2026 Regulatory Roadmap: Key MDR & IVDR Compliance Priorities

Started. Hello, everybody, and welcome. My name is Sean Smith, publisher of MedTech Leading Voice. Today's webinar is 2026, Regulatory Roadmap, Key MDR and IVDR Compliance Priorities. I'd like to thank Accra Team and all the speakers today. A few housekeeping announcements before, while people are still joining. First of all, this webinar will be recorded and will be made available tomorrow by email to all registrants. There are 800 registrants today, so welcome, everyone. Second of all, if you have questions for me, please put them in the chat. If you have questions for the speakers, please, please, please use the Q&A button.

Third, if you would like a certificate of attendance. for today's call, please put your name as you would like it to appear on the certificate, as well as your email address, in the chat, not the QA, the chat, right? So, communications with me go in the chat, communications with the speakers go in the QA. That's how it works. I am going to put a few upcoming events in the chat as well. Please register for those. Those are exciting. And now I'm going to turn it over to Alexia Lynch from Acrateam.

Thank you so much, Sean. Hello to everyone. Thank you so much for joining us today. I'm Alexia Lynch from Accra Team, indeed, and it is my pleasure to kick off Our topic for today, as Sean said, we are going to be looking at the 2026 regulatory roadmap and into key MDR and IVDR compliance priorities. Of course, there has been some movement end of December, as we all know. We already also had a webinar to look into some details of the proposed revision to MDR and IVDR, and we're going to continue on this topic Today, our subject matter experts, that I have the pleasure to have on our webinar today are Julia Hoyer, who is Head of Medical Affairs, MHS with Two Food Product Service. Thank you, Julia, so much for being with us.

Tom Patton from GMED, who is IVDR, IVD International Manager, Eric Vollebrecht, partner at Accent Lawyers, and last but not least, my esteemed colleague, Basil Accra, CEO from Accra Team. Basil, I'll hand things over to you for a short presentation, then we will move into a panel where our speakers will answer a few prepared questions, and of course, as Sean did say, for the audience, if you have any questions for our speakers today, please do use the Q&A feature in the Zoom call, and we will make sure to take A maximum of those as well. Thank you so much, everyone. Handing things over to you, Basil.

Ladies and gentlemen, I'm happy to be here with you today, and thank you so much for joining us for this webinar. And as Alexia mentioned, we're gonna be talking about the changes, the changes that were actually communicated to us as proposals, since, actually, 2025 in December, we were, like, waiting, everyone excited for those Christmas presents to come. And they came on time. On the 16th of December, we got, actually, a proposal for future potential legislation. And I'm insisting to say future potential, because they are not final. They are still in the stage that we can read them, comment on them, and there is a lot of work which must happen before we have them actually adopted and can be actually used by us as the legal framework.

Nevertheless, what we wanted to do today is to give you some insight about what's happening, keeping in mind, whatever we're going to discuss today is based on the current view and interpretation and reading. A lot of things might change over the next months and years, so therefore, we need to Stay up-to-date and keep reading what's happening, following what is ongoing, and making sure that actually we are prepared and ready for whatever will come, because if we are surprised by legislation changes, we might be actually too late when it's actually available and ready to be implemented. Now, if we look to the situation, why we got those new proposals, why we got all of the communication, the new guidance document in 2025, and additional implementation plans and activities, why is this happening?

If we look to the European political guidelines and vision from the European Commission point of view, we know that Europe is looking toward actually being more competitive, looking toward more digitalization, simplification, and want to support innovations. This was actually the initial idea with AMDR and IBDR, which didn't succeed, but now they are re-looking to it and making sure that they have measures in place to make sure that we have a system which is streamlined, which is actually future-proof, and is able to support regulatory frame, which allow us, at the end, as European patients and citizens, to say our system is functioning in a good way. This is… they want to also make sure that they have a resilient systems, so we need to make sure that

Actually, we understand the main intention of all of these changes before we discuss them, and they come actually from a political guideline, which is focusing on what should happen between 2024 and 2029. On top of this, we need to understand as well that Currently, the European geopolitical situation is impacting, actually, what's happening in Europe. Europe is trying to be resilient and prepared, and being able to act in any case. In any case which means… which can include, perhaps, crisis. We learned from the COVID situation that there might be crisis which we can't influence, and we need to be able to act.

