Webinar: Top Considerations an EU MDR / IVDR Project Lead Should Have

The compliance dates for the European Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) are quickly approaching. In response, Treximo is hosting a webinar series that will cover a wide variety of pertinent subjects applicable to the device / diagnostics industries as they relate to the change in the regulatory framework in Europe.

The fourth training in our series was held on March 23, 2021 and focused on “The Top Considerations an EU MDR / IVDR Project Lead Should Have (Before / After Implementation).” Treximo’s VP of Life Sciences Consulting Rob Turner presented the session.

A full recording of the webinar can be accessed below.

In the training, Rob discussed how although learning and understanding the regulation is one extremely important and critical goal, knowing how to take that information and effectively drive an IVDR / MDR project to completion is another necessary and complementary element.

Rob’s presentation also covered various hurdles from kick-off to sustainability along with some recommendations on how to address those challenges. He also provided a review of the unique project management components that are apt to arise throughout implementation of an MDR or IVDR program, including what each means, how each is unique to MDR / IVDR, how to address each area and what happens if these steps are ignored.

A full transcript of the webinar is below along with a link to download the slides.

Topics covered included:

    1. mobilize project
    2. communication
    3. process impacts
    4. technology impacts
    5. roles & responsibilities
    6. partner alignment
    7. regulatory intel effort
    8. certification preparedness
    9. sustainability

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Part five of the series will be Tuesday, May 18th and feature “A Roadmap for a Successful IVDR Transition: a Cross-Functional Discussion with Key Focus Areas.” Register here.


Ron Freeze:

I will welcome you to our March webinar. Welcome to Treximo’s March webinar. I am Ron Freeze. I have the picture up there. I’m the Senior Vice President of Device Diagnostics and Manufacturing here at Treximo. I’ll do a quick overview of these training sessions and then I’ll hand it over to Rob Turner who’s doing the presentation today.

These are bi-monthly sessions. We’ve been running these since third quarter of last year. They’re focused on MDR and IVDR, the transition, to help our clients, our potential clients. Topics are really based on the most pressing concerns that we get from you. These are either things we actually get from the surveys that we send out after these training sessions or often just things we know we are dealing with, with the clients that we are working with.

In the past, we really focused on medical writing across MDR and IVDR. We focused on the notified body process overall. We were fortunate last month to have TÜV SÜD join us for a panel discussion. That panel discussion is available online. If you go into where you register, you’ll find it there and you can download that. Today we are looking at the transition areas of really key areas, those big topics that we should be thinking about as we continue through this process.

The mechanics today, we have Q and A that we’ve prepared, some of that from the registration, the registration website where questions were entered. Then we’ll take live questions as well. I’ll be monitoring the Q and A window, so just enter any questions you have into the chat window, and I’ll present those to Rob. Both in the middle, there’ll be a short break for Q and A, and at the end as well.

The slides and recording, as I already mentioned, will be available after the training. You’ll get a link. You’ll also get a survey. We take those surveys very seriously. It helps us set the agenda for the future as well. And so, I think that overall covers the structure mechanics. I’m going to turn it over to Rob Turner. He’s the Senior Vice President of Program Management here at Treximo. I’ve had the honor and privilege to work with Rob since I’ve started.

Rob is really the guy that brings that big picture view to the table, and thinks about not just those technical things that we focus on within my organization, of how to write the documents, the content of the documents, how to manage the quality of positions, but really is thinking at that higher level of, how do you bring an organization from left side to right side through a huge transition like this that really has to encompass a change of thinking within your organization?

Rob today is going to talk about the top considerations an EU MDR and IVDR a program manager or project lead should have before, during, and very importantly now, as we think about it after the implementation of the new regulation. With that, I’ll hand it over to Rob.

Rob Turner:

Thank you, Ron. Very honored and very excited to talk to you all today. The very first thing you are probably wondering is who am I? Who am I? My background is primarily science. I went to Morehouse College, got my undergrad degree. Learned what Krispy Kreme was, which was a really exciting discovery. Then I went to Yale to get my PhD in biophysics and biochemistry. Right after that, rather than do academic research, I went and worked in consulting.

