MDR/IVDR in Transition: Expert Insights on Regulatory Changes and Compliance Strategies

Hello and welcome. My name is Sean Smith. Welcome to today's webinar on MDR and IVDR in transition. A couple of housekeeping notes before we get started. This webinar will be recorded, and the recording and slides will be made available tomorrow to everyone who has registered. By way of information, 1,245 people have what registered for this webinar, which is outstanding, and given the timeliness of the subject matter, it's not surprising. While people are still logging in. I would like to take a moment, to, say, Dr. Basil Akra and Eric Volbrecht are going to be doing, a webinar on January 22nd to get your year started off right, planning, and so there will undoubtedly be more discussion on this topic on January 22nd. So, I will put the link to register for that in the chat, and please join MLVX

tomorrow and Friday for, honing your MedTech message. I'll put information about that in the chat as well. Alexia, over to you.

Thank you so much, Sean. Welcome to everyone for our webinar today. Indeed. Thank you, Sean, for kicking us off. I do want to insist indeed on the fact that on January 22nd, we also have Somewhat of a follow-up to this topic today, on January 22nd, we will be talking about pretty much the regulatory roadmap for 2026, and how to get organized for the year as regulatory quality or clinical individuals. That will be with Basil Accra, our CEO at ACRA team, and Eric Volibricht from Axon Lawyers, as well as Tom Patton. from GMED, so do make sure that you register for that one as well. For today, exciting times and an exciting topic, as everyone has seen that the European Commission has indeed released the proposed revisions to MDR and IVDR just two days ago.

So we are going to look at exchanging today expert insights on regulatory changes and compliance strategies. Of course, in just a short hour, as you can imagine, we won't have time to go absolutely through everything, but we're going to start to digest the content For you all, and we're very much looking forward to knowing what type of questions you might have. For that, we are going to be working today with my esteemed colleague, Filippo Clare, who is a senior consultant with us at ACRA Team. We also have the pleasure of being with Tyrion Evans, who is Head of Notified Body and Approved Body at Scarlett, Madelena Pinzi, who is Associate Head of Medical Devices, Notified Body, and Senior Regulatory

lead with BSI, and nonetheless, as well, we have The infamous Alex Lan, who is head of IVD, notified body with BSI. We will have a two-fold session today, I'm sorry. First, a short presentation that Philippe will conduct, walking us through some of the most important areas of change to expect with the proposal, and then we will move into a panel discussion where our speakers will go through certain areas of focus and exchange perspectives on those various topics. Philippe, I will share my screen with your presentation and hand things over to you.

Thank you, Alexa, for this very kind introduction. And many thanks to everyone for receiving us at your home or your place of business today. This is very much appreciated. Yeah, the screen is coming up… Yeah, and this is very timely indeed, because this proposal of amendment to the regulation of MDR and IVD was released, what, 48 hours ago? So it's hot from the press. And it's very timely that we can have this webinar to walk you through some of the content of it. So, the disclaimer, a standard disclaimer, well, this presentation is educational purpose, does not represent anything legal.

or any of Accra team opinion and presentation. So in this short presentation, there probably will be a mistake. This is my presentation and will be my mistake. And I will assume then, especially given that the release of the draft of regulation is so fresh. So, next slide, please. So, history of this, of this, presentation. The presentation resulted from a large, I'm waiting for the slide… a large consultation, which has been collected by the Commission, and which, finished, in October this, this year. What you have on the screen, again, slide will be made available through the recording. You have the link which can guide you to the document itself.

The document was released on the 16th of, of December. So, what is next? Well, this is a draft. And this revision, draft revision, will undergo the legislative process. So, in principle, it is the ordinary legislative process with navigating from the Parliament to the Council, back and forth. And, traditionally, it takes 9 to 11 months. So, this gives us a flavor of when we can expect the proposal to be ratified. Now, it can go faster. It can go faster if there's a political will, and also taking into account that the MDR and IVDR will have a formal review Which will take place in late 2027, which may be a trigger.

To release this document earlier, so that it can be trialed and tested before the full, the full revision kicks in at the end of 2027. So, takeaway here, this is a proposal. We can walk to the proposal, we can digest the proposal, but nothing tells us that this will be what will be approved eventually. There will be change. There will be change, so we need to take… The content at this stage with some pinch of salt, because it is not, approved. Next slide, please. So, I also would encourage you to go to the website of the European Commission. They posted on the 16, on the same day as the proposal, they posted a fact sheet and a Q&A

Which is extremely interesting to go through, to get the background and the smell of the content of this, this proposal. So, I will walk you very quickly through, the gist of the, the proposal. It's a simplification of the MDR and IVDR, so I tell you that without a pun, because the simplification is 170 pages, plus 40 pages for the annexes. So, what do we have in this, in this document? Well, it is split, or we can split that in several chapters. I will start with simplification and proportionality.

