Fear No Regulation A Step-by-Step Guide to EU Clinical Market Success

Hello and welcome everyone. Thank you for joining us today. Today's webinar is fear, no regulation, a step-by-step guide to EU clinical market success. This is part 3 of 3 of the clinical series with Yoner Institute, and today I'm very pleased to have with us Dr. Bettina Martin, who is head of clinical at yoner if you missed parts one and 2, I'm going to put those in in the chat momentarily. A couple housekeeping notes which I will also post in the chat number one. Please use the Q. And a button for questions, and the chat button for all other comments to me or or concerns, I would

there will be a recording and slides available. They'll be sent 24 h following this event, so you should get them tomorrow. Those of you who would like to request a certificate of attendance today. Please put your name as you would like it to appear on the certificate along with your email address. Your email address is very important. So please include that, put that in the chat button. So in the chat, all you need to do is put your name and your email address. And there you go. That's exactly correct, and those will be mailed out, you know, within 48 to 72 h. We have to create them manually. So please be patient with us, but they're fun to have, and I encourage you to share them on social media, on Linkedin and say, Hey, you know I attended this series, and it was worth it, and I liked what she had to say about this, that, or the other thing.

you know. That helps us. And it helps you. So with that in mind, yeah. Use the Q&A button vigorously. We'll try to get to the questions if we do not get to the questions, I understand that someone from will follow up. Also. I just found out about this cool service that yoner has, which is a clinical hotline subscription service. If you'd like details about that, I'm going to put some information about it, and where to contact them. But basically, you know, get your clinical questions answered by email. This is an amazing idea. I love it. And I encourage you to look into it.

There's going to be a poll about 20 min into the session, and there'll be survey questions afterwards with all the housekeeping announcements out of the way again. I will put them in the chat. I hope you enjoy the webinar. I'm going to turn it over. But to Dr. Martin, thank you very much.

Thanks, Sean, so much for the lovely intro can you see the screen? Can you give me a thumbs up? Please? Yeah, perfect. Thank you. So let's start the webinar. Good evening, or Good morning, everyone. If you can remember. Our 1st webinar was about winning the EU market crafting a bulletproof clinical strategy, where where Leah Wetloff offered you some great insights on how to always start thinking about the intended use. The second part of the series was presented by Johannes Goldman and data beyond trials where he showed you which types of clinical data can be used for market access and how to use them effectively

today in this session I will walk you through the step by step. You need to take, achieve a clinical market access in Europe. As Sean already mentioned, my name is Dr. Bettina Martin. I'm head of clinical and safety affairs from the Una Institute, and I'm joining the team now for 6 years. In case you want to add me on Linkedin, you can make a picture of discord or download it later in your presentation. What is maybe also really important to know for you about me is, I'm also a patient. So my journey in healthcare is deeply personal. So this is me and my mom.

I live with a condition which is called endometriosis. It's a chronic inflammatory disease that causes adhesions in the abdomen, including the bowel, the uterus, and the intestine. and I have experienced firsthand what it means to navigate through a healthcare system which doesn't always work the way it should. without certain medical devices. For example, the Da Vinci robot, I honestly would not be able to work any longer. So that's exactly why I'm at the Yona Institute. Our mission is to use science and technology to make life better for everyone. And I'm really passionate about that. We help medical device manufacturers, overcome regulatory challenges and bring safe products on the market faster, and if I see the politics at the moment worldwide, I want to bring it to Europe market, for sure. So we support the manufacturers with every detail of the regulatory market access and the process.

So this is my team. We are a group of 10 experts working on clinical strategies, clinical evaluation reports, clinical trials, biocompatibility, and as well as consulting on cleaning, disinfection and sterilization. So I really have an awesome team. So before we dive into our step by step. Guide, I want to do a quick recap for the last webinars, because for me it's really important that you understand how the regulatory framework for clinical evaluation works in Europe. You might remember from Leah's webinar that the main objective of a clinical evaluation is to demonstrate safety performance and the clinical benefit of your device.

