IVDR Proposed Revision

Hello, welcome everyone. My name is Sean Smith. Today's webinar is IVDR Proposed Revision, Practical Breakdown and Implications for IVD Manufacturers. speakers today, Marta Carnelli, Head of Certification IVD to Sud, Tom Patton, IVDR, IVD International Manager from GMID, and Bisille Accra, CEO of Accra Team. Welcome, everyone, and before we get started, I have a few minor housekeeping announcements. Recording and slides will be made available to all registrants tomorrow, 24 hours after the fact. If you would like a certificate of attendance, please put your name as you would like it to appear, and your email in the chat.

Use the chat function for communicating with me, use the Q&A function for communicating with the panelists. Unfortunately, I cannot copy-paste your chats into the Q&A, so if you do it, I'm going to ask you to do it yourself. And there will be a brief poll following the presentation, and a post-webinar survey. Please share your feedback during both of them. We really value your communication. Also, I want to thank you for joining us today. I will cut and paste the housekeeping announcements along with the introduction into the chat, and from here, I'm going to turn it over to Dr. Akra. Thank you.

Thank you, Sean. Thank you for the introduction, and it's great to be here with you and with this great audience to talk about a very important topic, IBDR, and to get some insight from the notified bodies and from industry as well. about the new proposal that was published last year, and get also your question answered, hopefully, with Tom and Marta joining us. Just for your information, you don't see Marta with us at this moment. She will be joining very soon. She's ramping up a critical audit and coming to join us and be with us and answer your questions as well. So what I'm gonna start doing is actually give you a bit of background and, some insight about where we are.

And, will share my slide in a second. Perfect. Good. Sean, you can see the slide now? Yes. Good.

And if everybody could give a thumbs up if they can hear, because I got a message from one person that he… that he could not. Can everybody hear? Yay? Thumbs up? Great, thank you. Just checking.

Perfect. Good. So, the IBDR is still like the MDR in transition, and today we want to just give you an insight on where we are with the recent proposal, and what does it mean for the manufacturers. So, whatever we're going to tell you today is very important to keep in mind. We are talking about the proposal, so it's not actually finalized text. Don't rush out and say, Tom, Marta, Basil told us today, and based on this, this is what we need to do. You need to be waiting to see what will be actually the final legal tax, and based on that, you need to take actions. But important is to keep up to date, and to learn the implication of such a legislative potential change.

So, what is the background? Let's start with that to start talking about why we are here, why we are after, actually, 9 years of publication of the initial text of the IVDR, as well of the MDR, rediscussing those regulations. As you know, a lot of you actually have been watching the situation in Europe and the development over the past years. In 2022, with the date of application, we were, like, really very thin on the number of notified bodies who were designated for the IVDR, and the movement to get application at that time was very slow. connected to multiple reasons related to the number of applications of notified bodies who got designated, but also the readiness of the system to move notified bodies and allow them to get designated under the new approach.

Reality is, at the end, over the time, the number of designated notified bodies was growing. And then manufacturers started applying, Ford certification under the new legislation. Over the time. But the process was running very slow at the very beginning, and now we… if we're looking to the number of applications versus number of certification. And those numbers are from the study monitoring medical devices in the European Union. It shows us that actually by last year, end of last year, there were, like, much more recent numbers, which I couldn't find publicly, but I can tell you that we have nearly 3,600 applications as of last year for IVD manufacturers, and out of those applications, more than 50%

got a certificate under the IBDR. But looking to this number and looking to this graphical overview, we see that we are moving, but we are moving like a snail, very slowly, and this is connected to multiple elements, which we will see later on when we talk about the proposal, and… but is important, there is a move It's getting better, but we are still not there, and this might take a lot of time till we actually get the two curves connected to each other. What is Europe doing? Now, in parallel, looking to all of these developments, we are learning, and actually everyone who we can ask in this field, it's very clear, it's not acceptable what we have been facing the past years. Notified bodies are not satisfied. Authorities are not satisfied.

But also, very important, manufacturers and innovators are not satisfied. So the European legislator are looking also to the system, and we started seeing, actually, noises from Ministry of Health, we see voices from authorities, from all stakeholders saying, we need a change, we need something different. And the European Commission put, actually, on the political agenda that they want to do some changes, and this is in their agenda from 2024 to 2029, where they said, we need to be more competitive, we need to improve our system, move toward better digitalized systems, simplify, be more supportive for innovation, but very important also being resilient, having a system which is resilient and enabling us to act when it's necessary.

And this is actually a good driver to why we are getting such a proposal, which got in December last year. As you know, after all of these complaints, the European Commission did a good job in 2022, where they started Doing much more proactive measures, collecting data, evidence, to understand why we are where we are here today. Because a lot of people might complain, but if you don't have supportive evidence, and try to understand what is the real reason for that. any action that you would take might not be actually justifiable. So they start in 2022 to do a lot of survey, discussion with stakeholders, notified bodies, authorities, manufacturers, doing public questionnaire, trying to get, actually, better clarity understanding. Now, every expert in this field could answer this question in the same way, because it reflected, actually, our view

that we need a change. And they promised us to do a change, which they proposed end of last year. A lot of people would say it is not perfect, a lot of people would say why we are moving to such a new tax again, and we are discussing this again. there is a necessity for a change. Whether it's perfect or not, it's important that we look to it and make the best out of it, because we need to have something different. We cannot keep in an administrative monster system, as some politicians said, and we need to do something which is very positive. For our future, for our legislative frame, and the recent,

event in Brussel, the European Commissioner said something which I kept with me, which I think we need to keep with us as well when we talk about future Europe. He said we need to do smarter regulation, which I think this is a very good summary of what we are targeting here. Not to actually downscale the safety acceptability, but actually to make sure that we keep the level of safety, level of performance expectation on device on the same level. But we do that in a much more professional and smart way to ensure that we are not spending a lot of time on things which are unnecessary. And I think this is very important when we look to the new proposal.