And we learned a lot from that experience. But now, today, we see a lot of things happening on a geopolitical level which might impact the current situation in Europe or in other countries. And Europe is looking also to be resilient, to be prepared and ready for any kind of situation. This is why they want to have efficient system, simplified system, and a system which enables good collaboration between the various parties. And as you know. European system is not based on a single central agency which is dealing with medical devices and other kind of combination devices or pharmaceutical product. Therefore, we need to have something which enables us to deal with that on a European level, with all kind of member states, with all kinds of stakeholders, in a way which allows us to be efficient and be ready for any kind of situation

Which we might face in the future. And therefore, all of this situation led, actually, to the European legislator after listening as well to the recommendation and feedback from Parliament, from stakeholders, from member states, saying, we need to look to medical device and IBDs, we need to improve what we have today. Med-tech industry, notified bodies, everyone was looking toward, actually, a change. We learned since 2017 that something is going wrong, and we need to change what we have today to be able to say we have a better future And this is what they are proposing today to us, and what we're gonna discuss during this event with all of you, to give you, like, some insight about the ideas.

about the proposals. They might not be perfect, but they are much better than what we had before, and we need to learn what is the beauty of them, and what might be challenging, but we need to make it actually happen. We need to make sure that the future system is actually addressing the patient need and what they are looking for Device continuity on the market to ensure that the healthcare system can function without actually problems that we faced in the past years. Why implementing a new regulation, but forgetting at the end The necessity of having devices on time to the market, treating patients, pediatric patients, orphan patients, and also supporting innovative devices to get to the market on time, ensuring that the healthcare system is benefiting from what innovators are creating.

Now, looking to the numbers, it shows us, actually, also another reason what… why legislators needed to retouch the medical device regulation and IBDR. It's not the mistake of any of the parties, it's the mistake of a system which has actually decided to start again from scratch by having re-designation of notified bodies, re-activation of a holistic system which was functioning, which required some improvement, but we decided to say we need to have every single device getting an approval again under a new frame. We got up-classification, we got a lot of requirement, we got higher clinical expectations, which led to a lot of cost, a lot of bureaucracy, a lot of administrative burden for all parties. So at the end, after 8 years of publication of the legislation, we just saw that 50% of the devices which were already on the market were able to move toward the new legislation.

And this is one of the reasons where people are saying, what is going wrong? Why do we need… Why… why do we have all of these requirements? Can we stay as we are today, or we need something better? And this is why we are working on it from European point of view, to make the system actually much better. And this is where the European Commission came with a proposal in December, trying to help us actually getting a better future. And now, everyone who's gonna read that proposal might have her or his interpretation that this might be good or not good enough, and all parties might have different opinions about it, but the intention is simplification. The intention is streamlining. The intention is using new technologies to be actually much more digital, much more actually patient-oriented, and this is where I think it is positive.

It's not bad, it's as good. Foundation to help us to have a better future. Now, looking into the details of this proposal, we will have some discussion on it, but we would need a lot of discussion to make sure that everyone is aware and prepared. But key is, it's actually looking toward having a better, predictable system. Looking to have better structure for notified bodies, for the stakeholders acting in this field. Applying the rules of proportionality, ensuring that actually we have simpler and much more streamlined processes. Reducing administrative burdens, because the system which we've faced the past 8 years led to a lot of administration, a lot of paper creation, a lot of report creation.

Too many reports which became redundant and unnecessary and raised the question, are we doing what is important for the healthcare system? Is this what we are doing so far actually necessary? And this is why I think it is good what we are seeing in front of us, because it is giving us, actually, an opportunity to improve, to rethink about our processes. And the key, and what is very important, the intention also of this new proposal is also to support innovation, support orphan device manufacturer, but also keep an eye on SMEs. Europe has a majority of the medical device industry and IBDs are SMEs, and they weren't actually considered in the previous legislation.

And now, with this new proposal, they are looking to get, actually, much more attention by having a better frame where they can actually deal with it and can survive to make sure that Europe is getting SMEs focusing on European market first instead of going somewhere else. Governance is one key topic where everyone was questioning. If something goes wrong, if there is a disalignment between an authority, a notified body, a manufacturer, who's gonna be able to say what is actually right? The system in the past was not built for that. The only thing which we could clarify in some member state was classification or other dispute, there was no possibility.

Conversation between notified bodies, manufacturer, it was… In the past, under the directive possible, with the MDR-IFDR, there was actually a Chinese wall between notified bodies and manufacturers, which led to a lot of challenging situations for both sides, the manufacturer as well as the notified body, because they were not able to speak as they wished to speak. No one was hesitant to speak, but they weren't able. And the new proposal is looking toward actually making that conversation possible, looking toward supporting both sides to ensure at the end that the device is getting to the market on time. This is… all of these measures are actually preparing the system in Europe to be streamlined, to make sure that we are actually attractive, and allowing manufacturers to say, I want to go back to Europe

first. So we are competing again with this proposal, with the past experience, was a lot of manufacturers decided to decide to target a different market first instead of getting to Europe. So I think what we are seeing today with the proposal was all of these elements, including digitalization, is showing us, actually, a big push of the European legislator toward making Europe a place where manufacturers should start their business, a place where med tech industry would say, I want to start getting my approval, my market access in Europe first, instead of going to other countries. We lost this opportunity the past 8 years, and I'm happy to see that there is a move

a movement or an intention to move in the direction to get Europe again as the first place to get the devices in market. No. All of these measures that the European legislators are putting in place, they are trying as well to make sure that we have leaner processes, and in connection with that, when you do this, you're going to reduce costs. And cost is a topic which is discussed everywhere. Everyone now today is complaining. If you go to a grocery mark, people are complaining about increased costs. If you go to a healthcare system, people are complaining about increased costs. And everyone is trying to actually see how can we get a better managing system to make sure that actually we manage our costs. And with those measures, we are calculating, from a European perspective, a reduction of costs of approximately $3 billion per year. Now, a lot of people might say, where is this number coming from? Reality is streamlining processes reduce costs. It doesn't mean that this cost is a reduction of costs of not

