been extended. If you are in legacy frame, you must have seen that the timelines have been extended. If you are in legacy frame, you must have seen that the timelines have been extended. If you are in legacy frame, you have in the staggered frame, depending on the classification, longer time to get through that hurdle, but you need to get your quality system reviewed and the application launched before May

this year. If not, then the whole shebang stops and you should have your MDR on the spot at this moment. So not a lot of time to waste to get into the Net-A-File body if you haven't. Well, similar slides for the IVD. We have to go to 8,000, I believe. We're now at 8,000, at 1,000. Not a lot of certificates issued because the capacity of IVD Notified Bodies was lacking. There's a catch-up at this moment, so there's more and more IVD Notified Bodies coming in. Reasons for refusal are slightly different here. Mostly that the application is incomplete, but not anymore the mistakes like, well, we asked the Notified Body and they cannot do this because

they're not allowed to take up this type of technology. Completeness of submission is slightly better now also than medical devices. So you can see that large industry, if you put everyone together, has started to learn and take the application reviews in the early, getting it right, more serious than before. Time to read certificates. It's long. If you have product certificates, 13 to 18 months or even up to two years. If that is Class D, the highest class, some indicate it might be even more, especially if you're Notified Body is not willing to go ahead without a reference lab, knowing that we don't have a reference lab for all products at this stage.

Commission is starting to panic. And so there's a new proposal. Basically, this is for the IVD to have a staggered deadline as well, extended all the way up to 2030 for the lowest risk classifications. But with that, they also want to have the transparency, the transparency of the information that is being provided. And that's the most important part and also, we have some model applications. For example, the European database, the Unimed database launched, basically. The laws say, both MDR and IVD, that they can only be launched when the whole system is ready. And what they want is kind of a building block approach

where some modules can be released and then others will follow later. That will get us a lot of transparency. And until then, we need to know in Europe, and Commission wants to know, member states want to know, which products will stay on the market, because they are afraid that hospitals are going to be discussed. us will have to close because there's no scalpel or whatever else is missing um so in that sense they have asked notified bodies to provide all of that intel well notify bodies don't know especially not for ivds because many of them never hit the notify bodies they asked a big medtech industry medtech industry didn't know so now they will put it in the law that every

manufacturer will have to inform the authority six months in advance when they stop critical product delivery um so that will be interesting with these timelines uh conscious of time we'll try and and see that we end in a few minutes um until 2030 um the european database these are then the the one two and three is basically ready and so the the actors the udi database and notify body certificates in a transparent way hopefully then we'll start making it to that transparency and the rest will follow later with the clinical investigation part being the latest the last one um as mentioned commission is working on on like

a hundred projects uh guidance a combined project uh well too much to to tell here new focus in europe is on orphan devices on devices that are small are large are for children babies and whatever that are all kind of removed from certificates by manufacturers so a lot of the the well-needed products will basically be phased out because there's not enough clinical evidence for some of these uh specialties um interaction with a lot of different legislation on our way ai act being the latest kid on the block how can you keep up to date i added here five references um it used to be all in one place

now you have to scroll the internet or just find reliable sources of people that are summarizing for you what the state of play is what does that mean for you why would you continue to do that weWhere is paytough? paytough is a platform population if if paying three four or five times the cost of keeping your market approval is worth it for any particular product that you want to put or keep in the market and what we've learned

so far is that many people in regulatory quality as you might well be know what to do and and where do companies block well that basically is for lack of leadership so if you don't have full buy-in from your management from the top management and you have the budgets aligned um stop talking to you not if I'll be in first go to the boardroom get your money in place and then start acting um with that we come to the end of my slide act questions either now or later you can also email me if after the show you're not ready and with that I hand over the floor back to Sean and David thank you John I don't know if you had another poll question to put through but I would while

you're maybe you want to put that through that I'll maybe uh launch one question that I heard before we move on gonna do that yeah I launched the poll question um thank you hurt uh that was very helpful um feel free to ask a question David yeah well I just I mean there's plenty of stuff coming through as always and some of that would be uh uh I would also get to after after we're all done but I wanted to uh just one thought that came to mind while looking at the slides it was just um um harmonization throughout the EU in terms of getting you know consistent um feedback and response from different notified bodies but also country by country obviously without like

you know without you to med and play you know there's there's different National databases but also I think there was a question in the QA different symbol requirements country by country how is it how much of a this sort of single Market feel and free and total free trade feel between consistency is there another thing would you say right now and where is that going um so interesting question I I do believe if you ask me personally that it is better than it's ever been before um and why doesn't not feel that way because we're more transparent we communicate much more there's so much on the social media and so on we see all the things that are different whereas in

