PODCAST: Stuck in a Holding Pattern: The IVDR Revision and Planning for Two Markets at Once

Sarah Barchard: I'm Sarah Barchard, Senior Clinical Trials Manager at DCN Dx.

Dan Simpson: And I'm Dan Simpson, Director of Regulatory Affairs at DCN Dx. And this is Expert Insights. There's no host today. Sarah and I are going to talk through something a lot of people are dealing with right now, and we come at it from two different chairs.

Sarah: It's hard to miss what's going on. As of late May, notified bodies are warning that IVDR submissions have slowed down so much that some of them might have to close, because companies are waiting to see what the IVDR revision looks like before they file, and the old deadlines are still running out. So that's what we want to get into today — what the waiting really costs, and what it looks like to plan well when you have to sell in both the EU and the US.

Dan: It's great to be chatting with you today, Sarah.

Sarah: I'm so happy to be here, Dan. It looks like we're going to talk through some of the things surrounding the IVDR today and what's going on in the industry. For background knowledge, everybody — there was a proposed change to the IVDR at the end of 2025, and Dan and I are going to talk a little bit about that. There was also a document that the notified bodies issued at the end of April, I believe early May, talking about some of their concerns that are encompassed in that proposal.

Dan: Yeah. So I think there's always a lot of angst and concern amongst our clients about IVDR, and hopefully we can add some calming effect to people out there. But also we're going to be doing a webinar soon about how you can plan for both a US and an EU submission. That will probably be more of the second part of this podcast. But I think probably on people's minds first is this revision to the IVDR.

Sarah: Right. So Dan, do we want to talk a little bit about what was primarily included in those proposed changes? I think maybe just from your perspective, the really big highlights would be helpful for people. And then maybe we talk a little bit about what the concerns are from the notified bodies' perspective.

Dan: Yeah, absolutely. So as I think everybody knows, the transition to IVDR has not been very smooth. It's been rather bumpy. It's been going on for more than ten years now. And really what the problem is, is back in the day with the In Vitro Diagnostic Directive, 90% of IVD companies didn't have to go through a notified body — you could self-declare. Now it's kind of inverted. Now 90% have to go through a notified body. So guess who's really stressing? It's the notified bodies, because they have all this massive workload now. And so that has been the issue. So the EC — the European Commission — has realized this. And what they're worried about now is that there could be a public health crisis, because if companies can't get their products on the market in the EU, EU patients are going to be the ones that suffer from a public health perspective. So they're stepping in now and trying to alleviate some of the burden on the notified bodies. And it really comes down to the Class B and Class C devices — Class B being the more moderate risk classification and Class C being higher risk, even though the highest risk is Class D. So with Class B devices, they're really talking about the technical documentation — that you could have a whole product family under the same technical documentation, where before it was very much product to product. That's in their proposed document. And then there's a lot of just administrative things that they're trying to alleviate.

Sarah: So you mentioned some of the concerns the notified bodies have now, which is interesting — because before they were like, "Oh, this is too much stuff for us to do." Now they're saying they don't think the new proposal is actually going to protect public health, because it's going to mean not enough information to prove safety and efficacy.

Dan: So it's kind of what the EU is dealing with — the old regulatory pendulum swing. We went too far one way, now we're going too far the other way. And when are we going to actually land in the middle? Yeah, clients are waiting now to see what happens, which might be a good thing to do especially if it's a new product, because we're not exactly sure where it's going to end up on that pendulum.

Sarah: I think for the most part, a lot of it's not going to change the requirements — it's going to be more on the administrative side. But there could be some things about technical documentation that might be more lenient. It's kind of a decision whether you want to proceed with what the requirements are now or wait. But I mean, it sounds to me like what you're saying is not necessarily that the framework or the requirements are going to change with this proposed change, right?

Dan: It's more that we're going to see a less burdensome pathway than what's originally proposed in the IVDR, if they incorporate some of the changes. I think they've released the proposed changes, but they're not going to act on them — they're not going to do anything with them until the end of the year. And then they're going to put them out for comment, just like they do here. So we're not going to see any real decision on any of those changes for probably another year.