Safety is defined as the absence of harm, and more precisely freedom of unacceptable risks. The clinical benefit refers to a positive impact on the patient and sometimes also on the public health. And the performance means that the device can actually do what it's intended to do. You might also remember that there are different types of data. You need to demonstrate these 3 objectives. There are preclinical data and clinical data. For example, for safety, you can rely on post-market surveillance data like safety databases and vigilant reports, or on verification against applicable standards, such as biocompatibility testing or electrical safety

for the clinical benefit and the performance. You usually need clinical data to demonstrate the benefit you should evaluate the current state of the art. We will come to that later, because it's really important. And consider medical Society guidelines and use clinical data that includes clearly defined outcome parameter with acceptance criteria. This is also really important for the clinical evaluation for performance. If the device has an indirect clinical benefit bench testing might be enough. However, if not, clinical studies are needed, and again, you have to define measurable parameters with specific acceptance criteria.

The clinical evaluation pro is a systemic plan process which spans the entire lifecycle of a product. Usually usually there are several key steps which you have to think about. First, st you need to plan your clinical strategy. We have a closer look to that later. Then it comes to identification and collection of the relevant data. And after that you move on to evaluating the data and performing the analysis, and finally document everything in your clinical evaluation report for each of the steps. Also you need specific documents, for example. a clinical evaluation plan which outlines your clinical strategy.

Then you have a literature search, protocol, and a report where you systemically and transparent protocol everything you have found in the literature, and it covers the state of the art, and finally, the clinical evaluation reports which brings everything together. So here you have a summary and analysis of all the data you have collected. something you should always remember from Leia's webinar you always start with the intended use. Please don't wait until the clinical evaluation report to think about this. Start early. Ideally during the development phase, or even before when you have the draft.

If you don't do that, you will end up with a lot with losing a lot of time and money starting. start developing your clinical strategy as soon as you have the draft of the intended use. Why, this is so important because clinical strategy includes an evaluation of the state of the art for your type of device. and it gives you valuable input for refining your intended use and identifying potential hazards for the risk analysis. And here's the key point. If you realize you don't have enough clinical evidence, either from the state of the art or from other sources. You need to plan a clinical trial.

and, as we all know, clinical trials take time. so the earlier the start, the better. It is so, Sean, if you want to do your question now, you can start now, because now we have recapped the takeaways from the 1st 2 webinars, and we are ready to dive into the 1st step towards au clinical market access.

Are you seeing the poll question? Okay, you can. You can talk over the pole while it runs? It's just 3 questions

Okay, perfect. Thank you. So the 1st step to clinical market access in Europe is to develop a really good clinical evaluation plan. That means this should define the scope, the methods, and the criteria for your clinical evaluation in this document. What you have to consider in the clinical evaluation plan is the device classification, because this is important. If a notified body is involved or not. Your intended use, your indications, your contraindications, your patient population, and your users.

What you also have, or what you also should include, is the claims that you have to fill with data in the course of the clinical evaluation as well as the side effects of your device. Key elements of the clinical evaluation plan is scope. The definition which kind of preclinical data you take for? Yeah, for proof, safety, performance, and benefit of your device, which clinical data you take for that, and which is the state of the art. So we recommend to put the state of the art already in the clinical evaluation plan, and not later, because it's too late. You need the information before.

and what you also need is measurable outcome parameters for your intended clinical benefits. You get this from the state of the art. The clinical evidence means that you need to have enough clinical evidence to prove your safety performance and your intended benefit. This slide gives you an overview of what a clinical evaluation plan should cover. According to Mdr no need to read through it now. It's just for your reference, and you have it available when you download the presentation. It's just important that you have to go through certain steps, and it has to be really strict in wording, in your clinical evaluation plan like that.