the past nobody really talked about it or or it wasn't shared um if we talk about harmonization to pick a few of the things that you mentioned because you had a load of them if you talk about harmonization between the reviewers um um one thing that is currently happening is that the joint notified bodies are giving workshops and sessions and and and so on not only to industry with which I've done but they started first to train their own uh notified body staff the reviewers and the auditors so jointly so not just one notify body joining their own uh training their own staff but they would train and part of

the training was then also carried on to all the notified bodies and so on so so much more harmonization in the training and to get there they needed to get a joint feeling of well what do all these requirements mean when is it good enough what are we focusing on and yes you will still feel that there's some differences uh one notify body does clinical audits another one that focuses a lot on sterilization and so on but overall a lot of the technical questions between notified bodies are as dispersed as they would be between reviewers from the same notify one right it still is a person reading it with their background and

knowledge they might have slightly different questions but I feel we're making a lot of progress in getting a much more unified approach and and similarly you see that with the authorities supervising the market surveillance to supervising vigilance not yet in approving clinical trials I would say that that's really where it is more chaos than ever before but no that's good to hear this improvement there because that's always that was an area of challenge for some time I feel um well well thank you for that and I think that's it for this session thank you very much and I hope that was helpful.

I know we saw the the poll results I don't know sorry they're off the screen already but it looked I uh but but we will take a look at those and and use that as feedback for for who who's listening um uh but I think before and before I think we're ready to um move on to uh Michelle is that right or is there anything else Sean we wanted to well it was about half the people are planning on bringing new product to market uh a quarter are not and a quarter are uncertain so that's yes thank you. I'll take a summary of them well honestly the word I haven't heard the word easy as many times in MDR presentations before as I just heard from her so maybe that'll encourage more people to uh to to to take the launch

um just get going and just get going and it's easier than you think yes great all right well let's move to uh my neck of the woods in the U.S. and let's hear what Michelle has to say about what's what the FDA and what's going on yeah I do want to give just some context to the easy around what her just said and that's he said go to your boss and make sure you have enough money and it's funny when you have enough money how much easier things can get you have to do it right so okay are we uh good to go here okay so we are gonna um shift the screen

I'm seeing first size on the screen I don't know share your screen okay it's switched okay so we're gonna um shift your gears here and we're gonna talk about U.S. pathways um you guys uh know me this is my executive team that helps with the aforementioned grief counseling they are asleep again right now but I apologize for any background noise that might pop up um so I'm going to briefly review like how the FDA classifies risks so you guys have some context compared to the other markets that we talked about.

Some of this I'm going to move through pretty quickly. So if you want to talk more about this, either send me a direct message or an email later and we can schedule a call to follow up. So in the U.S., there are like three and a redheaded stepchild of device categories. And those are class one, class two, class three, and unclassified. So unlike Europe, we don't have subdivisions of one, one S, one R, one M. We don't have two A, two B. But that doesn't mean that it's necessarily any more clear cut. And then we've got this weird little category that's unclassified.

Most of these are pre-admendment, meaning when they first put the regulations in place, they're going to be pre-admendment. So they're going to be pre-admendment. So when they first put the regulations in place that are product specific in the U.S., there was this group that for whatever reason they didn't create a regulation for. These are risk-based. About 40 to 45% fall into a class one category. Class two makes up another 40 to 45%. And those higher risk and unclassified devices really only make up five to 10%. And they're usually like things like either high-risk implants, or life-supporting, life-sustaining devices.

This is really unique to the way that FDA has organized exemptions and requirements for different classifications of device. We really have three sets of controls. You've got your general control. So no matter what, even for all your class one devices that might be 510K exempt, and GMP exempt for a certain subset, you're going to have some basic requirements, but they are very minimal. Class two have other types of requirements, including the requirement of a 510K, other special controls like guidance documents, and then class two PMAs require this kind of different,

more complex submission. Generally the unclassified devices require what's called a 510K. So long story short about all of that. You can see, this is a matrix of what type of controls, submission requirements, and trials that you may end up with. So it can be, while it is a blessing to have a whole set of exemptions that generally don't apply in other geographies, it can also be very complex to navigate and make sure that you do have the right and basic set of requirements. In the U.S., there are five basic steps to market, and we'll touch on each of these quickly.

So the first is to define the product. This is done by defining your intended use, which is your core concept at the basis of the FDA regulations. It refers to the objective intent or purpose, which can be shown by the labeling, the advertising materials, the oral written statements, the implied or expressed claims, what you do on social media. So it's much more than just a regulatory statement that appears in your documentation in your design history file. You can think of your intended use like a document. You can have an overarching umbrella that kind of defines the overall context of what your device does.

And the indications for use are very specific subsets of that intended use that fit within that umbrella. These can be anything like a target population, a duration of use, or an anatomical site. And this is the indications for use are going to build. We're going to build on that throughout our regulatory strategy. And we're going to build on that throughout our regulatory strategy. So it's really important to clearly articulate it because it can also determine if you meet the definition of being a medical device at all, particularly if you're in the digital health space. And you have a software or an app-based product that may or may not meet this definition.