I will just go through the headers in the interest of time. So, there will be some changes on PRC requirements, which are softened, specifically in terms of their qualification. Another important change in simplification is that the 5-year certificate validity is lifted, doesn't exist any longer in this proposal, and it is replaced by a risk-based periodic review instead of a systematic recertification of the product. Clinical evidence is, is, is tackled a lot. with expanding some flexibility on how to demonstrate clinical evidence. Literature review is made easier, real-world evidence, in-silico testing.

use of equivalence device for clinical data. So, there are broader definitions… there is broader definition and more flexibility in, in using it. Well-established technology is now formally defined, it's made larger, and it's subject to lighter requirements, making it more flexible. And there's also a down-classification for selected device group. reusable instrument, or, for example, instruments which are used with implantable Class III devices. Next, please. Another chapter is the administrative burden reduction. This was one of the main concerns of the initial MDRI VDR.

So, in this chapter, we have the SSCP scope, which has been narrowed. There's no separate notified body validation, and it's only required for a subset of devices, those which requires full technical documentation. PSUR frequency reduced. Vigilance timeline has been expanded for non-critical incident to 30 days instead of 15 days. The vigilance reports are not any longer routinely sent to notified bodies. So, they are sent to the National Competent Authority, but only on some selected cases will they reach and be analyzed by the notified body.

Change management, clarify with predefined change. And the notified body certification for relabeling packaging has been removed. Again, sorry to hammer you several times with that. This is a proposal, and I think everyone is keen to hear from you what you think about those proposed changes. Next, please, Alexia. So, certification… Predictability and notified body reform. Yeah, we can have a whole symposium on each of these slides. So this one probably will be the core of our discussion in a few moments, because we have distinguished notified body speakers and panelists.

There will be reduced notifiable body involvement for some device class, and the sampling, and representing sampling instead of full portfolio reviews. This is something that certainly will need to be clarified. I didn't find it very crystal clear in the text itself. Remote audits are lowered. We use that in part during the COVID crisis. It will be lowered now. Unannounced audits are not mandatory any longer. They are only for 4 calls. Which, reduce the burden on both manufacturer and notified bodies. Very importantly, annual periodicity of QMS OD is relaxed. So the routine ODET do not need to be on an annual basis.

subject to agreement with the notified bodies. There can be some flexibility here. The pre-submission dialogue, which I'd started already, will become the norm now. It's something which is cast in stone in the text. And not subject to, to, permission prior to, to happening. And there's a new fee regulation which is introduced Specifically for small and medium enterprise and company which propose Or fan devices with reduced price. Next, please. Innovation, access pathways, breakthrough, an offline device.

There's some facilitation to bring them on the market, and a grandfathering for legacy or fan device, which may have been placed on the market beyond the end of the year transitional period. Emerging technology are detailed with some regulatory sandboxes, which will be established. And, also worth being noted, single-use device regime is rebalanced. In a sense, manufacturer must justify what it is single-use, and the reprocessing becomes default if it's not sufficiently justified. Next, please. Governance, stronger central coordination while keeping a decentralized system. Well, this sounds to me like a catch-22 here.

I think we probably will need to have guidance and other documents to clarify that, but this was a request from most of the stakeholders to have a stronger central coordination. There is also an expanded role of the expert panel, which signaled more involvement of the European Medicine Agency in this system. And, from a legal standpoint, a formal dispute resolution mechanism has been established between manufacturer and notified body. This does not exist in the, or does not exist in the current MDR and IVDR, and is something that probably will help To get a fluid, negotiation and discussion between, both parties, manufacturers and, and notified bodies.

Next, please. Digitalization, well, that was a long-awaited one, and I'm sure we will have, we will have questions during the panel on that. So, it's digital by default. now you're denomination, with, e-declaration of conformity, digital IFU, labels, fully electronic submission. We'll have to see how this can be put in place, but in a sense, this is a change and a path forward which has been really awaited for a long time. And next slide to round up this very high-level and helicopter view of the content of the proposal.

In terms of supply security and risk of crisis and shortage of, of product. Now, a central EUIT tool will be put in place instead of reporting to each of the member states. The EMA also will be empowered to identify critical devices. And, the Commission may directly authorized, market access during EU and public health, emergencies. So this is lesson learned from COVID here as well. Next, please. So, this is only the early crypto view. I mean, each of these slides could be a symposium and a webinar on its own, so before we move on to the, to the panel discussion, I just would like to leave you on this, with this quote.

from Donald Rensselb, that you may have, been exposed to in the past. Let me just read it, and you can ponder it after the webinar. I quote, there are no no's. These are things that we know that we know. The proposal? There are known unknowns, that is to say, things that we don't know that we don't know. This is a proposal, and what will be retained, and what will change. But there are also unknowns and no's. There are things that we don't know, we don't know. And these are the most dangerous, and this is why we need to prepare and monitor the legislative proposal approval and how the text will evolve.