modified bodies or manufacture. It's a holistic cost reduction, because if we streamline processes, cost gonna go down. And this is the intention, which is very positive, because if cost is reduced with regard to actually regulatory expectation, innovator can spend that money on innovating, getting new devices, supporting, actually, development of new devices, which is very positive for the system, and everyone can spend that money, which is going in the wrong direction, in the right direction by having, actually, a focus on what matters. more, and this is actually getting more innovation, ensuring better and more efficient devices on time to the market. So I think, in general, what we are seeing here in Europe as a summary is very positive. Sure, we need discussion. Sure, we need to understand what does it mean for every single party, and we need to work on it to make sure at the end

That we are not introducing unacceptable risk, that we make sure that actually patients are still getting safe and well-performing devices. But we need to sit all together and agree it is good that we are now opening a page of streamlining processes and ensuring that we are not over-regulating, but regulating to the level which is actually proportional to the risk which is connected to a specific device, and the European system is able, actually, to ensure market access on time for innovation, which must be on the market in Europe first, in my point. point of view. On top of all of what we are seeing, we finally have, actually, the European database, where people were complaining over years, when will UDAMAT be ready? Myself, I complained in the past about UDAMAT to be actually a long story that I might not see it before retiring. But thanks, God, I'm seeing this today, and I'm seeing that, actually, UDAMAT is actually in implementation, and the first deadline is on the 28th of May.

Where people need to register. So, this is in totality what I wanted to say to you today as a summary of what's happening in the EU, and I'm looking forward to our discussion with the audience, with the experts which are joining us today from notified bodies, from a legal firm. And let's have that discussion and see how we can go deeper in that regulation, understand what does it mean for me today, and what might happen in the upcoming months when I'm implementing this regulation. So… Thank you, Eric, Julia, for being with us here today, and Tom, as well, from Notified Body Perspective. We heard about, actually, some of the changes which might come. We are not there yet. We are still in the proposal phase. Everything is still actually a proposal, a suggestion. What might be requiring a lot of discussion, and I think a lot of you are already involved in lobbying and discussing.

in trying to understand the future, potential future of Europe, which might be positives for some organization, not positive for others. And from that point of view, what I would like to hear from you, Julia, and I know that you act a lot on the medical device field. What are the three to four most actually significant changes after your first reading of this proposal, which actually may blink in your brain and say, wow, what's happening in the EU? Can you tell us a bit more about your view?

Thank you, Basil. Thank you for giving us the frame also with your previous slides to understand the reasoning behind that. When it comes to the MDR, I'm speaking now for MDR, there is, Basically, when you say, what does manufacturer can expect when it comes to the compliance, what the manufacturer has to show, it actually is the same. GSPRs, NX1 is not changing, NX2 is not changing, NX3 is not changing. The way how potential notified bodies are getting involved. This is, proposed to get changed for certain classes. The well-established technologies are discussed again. I mean, we discussed it a lot because an implementing Act could have solved that situation also before, but it's now addressed or readdressed in the proposal.

There are some classification changes as well, when you say what blinks into your eyes, so I think we have to discuss that, but maybe one important thing is, when you are now as manufacturer in 2026, this is not happening in 2026 right now, and the Commission was very clear to us as notified bodies, let's put it that way, you have to comply with the rules which are now legally Established, and then this is a proposal, and then we work through the proposal as such. And, good that so many are on the call, because it's not easy to just read the change tracks and then get to understand what's actually affecting you, and where's maybe the link to something else. But, as you said, I can confirm that for the MDR,

manufacturers, there is supposed to be a less notified body involvement. Again, it does not take away your full responsibility and the liability on your side as manufacturers.

Thank you so much, Julia. I think you mentioned something very important. The new proposal will help us actually streamline some of the activities, but it doesn't mean that we don't need to do that. It means we are still required to be compliant. The question is, where is actually the benefit, for whom, and what does it mean for the resources and the capacities on manufacturer's side, on notified body's side? This is very key and very important. Thank you for reminding us about this, because a lot of people might ask. actually be confused and believe we don't need to have a quality management system, we don't need to have technical documentation. No, you still need it, but you might not be scrutinized in the same level like you have been done doing that in the past. So, Tom, we heard from Julia about the MDR. You deal every day with IBDR, and I still see that you don't have that gray hair like every IBD expert.

That's somewhere.

hair with her talk to Dad, so…

But…

IVD is a big challenge for a lot of manufacturers. Now you see this proposal, and you work for Notified Body, and you deal with IBD manufacturers. What are the three to four points where you would say it's actually a big change for IBD industry?