And primarily a medical device is going to diagnose, cure, mitigate, treat, or prevent a disease or condition. It does this by what is called a mode of action that is structural or mechanical in nature, which means it can't be metabolized or otherwise chemically processed by the body in a way that a drug is. So now that we have our intended use statement and we verified that our product is a medical device, we're going to move into how to determine the classification and pathway. Well, that's going to be a little bit more complicated. The FDA, and this is something that's unique, at least until Udamed is in full swing in the EU, which is a good ways away.

The FDA has always had a myriad of FDA databases. There are probably around a dozen or so. I typically start my product classification with a product code classification database and do different keyword searches that involve my intention. I typically start my product classification with a product code classification database and do different keyword searches that involve my intention. It also has very helpful information about your competitors in the device establishment registration listing database in the 510 database. And then there are others that are really helpful as you're formulating that early regulatory strategy.

And again, this kind of sets the U.S. market apart. So once we understand our classification pathway. So once we understand our classification pathway. then we're going to move into developing the valid scientific evidence that we need to support that strategy. So this can take a range of different forms in the terms of, you know, being a non-clinical benchtop testing, performance standards, recognized consensus standards, animal or clinical. And FDA's new favorite is usability engineering or human factors. There are very few submissions anymore that are going to, that the FDA is accepting without some level of usability or human factors, at least assessment, if not testing.

So, and then in the U.S., there are different types of pre-market submissions. And that these can range anything in the realm of intensity from a walk in the park to an Ironman marathon. Because you could fall into one of those. So there's class two, or there's a handful of class one devices are generally 510K exempt. But then there's a subset that requires 510Ks. Class two devices usually require 510Ks, but there's a very small subset that are exempt from 510Ks. Then there's the de novo, which means of new. And then there is those class three devices that require pre-market approvals.

And that's a little bit more like training for an Ironman. So the 510K makes up the vast majority of submissions to the FDA. This is the pre-market submission for low and moderate risk devices. It's based on a concept known as substantial equivalence, which is a comparison between your product and a legally marketed device. Where you compare the intended use, the device features, and the performance testing. So next to getting the intended use and indications for use statement right. This is one of the next most critical decisions that you can make is choosing the right predicate device for this comparison.

Because this is going to be the argument that you're going to make throughout the body of your entire submission. A de novo is a submission for a device that has no existing classification regulation. Or clear predicate. Like I mentioned when I discussed the product classification database. The FDA actually has separate regulations and separate product codes for every product it regulates. And you use the intended use to guide you to picking the regulation that best fits your intended use statement and product features. That's another unique thing about it compared to...

About the FDA. About the US compared to the EU and other markets. Because those are generally more rule based and it's just a handful of rules. Not like specific to drilling down to, you know, thousands of different product types like the US does. This is the marketing act process for novel devices because you don't have a regulation or a clear predicate. And you can't make that substantial equivalence. Uh... Uh... Uh... Determination because of that. So... At the end of a de novo, it creates a new classification regulation. So the de novo process can actually be really powerful if you understand that you get to recommend to FDA during the course of the de novo contents.

The special controls. Special controls can be specific performance criteria. You can require... Uh... Uh... Clinical trials. You can require human factors. Uh... Uh... Dozens of tests. So... So the people that... That really are strategic about this. Um... These are actually some of the most detailed regulations that the FDA has drafted. And they're also some of the most more restrictive if you're trying to bring a competitive device to market. Um... This is an alternative to the pre-market approval. Um... And it's for those devices. They're kind of in between that life supporting, life sustaining, high risk implant.

Where you have a reasonable belief that because of their benefit risk, they're going to end up being ultimately classified as a class two. And in some cases, maybe even a class one. And in general, this is a reduced regulatory burden and cost. Um... Based off of the risk benefit profile of the device. Uh... PMAs are the pre-market approval. This is the market application for the highest risk of devices. And it gives you a reasonable assurance of safety and effectiveness. And in general, all the data and evidence you turn in into a PMA can stand on its own. So you're not relying on a substantial equivalence discussion.

And... And the FDA is accepting... Is inspecting your data. Not are you enough like your... Um... Your... Your predicate. But they're looking at your data as does this stand alone in terms of safety and efficacy? And that's why you can call these devices approved rather than cleared or granted. So roughly, if you look at how the 510 . How the 510 and PMAs compare. Um... You have got the 510 . Again, that these are kind of submission wise one of the easier cases to make. These are right around 1500 and up pages.

If you've got software and cybersecurity, you know, I've seen one get as crazy as 6000 pages. De novo is going to be, you know, at least two to three times that in scope. And a PMA. Um... Is, you know, what comes out to be about 30 plus three inch, three ring binders. The 510 process. Um... This is, I think, the whole review time based off of the classification risk is another big difference in what to expect when you compare this to the MDR technical file review specifically. Is that the FDA clock time for 510 is generally 90 days. And they're running. Right around 200 days, regardless of the type of device that you're having reviewed.