Throughout this, this process. Next. And you… since you, you connected to this, webinar, I'm sure you're fairly… knowledgeable with, Accra Team, who organizes this webinar with Sean. And, if you're not, just let me know that, you can contact Accra Team in confidence that, we can support you To identify, clarify, and support, any question you may have during the life cycle of medical device from cradle to grave, and guide you throughout this, this process. This, this will end this high-level presentation, and I think, Alexia, we can, we can move on to…

The panel discussion, if you're okay?

Yes, perfect, Philippe, thank you very much.

I can see you're a poll. You have a poll on the screen, please.

Yes, feel free to, fill in the poll, you can minimize it to get it off your, your screen, so you don't have to look at it, Philippe. I would like to remind everybody, if you would like a certificate of attendance, please put your name and email address your name as you would like it to appear on the certificate, and your email address in the chat, and we will send that. Questions for the speakers, please, please use the QA, not the chat. I cannot copy them. from the chat to the QA, it will not allow me to do that, so… If you put a question for the panelists in, the chat, please copy it to the QA, I appreciate it. That's all from me.

Thank you, Sean. So let's delve immediately with our distinguished panelists. And one question to start with, the proposal was released two days ago, so it's fresh for everyone, it's fresh for us, it's fresh for you as well. But from your reading, what amendment do you feel will lead to real improvement for MDR and NIVDR, and what are those which will be the most effective, at least in the way you read it at this stage? Tyrion, do you want to start with, with this question?

Sure, I hope you can hear me okay. Yeah, I mean, as you say, it's only… it's only been a couple of days that we've had… we've had the proposal in our hands, but, I think the… the items which stood out to me, kind of from the notified body perspective, is, you know, formally introducing the predetermined change control plans. I think the remote… the remote auditing's gonna have… make a real difference from, how we do conformity assessments. And also the structured dialogues being brought into the regulation, rather than just being in guidance. I think those are the things that I'm kind of most excited about in terms of…

yeah, notified body perspective. I think, I think for manufacturers, I see a lot of benefits in a kind of reduction in the reporting requirements, and in introducing a lot more digitalization. I think… I think that's going to make a big difference.

And from the other panelists, anything you would like to add? Or to share your view with the audience?

I… I also think it's, also in terms of governance, having a stronger EU-level coordination for classification disputes, and the publication of the outcome of these, classification disputes would increase alignment and, predictability, and And these are also improved by having, as Tillian was saying, a legal basis for structured dialogues and the early advice mechanism as well. The proposal also introduces a stronger, risk-based oversight, instead of, let's say, yeah, one size fits all, with a more proportionate oversight and, in some cases, less administrative burden, so let's think about the,

Proposed change to have a broader definition of clinical data, to include real-world evidence, or… post-market data, or the, removal of mandatory clinical investigation for Class 2A. implants, where there is sufficient evidence. We can also think about the removal of the actual list of the well-established technology with the definition replacing that, so this will expand the number of devices that can be considered as well-established technologies. And… and then also, obviously, it's important to have the legal basis for the special pathways. For innovation, so let's think about the breakthrough devices, orphan pediatric devices with conditional certifications for post-market, evidence plans. So, these are great improvements.

Okay. Thank you, Madelena. Unless there's anything to, to add, or Alex, do you have any view on that?

Before we move on.

Corona?

Yeah, no, I concur with what's already been said, so please move on. I think one thing to be said, the objective of the proposal is to make the existing regulations more simple and reduce burden. And in many areas that, I think that objective has been achieved. If I would point out one of the things that has already been said, I would say innovation and digitalization are, really elements that will help not only manufacturers and notified bodies, but also the patients further.

Thank you. So, yes, indeed, this is a Christmas present from the Commission with a lot to digest, and a lot of things that apparently were eagerly awaited by a lot of parties involved. But let's turn things around, and from what you've seen. What is missing? I mean, what really has not been mentioned in this MDRI VDR amendment proposal that you would have expected, or you would like to see being introduced during the legislative proposal? So I don't know, madelena, you want to, To share your view on that.