Yeah, thanks, thanks for having myself and Julia today. It's, it's… it's great that we can… we can come on these webinars and speak, and I hope the audience can appreciate as well that we can't maybe be as forthright as we would like to be at the moment, because it's still a proposal, so there's things in there that we like and we welcome, and I'm going to talk about a couple of those from the IBD side, and there's things in there as well that maybe everyone should be concerned about, and I'll give one example of that, kind of, in relation to IBDs as well. So the things… the things… first of all, what's going to change in 2026 for you as an IBD manufacturer? Like Julia said, very, very little. It's a proposal. Let's get through the… get through the year.

And see what comes out at the end. As opposed to things that are in the proposal that, made me go, oh, that's interesting. I'll start with companion diagnostics, and I will say that, Bringing in… equivalents for companion diagnostics in relation to medicinal components, so an equivalent medicinal component won't need to go through a separate EMA consultation. Fantastic. That's great. So you're approved for use with this medicinal product, and then you can use a similar medicinal product for your pionasic. That's just wonderful. I think that's a huge benefit for patients. As more, say, generics come online, they get access to the test that you can use with them.

Another kind of one that I think is proportionate, and again, what you will see me saying, and I've been saying this for years, what I want as a regulator and as a patient. is patient… data-driven, patient-focused change. And a good kind of area where I see proportionality in that in the proposal is, instead of, say, all Class C devices needing an SSP, that's kind of going to Class C devices that are for self-testing or companion diagnostics. I think that overall makes sense in terms of everything else. And then one other consideration for… for manufacturers, maybe, of, say, Class A steroid products.

So, the proposal calls out that these will go to self-declaration, so the CE number will come off your product. So that will mean that you are fully responsible for this product. So, your 134885 cert, and I would guess your, probably, contract with your notified body, if they're a certification provider, will be very explicit in stating that you're the manufacturer of this product, it's a Class A product, and you will need to comply to the IBDR. So, if something goes wrong, you have full responsibility for that product. And the reason I'm calling out Class A products is… so, again, I'm an IBD head, I used to work in laboratories for years. I would say, on average, across Europe, you're looking at probably 10 to 12 billion tests.

From those 10 to 12 billion tests, I would say half of them are coming from a Class A-style receptacle. It's a lot of responsibility.

Thank you so much, Tom. So, I think this is very key and important, keeping in mind that the responsibility for medical devices, or IBD is always with the legal manufacturer, and the notified body will never actually take over the responsibility other than actually being involved in a conformity assessment, which remains always under the responsibility of a legal manufacturer, but with involvement of an independent party or not, and this is actually what might be… the implication of moving down in classification might mean that I need to have additional measures as a manufacturer to ensure that what I have done is compliant, and now, because I don't have a third party looking to my file. So, I think there is a lot of necessity to have that understanding for the industry as well, for the notified bodies, have that discussion, see

What are the pros and cons connected to every measure suggested in the legislation? Eric, we speak about proposal, and you are acting legally on various, like, let's say, places, trying to actually look to legislation, and you know the European system very well. Can you tell us a bit more about, you know, what are the timelines, typically, after such a proposal? What is the process, and what are the timelines that you can expect? Because a lot of people see the proposal, and they will come to Julia, to Tom, to yourself, myself, and say, is it already official? Can we get it now? And some people, I saw already some people using justification from the proposal to explain to notified bodies why they are not doing things.

Give us a bit of insight and clarity about the timelines and the process that we can expect in the upcoming months.

Sure, happy to do that, Basil. I think it's really important, what Julia said, and what Tom echoed, is that on substance. Like, really, on the bare substance. Basically, not that much changes. On the procedure, a lot. And that is really what this proposal is about. Like you've said, it's about simplification, streamlining. And, some, some other points. So, what we have now is we have a commission proposal for a regulation that's going to change the MDR and the IDR to amend it. So, that means that, This goes into the European co-decision procedure, or the ordinary legislative procedure, as you would call it.

Now, you might remember that in 2012, when we had the MDR and the IVDR, this process took 5 years, right? Almost. 26th September 2012 proposal. what was it? 26th May, 2017, entry into force. Okay. So this was actually quite a process, and… The length of the procedure depends on politics, unfortunately, because now we have left the area of, let's say, technocrats, which is the commission preparing the proposal. now we are in the field of politics, because both the member states, through the European Council.

And the parliament, through the political parties in the parliament, they get to weigh in on what they would like to see in terms of changes to this proposal. And now things get really interesting. Beagles… My best information at this point is that, the Parliament is, I would say, quite okay with the way the proposal looks, because it aligns quite well with what I understand the political parties in the Parliament like. Council, member states? Not so much, because I've heard that there are several member states that are actually of the opinion that other things should change, more things should change, so what I expect in the procedure is that, while we have seen

in the MDR and the IVDR, that was mainly the Parliament that was very active. now we will see more activity from the Council, actually, with proposals. This is unfortunate, I think, because I think, personally, that the Commission's proposal is as balanced as the Commission could make it, and as politically acceptable as the Commission could make it. further tinkering on this by the council will just, yeah, basically stretch out the legislative procedure. For how long? Well, if we count back… So there is currently, there's a 6-month transitional period in the proposal. Then you come back to the moment that the proposal is published, and then you need the additional time for the logistic procedure to run its course, which is

in the best of circumstances a year, probably more. So that means that in the most quickest of scenarios, we would see a proposal enter into force between one and a half and two years from now, which is also why Yeah, people should start to plan about this, but they shouldn't plan exactly on the text of the proposal as it is, because a lot may still change.