De novo. The clock time is 120 days. These are actually running about 400 days on average. PMAs. This is the funniest one to me. 180 days is the FDA clock time. But these are really pushing the 8 to 900 range. Um... So, you know, you have to have a preapproval inspection. Which, you know, in the AU, you do have to have your quality management system inspection. And your technical file documentation kind of all cleared or certified. You know, kind of moving in some level of parallel where they all eventually come together.

Whereas in the United States, it's really only the premarket approvals. So, you have to have a preapproval inspection. The user fees, you know, this is the FDA fees. This ranges anywhere from about $5,000 up to $120,000 if you have a small business designation. And so, the fees are significantly reduced over other market geographies. For a 510 , you can say these are cleared. De novos, you can say cleared or granted. And then, when you end up in that premarket approval, that's the only time you can say FDA approved. So, that's an important distinction. Or the FDA will deem your products misbranded and adulterated in their advertising.

So, advantages of the U.S. market. So, in the United States, the FDA is the FDA. It's really the only agency. Technically, we have about five years. We have about five or six third-party reviews. But they do their reviews and then they have to turn their review into the FDA. And the FDA is the final authority if you get cleared or not. Whereas in the EU, you have, you know, dozens, a little over two dozen now, a little, almost three dozen notified bodies who can all be your reviewers. These are private entities. So, while the EU is moving to try to get these groups all trained together so everybody gets the same information at the same time to standardize their interpretation,

this, that traditionally hasn't been most people's experience with the review process with the notified bodies. These are also individual private for-profit. As opposed to government entities. Each notified body, once they certify your technical documentation, they now become the defenders of your technical documentation in front of national competent authorities. And there can be, there are, for every country there in the EU, there is at least one competent authority, if not a handful. So, this can get to be a little bit more complicated. But, you know, it's not a problem to be, especially if you have a problem in the market.

This can be quite onerous and quite the level of liability for the notified body. So, because of that difference in governance structure, coupled with the challenges that the MDR and that higher bar that the MDR has brought, particularly in the areas of clinical documentation, we've had a paradigm shift. We've had a paradigm shift in that go-to-market strategy. Where, you know, the EU used to have the reputation of being easier to entry, lower clinical trial requirements. Those have actually shifted in as MDR has come closer and closer to fruition.

If you compare and contrast both the ways of communicating and the budget, you need to have for that communications, both before and during the technical review process. In the FDA, we have got a number of ways that you can engage with the FDA for free. The only cost to you is the cost to get maybe to have somebody prepare the submission to the FDA and maybe some initial protocols. So, that's a little bit more complicated. But, in terms of the MDR, it's a little bit more complicated. The notified bodies, they really don't have anything like a pre-sub. Some of them have a little bit of a pre-assessment process about, are you ready or not, but it's not, certainly not free and not to the level of communication that you get through the pre-sub process.

Right now, it's also difficult to find, to have application process. Successfully completed. And part of that is due to the notified body, both qualifications and capacity. You may be knocking on doors trying to find a notified body, especially now as we're ticking down to May 26th, that has got the time and resources to even be able to process your application. If you look at the cost of an actual review, the 510 s like we saw on the neighborhood application, it's a little bit more complicated. It's a little bit more complicated. I was on the neighborhood of $5,000. In general, these pale in comparison to the amount of money that you're going to spend with between the review rounds with the notified bodies.

And I have even had a client with a 2A sterile commodity product that had been on the market in the EU for 50 years that their notified body, you know, treated it like it was a whole brand new thing. Right. And they had never been on the market before. And they finally resented their application after they had gotten over $100,000 in fees and couldn't come to, were at an impasse on certain technological features that they didn't all agree on the interpretation of the product. Another advantage, and this is pretty significant, is the small business designation.

So if you make a small business designation, you're going to have to have a lot of money. So if you make less than $100 million a year, you, and that's globally, you are considered a small business in the US, which means your fees are deeply discounted between 50 to 75%. And as of yet, there is no such discount across the notified bodies just because you're a small business or a startup. So don't pass up the power of a pre-submission. Right. So pre-submission, again, it's free. And this is like inviting the FDA to almost be like a part of your problem solving team. You give them an opportunity to, before you're in submission, introduce your technology to them and find out where they stand.

What is their current thinking? What is their understanding? Is there gaps in their understanding? Is there gaps in your understanding? So this is a really powerful process. You can ask very specific questions around your protocols. You can't turn in data, but you can turn in protocols that you haven't run. You can get feedback about acceptance criteria, sample sizes, statistical plans, and more. And did I mention it's free? Other types of pre-submissions that are really important for either novel or safer or more effective technologies are the broad. And the safer technologies or step programs.