Sarah: That's correct. And I think it's also important to note — we're talking about new products here. I think there hopefully isn't confusion if you're transitioning your products from the IVDD to IVDR. Those timelines are still in effect because for those timelines, like Class C, you should have already sent an application in to the notified body — you should have that in place because that is a requirement. So that is still continuing. Class C products don't have to actually be on the market for many years still, but you still have to have an agreement with a notified body and get some of that application work done. That isn't being affected by this transition.

Dan: So just a note on that side. In the States, we talk a lot about whether something is a Class 1, Class 2, or Class 3, and that's kind of how we set up our clinical studies and decide on a regulatory pathway for some products. Can we talk a little bit about what a Class B product really looks like and what a Class C product is considered in the US vs. the EU — and then how that's going to change our regulatory pathway?

Sarah: So the pathways are definitely different. I mean, they're visibly different — the words are all different. They don't make it easy for the average person to understand. But when it comes down to it from a development perspective, you're usually doing the same validations, the same tests. Where it really comes out differently is the regulatory submission, the pathway, and the documentation.

Dan: The documentation is much more — I would say aggressive — on the IVDR side. A lot more of it, and it has to be more proactive. Going into risk classification — that's a great place to start. Obviously in the US you have Class 1, 2, and 3. Over in the EU under IVDR you have A, B, C, D. What that means is you get classified differently. In the US, you look for product codes that are already on the market that are similar to yours, and it'll tell you if you're Class 1, 2, or 3 — and it'll even tell you what the submission type is. You look for predicate devices to do a 510(k) pathway. Over in the EU, they have classification rules that you go through, and it doesn't have anything to do with what's already on the market. It's exactly how your device performs. So that's really the biggest difference — there's no such thing as a 510(k) under the IVDR. So you could have a test that has a million predicates in the US, but over there you're going to be classified according to those classification rules. You might be a me-too 510(k) in the US, but you could be a Class C or even a Class D in the IVDR and require a lot more documentation and validation-type studies.

Sarah: So that can be where the disconnect happens. And I think it's really important for us to look at that when we're planning for a product that could potentially go into both markets — if we have a client that comes in and they want to market their product here in the US and also in the EU at some point, it's important for our teams to get together to do a parallel planning. Because like you were saying, the documentation is different. Maybe not necessarily the way that we run the study. We've talked about this before — I think you agree that we could potentially run a clinical study that generates evidence to support both an FDA submission and a submission in the EU. We could do that with a single protocol. We could do something where it has a different version depending on the regions, only because the protocol — a lot of the time the study plan has to get submitted to an ethics committee before we can execute on the studies. And that's the same for the analytical pieces in the EU versus here in the US.

Dan: That's another documentation piece that differs. Here in the US we may have a plan, but we don't necessarily have to submit it to the FDA and get them to sign off on it — or even internally sign off on it — before we actually execute on the study. That's a big thing in the regulatory documentation piece for an IVDR study.

Sarah: Right. And I think what you're referring to is what they call the Performance Evaluation Plan — and then the report. So performance evaluation under the IVDR includes scientific validity and analytical testing, and then the clinical testing — the clinical validation that you would do. A lot of people talk about performance evaluation in the US and they might just mean analytical, or they might mean clinical — but it's not that comprehensive definition that they have in the IVDR. And to your point, you have to have a plan for how you're going to do all of that. And a lot of times in the EU that means you do a lot of literature searching even before you do any of your analytical or clinical work, because you have to prove that scientific validity part — which isn't as big in the US. And they also talk about "state of the art" — which in the EU you might think of in the patent sense, as in "I'm state of the art because I'm novel and good." In this case, it's not necessarily good to be novel, because you want to show that there's a lot of evidence out there that your device will be safe and effective — because there are other products on the market with good safety and performance data.

Dan: That's what you have to deal with as far as differences. Again, the documentation — you can't leverage a lot of things that you've done before like you can in the US. You do go off of standards, but you have to also go beyond that. And so I think that points to what you were talking about earlier — proactive with the IVDR versus reactive.

Sarah: Right. So we're planning everything on the IVDR side upfront. It's not that we don't plan things here in the US, but there's a lot less of a case that you have to build before you can move forward. You have to document it and show your planning in the IVDR — and again, like we always see in the regulatory world: it didn't happen if you didn't document it.