Thank you so much for this clarification, Eric, because I think this is key for a lot of manufacturers, especially the ones that are actually hitting a deadline very soon, which are believing that we can delay again, because there is a deadline which is coming for a lot of devices in December 2027, where some manufacturers might believe, new proposal, shall I wait? And I think none of the manufacturer should wait, because as Julia said, what is applicable is what we have today, and if this might change. we need to wait till we have a finally published adopted text, and then we can say, yes, now we can apply those rules, because then we understand what is actually the final agreed tax, and how it will function. Or what we have today is nothing else than a proposal, which is positive in some extent, but… to some extent, but we need to understand what out of this proposal will be actually final and realistic.

Now, looking to what we see in the proposal, Julia, one of the measures in the proposal is actually to ensure a better capacity for notified bodies by giving them enough resources. You know, when MDR and IBDR started, it was rare to find a notified body. Today, we are moving toward, actually, a number which is similar to what we had under the directive. more than 50 notified bodies for the MDs, nearly 20 for the IVDR, so, are we still having capacity challenged today, and do we need those measures to actually free up capacities for the notified bodies for the future? If you can share your opinion, Tom, you can also elaborate on this after her. This would be helpful for us to understand what is the current status, and what might be actually the implication of the change.

Yeah, thank you, very good question. I can just… agree with you, these discussions from capacity issues. I mean, we had the first notified bodies designated 2019 after quite some challenging designation procedures. Slowly, slowly, more notified bodies were designated. We had the COVID phase, then challenges until 2022, that was definitely a time where two less notified bodies could have done the work for all of this, re… let's call it new certification, not recertification, it was a brand new, certification, as you have mentioned before, Basil. And so, now we have, as you said, we had just a new notified body for MDR was announced, so we have 52

notified bodies now. We have, I think, 19 IBDR notified bodies, and the capacity is definitely there. So this discussion was very valid during the time 2019, 2022, but nowadays. I mean, it's a bit of a delayed discussion, basically, and I can definitely confirm there's sufficient capacities now with the notified bodies.

Thank you, Julia. Tom, can you confirm the same thing for the IVD sector, or is the IVD still actually the small baby running after the MDs and trying to catch up?

So, Basilia, I think… I think you know what I'm going to say to that. Just… just remember medical device manufacturers, particularly for the high-risk ones, that without the IVDs, none of your devices get implanted. So we play an important part, and I've always kind of pushed that. In terms of capacity, what I would say is Myself and Julia spoke about this during the weekend, and I think it's fair to say in the last 2 or 3 years, the nullified bodies, we have… we have optimized our staffing levels as best as we can. And I'm trying to be, I'm trying to recognize that a lot of people in MDs in the last couple of years have been let go because, we were over… we were over capacity.

We had resources waiting to do work, and work did not materialize at the rate it was expected. This is just the capitalist world that we live in. So I would say at the moment, our staffing levels are correct. Where I would say for… Where I would say maybe bottlenecks could appear would be in terms of… maintenance of codes on the IBD side. Maybe there's some specific codes where a notified body only got one file at the start of their designation, and hasn't gotten a file since, and then maybe that manufacturer is putting in a significant change, or is bringing another product onto the market, and because maintain… so there's 80 codes on the IBD side, and maintaining them all, maybe some NBs are struggling internally with very specific

issues. But I would say overall, for… as a… as a… as a… as a rule, capacity is… is not where… or capacity is not an issue like it was maybe 2 or 3 years ago. And again, the last thing as well is… Any business cannot function, cannot function by hiring for the peak in work. So… The MDR and the IBDR created peaks of work. Which is very difficult to… to have a… an ability to handle the peak, and then to maintain your resources afterwards. It was very tough for the last couple years, but like I said, we believe our staffing levels at the moment are optimized. If anyone's ever wondering the number of people that work for an MB, there's the lovely NBCG Med infographic that was published a couple of weeks ago. You can see just how many numbers we have, how many experts we have, and what our backgrounds are.

Thank you so much, Tom. I think it's, like, good to hear that notified bodies are consistent with regard to capacity, so people… coming back to the point, shall we delay and wait? So, make use of this opportunity, because notified bodies have availability today. And don't create a new peak, you know, because peaks might be not manageable from a project management point of view. Make sure that you actually Get your job ready, and if the new proposal will become reality, your future will be different, and make sure that you have that conversation early on time. Tom, you…

Thank you, Bessie. Current, current capacity is no guarantee of future capacity.