These are also no cost pre-submissions where you make a case for your product that it meets certain criteria for either breakthrough or step. If you get these designations for your novel or safer technology. In theory, the FDA is supposed to be a little bit more of your partner in your technology. Right. So you're not going to be a partner in your submission and not your product development in terms of technology or design inputs or outputs. But definitely like, for instance, on a clinical trial, where could you negotiate possible endpoints? And they're supposed to also be a method of once you get them, you can more informally engage with the FDA where they kind of become your partner.

And. Maybe instead of putting it through a formal pre-submission request, they might engage you offline via emails for certain levels of dialogue. For guidance documents. I think that this is another big advantage for the FDA, because not only do you have those product specific regulations like we talked about, but many of them also have these guidance documents that tell you what FDA's current theme is. On a particular either topic like sterilization or bio compatibility or a particular product type like IV sets or infusion pumps. So in the US, there are a lot more guidance documents that are available.

I think they're in the vicinity of about 700 for medical devices. They're very detailed and specific. Whereas. You know. In the EU. There are. There are some. And we're getting more as we progress towards the MDR. But they're a little bit more general and a little bit more system oriented as opposed to this level of detail where you can see what. What they are thinking specifically about a product or topic. Clinical trials are typically not required for 510ks. Which again make up the bulk of the.

Submissions in the United States. So this is like a huge cost savings. And you also because we have the pre submission process, even if you do have to do a clinical trial, you can discuss it with the FDA via the pre submission process, which can also save you a lot of time and money ahead of time. E star is becoming. It has. Its strengths and weaknesses. But overall, it is a huge help. Into getting the right types of information in the right places. To make sure that your submission is complete. And meets FDA expectations.

So this is an interactive PDF. System that the FDA has come up with to both create and compile your submission and then submit it and submit it to the FDA. And then submit it and upload it to the portal. That is supposed to facilitate their review. It has tons of all these blues here. Our help text. That give you. Point you to maybe specific guidance documents about how to make the right selection here. Or maybe clarify some of their expectations. In terms of. They've got some very specific recommendations in their bio compatibility and cybersecurity sections. Disadvantages of the US market. It's right now.

It's really made. Kind of around both COVID and those guidance documents. So the guidance documents are a little bit of a double edged sword. The COVID turnover. Really? We had so much new staff. And loss and attrition of older people that knew the systems and ways. So that's given a lot of inconsistency. To the reviews. So you might not really know what to expect or have the same experience from both reviewer to reviewer within a division, but especially within divisions. And that's, that's right up to high level interpretation. Of policy.

And then those guidance documents, the FDA publishes about. Between 50 and 60. Years. So. The. Year. So their current thinking is constantly evolving. And it can be difficult to keep up with. Also for things that are published in draft. Yeah. I regularly hear from my clients who aren't quality and regulatory people. Well, that's just a draft. I don't have to pay attention to it. Because even finals are non-binding. And, and all that's true. But again, these reflect FDA's current thinking. And if you're not aware of what they're thinking, you're not going to be aware. How to respond to it. And you're going to be caught off guard.

With your additional information requests. So I'm just going to. You know, I've got just a handful of slides on the QMSR or the quality management system regulation, which came out. Just last Friday. I'm not going to get into any detail here. Because I'm doing a whole separate presentation. We're going to do a whole hour on just the QMSR. So I'm going to kind of skip through these. But just know that that's come that that's here now. And it's coming and we're going to do a deeper dive on it. It was published again last Friday. We're going to have two years to comply. It's going to be a big transition for both industry, but for the FDA as well.

In terms of their inspection methodology. They're calling it substantially similar to our. So 13, 4 85. With a few key differences. Again, stay tuned and we will talk about that. And just about a month. So. Monitor those FDA guidance documents and. Updates know that QMSR is. Coming be prepared. You know, make sure that you select the right regulatory path. It could, there's a lot of nuances with the FDA. And really capitalize. On those FDA pre-submissions. You could go to my website and get a regulatory pathway assessment. And a variety of other tools, if you care to. And so just let me know how it can be helpful.

That was awesome. Not much to keep track of. Hey. It's like we have our latest regulatory summit poll on what markets are you considering? It's almost a popular. It's almost a popularity vote for our presentations here. Over the next 12 to 18 months. So feel free to vote on those. And while I'm doing that, I think let's, I mean, I think it makes sense to, I'll let. Feel free Sean to chime in when we have results and you want to show those. But why don't we get everybody else. Up on the. Up on the board.