So sorry in the clinical evaluation plan. You define your clinical strategy, which sets the direction for the entire clinical evaluation. But what makes a clinical strategy truly efficient. It's the one that causes the fewest regulatory issues and is the most cost effective for your company, of course. So that question you can only answer. If once you've determined the state of the art. Whether or not you need a clinical study really depends on what kind of data you already find in the literature about your device group and which performance and safety parameters you need to address.

Of course, it also depends on the device specification and risk profile. But what's essential is to perform a systemic literature, search to establish the state of the art. That's your foundation. Once you've done that, you move forward with your strategy, whether that's based on performance data or on clinical data. If you choose the clinical data you would. You need you need to think about if you have sufficient data from an equivalent device? Or do you need data from your own device? This is a critical step where many mistakes happen, and if your clinical strategy is not appropriate. Notified bodies will flag that, and you likely end up with a deviation report. That's why it's so important to do it correct in the beginning.

But don't worry. We go to walk through the different clinical strategies in the next steps. You see exactly what you need to do to get faster market access without and without running into extra costs. So let's move to step 2 choosing the right clinical strategy. and the right data, because it can save you a lot of time and money. If you have a class 3 or a class 2, B implantable device. One of the 1st things you check is whether there's already sufficient clinical data available from other markers. For example, if you have already an FDA approval.

the key here is that the patient population must be transferable. If if it is, you need to provide a clear justification for that, and also the standard of care in that market should be the same comparable to Europe. You should also identify any safety or benefit gaps and plan to address those in post-market clinical follow-up activities for the au market. We will come to that later. Another really important point is stick to the relevant European guidelines. It's, for example, to the din and Eso 1, 4, 1, 5, 5, which is the standard for good clinical practice. So one possible strategy is to bring your device to the Us. Market. First, st because maybe you can go there a 5, 10 K. Pathway.

Why are already collecting clinical data in line with European standards? You can then use the data to support your European market access. and in some cases this approach is much more cost effective than going to the EU approval. First, st because Au means especially for high risk devices. You often need a full clinical investigation, which means more documentation, more time, and higher costs. As an example, you can see here the strategy for a knee implant, which is, of course, class 3, because the product has a clear benefit, a clinical benefit. You can't rely on performance data alone. In this case you need clinical data to demonstrate both safety and performance.

Of course, the cheapest way to do a clinical strategy for a class 3 implant or to be implantable device would be the equivalent data route. But under Mdr. Claiming equivalence has become much more difficult in you now need the full access of the technical documentation from your competitor, and that usually usually means you're having a contract with your competitor. It's not like 5, 10 k. Any longer. So this isn't a realistic option in most cases anymore. That's why, in many situations, you need to plan and conduct your clinical study to get a real market access. we only recommend to using equivalence in cases where device comes from the same manufacturer. And it's a further development of an existing product. In this case you can still rely on equivalence data, because you have full access to your own technical documentation. Of course, here's an example for A B polar device which only differs in the jaw design, which is called Maryland.

So this is a further development of a B polar device from be brown. So in this case, using equivalent is equivalence route is absolutely valid under Mdr. Providing equivalence is much stricter than it used to be. For example, for technical perspective, the device has to be very similar. You need a solid scientific justification to show that there's no relevant difference in terms of safety and clinical performance from a biological perspective. It has to be the same material, the same duration of contact with the human body, and similar characteristics, like degradation of project and Legibles. So

I'm interested in how you find that out from your competitor without having access to technical documentation, and clinically, the device must be used under the same clinical conditions, the same anatomical site with a similar patient population, similar users and equivalent critical performance and clinical effects. So you can see it's extremely difficult to meet all these requirements. That's why, at the moment we usually recommend avoiding the equivalent strategy. Unless you truly meet all this criteria. And it's a further development of your own product. Let's move to step 3. How to avoid doing a clinical study for your device.