Good. Eric, looking to this proposal, we see a lot of changes as well, technical changes, regulatory requirement changes, one big topic. was always in the past, everyone was complaining about clinical expectation, clinical requirement, and the new proposal waved away some of the requirement for, for example, Class 2A implantable devices, allow wider acceptability of evidence, such as non-peer-reviewed journals, such as real-world evidence, such as in silico data, and so on. Would that actually have a positive impact on manufacturers? Do they need to change their way of acting, considering what is actually written in that proposal?

Well, I would say, again, going back to Julia and Tom, the substance doesn't change, right? So the level of clinical performance that you need to show in the end, that hasn't changed, except that the types of data available are, have been explicitly broadened. Some notified bodies may already have accepted some of the additional sources that are now explicitly called out. But… it, I think, does afford manufacturers new capabilities. Like, for example, in silico data, allows you to make simulations, right? And simulations can be very interesting if you are, for example, dealing with a node pipe body for an AI, for example, where you can simulate how a particular model might develop.

Right? So this is… this is absolutely fascinating and… and important. But on the, yeah, basically the, the threshold, or, the yardstick of clinical data. In the end, or performance data when it comes to IBDs, in the end, you still need to demonstrate the same endpoints, right? Just the means to demonstrate them have been broadened.

Thank you so much, Eric. So I think it is… it is good to know that, actually, for, Those evidence requirements might have been different, but now they are legalized in this proposal, so what they are looking for, to give, actually, black-on-white expectation that some notified bodies were beaten, actually, by their member state if they accepted things which were not written and settled in stone. And based on that, now, with this proposal, the European legislators are giving you, actually. foundation where you can justify and say what I'm doing is right, because, you know, notified bodies might have their own opinion on some aspect, and some might deviate to others, like you said, but it wasn't consistently applied, but if we have it now in low, this would mean that actually no one can justify not to apply it and not to accept different sources of data.

I'm gonna switch a bit more, because I think this topic might take us, like, months to speak about, because there is a lot of topics in the legislation which might be of interest. I want to move to the topic of, actually, quality management system a bit, and focus on that topic. You know, with the new proposal, there are two elements which might be very relevant for a lot of manufacturers, as well for notified bodies, which are target for simplification. as well. In the past, notified bodies were auditing manufacturers on a yearly basis. Unannounced audits were actually expected as a minimum in a 5-year cycle to do, like, a number of unannounced audits. Now, the new proposal is allowing, actually, less

Regular audits and unannounced audits to go on cause. Julia, from your point of view, what are the pros and cons connected to such an approach? Just, I know that it is, like, it might be your personal view, not reflecting your notified body view at this moment. We are talking openly, and everything which we are talking about is actually based on the proposal. So I just want to remind everyone on this call, it's not actually to absolute position, if Julia is saying, or Tom's GMAT position, and not even Team NB position, is nothing else than an expert discussion today, so please, can you share your view on that?

Yeah, thank you, Basil. I think, good point, the, As you have said perfectly, in the current MDR, IVDR, there's the on-site requirement of auditing each year. This is very similar, or same, very same as for… we all know the grounds of the ISO 13485, same requirements, even if you have as manufacturer knowledge about MDSUB, all same requirements. what the MDR proposal and IBDR proposal is saying, okay, I, if a manufacturer has shown evidence that he is on a good track, like a mature quality management system, maybe even low-class devices, but still notified by the oversight, less post-market surveillance issues.

Then, with a rationale, there can be, either a switch to a hybrid or a remote audit only, or even you can skip an audit. This, and if you do that, manufacturers who are in a very good compliance benefit from that. it pushes, still then, from the preventive character of the MDR and IVDR as it is now, it pushes it to a more reactive situation. So, you only, as… competent authority markets of a notified body, or whoever will only get to know if something happens afterwards. So, this is the concept we have to understand, how far can we go with that, what is reasonable, and as the Commission wrote in their explanatory memorandum, I want to… we want to maintain the highest level of patient safety.

what is balanced in all what you have said before in the complex environment we are in. So, thresholds might change, and I think it is… it's a good thing to… to not overburden those who really show continuous good compliance. To really reward them is much better than to punish everyone because some have not been performed very well. We just need to see that it does not become a system back on the shoulders of a patient only after he had an… an issue.

Very good point. So I think what you are saying in summary, we need to always keep whatever we do as a measure patient-centric, so we need to keep the patient actually in our mentality when we are applying a measure to be proportional to the risk. So it depends. It is… it's suitable for some manufacturer, it might not be suitable for everyone, and therefore, there should be actually clear rules for applying this in a reasonable way, without putting the system on the risk that we have, again, a situation which might lead to, you know, an explosion, like… like a fraud situation or a scandal. Therefore, we need to apply the rules in a way which is reasonable. So, thank you for this clarification, Julia. I think this is very useful. Tom, you know.

One of the topics which was always in the past a big discussion, talking to notified bodies, asking them in advance about, you know, what the manufacturer has planned. It was possible under the directive to have this kind of conversation. It went away totally under the MDR, because people justified to say it's not… it's impacting notified bodies, impartiality, independency. And now we are seeing that there is a lot of push toward reintroducing this conversation possibility with notified bodies, with expert panel from IMA. What is your view on this from a notified body perspective? Is this something which is needed, or is it something that is unnecessary?