Now, looking to the proposal, it's very important for all of you. Like I said at the very beginning, it's still a proposal, but you need to read it, and you need to read it, perhaps, in combination with MDR and also all other supportive evidence which are created in that proposal. Why? Because it's going to give you an understanding On what they are trying to achieve, and will give you an understanding what might be the implication on you as an organization. What does this proposal bring with it? If you look to it from perspective NDR, IVDR, you will see… The intention is simplification. The intention as well is to give back

a reply to the industry, to the patient association, to the notified body, say, how can we simplify? How can we get rid of things which were, like, driving everyone in a complex principle and get the system running in a smoother way? So they are suggesting to reduce notified body involvement in some Class BC devices, where they are based on sampling, to say, we don't sample based on all of these complex criteria, but we take away the word at least one. To go to one technical documentation. They are moving from actually saying we do not allow remote audits to allow remote audits. They are taking the obligation of saying unannounced audit must happen in a regular schedule to say we do it just four calls if something is going wrong.

The periodicity of the quality management system audit is becoming relaxed, and they allow manufacturers as well as notified bodies to benefit from good experience, and to justify that they don't need to do it on a yearly basis. Structured dialogue is becoming, actually, the norm. This is what the legislators are recommending. Let's see how this can be adopted. What does it mean? All of these questions will remain, but we are moving toward much more collaborative system, which is very good for everyone. Now, there are also some recommendations to regulate the fees, create as well for SMEs and orphan device manufacturing environment, which is supportive for them, and allow them actually to get to Europe first.

The system as well, in the new proposal, is looking forward to creating a breakthrough technology system, orphan device system, which is also for the benefit of a lot of people that were saying Europe is killing innovation, Europe is not allowing key devices to come back to European system, which can be actually possible with the new proposal. But even without the proposal, we got already guidance document, which can be applied today. But there is also some additional elements which are also helpful to see. For example, the regulatory sandbox, which is enabling manufacturers who are working on emerging technology to have the possibilities to start testing their devices early in the time.

Much more central coordination activities, much more responsibility are going to email, but the most important piece that we need to keep in mind, there will be also possibility in the future, which we didn't have before. to clarify dispute between, actually, notified bodies and manufacturers. In the past, it was just possible for classification dispute, and now they are suggesting that we have a wider scope of that dispute process, which enables, actually, manufacturer and notified bodies to get their things Systematically clarified. Now, with regard to digitalization, as I said before, they want to actually, as well, ensure that there is a possibility to get leaner processes in the future. A lot of people, were complaining about Excel sheets, submission.

paper format, whatever, Word documents, PDFs, all of these things which became actually complex for all of us. Now they are suggesting to go toward, actually, much more digital-friendly systems, saying we want to allow e-declaration of conformity. They started already by widening the scope of EIFU last year, enabling, perhaps, digital labels, and the most important piece, which I think is very useful and very important for a lot of us, is the push on notified bodies and manufacturers to work on digital submission, which improves, actually, the efficiency of the conformity assessment process between both parties.

Now, Europe, as I said, they want to be also resilient, prepared, and therefore, they are working on proposing here a system which allows the European Commission, where there is a necessity for health emergency, to take action directly without actually moving to the single member state level, which shows as well how they are preparing themselves for what is actually happening on a geopolitical level, enabling the Commission and also IMA to be empowered to take some activities which are helpful for the European patient, which is good for all of us. Now, if we look in the main changes on IVDR and we try to summarize them, we'll see, like, that there are some removals of notified body involvement.

for example, for Class A sterile IVDs, self-certification by manufacturer with proportionate checks, then we have limitation of summary of safety and performance to high-risk devices, which reduce the scope of how many SSP you need to write, risk-based frequency for periodic safety update report to go to a binial or as needed for Class BCD devices, which is also a good thing for a lot of manufacturers, because all of these reporting created a lot of cumbersome process for manufacturer resources and capacity which is available. Also, for the notified bodies, they will have much more flexible approach

To look into those documentation over the surveillance activities instead of actually doing this on a systematic manner in on off-site activity in combination with requests or technical documentation assessment. clinical or performance studies, for low-risk devices, we will have an exemption from authorization notification for low-risk performance studies, reduced notified body involvement for medium-risk IBDs. I said that before, on a sampling basis, we moved toward, actually. One instead of actually at least one. Removal of consultation for performance evaluation consultation procedure, early expert panel advice for high-risk Class C and D devices is coming with the proposal.

Clarification for companion diagnostics, so linkage to multiple medicine, coordinated assessment with email, medicinal authorities. All of these things are actually clarified, which allow the system to run smoother and faster, and there is an enhanced EMA support, especially in coordination. of studies, vigilance, derogation, SME assistance, especially when we are dealing with companion diagnostics. So there will be more involvement of EMA as a guidance authority to help, actually, manufacturers who are struggling understanding legislation, and especially if they are dealing with complex devices and they are an SME.