In some cases there's an alternative approach described in the Mdr. In Article 61, 10. This allows you to justify that generating clinical data is not necessary or more specific, not appropriate. If certain conditions are met. To use this route, you need to conduct a thorough screening of the scientific literature to identify relevant risk and state of the art data to support your device. Again, you see, you need the state of the art. First, st however, it's important to note that this approach is not suitable for all type of devices. It's not recommended for standalone software or new technologies.

and it only works if your device make no claims in involving clinical endpoints and just a reminder for you claims can be hidden in several places. You need to be really careful with that. Look closely at your intended use, your clinical benefit, your marketing materials. and the clinical performance you're planning to claim. If there are any clinical claims in those documents, you need to back them with actual clinical data. For example, one of the clinical claim can be pain reduction. In that case you can't use the article 61, 10 route.

Here's an example on when you can solely rely on performance data. This is a workstation used for recording tests and measurements in ophthalmology. The product itself doesn't have a direct clinical benefit. It functions as a support unit enabling other ophthalmology devices to fulfill that clinical purpose. Because of this indirect role, you can use performance data and demonstrate it with general safety and performance requirements. You don't need clinical data in this case. And also later, you don't need postmarker clinical follow-up data. Only Pms data.

If you decide to do to use this clinical strategy based on performance data. There are a few important things to keep in mind. First, st you need to discuss the outcomes of your risk analysis, especially the specific interaction between the device and the human body and the intended clinical performance and the claims you're making as a manufacturer. As I said before, and second, you have to show the conformity with the general safety and performance requirements based on product testing. This could include technical testing in vitro testing or other forms of preclinical evaluation, and the research from that preclinical testing should be critically assessed and discussed.

But again, it's really important to note performance. Data route doesn't work for class 3 or class 2 B implantable devices for this clinical data, always mandatory. So let's move to the final step. The final step. You need to consider is preparing the clinical evaluation report and setting up a post-market clinical follow-up system. This allows you to proactively collect clinical data to keep your Cr up to date. Remember, it's over. The whole lifecycle clinical aviation report brings together all the documentation results and conclusion from your process. But there's the catch the most deviation reports from notified bodies happen because manufacturers don't implement proper. Pmcf. Measures.

You need to have a clear Pmcf. Plan. This can be part of your overall post-market surveillance system. But be careful. Pms data alone is not considered as sufficient. Only if you're following the performance data route, and then you need a justification for that. Otherwise you need to go further. That means conducting systemic literature, search after. So post market collecting structured feedback or service from users using registry data if available and updating your Pmcf report on a regular base. And this Pmcf report should then feed back into your clinical evaluation report, ensuring it stays current throughout the entire lifecycle of the device.

Here you can see a really helpful overview created by Namza, and it shows the difference between reactive and proactive post-market activities. And this is important, because when it comes to Pmcf activities, you should focus on proactive measures. Again, we are. We are not going through that. You have it in your in your presentation later for download. So yeah, that was the step-by-step guide, and hopefully, your key to successfully achieving clinical market access in the EU just to recap. Here are the key points to remember for successful market access.

Start with the clinical strategy early, ideally, as soon as you have a draft of your intended use. That's your foundation for everything that follows. and next determine the state of the art and choose the right clinical strategy for your specific device. If you have Class 3 or to be implantable. Device check, whether clinical data from other markers are available, for example from an FDA approval what you can use. But if not, you have to plan a clinical study that aligns with the European standard is a 1, 4, 1, 5, 5, and make sure it's designed to demonstrate both safety and performance.

Then you begin to collect and apprising your data and always gather performance data in the clinical evaluation, and if clinical data is needed, summarize it appropriately. Finally, you compile everything in your clinical evaluation report and make sure you establish a Pmcf. System, especially if clinical data are needed. Last, but not least. Here are some final tips to help you succeed with your market access. Talk to your notified body. If if the notified body is involved, talk to them early about your clinical strategy

ideally, before you finalize the clinical evaluation plan aligning early can save you. Major issues later on. and please please stick to the wording and structure of the Mdr. And all your documentation. This is especially important for the clinical evaluation plan and the clinical evaluation report notified products. Expect to see this alignment and last, use the Mdcg guidelines. They're available online and take advantage of templates providing in these documents, and they're incredibly helpful for structuring a compliant clinical evaluation file. Again, this slide is just for your reference. It shows the important Mdcg. Documents to prepare a good clinical evaluation file. You have the Mdcg. Document 2021, 5, 6, 7, 8, and 13.