Yeah, so we've all heard the buzzwords over the last couple of years of structured dialogue, Yeah, they're… they're great, but what's more important is having a relationship with your notified body, that you know when something goes wrong, that you have a point of contact that you can escalate something to, and you can have a conversation with. And it needs to be a straight conversation. Sometimes that needs to be a technical conversation between a sterilization expert and a sterilization expert. Sometimes that needs to be a high-level, regulatory, conversation about… we have, again, an example, we have PSURs coming in every single month. Can we have a structured dialogue to formulate a strategy, to group these together, and to perform our PMS activities collectively, and then submit in a more…

efficient manner. So, how you work with your NB is what's… what has always been really crucial, and over the next, I would say, 12 to 18 months, it is going to be probably even more important, because some of the the proposals for the transition implementation timelines for the Annex 7 stuff, and for this… will impact us. They will impact us as we update our QMS, and as we train our staff on the new processes, and we will need time to figure them out. figure out what it means for our organization, figure out what it means collectively for our organizations, and then try to find some harmonization across the board for how we implement for our customers, which are you guys, the manufacturers. So, I think everybody on this call, would always value,

the importance of having an open, constructive conversation, and I think that is the message that I would say for… from… for any activity that you're concerned about over the next, at least 12 months or so, but just in general, make sure that you have somebody in the notify body that you know that you can… that you can speak to.

Perfect, thank you so much. I think this is a very good recommendation. Communication is key, so it doesn't matter who you have as a partner, if you don't talk to each other, you will not be able, actually, to find solution and be able to navigate through that. So, whatever you would name it, whatever title you would give it, it's important to talk. This is important.

Yep.

So, Eric, now, looking to the proposal, there is something which is in that proposal which we didn't have in the past. The ability to complain, to complain and get, actually, a solution, because in the past, just you could actually justify, that you have a dispute on classification, and in some member states, it was functioning, that you could get, actually, a feedback. A lot of member states do not even have a process for it, then manufacturers are left alone, and they can't actually get the feedback, and this is complex. Now, today, we have a proposal which is talking more to be able to actually, if you have a dispute on regulatory requirement, that you can get an opinion. What is your view on this? Can you share some insights?

Yeah, this is just, I think, a really interesting theme to me as a lawyer. Like they say, war is politics by other means. I would say lawyering up is communication by other means, and depending on how you look at it, this is, I think, a new option in the proposal. And it's… it's interesting, because if you… if you read the, explanatory memorandum of the proposal. There's a table at the beginning that says, we are introducing an ombudsperson feature. Right? So that is, but then, if you look at the text of the provision that is proposed, it says.

competent authorities, or… Notified bodies need to have a function that allows you to complain, and then this is where it gets interesting. It says that the competitor authority must hear and shall decide. This is where, from a legal perspective, it gets interesting, and it depends on how you interpret this. Because if you interpret this as, oh, we have an ombudsman, or an ombudsperson. An ombudsperson is, historically, is a person that intermediates between a private party and And government authority, and mediates, right?

it's a mediation. There is no formal decision. Basically, it tries to basically talk sense into both parties, and then hopefully they will, as we were just discussing, they will improve their discussion and reach, a point that works for both. If you say decide, decides has a legal meaning, because if the competent authority must decide, then they take a formal decision. If a competent authority takes a formal decision. in the EU, that means that this is a formal decision that you can appeal to court if you don't, if you don't agree. So, it'll be very, very interesting to see how this develops, whether this stays as it is, because if the

text is adopted as is, I would argue this is a formal appeal to, to courts, so basically we have legal review of potentially every notified body decision, where we used to have our declassification, now we have legal review of every decision of a notified body, if this Goes through the way it's written. On the other hand, if there are amendments during the legislative procedure. to tune this text more towards an ombudsperson situation, then we will have, rather more of a mediation situation. It's very interesting to see how this will develop, but it can go both ways. Or it can be both ways.

Thank you so much.

together.

Yeah, I think it's, I mean, it is, it is everything when you read it for the first time, you need to to start understanding what does it mean, how does it work, who are going to be those parties, but those are ideas, and that's why it's a proposal and suggestion, but I don't think that the legislator proposed something without putting those sources behind it to understand how it would work. It's just now, for us, we need some clarification, and then we will get it when it's actually final, because then we know this is what we need to navigate through. Tom, one of the audience is asking us, is the proposal for sterile Class A product to have less involvement with notified bodies, or the manufacturer self-certify without notified body?

Manufacturer will self-declare.

Perfect, thank you so much. Julia, I'm going now through the question of the audience, which are actually coming through the Q&A, and one of them is actually saying, asking, do we have a date when NX7 proposed update will be implemented?

The… the Implementing Act is, by the Commission, considered to be, the date of application is July 2026, so that was what I understand is the goal. Until tomorrow, feedback can be delivered on the homepage of the European Commission. Then, as usual, all that feedback is considered, and as mentioned, the goal was July 2026.

Thank you so much. Eric, regarding the IBDR, will the new proposal lead to a delay of application to the transition of IBD to IBDR?