So, what we are doing today here with MLV is actually that we share with you from ACRA team, and also from the Notified Body perspective, how you need to prepare, what does it mean for you? What does it mean, all of these changes that we are facing? And, I think what is very important, and what we always would recommend. Make yourself, aware about the content of this legislative proposal. prepare yourself, even if it's not adopted yet. Chuck, actually, what does it mean for me? How can I actually make use of it when it is valid? Because at this moment, it's under discussion. But you need to understand its implication.

If it happens or it doesn't. But if it happens, what does it mean for me cost-wise? What does it mean for my quality management system? What does it mean for my quality processes and technical documentation? And what does it mean for my resources and registration worldwide? Because all of these things will be very important to consider early in the process. And if you don't prepare yourself and you wait till it's published, it might be too late to make use of the benefit on time, and you might be delayed in getting the benefit which might be connected with that legislation. This is a short summary that I wanted to share with you, just to kick off the discussion today, and I'm looking forward for fruitful discussion with all of you, but before doing that, I would request Sean to help us with a poll, and to give us also some additional feedback on some matters

that we need to care about, especially with regard to a formal aspect, and remind us about where to raise the questions.

Yes, thank you very much. So, I believe all the panelists have joined, which is fantastic. And, the, reminders are to, use the Q&A function to submit questions to the panelists. and the chat function to communicate with me. If you would like a certificate of attendance, please put your name and email address in the chat function as you would like it to appear. Give us about 48 hours before you start pinging me asking where your certificate is. We make them by hand. And And yes, this will be recorded, and the slides will be made available tomorrow to all registrants. That's it for me. Please complete the survey.

Wait, throwing…

Thank you, Sean. So, while it's running. Perhaps you can tell us later on what was the result. Marta, welcome! You are on time. We just finished the presentation and happy to have you here for the panel discussion and exchange. I think people will value your feedback and Tom's feedback on the proposal. And, so today, I just shared the presentation on, actually, a summary of what is happening, tried to get, actually, the main point all together. Tom… From your experience, looking to what I just presented, what is the single most impactful change in the December proposal, and do you think it will survive the legislative negotiation which can happen between Parliament and Council till we get to a final alignment after three parties' discussions?

Hey, Basil, and hey Sean, and hey Marta, and thanks for having me, and that's a lovely question to kind of start off. I will… I'll start off positive, I always like to start off positive. I think, from a manufacturer's point of view, what I'd call out would more than likely be the removal of the fixed 5-year certificate. I think that would be… a huge benefit to manufacturers, I think it'd be in terms of global registration, it's just in terms of how, the… the kind of… the fear, maybe, that is often talked about when it's, oh, it's coming up to the end of the five-year cycle, we have so much work to kind of do, and that kind of is now… I won't say it shouldn't… the work isn't going to be there, it's just going to be distributed kind of differently. Yeah, I think that would be kind of…

the single biggest change, and I think it will probably survive in some form. We might hammer out what needs to be there to make sure that there's a… a appropriate level of oversight maintained, but I think that's one of… one of the big ones that, will benefit manufacturers the most.

Thank you so much, Tom. Yes, manufacturers were asking for it as well. People from the Parliament recommended taking this measure. Marta, if I hear that, and you are working for one of the largest notified bodies in Europe, how do you see this change Impacting your workload and planning cycle. on your side, but also for the manufacturers in the future, because, Tom, I remember when I worked for a notified body, we knew, actually, every second year there was a type of product which was gonna be, like, coming to us in a recertification cycle. Is this actually to be deemed now a benefit for your workload? Will it allow you to be more flexible, and you will allow to be dealing with submission much faster? Tell us a bit more about your impact assessment when you hear that.

marta Carnielli: Thank you for the question, Basil, and thank you for inviting me to speak and to join the webinar, and say to everyone. Yes, it's a major change for manufacturer, but it's a major change for notified bodies, too, because recertification used to be a kind of set stone every five years. marta Carnielli: you knew you had to check whether you'd covered everything for that particular certificate, done all the audit you needed to do, done all the TD assessment. Now it's becoming a little bit less predictable, also because at this moment, the regulation talks about periodic reviews, but

marta Carnielli: Periodic are not defined, so it will be an adjustment that, well, notified body and manufacturers marta Carnielli: Because, obviously, I see the notified body's point of view, in a process adjustment, but, the same will apply to manufacturer. There is a need, there will be the need to have more flexible, processes and, ensure marta Carnielli: This periodic review covers all the necessary points, and it's not too short, it's not too long, so it's a major impact for our notified body as well.