It's for devices which are already on the market for software. You have there a template, and also how the notified bodies as evaluate your clinical evaluation file. and what is also might be interesting for you is that Medf 2, 7, 1 revision 4 is still valid because it Mdcg. Guidance augments reference it. However, this was a guideline under Ndd. But it's still helpful under Mdr. So as we come to the end of the presentation, here are a few important reminders. A clinical evaluation is a systemic and a systemic and ongoing process. And it's absolutely essential for EU, Mdr. Mark, compliance

and collecting clinical data isn't a 1-time task. It continues throughout the whole lifecycle of the device supporting by robust Pmcf activities and engage with your notified bodies early, especially when your clinical strategy is ready. This can prevent delays and major deviations later and finally use structured Mdr. Compliant documentation. Align your documents with Mdcg. Guidance to ensure clarity, consistency, and regulatory acceptance. So thank you really much for your attention. and we can go on with questions

Which we have a lot of

First, st

Question is, yes, the slides will be available, and the recording will be available tomorrow. Some of you joined late. Please go back and read the chat notes that are in there to everyone, so that you get the links to the previous things, and those will be sent out tomorrow. A reminder that if you would like a certificate of attendance to put your name and email address into the chat function, we have a ton of questions. I'm going to start with one of my own, which is where does well established technologies fit into all of this mix

Okay, so well established technologies. We have a Mdcg guidance for that. It's 2026. And yeah, there you have the options to have lower clinical evidence. For example, in the Mdcg. Guideline. In the end there is an annex, and it says you, which kind of evidence which kind of clinical data has. So, for example. Rct. Is really high evidence. Post-market is really low evidence, however, in the Mdr. The evidence is established by the manufacturer that means as a manufacturer, you can say, for my

for showing performance of my well-established technology, this evidence is enough. So I collect maybe user experience in Pmcf. Activity. It has low evidence, but however, it's still enough for me. So Mdcg. Guidance 2026 is the most important for that

That's great advice. Next question, is it necessary to use equivalent device in your clinical study?

No, it really depends on the question it's always to to. It's always a good advice to have a control group. But it does mean that the control group has always to be an equivalent device

Understood. This is an interesting question. It seems fairly basic on the surface. But I looked it up on Chat Gpt, and it's a little more nuanced than that is, which is what is the is there a difference between clinical trial and clinical study?

Oh, my God, yeah, that's that's a good question. so we we have the same. We have the same issue in German. So we have the same. So I would say so for German. Any clinic yeah means that you do you? You want to prove the safety and performance of a medical device. A clinical study is more on a meta. Serve so any clinical study? It's it's not a really quick one.

Right in English.

Owing the performance

It would it would. Pmc. Off, could be a study

Yeah, exactly.

But a clinical trial is a clinical trial is a clinical trial on people. You know

Yeah, yeah.

That's kind of the the yeah, the core of it, at least in English.

It's

So.

In German.

We have a ton of questions. What is the difference between performance data and clinical data?

Okay, so performance data is preclinical data. That means data without patients, for example, biocompatibility testing testing on a device electricity, disinfection stuff like that. And clinical data are data with where a patient is included. So under Ndr, there's a different definition. So under Ndr. Clinical data is post-market surveillance, literature, clinical trial, clinical trial from an equivalent device. And yeah, that's that's it. But normally as patient is involved. And it's not just testing on the device

Okay. So this I don't think that there's an exact answer to this. But how long does it take a clinical investigation? Approximately

Half a year to 5 years. It really depends on the medical device, and also on which kind of trial you do. Do you do our Rct. Do you do one arm, 2 arm. Do you do it in different countries? That really depends