Dan: Another thing we wanted to talk about, Sarah, was self-testing devices — what we call over-the-counter in the US — and near-patient devices, which we call point-of-care, and the differences there. Maybe you could start with the clinical study side and how we do it in the US, and then we can talk about some of the differences that might happen.

Sarah: Yeah. So for a CLIA-waived test that's over-the-counter here in the US — we're designing a study that's essentially going to be looking at how a lay user is going to interact with the test, and if they're going to be able to get the expected results, if it's safe for them to use it, and if it works the way that we say it does. And we do that in a number of ways — we test from a user standpoint how easy it is for them to interact with the product. So is it easy to open the packaging? Is it easy for them to follow the instructions? Is it easy for them to conduct the test? When we do something that's more of a point-of-care — you're talking about a user who's not necessarily laboratory trained, but they are medically trained. So they can handle infectious samples, they know how to keep themselves safe from potential contamination — but they may not have run high-complexity assays in a laboratory setting. It may be that you're putting a specific sample collected in the clinic onto something that sits on a tabletop and testing that, looking for results in a quicker amount of time, essentially. Those studies we look at from the user standpoint, depending on whether they're a lay user or somebody who's more medically trained. The FDA, I would say in the last 5 to 7 years — especially with the pandemic, when we saw all of the upper respiratory tests that were coming in and being submitted — the agency has been scrutinizing them more, and they've also become more understanding, and the pathway to getting those to market has become less burdensome than it was initially.

Dan: I think under the IVDR, those tests are looked at differently — they require a special type of review only because they're considered Class C. So the self-testing devices are all Class C. That can be a little different than in the US. For near-patient or point-of-care, they're classified as they normally would be. What I see as the difference from what you were just saying — everything you said in the US is under that CLIA waiver guidance. The FDA is very prescriptive about the type of testing. If you look at the guidance, it says you need to look at the orientation of an instrument — all these things that users could potentially get wrong — and environmental conditions, which is one of the big things. In the EU, when you do what's called a conformity assessment pathway — which is the submission pathway for IVDR — there is a section in those annexes about near-patient and self-testing assays. All it really says is that the notified body will take into account the intended user and the intended use environment, and ensure that the validation the sponsor is doing addresses the needs there. So you go from very prescriptive on the US side to every product potentially being different in the IVDR.

Sarah: And hopefully if you do CLIA waiver testing in the US and then go to IVDR, the notified body will say the FDA liked this type of testing — and hopefully they will too. But you're not guaranteed — they may want simulated use testing. That's something you have to be cognizant about as a manufacturer. You were talking about how potentially the ethics committees could accept clinical work similar to what we do here in the US for a CLIA-waived product. And we talked a little earlier about developers and manufacturers wanting to plan for both a US and EU market. That's something really important for clients to consider when designing their clinical evidence and analytical evidence — that we're satisfying both markets, or at least we can draw from a single data set to satisfy the requirements for both submissions.

Dan: Yeah. I think the message here, if I look at it from a regulatory perspective, is that you can design a single protocol to rule them both. And once you do that, it comes down to showing that the US population versus the EU population are going to be a similar data set from the disease state — ethnic diversity and how that might affect that particular disease state. That's where I've seen FDA have a lot of issues with using foreign data. The EU will be the same way. And remember, the EU is not one country — it's a region of many countries and many ethnicities. So there are different competent authorities within the EU, even though they all kind of talk to each other under IVDR.

Sarah: I think you and I had talked about this — when it comes to clinical studies, even though a submission for IVDR covers all over the EU, when you're doing a study in the EU, you have to go to the individual competent authority to do that study, especially if it's what you call an interventional trial — which is like the IDE in the US. That's who looks over the clinical study. And you'll probably go to an ethics committee within that country. So that's where there's a big difference. And you really have to make sure in the EU that where you're running the study is representative of the whole EU as well.

Dan: That's where it can get a little complicated with the IVDR for sure. I think also it'll get a little complicated because each of the ethics committees could potentially have a different interpretation or a different requirement for the study depending on the region or country they're in. And from just a bird's-eye view, the focus for a lot of the ethics committees is more on the continual evaluation of the product over its entire lifecycle — versus here where we have the IRB, where we submit to an independent review committee to have them review the study for research and whether the subjects' rights and welfare are being protected.