I worked for Accenture Consulting. It was smaller life sciences commercial strategy consulting. And then I went to Deloitte. At both companies, I was mainly in the life sciences group and did a lot of great work around project management, process optimization, organizational change management across the entire R and D spectrum. So I’ve got a lot of great experiences across both of those universities.

Then, after that, I went to work for Praxis, much, much smaller company that was located in the northern part of Chicago. It was great because I was finally local and we did a lot of great work with a lot of our local companies doing a lot of the same things that I did at Accenture and Deloitte, but I could just do it here. That went extremely well, and we were actually then acquired by Treximo Life Sciences. Right now I serve as not only the senior vice president within program management, but I also am the head of the diversity, equity, and inclusion program, so just in case I wasn’t doing enough work and wanted to give myself a little bit more to do. But everything is goodness and I truly love all the work that I’m doing.

Overview. Today what we’re going to do is we’re going to talk about the key project management issues that occur across the implementation of an MDR and IVDR program. What I decided to do was break this up into nine sections because I thought, “Okay, well, how can I lay this out in a way that works for people?” When you think about it, you have a beginning, a middle, and an end. And so that’s how I want to tell this story.

Through each of these, I’ll have slides that talk about, what does this mean? What’s unique to MDR, IVDR? How are some ways that we can address this within the area, and what happens if you ignore this? Now, why should you care? Because most people, like me, I’ve been on a number of these calls. You’ve seen me go, “Okay, well, why would I care?” Well, first of all, there’s been a great amount of work that’s been done interpreting and understanding regulation.

I mean, our own Binnie Larson has done amazing work. If you’ve not heard her webinars, please, after this one, not during this one, after this one, go to our site and listen to her talks. She has done great, great work. Because of that, our discussion won’t be a retread of that. We want to be additive. So we’re going to talk about project management related things.

This is really a typically forgotten area or treated like an afterthought. It’s only when projects are struggling that suddenly somebody goes, “Oh, we need project management.” And so, people like me are typically brought in to help course correct those sorts of things. Now, if you’re a large company, you’re probably doing a lot of this, and if not, this should be a good double check to make sure that you’ve covered off all the different things that are critical.

Now, if you’re a smaller to mid-sized company, you may not have the same resources and the capabilities. So this is a really, really good check to make sure that you’ve done a lot of the key things that you would need to do for an MDR IVDR project. 

Now, one thing that’s really critical is that this is March. We’re two months away from the big May deadline for MDR. So there’s probably going to be not a ton of benefit for MDR people, except for the sustainability part. But this will be a good double-check.

However, if you are a diagnostics company, I’m sure that you probably have your pens, your highlighters, and you are ready to take some notes. You will probably benefit from this a whole lot more since you have another 14 months left to go versus the couple of months that the MDR companies have. 

The very first topic, mobilize project. What does this mean? Well, this means that we’re going to build all the foundational components that you need to successfully initiate and execute a project.

Now, what typically happens, and this is just human behavior, you see a brand new set of regulation come out. And what do you do? You dive deeply into the regulation. You start studying, what’s changed, what’s different? But what most people don’t do is they don’t start with, “Well, how are we going to get this project done? How do we even define what done is?” And so, what we typically recommend to people is that when you enter into a project of this scope, then you define what done is. What are the five or six elements that say that you have successfully completed this project?

From there, you can determine what the objectives are, the scope, the core activities, and then all these other pieces start to cascade out. You’ll start to figure out, what should our work streams be? Who should we have on these teams? You suddenly start to figure out that this is our structure of our project. This is how we’re doing things. These are our timelines, our key milestones. These are our integration points.

Before long, and it does take a little bit of time, you start to have a really good working structure of how you want to implement this project. You may not always end up exactly where you started in terms of implementation, but you do have a good starting plan for getting to where you need to go. That really saves a lot of rework and just making sure that there’s a clarity of direction. That’s one of the key things that we really truly recommend at the very, very beginning of you getting started with these sort of projects.