Well, that's a really good one. Well, it shouldn't, because if people are smart, then they will, they will actually, they will make sure that they understand the, well, quite complex, I would say, legacy device regime for the, for the IPDR. But, yeah, of course, I mean, there will always be situations, but that will be a limited amount of manufacturers, I would think, that are currently Going… that are not already in a legacy device application scenario, where they need to decide, am I going to apply now? for a completely de novo IDR application, or am I going to wait until the proposal is finalized and is normal?

again, I would say, look, we've established that also for IVDs, The substance is the same. Procedures are different. it might be, you might be in a situation where things would get simpler if you are currently in the development stage, because for IVDs, I think there is a lot of very interesting stuff in the proposal. Tom has already mentioned companion diagnostics. if you are working on, let's say, an essay that is specifically clinical trial only, for example. then things will be very much simplified under the proposal, right? So this is because, basically, you can… you don't have to go through full CE marking for that essay anymore. It'll be kind of an in-house situation. So that is super interesting.

For these very specific situations, that might be useful to wait. Another situation is where you want to do a combination trial, so basically where you want to test the medicine and an IBD at the same time, because currently you must, because if it's, if it's an IBD, Under the, under the, amendment, you will be able to do combination trials by default. There's currently an EU pilot running. Personally, I have expected that they would sit out the pilot before they would propose this, but they actually jumped the gun on this. So also there, it might be useful to look a bit closer, but in all other scenarios, business as usual.

Thank you so much. Thank you so much, Eric. Julia, there is one question. I will just rephrase it in a way which is friendly, and much more professional. Is UDAMet functioning, and is it actually, can we use it today?

How shall I be as well? Yes, so voluntarily, you… or depending on the member state you are, you had to use that already for the SRN as manufacturer, so the economic operator module is functioning. You can upload your, as notified body, your certificates already also now, from… it's… it's the minimal viable Product, let's put it that way. It's manual. We are all keen on the machine-to-machine, so this machine-to-machine uploads might not Functioning perfectly when… like we hoped so, but manual uploads is definitely possible, and

I can't say that there is not one or other obstacle or a bug, but what you have said, May 26th is the starting point for mandatory use. There's still, for legacy devices, a kind of transition time. But, from there, we can expect that this, URMAT database is getting populated quite some… some bit.

Thank you so much. So I think, so it is, it is functional, it's not perfect, it is functional, and to expect something to be perfect from today, it's not possible. But I think there is a commitment, and we are seeing that they are continuously improving and adopting, addressing, actually, stakeholders' needs. If you want to have changes, make sure that you communicate, that you get vocal, because Just complaining about the system not functioning and complaining internally doesn't hit, actually, the people who are working on it, so make sure that you share your feedback and tell how Is actually the system running as of today, and what you would see as potential change, which would… might improve the future.

I think we had a lot of discussion, and I see we still have a lot of questions, but we are reaching end of this webinar, and I want to be respectful to everyone's time. Therefore, I would just conclude from my side and hand it over to Sean, and as well to Alexia to close this webinar. For everyone who were listening to us today, this is a proposal. It's not the final text that you can say it is already adoptable and you can start implementing. But you need to be aware, this is why we are here today, to raise awareness, to make you actually preparing yourself. You need, even if you don't have to implement it immediately, you need to start preparing and educating your team, making sure that they understand the implications.

potential impact on resources, costs, and processes, because as soon as adopted, then you need to start changing, and a lot of people might ask, what does it mean that I need to get an approval from a notified body for changing to regulation? All of these discussions are subject to structured dialogue, where you can talk to your notified body, and then can have discussion with your notified body. We're going to continue doing more and more deep insight and details about these kind of, like, proposal and the changes, and we're going to help you understand specifically common changes, but keep following us, learning from us, and I think all of us, we're gonna learn all together with this new proposal what will be the future, and I'm happy to be with you here today, and I'm thankful for all the experts that were with us today, and we supported us on this event. And now, Alexia, the hand…

I will hand it over to you. You can take it over and finalize it.

Thank you so much, Basil. Thank you to all of you, really, for such an interesting and insightful session today, the presentation, Basil, and as well, the, questions that you all answered through the panel. The questions from the audience, all of the interactions from the audience as well throughout the session that have been very much appreciated. As a reminder, you will all receive a recording and, certificates of attendance for those that have asked for it. Recording will be sent through a link by email. If you have any questions for us, especially Basil and I, perhaps Eric as well, do not hesitate to let us know as well, through LinkedIn or, any other means.

And, once more, thank you to our speakers, Julia and Tom. We know how busy you are in notified bodies at this time, so it is very much appreciated that you have shared your time and knowledge with participants today. Sean, any final notes?

I would just like to thank the audience for their time and attendance. If they have any questions, please reach out to me directly. Thank you very much, everyone, and the speakers.

Thank you.

Perfect. Thanks so much, everyone. Have a very good rest of the day.

Thanks, everyone. Take care. Bye-bye.

Thanks so much.

Bye-bye.

Bye.