Thank you so much, Marta. So, actually, you mentioned something which is always very interesting for me. When we talk about new proposal, new legislation, we always say, what does it mean, what it's saying? So, we typically, as human beings, when we read a sentence, we start actually building our opinion, our mentality, because we never have actually enough text to tell us what is enough. And we recognize, and we learned that, actually, in the past. when the MDR and IVDR came out, a lot of people were raising their hand and saying, please, more guidance. It clarified for us. At the beginning, when I spoke to commissioned people at that time, they said.

we wrote it in a lengthy way to be actually clear enough. Now, we have more than 120 guidance documents trying to explain what was written clear enough, and actually the guidance needs guidance to understand what the guidance is telling you. So we need to be as well careful and use our proportionate and reasonable manner. And this pushed me to the next topic, looking to you, Tom. And the next topic, which I always, like, look to is, you know, people are, like, raising always the question. how can I clarify my situation? Can I talk to a notified body? When the IVDR and the MDR came into place, conversation became actually not possible, or sometimes

less structured in a way that the benefit was given to both sides. This is not because notified bodies didn't want to do it, but they were not allowed to do it anymore, because they were deemed actually impacting the impartiality and dependency if they talk to manufacturers. Now, the new proposal is saying And even before, in the guidance document in 2022, when the measure started, they started to talk about, we need to actually encourage both sides to have structured dialogue. But then everyone asks, what is structured dialogue? Now we are getting again to say it will be the norm instead of being actually,

a special case, and still. How… how can you tell us a bit more? What does it mean? What would be beneficial for the notified body in a structured dialogue if this will come, and what would be, in your view, beneficial for the manufacturer?

Yeah, Basil, I think… I think I've spoken a lot about structured dialogue, about how it's, new words for probably an old process that should always have been there. We like to talk, the Notify Body likes to talk with manufacturers. We like when manufacturers come and present their project to us, and I say this as often as I can, and are proud of their product, and are able to show it off to us and say, look, this is a product, we know it works. We want to get this on the market. I would say nearly everybody who I have worked with in the notified body world, be it in my organizations that I have with, or like Mara said, like colleagues in other organizations, we want to put your products on the market. So, we're both wanting the same end goal, and how do we do that?

The new proposals around structured dialogue over the last couple of years allow us to communicate more formally and, are kind of… it's just kind of formalizing the rules that may not have been as clear beforehand. But ultimately, you as a manufacturer should have data to support your product, or else know how to get that data. And yeah, there's the full caveat, there's probably some grey areas that we need to discuss, and the structure dialogue is aimed to make those grey areas a little clearer. But ultimately, it will always come down to having data to fulfill the requirements for your for your product, and we get into a bit of a back and forth over it. Structured dialogues are going to be

more formalized in terms of, the outputs of them. We will have notes, we will have Udamed, and that's also a good thing. It means… it keeps… it keeps both sides of the table, fair. It means that we can't consult, we can't tell you exactly how many patients you need, but we can, we can be forthright and, and, and… get value out of it, because that's what we want to have with you as a manufacturer. We want to have a conversation that gives value to us to go, okay, this manufacturer, they're in control, they have a product, the product works, and they're on the right path. And you as a manufacturer want to know that you have a partner who wants to put your product on the market, and

Ultimately, I think that's what the aim of structured dialogue is. It will probably take a couple of months or a couple of years until all of the notified bodies and all of the manufacturers end up in a place where that is what the process… where the process that's intended is the process that's in place.

I totally agree. I think what you just summarized is, as nothing else, you know, you can name it whatever you want. I mean, I went through all kinds of names when I started the notified body. All kind of names came to it. It's all about conversation, early conversation, and understanding the obligation and duties of every single party. If this is respected, the conversation can lead to a benefit for both sides. Tom, I will stay with you shortly, because there is, there is a removal of no equivalent product on the market requirement for in-house devices. Which is a major shift. Does this open the door too wide, or do I need a structured dialogue to understand it?

Article 55. Basil, stop me when I start talking about this. So this is what… this is not my favorite article, but this is the article in the regulations that I think, probably touches the most patients. So if you look at… if you read the IBDR and you go, which… which article is going to touch the most patients, it's probably Article 5.5, because it talks about health institutes. So yeah, there's a broadening of this article and how it applies, and in isolation, that is possibly a good thing, but ultimately, overall, for Article 55, I feel there's still areas that could have been improved. I feel the definition of a health institute across Europe is not standardized. I feel the application of… I think it's, health… or Article 55 should not apply to many… to…

organizations that don't operate at an industrial scale. I don't think that's applied consistently across Europe, and ultimately. everything to do with 5-5, you should come back to… there should be a regulatory history of where articles come from, and this is a really good one to look into. Where did this article come from? So if you go back through it, one of the main drivers for this article was there was a study done, I think, in France, where same sample was tested across multiple labs for KRS for cancer, and different results were obtained in different labs. And ultimately, that's not a good thing, because you should all get the same results from the same sample, being tested in the same labs. And that's kind of where… one of the reasons where this came from. And if we just look at,

how in-house devices, if we look at the news stories across Europe and UK and the US in the last couple of years, where health institutes have used lab-developed tests or in-house devices, and when it goes wrong, look at the number of patients that are impacted by that. So there was a diabetes test in the UK, and it was both positives from COVID, where the primers didn't pick up the new variants, and these are real patients that are impacted by this article.

You're going fine.

thousands of them. It's not that I don't like it. It's not that I don't like it, Basil. I think that it is disrespectful to these types of devices how they haven't gotten the same consideration. If the EU really wanted to deal with these types of devices correctly, we could have an annex. We could have an annex like annex 616 of the MDR for medical devices with a non-medical purpose. We could have an annex for in-house devices in the IVDR that would deal with these devices with the respect that they need. So ultimately, that's kind of where I sit in it. I think it's really good that it's now broadened.