The second thing is around communication. Now, communication is a critical piece because you really do need to have that central platform to keep impacted stakeholders updated on project progress, issues, risks, and regulatory updates. Now, one of the key things that most companies tend to ignore is just this general mechanism of communication. Why is this important? Well, when I sat in a few separate meetings early on with reps, a lot of people didn’t know how to properly discuss what this project for MDR was all about, why their leadership should care and provide resources or funding or whatever was necessary.

So having a very strong communications effort will help make sure that the people who need to understand what this is about can be educated on what this is about. Then the other pieces to this is that when you think about a project of this scope and size, there is a lot going on. At any given moment, there’s lots of different like issues, risks. There’s lots of things being achieved. So having a way to have each of the different groups within the team communicate with one another is pretty critical.

And so, we’ve done this by having a lot of team meetings, by having also senior leadership update meetings. Different people call these different things, but just ways to make sure that across our teams, we know what’s going on. And then we’re able to communicate up to our leadership what’s going on. So that way, we have a pretty clear view so that everyone who’s impacted has a pretty clear view of how to do this. This all falls under this concept of communication strategy and planning.

It’s typically a very simple task if you do it in the beginning, and it covers off a lot of the key things that you need to think about in terms of making sure that everyone’s aware of the project, why it’s important, how they’re impacted, and that the clear awareness of success is being shared with the rest of the stakeholders.

Process impacts. Now, process impacts, I want to take a little bit of time with, with this one and the next few, because the first couple were very general initial concepts. When you think about communication and project management, those are really the foundational pieces that really get the infrastructure of the team going. Now we start to dive into the more interesting elements of this.

With process impacts, one of the key things is that you’re really now doing, after you’ve truly set up a team, now it’s time to review the regulation, assess, and optimize the impacted processes. And then you create new as needed. With this particular thing, especially with MDR and IVDR, one of the first key steps that all of us have had to do is to do that classification. What I mean by the classification is that you have to go through, look at all your devices or diagnostics, and see, based off of the guidance that’s provided, what is the new or the updated classification per MDR or IVDR?

Why is this important? Well, this is important because what could very easily end up happening is that as a result of the new classification, you now have a number of new reports or requirements that you have to follow because you have a newly classified device. If you could take something like the IVD, where 80% of these diagnostics are going to be classes B, C, and D which will require notified body support, that there’s also this increased need to have all these other types of reports, or procedures, or SOPs that you need to produce.

Knowing going in, number one, what your classification is really sets the stage for how you’re going to move forward with all the different elements of your implementation. So there’s that. That’s the first piece. 

The second piece then is really conducting that impact or gap analysis because, okay, what are the things that you need to create brand new and what are the things that you have a true gap? This is going to really differ depending on the size of the company you are.

If you’re a smaller mid-sized company, you’re going to look at this gap analysis and go, “Oh my God, we have lots of gaps.” If you’re a larger company, you may be able to absorb some of this or figure out a way to serve addresses where you can mitigate the level of impact to your organization. But either way, you’re going to have to do this impact and gap analysis to figure out what needs to be created or updated.

The other thing too is once you’ve started to figure out all these different processes, you’ve done your classification, you figure out these processes, then you need to start to figure out, okay, well, who are our business process owners? I’ll talk about people shortly, but certainly, you need to figure that out. You need to figure out the different dependencies, alignments between all the different processes, because a lot of these processes don’t exist in a vacuum, and there’s a lot of connections between the two.

You also need to figure out, well, how does this fit currently within my QMS, because, for most companies, they do have this structured QMS. How does the QMS change or be adapted to include all these new elements or these updated elements that you are including? And then, some of the other things are just making sure, and this is to serve like a forethought for inspection readiness, is just if someone’s looking through your QMS, is it clear to them how to find all the different pieces that you’ve updated and changed? Because you do want it to be rather self-explanatory.