Okay, so, There are some points that we highlighted as notified bodies that, have actually not been included in the proposal that we saw. Let's… So, for example, simplification of codes. So, this might not be fully visible to manufacturers, but there is the need to consolidate and simplify notify body codes for medical devices and RVDs. Because the, current granularity of these codes is, burdensome, and, having them being consolidated would increase, efficiency, coherence, and… and… and also will increase the efficient use of notified body resources. Obviously, this has

an impact on manufacturers as well in the end, because consolidation of codes would allow for more flexible deployment of our assessors, technical experts, and therefore, this would result in better, lead times. And, the second point, that is impacting notified bodies, but indirectly manufacturers as well, is in relation to designation of notified bodies and the requirements for our personnel. The proposal introduces some target measures to improve, the efficiency, in relation to oversight, for notified bodies, but it does not address,

needs in relation to competence, proof, or consolidating, as I said, codes, and So, one critical area that remains unaddressed is the challenge of demonstrating our personal competencies, and this, again, impacts manufacturers indirectly because of the impact on our resources.

Thank you. Theory and Alex, anything you would like to add to this wish list?

Well, from IVD perspective, I think it would have been a good opportunity if there were also, you know, specific rules for genetic tests and IUD software for classification. but also multi-analyte assays. This is a theme that many IVD-notified bodies still need to get to grips. It is practice, it is reality, but it's quite difficult to wrap a certificate around it, so it would have been nice if that had been taken on board. The objective, as said, of this proposal is to simplify things, and one of the simplifications is there are many mutual responsibilities that reside with competent authorities and notified bodies.

for instance, vigilance, would have been, you know, better if they would take a further step to connect, and disconnect these responsibilities, which still creates a lot of confusion. So I think that's… that's also something that is missed, Yeah, that would be it from my end.

Okay… Anything else to add, Tyrion?

Yeah, I mean, I… yeah, I agree. Maybe not so much on the IVD side, because Alex is the expert, and Scarlett doesn't get involved with IVDs, but, yeah, I definitely agree with Madelena that, you know, there was a lot of opportunities for reducing administrative burden for notified bodies, and that would result in, kind of, I guess, the cost savings that manufacturers have been calling out for. and those kind of seem like missed opportunities at the moment. I think even, you know, there was a big focus on digitalization, and, you know, there was even sections on digitalization of conformity assessment, but no real discussion of what that would look like. There's still a lot of, kind of.

paper-based language, around conformity assessment and the reports that notified bodies need to produce. So yeah, but I guess… I guess we'll see. It's… it's still early days in the… in the proposal, so yeah.

Thank you. Yes, it's early days indeed. Alex, you mentioned IVD. I would like briefly to come back to that, because I did not detail IVD in my helicopter view. What do you see as the main changes on IVD in these proposals?

I think, first up, that… A very good change is the introduction of a special pathway for orphan devices and breakthrough devices. In the past, under the IFD directive, most of these devices would go through cell decoration, which would give manufacturers a little bit more freedom to place these on the market. if they now need to go through the notified body system, in some cases even go through consultations, that does give a lot of burden. And if you compare that with the risk versus benefit, if it's a device which really benefits the patients much more than any other alternatives. you need to have a special process for that. And I think the document that is being put forward really lays the groundwork for that. There's perhaps some discussion back and forth, but I think it's looking quite nice.

I think for IVD, again, there are some requirements on in-house testing, which make it a little bit more helpful for health institutes to place these on the market. Sometimes in-house devices could actually transfer between locations. I think as well, Companion Diagnostics, the consultation process, has also led to some simplifications, which I think is good. And also for conducting studies, which I think a lot that ended up here in this proposal came from the combined project, which was put forward. And especially, again, to support innovation, to make sure that devices are placed on the market in a quick fashion, and also done in a safe manner.

is really being supported. So, I think that's, that's, these, all of these things are the ones that really have an impact. Yep.

Okay, well, thank you. Lots of, of proposal, and from what I hear, most of them positive at this stage. We need to see how they will pan out, and they will be developed, but, very, very interesting. Changing gears, I see in the, in the audience list that we have mostly manufacture. Now, you, you panelists are a distinguished notified body. for manufacture, what would you advise them to do at this stage, knowing that we have this proposal, not final, but this proposal, which will lead to legislative changes during the course or towards the end of 2026? What would you recommend them? I… I don't know, Tyrone, if you want to start with, with your view.

Yeah, I think… I think everybody can agree that there's a lot of changes that are being proposed at the moment, In terms of advice, I think… especially at this point, while there is so much noise, and I think it can become very easy to get distracted, and to… to worry about the timelines, and to, maybe not… not necessarily be certain what… what you should be doing from your, kind of, compliance strategy. I think we've seen, you know, often there are changes, and then there are revisions to the changes, and then there are more revisions, and I think, you know, it's… it's almost, kind of, ignore the noise and just keep doing what you're doing. While we have, kind of, certainty in what the regulatory framework looks like at the moment, then you can have, kind of, confidence that your current strategy works, and if you can get your devices through conformity assessment and onto the market while it's… before these changes come into effect, I think…

There will be a lot more certainty.

Thank you.