But with that broadening comes a greater risk, and not to… the institutes using these tests, because ultimately, we're talking about hospitals here for a large portion of these health institutes. I think everyone who works in a hospital does an amazing job, and wants to do a really good job, and they need to be supported to do that job correctly, and I don't think 5-5, how it's written, currently supports them as well as it could. Sorry for the little, the little rant. I just… I think this is a… this is also…

good job. You summarized, actually, your view, and you kept, actually, the patient and the focus, which is very important. So all what we do here is actually to look into being balanced, and not forgetting, actually, our main aim as subject matter expert to enable access to the patient, but also ensure that the patient are getting the benefit of what they are getting, and the healthcare system is not putting on the risk, which is unacceptable. And you did a good summary of that.

The last point on it as well is these devices would not fall under the NB, they would fall under the remit of the competent party. So we would expect that competent parties across Europe are staffing themselves to be able to support this article.

Yeah. So, this is a shout-out for the count authorities to start hiring, so recruiters who are attending this call, potentially, will start calling them. And checking if they have open positions. Now, Marta, we have also for performance studies involving routine blood draws, removing pre-authorization requirements, sounds like a win for innovators. Are the patient safety considerations there? Are we having similar issues, or is it okay to have such an opener now again?

marta Carnielli: So the request to remove a pre-approval of this low-risk procedure has been a long-standing request from manufacturers. marta Carnielli: Big and smaller companies. And, marta Carnielli: On a general level, there was also broader agreement that this procedure would be, low risk for the patient. marta Carnielli: Which led to the introduction or the removal of the requirement for notification in the current proposal. marta Carnielli: So, in this case, it was really, hearing the user, the Commission really heard the request of the user. Now, if on one side this is positive, on the other side, what is still unclear is, well, how do you set the burden, the border, between

marta Carnielli: low risk, what is really low risk, and when it's becoming high risk? For example, if you have vulnerable population, if you have elderly or babies, would this still be acceptable? So. marta Carnielli: In, principle? marta Carnielli: It's a move towards simplification. marta Carnielli: helping innovation, helping the tearing out of these performance studies, but it needs to be a little bit better defined. What is the limit that this procedure is really low risk, or marta Carnielli: because of the population I have under the studies, it still brings a risk to the patient, and this

marta Carnielli: In the current proposal, it's not fully, defined. marta Carnielli: No doubt it's a part that will need further discussion and further alignment to really assure patient… no patient is subject to risk because of this, the removal of this requirement.

Thank you so much, Martin. I think, I mean, in general, I always remind every manufacturer that with or without approval, with or without authorization, you still have the full responsibility to ensure that you are doing whatever is relevant before you put a device or you use a device in connection with the human being, because this is a good clinical practice. Now, authorization, as we see, you know, they might be done in a systematic manner, but it is not done even with the notified body, so notified bodies are not involved at all in those kind of activities. So, this is, your commands are not related to what you do today, your commands are actually focusing on

The patient safety, which is very important to remember, because a lot of people might believe that you are unhappy because you are not involved, but it is not your job, it's the job of the combat authorities, and what you are saying here, they should be having the relevant proportionate measure to make sure that they actually not wave away something which might be still important. Because, like Tom was saying before, a lot of requirements came because of a reason, and therefore we need to think about, are those reasons not valid anymore? And if they are not valid, it's good to get them… to let them go, but we need to keep an eye on that to see how effective was the measure that we introduced now.

Good. So, moving… shifting a bit of gears and moving to a different topic. So, we spoke about, actually, removal, but there are a lot of introductions with the new proposal. For MDR and IVDR, we talk about, actually, pathways term for breakthrough and orphan Devices. Breakthrough, a lot of people were complaining that innovation doesn't come to Europe anymore, it's going somewhere else. Orphan device manufacturers in Europe were actually pulling their devices back, or not actually manufacturing those devices anymore, because of the complexity of the system regarding MDR or IVDR. Now. How do you… how do you think about… how do you feel about the new proposal, Tom, with regard to the criteria that are provided? Do you think, is it enough? Is it clear? Can you work around it? Can you do the conformity assessment? Or you still need some clarification and, some structured dialogue with the European Commission on that?

Yeah, Basil, I think on this one, it's been pretty much everywhere for the last, number of months now in terms of breakthrough in orphans. Yeah, it's great we finally have a pathway for these types of devices, but again, ultimately, it's important to remember that the number of these devices coming in every year is going to be a tiny number. We have… we have a pathway for those devices now. It's great. These… these patients who will need these devices have, have a… have a way that we can get these devices to these patients. That's wonderful. Yeah, and it was… it was… it has been lacking since the regulations probably came in in 2017. So, it's great that it's here right now, but again, we should really think

We should really think, overall, the number of devices and the number of patients is very, very small. It is great that this is here for this… these number of patients, and they're going to be catered for. Proportionately. And yeah, let's… let's see how it goes. Is it at the right level? I would hope so. I know that the people who have worked on this have put a lot of time in. That's people from the Commission, people from MDs, people from common authorities. They've put so much time into getting this right, and there's a TMNB position paper on it where we welcomed the proposal. And ultimately, yeah, let's just… now let's not… let's stop talking about this, and let's start getting these devices on the market.