You sit down, you think about it. “Okay, well, I have this classified. I have figured out the gaps. I’ve figured out the dependencies and the integration points.” Then the last piece of this is making sure that all the stakeholders are trained, because once you have all your documentation done, having a robust training process is critical to making sure that there’s clear understanding across all these impacted stakeholders, what the new processes are, or how the existing processes have changed.

As I said before, as I intimated before, along with project management, this is a core foundational piece. If you don’t have your processes properly updated, or newly created to support your QMS, your updated QMS, then everything else is at risk. So this is the part that you have to get right. I can’t state that more significantly, that this is very, very important.

Technology impacts. Technology impacts are a pretty significant thing as well because when you look at MDR and IVDR, it really breaks out into three groups. Well, to me, it breaks out to three groups. Others may see it a little differently. When we think about technology impacts for a regulation of a thing, there’s almost always IT strategy.  So how our systems need to be updated as a result of this new regulation.

When we think about MDR/IVDR, there are certain things, like some people have enhanced or some have introduced much more effective trending, ways that they do their trending. Others have just figured out, “Okay, well, maybe we need to move this process from being manual to automated.” These types of things will be constant typical considerations that you need to have with MDR, IVDR, or any other type of regulation like this.

But there’s two other pieces that are a bit more unique to MDR.  First with EUDAMED. EUDAMED, and for those who don’t know, that’s the system where healthcare practitioners or patients can look up various types of reports. There’s an added level of transparency around each of the either diagnostics or devices. Due to that, there is a very stage roll-out that is in play, where we’re starting off first with the actor registration, and then we have the notified body certification modules. Then we have the UDI registration.

So we have a series of registrations that are going to be happening in a staged manner. And then we have all the different clinical and post-market surveillance related modules coming out after that. Those, the latter set, will come out in 2022. The earlier ones I mentioned, except for actor, those will come out in September and actor it’s currently out right now. But this is an extra technology piece of work that you have to do that you need to have a clear strategy on what you’re going to do.

You need to not only have the process pieces that we talked about  and the templates needed to support your ability to work within EUDAMED. But then you also need to address any of the technology needs that may result. When it’s time to register devices, how will you do that? It could vary depending on the amount of information, amount of devices that you have to register. If it’s just a few devices, you can do that manually, all the way up to if you have in the tens of thousands of devices, there may need to be machine-to-machine interfaces.

So sitting down and identifying what those things are, the amount of work that needs to be done, the how, which accompanies the amount of work, the who, that’s going to be critical to making sure that you’ve built out the time and you’re successful with addressing these technology impacts. That’s the second piece. Just as a side note too with EUDAMED, I mean, there is also the pieces around your notified bodies and some of their expectations when it comes to registering your actors.

What I would recommend is do not underestimate the length of time that it may need to take to do this registration with EUDAMED in your actors, because I’ve heard some things where it’s taken a little bit longer than expected because the notified body would review what you’ve submitted and they would go, “No, no, no. You need to do this, this, and that.” So it’s not just a simple process of filling in your information and calling it done. It may be a bit more. So sitting there and thinking through what that impact is and the level of work that you need to do will be critical.

Finally, Software as a Medical Device. That’s what SaMD stands for. There’s been a lot of regulation included within the MDR and IVDR about how you manage a set of software that functions as a medical device as part of clinical program. If you really look at the way our industry is going today, lots and lots of programs, like clinical programs and different types of treatment, have a software element. As a result, you have to think of this as, number one, “Let me go through and identify all my software to make sure that I understand the classification.”

Once you understand the classification for your software, then you’re able to determine what needs to be done as a result of its classification. Now, I want to tell you, I’ll give you a story. One of the things I have worked on was trying to figure out what were all the different software applications that my client had used. And so, we had a list and it turned out that list was wrong. It was very much outdated. I had to spend what amounted to a month. It wasn’t every eight hours for the month, but it was like four or five hours here, an hour there, emailing, calling, setting up chats. And it was just insane.