I mean, for IVD, I've said it before, and I keep repeating it, stick to the plan. The current regulation is still in force. This is a proposal, and a proposal means it's going to be negotiated back and forth between parties. And, if, you know, as a manufacturer, you would, already bank on some of the things that are mentioned in the proposal. while the current regulation is into force, and it turns out that the proposal changes, then you need to basically go back in your original strategy, which always leads to a big mess, I would say. So, again, until there's full certainty on actually what the regulation is going to look like, I wouldn't bank on it too much. Wait what comes out of the trial log. The trial log will take months, if not years.

And, I'm pretty sure that a lot of good stuff will remain in the proposal as is, but, you know. Don't, don't, already, bank on that.

Yeah, I agree, these are, as Alex was saying, this is just a proposal, so we don't know exactly what the final text is going to be, and we don't know exactly when these changes are going to be implemented, so it's really important to just Do not pause, your efforts as manufacturers. Do not wait and, proceed with your transition to MDR and IVDR. Maybe, you know. Taking into consideration, or looking at the further developments, but still, we don't know exactly what the final tax is going to be and when.

And indeed, as you mentioned, the transition time are not changed and modified. So, this is the structures, this is the framework, this is the governance, and some of… plenty of other details, indeed. But the timeline remains as such, so effort should proceed without stopping, and I think no one will advise manufacturers to sit on their fingers and await to believing that everything will become free and easy and cheap. This is certainly not the case. So, for manufacturer, yes. For notified bodies, I mean, Magnalena, maybe you have a view on that, or you can start audits. I mean, there's a lot of changes in this proposal on audits.

I mean, unannounced audit, only 4 calls, the periodicity of the routine audit, remote audit being lowered. How do you perceive that? What is your feel as a notified buddy and an auditor?

So, yeah, as you were saying, there are many changes that are being introduced in this proposal. I think they can, these changes can maintain, evaluate oversight if. They are implemented with strong safeguards, but they also, I think, introduce some kind… some risks. That need to be, managed, you know, carefully. So, the proposal is to move away, in some cases, from annual surveillance audits or, routine technical documentation sampling towards a more, risk-trigger kind of reviews. Obviously, this can allow the third body to focus resources on.

High-grist devices, for example, or on manufacturers that have some, let's say, compliance signals. and also in relation to remote audits, they, prove themselves to be actually effective during the COVID period for certain scenarios. We are already, using them, so there is proof that they can actually ensure the same level of oversight as the on-site audits, so, having them been formalized, obviously, it's, it's an improvement from our perspective, but as I was saying, there are also, potential risks. For example. Because eliminating this routine, surveillance, might, reduce early detection of, some issues.

And… and especially in relation to the removal of the, periodic unannounced audit that is now proposed to be, limited to, for-cost audits. While proportionate this removes, I think, a powerful deterrent, so the, it's important to, have, transparent and consistent criteria to, what's going to trigger a full cause audit. So, there is no, actual, So the proposed changes do not fundamentally weaken, oursight, but, it's really important to have some clear risk-based criteria when there is a need for deeper checks, or, and it's really important to have, for manufacturers, to have a strong

Post-market systems and vigilance systems, to… To make sure the device is continuously to be safe and effective.

Excellent, excellent. I can see time is running away. I want to make sure to cover, Tyron, digitalization. I mean, your notified body, as by its scope, is very involved in everything which is digital. How do you see the proposed changes, and what would you suggest?

Yeah, I think, I mean, in terms of, I guess, software and AI medical devices, I think one of the… one of the really interesting changes in there is, the change to the classification rules around, so, Rule 11. It's not a… it's not a huge change that's been brought in, and I think the, you know, on… on first read, there's still a lot of… gonna be a lot of, kind of, confusion about Class 1, software medical devices and if that exists. So I think… I think… I think that's one of the… one of the big changes, and one of the, kind of, conversations that we're… we're talking about a lot since the proposal has come in.

I think another one of the big changes in there is, in regards to the AI Act. I think everybody, or at least I was expecting, this targeted revision to focus solely on the, the MDR and the IBDR, but they… but there is a provision in there which moves, how medical devices and IVDs are treated within the AI Act. It seems, kind of, on first read, like, the conformity assessments are going to be quite aligned, and in general, the AI Act conformity assessment is going to be brought within the, kind of, MDR. conformity assessment, but the notified bodies are still going to have to be designated under the AI Act. So I think it's going to be a really interesting area to keep an eye on and to understand. Obviously, the digital omnibus came out recently,

And that's kind of proposing different changes as well. So there's obviously lots of things going on, and to echo the kind of earlier point that we were talking of, kind of stick to the plan, and let's see how these things settle.