Perfect. This is… this is a good message for everyone, because actually, it might be too late when the proposal is actually legislation. Those devices might be already out of market, because a majority of them are already in transition, and they might not have an ability, unless you give them the ability very early, that they can actually get approved under IVDR or MDR. So, Marta, a lot of changes. Notified Bodies have been building capacities the past years, even in my time when I was working for Notified Body. We were, like, hiring year by year, because we were, like, looking to the regulations, saying, oh my god, how are you going to tackle with all of that? You need to have more capacity to be able to deal with it. Now, the shift is going, actually, in a different direction. We are getting stacked back.

It took us 9 years to recognize we overkilled the system, now we are going back. What does it mean for your capacity? Will that affect your capacity resources in the future? Will it affect, actually, the available notified bodies? Will we have less notified bodies with more capacity? Or, actually, you will keep running as you are today?

marta Carnielli: Well, to keep running as we are today, with a different rhythm, with adjusted requirement. marta Carnielli: is not going to be, possible. So there will be a need to adjust notified body capacity. Now, for especially… you mentioned the increase in capacity that, notified body, executed when preparing for the regulation. That was particularly, visible for the in vitro diagnosis. marta Carnielli: because of the number of additional devices of different, areas, therapeutic areas that were added to the IVDR compared to the IVDD. So for that.

marta Carnielli: The shift was even larger than for medical devices. Obviously, that was planned on the requirements of the current IVDR. marta Carnielli: The revision introduces a lot of, changes, for example, for, mandatory annual audit, the current proposal gives the opportunity to reduce the frequency to biannual, audits, so every 24 months. There are, the, there is a reduction in. marta Carnielli: technical documentation, review. At the same time, marta Carnielli: the regulation says, no, if everybody, you need to do, for example, for Class B, at least one TD when you initially, when you do the initial certification, and then for codes. The additional TD assessment will be for codes. So there will be a lot of analysis on

marta Carnielli: Is there a cause? Is there a reason, to, do, to sample additional technical documentation for a given manufacturer? Is there a reason to do an unannounced study? So, there is an adjustment of the way notified body will need to do. marta Carnielli: Now, marta Carnielli: The challenge is also that, you need to have sufficient stuff with sufficient knowledge to maintain your scope, and at this point, the, marta Carnielli: the activity is… can no longer be, planned. So, that will be a challenge for the notified body, of course. It's hard to predict the future, but it will be a challenge for the notified bodies to maintain the full scope and the current stuff. And of course.

marta Carnielli: If the notified body will have to reuse the stuff, then there will be a risk for longer queue for marta Carnielli: the remaining either notified bodies or personnel within the notified body to handle those certification, those reduced, I would say, certification activities.

Thank you so much, Martha. Very comprehensive answer and summary, which is, at the end, actually telling us, We will not be able to have the same amount of resources in the future because of all of these reductions. Which might lead, again, to a new potential problem, which we need to take care of and keep an eye on. So, thank you for this summary. Tom, when we started, you told us what is the most beautiful part of this proposal for the industry and for stakeholders in this field. If we look to it from a negative point of view, where do you think there will be the biggest pushback? during the Parliament Council, discussion, which part of that legislation will not be really well… well received from the Parliament and Council?

Yeah, this is an interesting enough one. So, from the Parliament to the Council, I don't really know which way it's going to go, because it's going to be different. There's, lobby groups are out in force, and they're… they're… they're pushing… they're pushing to keep as much of the current proposals in as possible, I understand that, but I do see… I do see risks, I like certain things, I like the companion diagnostic aspect that you called out. I like when one drug approval goes through, it can be used. for other CDs, for other tests, that's good, that's smart, it makes sense, but then. Overall, I see, I see risks. I see risks around the removal of, say, manufacturers needing to have liability. Don't understand why that's coming out there, unless it's going to be covered by another regulation that's coming in. Don't know why that'll come out. I see risks to patients in the overall

Reduction in oversight mechanisms, not individually, but if you look at things cumulatively, if you look at the reduction of going from one audit, every 12 months to one audit every 24 months, and the reduction of… or the removal of unannounced audits. Again, regulatory history, where did unannounced audits come from? Why were they brought in in the first place? So again, people should go back and look that up. And again, looking at technical documentation sampling, going to one representative device, I think that is something that needs to be looked at and thought about. In terms of, under the IBDR, we have sampling groups that could have 80, 90, 100 devices in it, and now I have to pick one that is representative of all of those.

and then I have to do four calls on the other. I don't know how to do that. I don't think anybody in the Notify Body does that, but what it does create is an area of a portfolio where a manufacturer will know that nothing is going to be looked at in this part of my portfolio. And we know the human nature is, we know what human nature is, and we know what capitalism is, and we know what reduction in costs is, and we know where this is going to go, and we can see it coming, and yet we are not talking about it. So, that's… that's kind of… that's kind of the… the overall… the overall feelings that I have towards, some of… some of the… some of the proposal.

when listening to you, I felt, actually, what kind of conversation will happen in the Parliament and Council, so it felt a bit political discussion, which we're gonna have. And what is important, and I think this is what the Commissioner said. they didn't want to put the patient safety under a risk now, and they want to make sure that it is a smarter regulation. Let's see, let's move toward a smarter regulation, and we need to look to what can be actually the best out of it, and I think this is where negotiation will go in that direction. And people need to talk about it, like you said, we should not forget things which happened in the past, try to find a balanced solution, because it doesn't help us to move from one system to a new system, which creates a new problem, and 9 years from now, we get back. Now, every one of us

We'll be potentially, with a smile, because we are still there, and say, job security, but this is not what we are looking for, because patients might say, actually, let's make sure that we get actually safe, well-performing devices in a balanced, proportionate manner, instead of creating too much complexity, but we don't want to get also devices which are unsafe, and we don't want to allow every single device to get to the market without clear rules. So I think this is a key message which I'm getting from you, which is good. Now, Marta. before I start looking into the question from the audience, which are now getting more and more, one last question to you.