And we could maybe have a few minutes chat about. So maybe some connecting points of these presentations. Thank you so much, Sean. And I think that's kind of the focus. I'm sure there's so many details here. It points to this challenge of. Is industry and of regulatory affairs that we could dive into that. We couldn't. We can't get into all the nooks and crannies in this broader session. And we'll look at some of the, all the questions coming through. But I do think kind of an idea and some of the things brought up by Michelle and some of her comparisons. Between, you know, some of the FDA and you.

and where there's areas of alignment that are helpful and that companies may be able to leverage. There's some questions in the Q&A about, can you use the same technical file in the UK and the EU or the difference between CMARC and UKCA? I know UK is still in development, but also bringing FDA into that conversation. Where are there areas where there's helpful, that might be helpful in terms of leveraging documentation or data for one of these jurisdictions for the other? And where maybe there'd be some disalignment that's really unhelpful. Does that prompt any thoughts from the panel? Well, here, before we do that,

why don't we take a look at these results? Looks like US wins for now, but there's obviously a real balance here in terms of where everybody's looking at. And that's really, it's a global industry. And that's the point of these types of considerations is everybody's trying to get the best out of the world. And how do we get in all of these markets and how do we sort of leverage them and use them and build into a global market? So, yeah. If the people that marked other want to drop into the chat, what other markets are considering, that might be interesting as well. And I'm going to stop sharing this.

So what have you in terms of that point about alignment between these different markets and thoughts to think through there? Does anybody want to jump in first? Yeah, I can go first. Go ahead, Michelle. Yeah, I'll just hop in real quick because I could really speak to the dissimilarity of the FDA to everything that her and Matt were about to share. And that's that the FDA, I mentioned the E-Star briefly, but they've really gone all in on E-Star and effective October of last year. That's the only way you can submit a submission to the FDA anymore is through the E-Star. And the E-Star, they have spent years

on the E-Star. They've spent years aligning it to the 510K, the NOVO, and PMA processes. So you might be able to use some of the same technical reports if you plan well in advance and selected the right country-specific criteria across all the geographies you want to go, but you're not going to really be able to use the same story if you will. Like, it's not a, you're going to be able to copy, paste, upload, or turn the same submission in the same format. And, and reuse submissions in that way. So that's the U.S. So I would, I would add to that. Well, thank you for, for, for that part. 11 years ago, there was a program from my MDRF working

on this called Table of Content. And they produced actually a few documents on how to build your dossier in a structured way to align with commonalities between FDA Europe and some other jurisdictions. The intent was to really have a portal where you could just, you know, just submit electronically the same files and so on. Well, that process ultimately, well, was, was filed in a cabinet. But, but some of these documents are still helpful in getting through that strategy of, well, which documents and how can I formulate my biocompatibility validation or whatever underlying document in such a way

that one document covers all the requirements. Because these old documents from the IMDRF, they still have that comparison table, like, well, this is the basics. And this is what you add. And this is what you add for the US. And this is what you add for Europe and so on, on all kinds of specific elements. So, so that could be a, a good starting point to, to help you. And then the submissions, as, as Michelle says, they are separate to a notified body, to the UK ultimately, to FDA, and hopefully in a couple of years' time, everyone will, will start thinking about it again. And, and maybe there will be more portal sharings and with

that more commonalities in the approval. But I guess that's a decade or a few decades. But in terms of the data itself, where that were the, the, the, the, there, there's still, presumably ways of, of, of, of, you know, incorporating the work you've done, maybe, if not via a single submission, obviously that's. Of course, I answered a few of the questions online already, like asking for, for this as well. Like what, what is good enough? And if you compare that to FDA, well, for Europe high-risk devices, the moment, if you have your clinical data and so on for PMA, that's likely to be good enough for, for Europe.

On the other hand, if you get through a notified body review for a combination product, then you're probably well on your way to have the validation data to support your, your, your FDA submission. But the devil is in the details. I want to chime in and say that Michelle, actually I'm a huge fan of the E-Star. I originally, I come from the medicinal side, writing ECD, ECTD dossier sections. And I found that the E-Star is amazing, because it's really like a different level of information. It's like you're using that, knowing you're prescribed what goes where it's all identified. It's named, it's very precise, you know,

what goes in there and there is a common expectation. And it's really easy to see a validation stage and it gets rejected. If nothing's in there, I felt back at home from my early phase of my career doing E-Star again. And it's wonderful. And I think that that is missing. And I see that even across the different jurisdictions that for manufacturers, aren't particularly. few products knowing what goes where and what it actually looks like it's one of the hardest parts of the battle and trying to to with experience show them what goes where what sections almost templating it for them and writing in blue text this is what goes here and it seems to just be

such a burn and you know a resource burn as well for notified bodies and different bodies might have slightly different expectations if we all had a common ground and we this core understanding even across the different jurisdictions i've always been a huge fan and would love to see that what i mean and what the issue i mean you know as i said in her presentation uh talking about mdr being easy a number of times was a was notable to me i mean there was a distinction there between obviously new devices and legacy devices and and there's a certain reference to costs and clinical evidence requirements etc but also thinking about you know michelle you're referencing