Okay. Again, time is moving, moving away. One last question before we move to, opening to the, to the audience. I mean, structured dialogue is something that you indeed have started, limited with restriction. How do you see this proposal to open that to be actually is a norm, and not only something which will be on a hadoc basis. Is there… Alex, do you want to take us to start with this one?

Yes, I think having the structured dialogue in as a requirement is very much an added value. I think the better there's a mutual understanding between notified bodies and manufacturers, the better the manufacturers are able to prepare what the notified body needs without, you know, being, you know, consulting. If you look at the Implementing Act, it, talks about structured dialogue, pre-quotation, so, before an application is sent in. My reading of the current proposal is that structured dialogue is not only before, but also after application, which I also think is a good thing. Again, structured dialogue is a bit of a new process, also, for notified bodies. Notified bodies

We'll need to also get this under their skin, but once it's properly prepared, and once manufacturers as well as notified bodies know where the pickets are, and every body remains within the pickets, it should be working fine. Now, there's also another, you know, requirement on early advice, and I think the… Proposal talks, or refers to that, to scientific advice. Now, scientific advice and technical and even regulatory advice is proposed to be handed over to the expert panels. That is going to be run by the EMA. Now. Expert panels very much have a good understanding of the science, and also of the state of the art, because sometimes they also see this in current practice.

I'm not so sure… How the expert panels will be able to understand the technical and regulatory requirements, especially for devices that combine all different kinds of technologies, and even also different kinds of regulations. That is, certainly a tall order. I would still… You know, very much emphasize that the notified bodies should have also a role in that, but then team up with the expert panels in any shape or form to make that happen. Otherwise, in my view, it's also going to be very complicated. Again, who's taking responsibility? Who listens to what? And, you know, notified bodies are sometimes compared with the FDA that have everything in one house. This will not make it always easier. So, I understand why it's there, but, you know, I'm a bit hesitant to see how it is actually going to work. Early advice.

Interesting. Any, any other view on, on this point?

Yeah, I… I mean, I fully agree, agree with the points there, and the concerns. I think, I think it's… I think it's great, and I think it's really helpful to have. a platform for notified bodies and manufacturers to have, kind of, open conversations with the right kind of protections in place, and kind of a shared understanding of the right protections as well. I think one of the concerns I have is that it just… it could become an extra step You know, if you're bringing in structured dialogues or early dialogues before application, before a manufacturer is kind of committed to a notified body, you know, from a notified body's perspective, there could be, you know, a lot more work there, kind of engaging in kind of

detailed conversations, but from a manufacturer's point of view, you could get kind of overwhelmed by wanting to speak to all these different notified bodies, and… and it could kind of actually delay… delay things. So yeah, it's… it's… it's gonna be… it's gonna be interesting, even just seeing how the dynamic between the notified bodies and the manufacturers plays out.

Excellent, excellent. Well, in closing for this, for your three panelists, I mean, can you very shortly give your view, your idea, your perception of the smell of this, of this proposal? How do you feel? Do you feel good? Do you feel like a Christmas gift? Do you feel bad? Do you feel weary? How would you… would you summarize that at this stage, knowing it's not fully digested and it's just a proposal at this stage? who want to start. Madelena?

Yeah, so, there are many proposed changes being introduced, Some that, I think are aligned with the expectations, others that, at least from our perspective, might be, maybe a little bit risky, to be introduced, but, But of course, as we were saying, there are… there is still time to, for stakeholders to provide, feedback and comments, so the… the current tax is not the, definitive one, so there is still time, and there are, proposals being introduced that will for sure, harmonize practices and.

We'll streamline The legislation, but there might be some, some proposals being introduced that, at least from a notified body perspective, might be a little bit risky.

Interesting. Yep. Yeah.

So… so… Alex? Now, to keep a little bit in the Christmas spirit, I see the proposal a little bit as a combination of the Ghost of Christmas past, the Ghost of Christmas present, and the Ghost of Christmas Future. I think the document has some very good elements in it that make it future-proof. At the same time, there are also elements in it that basically brings us back to the old directives. And, I personally do not see how that will, improve the safety, and as, as, you know, was already alluded to, removal of an announced audit just making them for cause. Limited sampling in some areas. I would even dare to say it would be less than what we've seen in the directive days. And I don't think that should be the objective of the regulation. Nobody will get better from it, and I do hope

That, you know, we'll have a better understanding on that. Apart from that, let's see how this document is going to smell in a couple of years from now, because let's see how this develops. It is good that it's put forward, and I understand the discussions, because that's what we like in Europe, but now let's see if we can really turn this into something nice.

Tyron, do you think as well, some of the part of it is a step backwards, and could actually, in fact, affect product safety?