I think this is this is a fairly manageable question, why 61, 10 is not recommended for Mdsw. Slash new technologies

So normally new technologies. You don't have good references in your state of the art. Right? So you cannot compare to to something. If you don't have a competitor. So if it's so new that you don't have competitors that nothing is like this on the market. what is your reference? So you need to do a clinical study for that. And standalone software is because we have so so we made the the. So we have. How do you say I missed the English word so the notified bodies they don't like when we do that. So we tried it a few times, but

they are always getting around the intended use. So it's really important what kind of intended use you have with a standalone software. And normally, if you have a stone standalone software, you always have a clinical benefit, and if you have a clinical benefit you cannot use 61, 10

Hmm, okay, here's an interesting question when the medical device is not in production anymore. No notified body, but still on the market lifetime is 7 years. Who who can request from us the Psur and Pmcf. Report so

Products on the market. Yeah.

Now notified body, and they want to know

Yeah, the the it's oh, how is it? I have to look up the word in English. So in Germany, for sure the land can do it

Oh!

Let me look it up landing authorities. So the the authorities from the different countries can do that, at least in Germany.

That makes perfect sense. So the competent authorities in the specific countries can request this information from

Yeah, exactly.

That's good regarding medical devices that contain a medicinal product. So what do we call those the combination product? Do you also need a clinical evaluation. Prr. C. Srn and Pmcf. Or is this covered by the directive? 2,001 83

No normally combination products are class 3 products. So you need all everything you need also for just the medical device and everything for the Pharma documentation

Understood. Can post-market, clinical, clinical, follow-up study be only bibliographic literature, you know, only only literature

Yeah.

No real study on a patient but collect collection of information. Post Ce. Mark, with available literature data publicly, information

Yeah, yeah, that's the lowest evidence and the lowest base you can do for Pmcf, you can say, I proactively search for literature in pubnet, for example, that's the lowest one you can do. Yeah.

So, considering the fact that it's the lowest one that you can do are the notified bodies gonna accept that is probably going to depend on the device

Yeah, yeah, exactly.

And the level of risk

Yeah. So if already you have shown really good performance, no safety issues in your vigilance database. It might be enough. Oh.

I think the answer to this one, I know, but I'm going to ask you if you if you don't have state of the art device. There's no state of the art being novel device without clinical claim, so no clinical claims, non-patient contact. So it doesn't contact indirect contact. Can you still claim Article 61, and not rely on clinical data. Just performance data. Thanks

Yeah, really depends. If you have a clinical benefit. Again, yeah. yeah. Why not? If it's a new technology and you don't interact with the patient. And you don't have a clinical claim. Yeah, it might. You might can use it. But I'm I'm it really. It depends so much on what kind of device it is, or is it just supporting other devices for its clinical benefit.

Probably a gun comes down to risk

Yeah.

Okay, next question with the ongoing health authority initiatives on public release information, public release information which is now seen on a global scale. Have there been challenges with the level of information required in the Sscp. Which I

No, not that. Not that I think of

if you are rationalizing, no proactive specific method. Pmcf, in the Pms, plan and performing general reactive methods is the Pmcf plan, required

James, yeah, that's complicated. So well, if you have clinical data route, and if you have a clinical benefit, you should always do Pmcf plan. but you can include it in your Pmcf. Plan in Pms plan. So it can be, you know, like an under chapter from your Pm. Pms. But normally, we don't recommend it. Because, yeah, we tried it before. And some notified to say, now we want really the different plans. because it's something else. And yeah, so it's better to do a Pmcf plan, even if it's more documentation

Okay, so is there any overlap between clinical evaluation plan and Pmcf plan? If so, what areas or sections? Well, we can't get into all the areas and sections. But we can answer clinical evaluation plan and Pmcf plan, overlap

I mean, the overlaps are always the device description you copy. And and this is really, I. Honestly, this is something really stupid in Mdr. You copy, paste your intended use exactly from your device description in the clinical evaluation plan in the Pmcf plan, and and so on. Also, it's the same for risk management. You just copy paste everything. So there, there are this overlaps that you have same device, description, same risk analysis. You have to think about same competitor devices you have to list and stuff, but otherwise it has no overlap

The overlap is that it might be that if you do a clinical evaluation plan for a benchmark device that you already put there. Okay, we do a Pm. Blah blah, but we are not finished with the reports. Stuff like that.