you know the change in dynamic towards more focus on us first which hadn't been the historic approach and uk's obviously new kid on the block here but how do are we i mean is that agreed upon like yeah us just gotta go us first because mdr's becomes you are or is there a reason to you know it's obviously there's business considerations but just from a regulatory standpoint you know how do we think about that question that go-to-market strategy um and you know how does it differ depending on the product area or company etc kurt do you want to jump in or yeah so so so sure and we get loads of this question i guess it depends also on what your product is and

where you're based so so if for instance manufacturers and i saw a few people call in from from uh from asia i think um if you're in asia we we get a lot of questions like why why shouldn't we go and maybe that's a good question why shouldn't we go to the us first and then later on with some pmcf surveys and getting the data and so on get back to europe for kind of that middle class 510k products and so on that's a good strategy if you're in europe for the same product it will be kind of difficult because a lot of submissions around the world they anticipate that you have your country of origin certified and so

if you don't have approval in your own country then you have a very hard time explaining it in many legislations and many countries around the world so in that sense i would say it depends for real innovative products that have really a great market potential i say just why why you're able to have a first go-to market why not doing them at the same time um if you have some simple products then yes maybe in some cases the fda is easier 510k especially if you have to do pma then it might be easier to go to europe first and collect data in europe and use that as additional clinical data in your pma so it depends and there's much more

iterations that we can go through michelle what did you mention earlier you know my Most of my clients are startups and small to mid-sized companies with limited budgets. And so as MDR got closer and closer, I actually got more outside of U.S. business of people who in Europe that didn't even want or have the resources to take on the MDR, especially with everything and interpretations and flux that chose U.S. as their first market, you know, knowing that they might have challenges with their global launch, but they would tackle that once they got initial commercial acceptance and key opinion leaders.

But to Gert's point, if in the U.S. you have to do either de novo or a PMA, you're already doing trials. You have. And so I think that the companies that are going to be truly successfully globally, regardless of what the regulations are. Are going to be those who already from a regulatory perspective, wherever you're at in the world, are going to have to tackle a clinical trial. Do you have any any thoughts or you can't come into this? I know you can. Yeah, and I does it for sure. And it has been a switch for me in the type of clients and I've had the very same type of clients for a long time.

And for the first time, it is the looking to U.S. first, particularly where there is an easily identifiable predicate. I think it's one of the things that we've learned in the last few years is that we can go into clinical trials and you can find the clinical evidence that is relevant to the clinical trials that you're looking for to help you. And I think it's a good thing that you're looking to. And I think it's a good thing that you're looking to. But I think in many ways, what we should not do is try to consider avoidance of generating clinical evidence. And for me as a professional, that's really important to demonstrate the clinical benefit

and just to go, Hey, let's just go the easiest, quickest route. there's all these questions about the US market. Is it already saturated with the product you have? What is the advantage? So it's not just as simple as a regulatory strategy. It needs to be a commercial. It needs to identify where the, is there an unmet need? And if there's an unmet need, then you're probably not looking at the 510k or you're looking at a more difficult justification. And then if you're going to come back and that is your process and you've basically got some real world data, but you don't have your clinical evidence that you need, there can be no avoidance

of generating that in many cases for UK and EU. And as Gert's rightly said, when you're looking to rest of world as well. So I think it's not as simple as quickly looking to the quickest alternative and finding a way to get return on investment. It has to be a really considered strategy and there shouldn't be an avoidance of doing the right thing to ensure you know about your device and you can trust it with a patient. So there's a trade-off here. There's a willingness to help, but also the willingness. To do it the right way for longevity. But if we talk about startups, then Matt, what we see a lot there as well is that people say, well,

let's go to the US because it helps us reach our milestone that our investors are looking for. At least we have a market approval proof of the product being able to be launched somewhere. Even if you don't sell it, we don't care if we don't want to sell it. We just want the approval. So we get our next milestone and our next payment in the financing round. So that could be something also for startups to take on board. It's not all negative in that sense. It might be a strategy. Absolutely. And as you say, it depends. It really does depend whether there's a handover at that point, whether you're just, you know, what the end goal is, what the intention is, and really that needs to be

considered. And there's a lot of skepticism and a lot of panic. And I think informing what you're doing, informing your strategy for the goals that which you intend that they need to be seen. And I think a lot of people don't lay down a clinical plan. They don't lay down a commercial strategy. They're just kind of moving along, hoping for the best. And for me, that's not a very safe or robust way of achieving your goals. So I like to sit down and go, OK, what do you want to do? Let's work out how you can do it in the best way possible. I think that's crucial. At the design input stage, ideally already, like very early on.

Sure. Absolutely. So I have a question for the panel, and it's about post-market surveillance and about vigilance and the difference in attitudes in the three regions towards that. Clearly, Europe is leading the way with, you know, two years ago, I wrote the post-market gamut. And really, my estimation, the game is going to be won or lost in the real world. Evidence is going to be, you know, you can do a clinical trial with 20 or 50 or 200 people. But the way that it's going to play out over time is going to be the. The ability to collect data and to show efficacy and to demonstrate safety through through that sort of thing, whereas the FDA seems to take a much leaner view of post-market surveillance.