I spent a full month trying to figure out what all the software applications were that existed, who is the current owner? Do they agree with the classification? And just any other status. I felt like every time I learned something new about one application, another two appeared. It was this weird game of software application Whac-a-mole and I did not enjoy it. Hopefully, but you sitting at home or in office, you’ve had a much better experience. But the experience was critical because we needed to know what was in the EU, what was actually on market, and what truly qualified as a medical device. So that way we could be certain that that was compliant to MDR.

As a result, that’s caused us to really, really beef up our software governance group. So that way we could be sure that we have much better oversight as these applications are being built. Because the other thing that we ran into was just, there were certain groups who just had money. They were like, “Oh, we have another $10,000. Let’s just build a software app.” So we wanted to make sure that we improve the level of governance around those apps, so that we wouldn’t have these problems going forward.

If this is all ignored, one of the key things that, and I think I talked to a little bit about this, but is really that you’re going to have an IT strategy, the needs aren’t going to be met and you won’t be in compliance. And there’s going to be a lot of effort to produce these reports if you decide to go the manual route, which I really hope you don’t. With the Software as a Medical Device, if you’re not making sure that you’re classified right, you’re going to miss the fact that some of these need to be a certain classification, which meets a set of requirements. That can result in non-compliance, and that could be a bit of an issue for you.

And then, EUDAMED, there’s just going to be a lot of unanticipated delays. If you don’t work proactively and work ahead, then you’re going to run into a lot of stumbling blocks or realize that some things are a lot harder than you expected them to be, or they’re a bit more time consuming, not necessarily harder. This is one thing that, along with process, it’s a bit harder. It takes a little bit more time. It’s not insurmountable, but it’s just making sure that you function very proactively, you try to think ahead of some of the key barriers that could result with these types of areas.

Roles and responsibilities. I hinted towards this a little bit with process and technology.   And, that’s really just making sure that you have the right person from the right function, with a clear understanding of the responsibilities so that they are performing the role effectively. This, quite honestly, sometimes you think that the process and the technology are the hard parts. It’s actually finding someone who wants to own it. That’s the hard part, because every time we have a process and we say, “Well, who should be the owner?” I feel like everybody just goes, “Not it.” And it’s clear that you have to have an owner, but no one really wants to own it.

I understand. You have already, a lot of you, on your plate. There’s a lot going on, but we still need to have somebody who owns these roles. Now, why is this important? As I said earlier, we have a lot of new processes or enhanced processes that are coming up. So since you do, we have to have individuals that own, for instance, the SSEP process, the enhanced post-market surveillance process. If you’re a diagnostics, they didn’t really have the same level of expectation. Now is fully amped up.

We have EUDAMED, UDI. There’s a lot of role. Now you’ve even tossed in communications because you still need to have somebody that’s the air traffic controller providing communications for quite some time. So this is a lot of new responsibility, a lot of new expectation. For some organizations, they’re just not big enough to be able to do this. Let’s just remove some of the massive companies. If you’re a mid-sized company, how do you handle this? I’m not sure. I don’t have those answers.

But they definitely need to think through who and how does this, because the key thing is that you can’t go to your notified body during your audit and say, “Well, we’re too small,” or, “I’m too busy.” There has to be an answer. You have to go down this path to figure out the logical entity for this role. Now, I will say that some groups, for the authorized rep have partnered with external organizations as their authorized rep for that particular role.

But beyond that, is just using your senior leadership team or your steering committee or whatever you want to call it, to play the role of identifying who should be those owners. Now I’ve dealt with this so many times, and really our way of addressing this the most effective, in the most effective manner, was to identify who we thought were the candidates for these roles and why we thought that was the case in our recommendation. And then taking that to our senior leadership team and having them make that final decision for us, based off of our recommendations. I think that’s something that’s incredibly critical that you need to consider, you need to have locked in.