Yeah, hard to say. I think, yeah, there are, I think there are still plenty of provisions in there which… which protect patient safety and… and kind of are… are an improvement on the… the directive days, but, I… I… I can also see that there's a balance. I think… I think the best… the best outcome of kind of having this targeted revision in hand at the moment is that you can see more concretely, you know, where are the areas that people are wanting to focus on. I think there has been so much noise in the build-up to this, and lots of different people putting forward different ideas, and now we have something concrete that we can actually, you know, work on, and provide feedback on, and kind of go from there. So yeah, I think it's an exciting, an exciting revision.

Smashing. Alexia, do we need to move on to, or can we move on to the, audience question?

Thank you so much, Philippe, and indeed, we received a lot of questions. Quick heads up to the audience. As you can imagine, in 10 short minutes, we won't have time to go through everything, but we will, of course, put in an effort to try to get back to you all individually post-webinar, as much as we can. So, Philippe, question to you before I suggest some. Have you identified some in the list that you would particularly want to priorit prioritize?

I did, I did, and I can run through that, but as you mentioned, realizing we will not cover all the questions, and in fact, we may not have all the answers. Certainly not.

Indeed.

So, but some of them stick to be extremely pointed and accurate. I would like to start with this one, and I read from the Q&A here. The proposal talks about issue with fragmentation, decentralization of notified body, lack of alignment. Do we have any hopes that this issue can be resolved or improved? And it resonates to me that, yes, it is embedded somehow in some part of the proposal, but we also have another document, which was released some day before this proposal. Which is a draft procedural requirement for notified body modifying Annex 7.

So, I don't know if our panelists have a view on that, and how that can lead to more harmonization.

I go first? I… I… I think, you know, from a… from a notified body perspective, like, I… I welcome more harmonization, especially kind of from the competent authorities and the different member states, and… and I know there's some suggestions in there to bring in joint… joint assessments. kind of more regularly, and although that might be a lot, it should bring in more harmonization and kind of the requirements that we're subject to. I think the, the implementing Act that was proposed for the Annex 7 notified body requirements, is a very interesting read, especially when put next to this targeted revision. There are some potentially conflicting requirements, especially around the recertification. So yeah, I think… I think it's interesting to think about how the notified body consistency can come in.

I also think that… You know, there is… there are some opportunities for… friendly competition between… between the notified bodies, and not… not so that we would kind of diverge in our approaches, but more that we can push… push ourselves forward, you know, thinking about the timelines. It's more exciting to think about, you know, competing with… with Madelina and Alex on improving timelines for conformity assessment, rather than trying to hit some strict timelines and stop clocks that are That are written into, to, to legislation. Yeah, interested in your thoughts.

Yeah, NXFN is very much an operational specification. If you look at it, it contains clock stops, timelines, monitoring. And, which will help to harmonize the notified bodies, I guess, on the primary process, but notified bodies do much more than that. I think if you take a look at the proposal, you also notice that the oversight of notified bodies is organized differently. One of the things that has been proposed is no reassessment or no redesignation audit. That typically is joined up by the joint audit team from the European Commission. But instead, they would like to do that more frequent, or, you know, during, the entirety of our designation.

Which, to me, means that, you know, the European Commission is much more on the shoulders of notified bodies than in the past. You know, and, perhaps that will also lead to more harmonization, but we need to see. I'd love to hear from you as well, and Madeline, on that.

I just want to add that greater harmonization is really a key priority for us as notified bodies, and it's something that we are actively pursuing. We do already collaborate really extensively to align our approaches within the remit of TMNB and NBCG Med, so we… there are many working groups, including representatives from various notified bodies, in order to harmonize practices and interpretation of regulatory requirements, because we want to ensure that there is consistency. across different notified bodies, we, continuously working… we are continuously working on developing and publishing guidance documents.

We do engage in regular discussions, as I said, working groups, we want… we always want to address emerging challenges, we do share best practices among us, we are really on common positions. There are also, within TeamNB, we do organize trainings that are open to notified bodies only, and so members from some notified bodies do train members of other notified bodies. We do have also trainings that are open to manufacturers as well. delivered by notified bodies representatives. So, really, harmonization is… it's really important for us as well, and we are already working on it, and we will continue.

To work towards that.

Yeah, we already do a lot.

Yes. Oh, goodness, yes.

Aaron, anything to add?

Yeah, no, I think, I think there's… I think there's loads of, you know, harmonization activities that… that we do get involved in, as… as the others have alluded to. I think even, you know, even when we're putting forward proposals for, you know, the input to what became this targeted revision. I think there's a huge amount of coordination that happens in the background, and, you know, discussion between notified bodies is a big part of how the system works.

Yep, thank you. Alex, that's a question on IVD, which is regarding companion diagnostic leftover specimen notification. how this is, handled. Notification may not be required for this study, but the ethical committee will still be. How do you read the provision? How do you foresee this, taking effect?