Sarah: Right. But the notified bodies in the EU are really looking at what the performance evaluation looks like for a product over its entire time on market — not just before you submit it to have it reviewed and cleared for use to the general population. I think it's good that we made that differentiation. So the ethics committees for the study are basically like the IRBs in the US — they're going to look at the same things. But the difference is if you're running it in different regions or countries in the EU, you might need several different ethics committees in those regions. And to clarify — the competent authorities in the EU, which are the FDA equivalents for the individual countries, do not do the reviews of your product like the FDA does. They outsource it to what are called notified bodies. So that's who's doing the review.

Dan: And yes, they are more concerned with the ongoing piece — which we may talk about more on the post-market side. But you're never done with the IVDR. In the US you do your 510(k) and you wipe your hands and walk away. You never have to continually go back. You do have to do that with the IVDR. I think before we leave the clinical study topic — Sarah, if you came to me and said, "What subjects do I need in what countries? What's FDA going to say if I use EU data?" — what would I tell you? I'm quizzing you right now.

Sarah: Oh, our favorite thing, Dan — we go in with a pre-sub! Yeah, why wouldn't we do that? That's our favorite thing.

Dan: That's the answer I was fishing for. Yes — anything to do with clinical study design, always go through a pre-sub. But here is the problem with the IVDR — there's no pre-sub equivalent over there, unfortunately. So you can't really get in front of the competent authorities. But the notified bodies are getting better about talking to sponsors, so you can get some of that information — it's just not going to be in a formal meeting. So that's kind of where the IVDR lags a little bit — on the early communication side. You're going to have to work a little harder with the notified bodies to get answers on what the EU might require for their study versus the US. But in the US, we have the beautiful pre-sub process where we can talk to FDA about what they want in the study ahead of time — before you get your 510(k) back saying you didn't do it right. And Sarah, you have a lot of experience doing that.

Sarah: And I think a lot of our clients give Dan a gold star for that — his interactions during the pre-sub process and during the review process. I think we've had a number of clients really say that they're happy with the services they get from regulatory. And Dan's seasoned in interacting with the agency. So I would encourage anybody who has any questions about the clinical or analytical work that they're needing to do for their product to come and chat with Dan offline about the need.

Dan: Well, thank you — the pre-sub is our favorite thing.

Sarah: It is — we both love the pre-sub. We do. So Dan — now that we've talked about pre-subs — what about afterwards? Post-market.

Dan: Yeah. Different philosophy in the EU about post-market. In the US we have complaint handling, we have adverse event reporting, we have recalls. All of that is very reactive. It's not that the FDA doesn't see the value of being proactive, but the requirements revolve around reactive methods of collecting data. So you don't know about it until something's going wrong in the field. Basically, in the EU, they've always described the post-market process as being "vigilance." So that word already tells you — you're being vigilant, you're looking ahead, you're monitoring, you're surveilling the situation, looking for anything that might indicate there's a problem before there's actually an injury or a death or a problem of any type. And so that means in the EU it's more about doing literature searches to see if people are maybe using your product off-label. There's the concept of feedback where it's not necessarily a complaint, but the customer is saying things that would improve your product — and thus might actually improve quality later on. There's also surveys and things like that. There's all these things that are more engaging with the customer.

Sarah: And then again, you have to prove you're thinking about this ahead of time. In the US we create procedures in our quality system for complaint handling, adverse event reporting, and recalls. You have to do that in the EU too, obviously under your quality system. But here you have to do what's called a Post-Market Surveillance Plan ahead of time. You have to show that to your notified body as part of the application. You have to think about it even before the product is developed — how you're going to monitor it in the field safely and show that you're being vigilant. And then every year you have to do a report off of that plan once it's on the market — showing you're meeting your objectives, keeping adverse events down to a certain rate, doing all of your follow-ups, checking in with customers.

Dan: So that really is just a completely different and more resource-intensive process than in the US. It's like 1 to 2 more people to maintain under IVDR, honestly — and that's what people have to know. And all that documentation lives in the technical file under the IVDR. You have to continuously update it — those reports go into the file, which you continue to update every year, because you get audited every year.

Sarah: Yes. Versus here with the FDA — you do your 510(k), you're done and dusted. The FDA looks at it, either approves it or rejects it, and that's kind of it.