If I'm a manufacturer now made of certification under IVDR, Shall I wait and see what will happen, or what would be your recommendation? Shall I push forward? Tell us, what… I hear this question a lot of time. People ask me, you know, oh, new proposal. So, are we… and there are some rumors, this will be an extension of time, let's wait and see and decide later on. What's your view?

marta Carnielli: So, my recommendation and view would be continue, continue to push forward. Right now, as you said at the beginning, Basil, this is a proposal, and we don't know how, so what the final text will look like, and when it will be available. So, right now, what we have is the RVDR. marta Carnielli: And the clock is ticking, so it's really important to continue and complete the certification process, or initiate it, if you haven't done so yet. marta Carnielli: And there is also one point. Yes, the scrutiny from the… and Tom actually already alluded to that, scrutiny from the notified body, or independent scrutiny.

marta Carnielli: might have decreased, but the requirements, for example, for an annex 2, for technical documentation, those requirements are still there, also in the proposal, and so they need to be taken into account. So yes, my recommendation is please continue. Don't wait. marta Carnielli: We have, a deadline coming up for classes in May, so it's, yeah, just 2 months away, so… marta Carnielli: Please… Go ahead and continue with application and certification to a VDR.

Thank you so much, Marta. So, actually, it's a recommendation now, if I would… if I allow myself to say that from everyone. Don't wait and wait for surprises. The surprises might be horrible, and therefore, let's wait, and let's keep going on with our work and make sure that actually we get it done. Because, you know, changes, might come, but… It's not clear when they will come, even if they are looking for an accelerated procedure. the time is running, and if you wait and you want to adopt something changing, this might take you more time than actually get it done now. So make sure that you talk to your notified body, get your certification, and if it comes earlier and there is a benefit, then you can make use of that benefit.

Now, Tom, we heard a lot about the proposal, the pros and cons, some emotional reactions, some positive reaction, some smiles, some cry, everything like that is happening, but we see as well that European system is moving toward much more centralization, and email is taking more and more roles in the activities, and one of them is that EMA will give consultation in the future, to, especially SMEs and other manufacturers who are actually asking for an advice. So you're gonna do a structural dialogue. the email will do the advisory activity. Will that be public, or will it be actually, behind the scene? And is it binding or not? Can you share some insight on that?

Yes, this is a big one. This is a big one. Yeah, so overall, will it be binding or not? I don't think it can be binding. I think that's how it's written. Will it be useful? Is it probably a better question? Should you do it? Yes and yes. I would hope so. Getting the correct people in the room is always a great start to every part of the conversation. So, the fact that this is now acknowledged and is now being catered for is the first step. I do think with a lot of… with a lot of, provisions, this one in particular. It won't be perfect at the start. It will need work, and it will need… I'm not saying it will need a guidance document. We will just need, excuse me, to go through it a few times, to go through a few iterations of it to find out the best way that it's going to work together.

And ultimately, yeah, it's, this is the thing I say most on… most when I speak at events, conversations, getting the right people in the room and having a conversation for your product is the best way you will get your product on the market in a timely fashion. This is another mechanism that you can use. that you can use. No, it will not be binding at the end of it, but yes, it will be useful.

Thank you so much. This is very helpful, Tom. Marta, there is a question from the audience saying, there are a number of provisions to reduce notified body involvement in certification, as well as surveillance. We hear a lot about the benefit to manufacturers in terms of work and cost. But can the panel comment on their view of safety of devices under this proposal? I'm giving you this question again, because actually you commented on this, but perhaps you can elaborate a bit more from a safety perspective on the patient.

marta Carnielli: Sure, marta Carnielli: I think you also alluded that the regulations were put in place a few years ago, because as a result of scandals that touched more the medical device for the in vitro diagnostics, but they were put in place for a reason, and maybe they went a little bit too cautious, but marta Carnielli: some aspects of this proposal take us the other way back, sometimes even at safety, or… marta Carnielli: surveillance level that are below what were our directive level, because under the directive, for example, we always had at least annual audit, and unannounced audits were also introduced

marta Carnielli: after the directive, but before the regulation came into place, so… marta Carnielli: Although patient safety is high on the agenda, as is mentioned several times, all the measures, put together, cumulative, can have, well, will reduce the level of scrutiny. marta Carnielli: and potentially reduce, or delay the detection of, ongoing or brewing safety, issues. So, it is, we will see what the final, provisions are, but there are some elements, like removal of unannounced audits, that, personally, I feel, take away a very good instrument of,

marta Carnielli: of surveillance.