I see this question all the time, so I'm going to ask it, even though there isn't a specific answer. What's a good number of participants for 1st in human investigation.

No idea.

Exactly.

No idea. It depends on the research question. It depends on the study design and yeah on the statistics you want to do for the study

Oh, yeah, it's for a class 3 device. That's that's clarification. Sorry I missed that part. Yeah, it. I mean, I see this question all the time, too. And this is the kind of question that people ask notified bodies and notified bodies. Say, Go, do your homework, you know

Yeah, you you need to make a calculation for that. It's it's all about statistics.

Right. And so it comes down to statistical analysis. And and what what is going to right? Yeah, exactly. Statistics which I barely passed in graduate school statistics. The hardest class. So how do you create safety, performance, clinical benefit, acceptance, criteria, when there is no or severely limited literature found in state of the art

You. You can also use books, or you can also use guidelines if you have, and for sure you have verification guidelines. For example, you have values in electricity, testing or values in biocompatibility testing which you can use for that in case you don't find proper literature on that

And the standards

Yeah. But yeah, that's what I mean. The standard

Okay, can we use data from a feasibility study as clinical data

Visibility, study.

Feasibility.

Feasibility study. And if this also depends, is your is your product already on the market? Is it post market data? How do you collect it? What is the evidence for that

Is literature considered good clinical data, just not your own

If it's not you on, it's a little bit difficult. But if you have, I mean, the best thing. What can happen is that your device is is is named in a meta analysis or a systemic review. That's the best. What you can have

Understood. which case is a clinical investigation. Exempt, eg. Well-established devices. Okay, there was another question about a well-established device up here that I wanted to go back to. Can we use wet? Can we use well-established technology route for Class 3 implantable, that is classified as wet, but does not have sufficient clinical evidence of its own. so they don't

Yeah, well.

Maybe

This is a mix up because, the well established technology route doesn't mean you don't need clinical data. This is a mix up so well established technologies doesn't mean you need clinical data. It just means you need less evidence of clinical data. So not maybe Rct clinical trial. But you can use systemic customer surveys for evidence of clinical data. and if you don't have clinical data by yourself, you have to do equivalence route that only works. If it's your own device and the further development. Or if you have a contract with your competitor for Class 3

Okay, can data from a bench test outside a clinical trial be used to prove claims, for example, retrospective study of an AI model without conducting a trial? Would this still warrant a trial to prove the claims

Yeah, just depends on the claims. So normally you can. There are some claims which can be only proved by preclinical stuff. For example, if you say it's it has an ergonomic handling, then it's the Usability study. You don't need clinical data for that. Or if you say you have, it's it's long term usable. You, you take another preclinical test for that, and you don't need clinical data for that. It really depends on the claim. What you cannot do is you claim, for example, if you have an AI model or a software, and you say it has this and this performance. And

there is a retrospective study of a prototype of this software. You cannot use that. You always need the data from your actual device and not prototype stuff. If it's prototype. It's always preclinical.

Got it. so this is an interesting question about structured dialogue. What are practical ways to have a conversation with your notified body about your clinical strategy prior to initial Mdr submission from my experience, notified bodies typically say they cannot give advice because they consider it to be consulting

No. yeah, I hear this. A lot. However. Structured dialogue always is a good one. Of course you should not ask them which kind of clinical strategy shall I use? That makes no sense. But you come with the strategy and you ask, do you go with it? So do you think you can stick with this strategy. And do you think it's fine? You just have to rearrange how you question things

Hmm, sorry I got the wrong screen. So then, The data is considered to be a confirmation of equivalence for medical devices that have been certified according to the Mdd. And the 3rd is the submission for registration, according to the Mdr. In case of Icu ventilator. So I guess we're asking about an Icu ventilator that was approved under Mdd.