It's a very specific question. I have also read that, indeed, for the notification of using a specimen. a leftover specimen for companion diagnostic, there is no, requirement anymore. In relation to, you know, ethics committee, approval, and whatnot, I think there's nothing set in the proposal, so I think that will remain as is, so…

Okay.

Based on what I've read.

Thank you. We have another question on the timeline for the implementation, so I think we more or less discussed that in the presentation earlier. This proposal will be subject to the trilogue. And this will go from the Parliament to the Council, and it will have to be discussed and approved. Normally, as I mentioned, it takes 9 to 11 months. But it may vary considerably. I think Alex was less optimistic and positive, with what you, you said. For the NDR IVDR, it took, it took nearly 3 years. But in this case, one may hope that it will get a little bit quicker, specifically because we have the formal review of the regulation, which is at the end of 2027.

So, probably all the players will want to put some experience under their belt, before this, this revision kicks in. But this is really crystal ball at this, at this stage.

I try to be realistic regarding the time, because I'm already too long in this space, but… I do think it's going to be faster than the original publication of the MDR and the IVDR, because it's a targeted revision, and I think there's been quite an extensive consultation, but You know, it's still Europe, so let's see how quick this goes.

Surprise are possible, always, yes. Yeah, and really interesting and provocative question as well. Have you identified requirements that are planned to be handled more stringently for medical device manufacturer? We've talked about simplification, but are there some provisions that will be more difficult for manufacturer to be met? That's a rather provocative question. Yeah.

off the top of my head, I'm… I'm struggling to think of, think of them. I don't know if Alex and Madelena have got any, but I think all… a lot of the areas where I've seen it actually being more stringent, are on the requirements around notified bodies, but, Yeah.

I think there are different requirements in Annex 1, the GSPR. I mean, we're mostly talking about the articles, but there's also the annexes, and specifically Annex 1. There are additional requirements, or change requirements, that could raise the bar, but this is very much on the technical and the design side for manufacturers. I think there's also a connection with other regulation, I mean, that needs to happen. But that would also not make lives easier for manufacturers, especially if they need to demonstrate the evidence and the technical documentation. Perhaps, you know, the digitalization and AI will solve all of that.

Who knows?

Any other view on this one? If not, we certainly can, can move on to, To some other question. There's a question about, drug-device combination. What are the impact on drug-device combination? Specifically, our notified body are looking into it for providing their opinion. Have you digested this, this part of the, the proposal, and, have some view on that?

They can't…

From an unified body standpoint?

I can't recall any change, any proposed changes impacted specifically that. So I don't know if others, have noticed it, but I'm not sure there are any changes impacted specifically. combination devices.

Now… not so much on combination devices. For IVD, there is the consultation process for companion diagnostics, and there are a few changes there, although you cannot really call a companion diagnostic a combination device. In the IVD, the definition of an IVD has changed, because it now further explains if it's combined with a medical device, under what regulation it tends to fall. And under the definitions, also the IVD kit has been, mentioned. that can also contain, you know, medical devices. So, if your question, Philippe, or of the audience is accommodation devices, medical device and IVD, there are a few changes in the IVDR. If we talk about drug-device combinations, I'm not able to tell.

Thank you, Alex. Alexia, how do we do with time?

We are perfectly… well, almost perfectly at time. We're over by 2 minutes. I hope that the audience will not bear a grudge, but of course, there's so much to go through, and thank you to the audience for all of these questions. As said before, we will do our utmost best to come back to everyone individually. I, of course, want to thank our speakers profusely for taking on the challenge. of looking at the first steps into digesting the proposed revision, and taking so much time with us to prepare this webinar. We're getting a lot of claps, a lot of thumbs up, so that goes to you all. Thank you again so much. Thank you, Sean and MLV, for hosting the webinar with us today. Accra team.

And, of course, for any follow-up questions, you know where to find us on LinkedIn, the speakers directly, or ourselves at ACRA Team, Sean with MLV. We do look forward to hearing more from you. We will be hosting more topics and webinars throughout 2026, so do stay tuned, and we hope to see you online for the January 22 webinar on the regulatory roadmap to plan out for 2027. 6. Again, thank you so much, everyone, and I wish you all a very pleasant day or evening.

Thank you, and if I may, I just would like to thank again our speaker, Alex, Madelena, Tyron, for the depth of their expertise and answer, and devoted time.

To this, to this webinar.

Thank you so much, and Merry Christmas.

Much appreciated, Philly. Everybody else, thank you very much, Happy New Year, and see you soon.

the holidays.

Thanks, everybody, for sharing your time with us today. Speakers, audience, please take the survey, provide your feedback, it's very useful to us in helping us understand what you'd like to see more of. Thank you, and have a great holiday.

Thanks, everyone, bye-bye.

Bye-bye.