Thank you so much, Marta. So, I hear a lot of that always, and I ask myself, from time to time, so I lived through the medical device directives and IBD directives. I look to, actually, what is FDA doing and other jurisdictions. And if you look to it, so I think what we need to keep in mind, manufacturers will still be responsible and liable for their product. So this is very important, because the element of modified bodies doesn't mean They are 100% liable for what the manufacturer is doing, but they are actually adding a kind of scrutiny and assurance to make sure that actually the system is always up and running in the right way.

And, as we know and we remember from the reason from unannounced audit, that reason would never actually identify fraud situations. So this is very important also to keep in mind, because I… I… I personally believe it's commitment from every side to say we do the right things for the patient, and if this is not happening with unannounced or without unannounced audit, we will not get that, actually, level of safety that we are looking for. But let's continue that discussion, because we can have a lot of this discussion about unannounced audit and unannounced audit. And by getting with Tom Guinness in Dublin or somewhere else, I think this is… you need some beer to be able to deal with such a discussion. But reality is, we are moving toward potential future legislation.

Where a lot of questions are arising, and we see that from the audience, and one of them connect to you, Tom. You spoke about structural dialogue, and there is, like, a question saying, is structural dialogue intended only for manufacturers who have a contract with a notified body, or is there some form of dialogue available to pharma sponsors of clinical trial using investigational device with the goal of discussing regulatory aspect Impacting the clinical co-development of IMP, NMDs, IVDs.

You always ask me the best questions, Basil. So, you can have a structured dialogue before you have a contract with the manufacturer, or with a notified body, and you can have a structured dialogue after you have a contract with the manufacturer, and the content of both is going to be different, depending on which side of the coin you… or which stage of the… of the area you're in. For the rest of it, I'm… I'm not really 100% sure on… on the specifics. But if it's… if you're bringing your product for CE marking, obviously you can have a structured dialogue before you have a contract with your notified body.

I would… I would… I would say be specific in the notified body you speak to, simply because make sure that they're able to have a decent conversation with you. Make sure you're able to get value out of that conversation, regardless of what the topic is. Full disclosure, I don't know the specifics on the question that was asked. Marta, if you want to jump in, please bail me out, but overall, yes, you can have a structured dialogue before you have a contract. But just make sure that you choose a notified body that you No can help you. Check the scope, check the expertise, ask your questions before you get on the call to make sure that the right people are on the call with you.

Thank you so much, Tom. I think… I think you answered the question. It's all about, actually, can I talk to you before I sign a contract with you? And the reality, yes, but like you said, very important. The conversation will be different, because there are some limitations on what you can talk about before the contract, and what you can talk about after the contract. But this can be clarified before the contract with the notified body, so you can get some clarities on what kind of conversation you can have. Marta, what is the notified body perspective on the separation of post-market surveillance from the IVDR technical documentation?

Is there a benefit? Now, you cannot consult, but share your opinion, perhaps.

marta Carnielli: Well, post-market surveillance is a very useful tool to see how the device is performing once it is in a manufacturer, say, in users' hands. So you have a large population of users, much larger than you can have in any clinical trial, so it can give a lot of information. Whether it's separated from the rest of the technical documentation. marta Carnielli: Or not, for me. marta Carnielli: That, per se, is not the critical part. The critical part is that whatever data you collect in the post-market surveillance phase, you then marta Carnielli: use them to look at your product design, whether any changes are needed, whether your risk management needs updating, whether your instruction for use is updating. So, for me, what is critical is really the connection between the post-market surveillance and the technical… the data you have in the technical documentation.

marta Carnielli: Whether they are together or separated, but they somehow talk to each other.

Yeah, and I think you cannot take, like, one size fits all. It depends on the structure of the organization, who's doing what, because, you know, you might decide to see a benefit because you are, like, a large organization who have enough resources, but it might be much leaner if you are, like, a small organization to have a combined manner, so… you need to look to it and see what are the benefits, pros and cons, but at the end, you need to do the job. This is the most important thing which Marta is telling us, and you need to do it with the principle of actually learning from post-market surveillance, educating your risk management, improving your technical documentation and evidence, making sure that you are always in a rotating process by planning, doing, checking, and acting, and post-market surveillance is one of the elements

That will always give you confirmation, allow you to understand if you are doing the right things, that allow you to take action on time. So, we are heading toward the end of this session. I would like to use the opportunity as well to say thank you, Marta, thank you, Tom. I know it's always a struggle to deal with something which is not settled in stone. You did a good job giving us enough information and answers on how to read the regulation. I think a lot of people might have a lot of questions, but keep watching us. I think we will keep doing events. Sean will be also organizing events to keep you up to date.

Don't wait. Submit today. As Marta and Tom said, you need to make sure that your IVDR approval are happening very soon. We want to celebrate with you. We don't want you to cry later on and say, we are late, because being late will not be actually a solution. And, thank you for listening to us. I hope you enjoyed it. And, Sean, it's… I return it to you to close the session and give the final closure comments. Thank you.

Thank you all for joining. We had huge participation on the polls. Most people, here came from IVD manufacturers, work in regulatory affairs, and are here to scope the, the project. That's the poll results, so I wanted to share that with you. I also wanted to thank all of you for your time today, especially the speakers. So, yeah, let's give them a thumbs up, and, until next time, thank you again. Complete the survey. Thank you, bye.

Thanks, Sean. Thanks, Basil. Thank you. Bye-bye.

marta Carnielli: Bye.