I don't. I think

It's it's, can you use the data from an equivalence device which is certified under Mdd. And use it under Mdr. No. So the equivalence device also have to be Mdr. Certified

Understood.

I think that's there's also Mdg. Mdcg document for that. Where this text exists exactly in, you cannot use Mdd. Certified medical devices, and if it's not Mdr. Or you need, you need to do a justification, because it's the same. But yeah, I would not do that. It's too too much work

Okay. consider a class 3. Device will be ce marked in accordance with the Mdr. For the 1st time by a legal manufacturer. When you claim equivalent when you claim equivalence, a device does, the equivalent device must be ce marked based on Mdr. Or can it be Mdd. Or Ce marked as well

Yeah, that's exactly the question from before the Mdcg. The Mdcg guidance says, no

Okay. Measurable outcome. Parameters are sometimes difficult to define. EG. Laser treatments are known. are known, they are effective. It is a well established method. But how to measure this? Patients don't have symptoms anymore. We are qualitatively known. We qualitatively know that from medical handbooks so medical literature. But it, but it is difficult to evaluate these outcomes quantitatively. so the outcome parameters for laser treatments

It. But this also really depends from the laser treatment. Because, for example, this this really depends again on the laser, because if you do skin lasering for sure you can. You can do histology. Yeah. But I don't know if it's a laser treatment in the eyes. I'm pretty sure you have a good state of the art. If you have a laser treatment, I think, for skin purposes you really have to. There you also have to differentiate. Is it like medical treatment, or is it like, you know, like a treatment for better, you know, like looking better. This is, you have to differentiate that completely. Yeah.

That's fantastic. I'd like to remind everybody for a moment that yoner Institute has started a new program called Clinical Hotline Service, where you can get your clinical questions answered by email, usually within 24 h. And you know it's it's a subscription service. But I'm going to go ahead and put that in the in the chat for everybody, and you can inquire for further information about that. I mean, there are so many questions here. We can't get through them all. We'll follow up with the ones that were not anonymous. Some of them asked anonymous questions. So the Lsp. I'm not sure what Lsp. Stands for. But maybe

Just Search Protocol.

Literature. Search Protocol may be part of the Cer. I plan to include a template and plan in the procedure for the clinical evaluation. Any comments on those ways. Thanks for the talk and dialogue. Shona Goose

So the literature, search, protocol and report don't have to be separate templates. You can put it in your clinical evaluation plan and report. However, I would not recommend it, because the documents get huge. and it's getting, you know, like confusing for the auditors. So I would try to do different templates for that

Thank you. Here's a question about software as a medical device. If you have a Samd that has a dose calculator that the claim the claims would be around helping nurses streamline their process. So for healthcare professionals it would be indirect clinical benefit. In this case I would follow Article 61 10. I am unsure. Why, you think 61, 10 is not suitable for software as a medical device. Could you please explain

It's not an indirect clinical claim. It's a claim which makes public health system better and more efficient. So this, for me, is a clinical claim. Remember, clinical benefit can be increasing patients health or in general public health health, because it makes things more efficient. So the the patient can be treated faster and more correct. That's for me. Not an indirect clinical benefit

Fabulous. So I'm gonna try to put all the links in the email tomorrow. Just remember you have to copy and paste links that are sent by zoom email. They don't automatically. You know they're they're never mind, Zoom is, you know, Zoom and I want to thank Dr. Martin for all your help today and everyone who attended. And please again, if you requested a certificate, we'll make sure that you get those in the next couple days, and if you have any questions you can email me or reach out to Bettina via Linkedin, and we'd be happy to help you. So yes, please thank you very much for your attendance and your participation

Thank you so much. Thank you so much on also for the lovely webinar

Thank you. Everyone. Take care!

Bye.