Udemyd isn't launched. That's a fiasco unto itself. And Mod is doing a fairly good job with adverse events and recalls. And and and that sort of thing. What's happening in the UK? What's what's the attitude there? And who wants to go? Anyone? Do you want me to go first? So I think that the post-market surveillance aspects are really significant. They're important. And I think part of the MDR people see the clinical requirements, how they inform sort of the post-market clinical follow up, the surveillance aspects that they are linked and they all come back to the risk management. Actually, it's crucial.

It's it's business critical. It's. It's. It's critical because nobody wants patient harm. Nobody wants litigious situation. And I think really people miss the point that it should be fully explored in the clinical evaluation and it should look and it should tell the story what's missing and what claims you're making. Are they underpinned? Are they supported? So in many ways, the European requirement seems much greater burden, particularly considered the US. But if it's done in the right way, it can inform some of the other work. So doing a clinical evaluation, for example, shows you where you might be missing.

So you can see what's missing in certain data, what else you need to do or what you need to do as an add on to get the extension of claims and and things like that. So in some ways, people see the MDR clinical expectations as a huge burden. In some ways, we could look at them in another way that actually give you your robust kind of state of the art. Underpin your claims and other right thing to do anyway. But I'm not paying those bills. So it's hard to argue with that. I fully agree with that approach. Especially also for PMAs and so on. If you want to go to the US as well, it is the only way forward.

But if I look at the projects that we run in our CRO, I do see that we're shifting over. Like in the panicking last few years, there were a lot of PMCF surveys, as you mentioned, trying to quickly get enough data sufficient to get through that hurdle of getting an MDR certificate. But now that a larger group of companies have the MDR certificate, it turns out that just following up next year, again and again, with the same PMCF surveys, is not going to cut it. So the expectations in that post-market phase, as Sean is saying, is much more. And so we see that shift in our CRO to really start PMCF clinical studies,

so post-market clinical studies, sometimes mixed also with entry to market in, say, the US and some other jurisdictions. And in other cases, companies, if there's not a national or other registry where they can just hook into, they start launching their own registries under control of a CRO to just get, well, basically every data from every patient that we could have to evaluate big data, utilizing some AI and so on to make sense of it all. But once you do, and that's a huge investment, I fully agree. Once you do, well, your life is set for the future unless you hit a trouble button, right? That's the danger. That's why people are so scared.

If we go to real world evidence and we have to really own up for all the things, and we have to analyze them away, or if it's really bad, we have to stop our product. That is a scary thinking. And I think that emotion is part of also why we see a hesitation to go there, not only the money, but also the consequence it could potentially have if we really honestly want to see all that happens to all the patients that are served with our products. But if we challenge that, if we take that on, I think the world would be a better place everywhere. Not just Europe, UK or America. Everywhere. Yeah. Michelle, I want you to bring us home.

But before I do, I want to say to everyone, if you're not subscribed to MedTech Leading Voice, please subscribe. Same with Market Pathways. And look forward to a series of new workshops, masterclasses and summits coming up on PMCF, cybersecurity and QMSR in the coming weeks. So please stay tuned for announcements, invites, and by all means, share them with your colleagues. Michelle, bring us home. What do you have to say about post-market surveillance? Well, you know, you guys all touched a little bit on the use of real-world evidence, and the FDA is not using it so much yet in the post-market space, but they're using it in the pre-market space,

which I think is a little bit more enticing for companies to kind of adapt. Delve in to it because it's not quite open kimono, like I heard said, because they're using that real-world evidence to bring a case about why their product should be cleared or approved or maybe have a new indication, patient population, et cetera. You know, if you look at some of the things that they're doing with some draft guidance in the 15K space, they're definitely not necessarily using real-world evidence, but they're expecting a higher level of vigilance. Right. Right. Right. Right. And they're expecting a higher level of vigilance and attention to product failures in the field

before you even bring a product to market, whether they're your failures or your competitors. So, but in terms of the PMS, what is coming for both the UK and MDR in terms of actual post-market, you know, the FDA is for the moment trailing far behind that. Somebody did ask if they... If they could get all... Receive answers to all the questions and answers. You know, I know my... I hopped right into this question section. So, I will for sure be going through the questions that are specific for my stuff and sending you guys, you know, follow-ups, you know, either one-on-one or as a group after that.

And answered in the Q&A so far. I saw heard and that I'm putting some responses there. So, definitely. There's a short survey. There's a survey coming up in two seconds as soon as we end the call. So, please complete the survey. Help us understand who you are, where you're coming from, how we can help. Thanks, everyone. Thanks for your time, everybody. I appreciate this, guys. Thank you. See you next time.