Dan: Right. We don't go back and update the files for the study or the technical documentation unless we need to. There's what's called the General Safety and Performance section in the technical file, and you list all of your standards that you're following — and they're all harmonized. If one of those standards updates, you have to analyze that update and then you might have to update your technical file. You might have to — let's say an analytical ISO standard updates — do new analytical testing to satisfy that, where in the US you wouldn't have to do that anymore unless you did a new submission. So that's the pain of IVDR.

Sarah: Yeah, one of the pains. So Dan, what do you think? We've talked a lot — we've talked about all of the different pieces that differ between the IVDR and the US, and we talked a lot about the documentation and how much more manpower it requires. Do you think that contributes to really why people are waiting to submit? Or do you really think it's this proposed change to the IVDR that has people pausing?

Dan: Yeah, I mean, it's probably a little bit of both. I do think — especially regulatory professionals, clinical professionals — we like to know what the rules are exactly. And I think we know it's not going to change that much, but not knowing exactly what it's going to be, we would rather wait if we could. If you have a new product, you might be more inclined to go to the US first and let the EU sort this out if you can. But if you're getting pressure to get a product onto the EU market, then you're going to have to move forward and hope your judgments are right on how they're going to change things.

Sarah: I think you brought up a good point — it's probably going to be less rigorous, so it would be easier to go from a more rigorous system to a less rigorous system. And that's something we work with clients on when they come to us. When we develop a regulatory strategy for them, we'll walk through the markets they want to go into and the timelines. And then Dan, you probably talk to clients about — depending on the type of assay or instrument — what it would mean to wait versus go ahead and submit your application.

Dan: Right. I think we're aligned on the products that are going to transition from IVDD to IVDR. And keeping in mind that the notified bodies have said they're done pushing back the timelines — they've already extended it all the way out to essentially the end of this decade. But what they did is put in these milestone checkpoints where if you're Class C, you should have already applied to a notified body. They're ensuring that you're doing a little bit before you get to the end and need to be fully compliant.

Sarah: So if you're transitioning and hoping that at the end of December they're going to extend it again — that's probably not going to happen because they're done doing that. But for new products, that's where this is going to come in. For the transition products, what you're doing now is setting up the systems for your technical file documentation, your Post-Market Surveillance Plan, and maybe even your high-level Performance Evaluation Plan. Just a high level — we're going to do this type of analytical testing, we're going to have a study that sort of looks like this, and we're going to do literature searching, because literature searching is a part of clinical evidence in the IVDR. Dan, this was so helpful — I always enjoy our chats. Is there something you thought about today that we didn't cover? I know we have an upcoming webinar — I don't want to spoil anything you have planned for that. But are there any things that we left unanswered?

Dan: I don't think so. I think this is a good high-level discussion that will hopefully get people hungry for the webinar coming up. I think the message should be that from a development perspective, things don't change much — you're still going off of a lot of the same standards. But it's really what that submission looks like — or what we call it in the US versus the EU, because they're called completely different things. The submission in the US and then the technical documentation in the EU — if you're going into the EU, it's really about having a good regulatory and quality base. Because that technical documentation is rooted in your quality system. You have to have the systems to support that technical documentation, and all the reviews have to continually happen. That's what notified bodies are looking for, and that's why they do a quality audit on top of the technical review — because it's all tied together.

Sarah: That's all great information. I think if somebody is looking for support with their IVDR technical documentation — I'm hoping they're finding this helpful and that they'll attend our webinar to see in more granularity what you'll actually go through — because Dan has so much experience working with the FDA, but also on the IVDR side with a number of our clients who are doing a transition or planning to move into the EU market.

Dan: All right, great. Thanks, Sarah. Thanks for talking through this with me today.

Sarah: And if this is on your plate right now, come spend an hour with us. Dan and I are presenting a RAPS-sponsored webcast — the IVDR Transition in 2026: Parallel Regulatory Planning for EU and US Market Entry — on June 17th from 12 to 1 p.m. Eastern Time. It's free and you can register through RAPS. We'll go through the case studies behind everything we talked about today and show how planning both markets early keeps these problems from showing up late and costing you. If you want to talk through your own program afterward, you can reach us at dcndx.com/contact. Thanks for listening to Expert Insights.