The other piece that I don’t have here, but I would recommend, is just putting the other on a RACI, responsible, accountable, consulted, informed, map that just lays out, once you have all the roles identified and their responsibilities, just to make sure you don’t have that overlap that could create confusion on who does what. Once you have that, and that’s something that could very easily be done after a lot of the core documents have been completed and you’ve put together what everyone’s responsibilities are.

Going through that RACI exercise shouldn’t take very long, but it does help because there’s always certain roles and responsibilities that sometimes will intermix. So you want to be sure that it’s clear who does what, and that it’s very clear to them that it is their responsibility. Also, it ensures that there’s a gap and you’ve covered off any gaps.

Amazingly, we have hit 26 minutes into the talk. I will take a brief moment to see if there are any questions. Ron, has anybody posted any questions or comments?

Ron Freeze:

I don’t see any questions or comments, but I will maybe give you one, just based on the last couple of slides, Rob, just listening to you and thinking through a couple of things. It’ll give people, if they want to post something, just post something into the Q and A. As I listened to you, and just thinking about the types of people we work with, again, across the range. You mentioned this, Rob, up from all the way to the largest companies that are augmenting teams, to companies that might have one or two devices that are really critical in the healthcare spectrum, and devices or diagnostic products that really are just looking at MDR, IVDR, trying to figure out how to transition across.

I think through it, and I think maybe one of the questions that people might have is:  If they’re more on that smaller side, where they have really been focused on just driving the technology and continuing to drive their device or diagnostic forward, and now they’re looking at, again, MDR probably we’d have to figure out that’s just May coming up here very shortly. IVDR, you look at it next year, hoping that it might get delayed, but knowing how hard it was to delay the MDR timeline.

We heard it from TÜV SÜD, that that timeline for diagnostics, everybody has to assume it won’t get delayed, won’t get pushed out for a year. I guess the question to you, Rob, is where would somebody even start? Just stepping back, you look at the slides you’re presenting. There’s a lot of information, a lot of things people have to think about. What sorts of tools, what sort of things do you help clients as they look at what they need to do to transition, to step back and think about, in a step-wise fashion, how to move from where they are today to transition across? What would you suggest to clients?

Rob Turner:

Honestly, I would start with the classification exercise because it gives us a sense for, “Well, how big is the change?” Because there’s, in some cases, the idea that if you have all class ones, and speaking from an MDR perspective, it’d be probably class A for diagnostics. Then there’s certainly going to be some things that need to change, but it won’t be too much of a heavy lift.

But if you’re going through your classification exercise and you realize, “Oh my God, I have a bunch of class threes.” And then you go through the regulation and you start to figure out, “Okay, well, what’s my impact or gaps based off of that?” Then you can really get a good sense of, this is going to be a significant effort that I really need to start shouting from the rooftops, “Hey, this is a thing.” Or you start to make that decision, and we’ve talked to some clients about this, where do we even want to continue to sell in the EU? Do we want to just pull out and focus our energy and time in other regions?

I think classification should be first, impact gap analysis, and then making a real decision as to, well, do we really want to go forward with this? A lot of the top 10, top 20 companies, the answer is going to always be yes. But as you were saying, Ron, if you’re a smaller to mid-size company, then the answer’s really around, it depends. I actually spoke some time ago with a client, with a potential client, and we spent a fair bit of time just talking through what their devices were.

We were able to very quickly say, “Hey, your devices are really going to be class one mostly, and there’s a class 2A.” So, I mean, it wasn’t a big lift. As I said, it’s up to you ultimately, if you want to keep your EU presence, and that’s fine. But if you don’t want to, then where else would you… How would you amp that? So it becomes a internal business decision if you decide that you don’t want to pursue MDR, IVDR. But that’s where I would start, because then that lays the path for how much effort, how much time, how many resources, how much of everything that you need to do.

Ron Freeze:

Perfect. Perfect. No, thank you, Rob. I have one question here from internal as well. We’ll probably address that maybe at the end as well. I think that’s one of the advantages we can definitely help clients, as you say, scope how big the project is. And then, definitely, as you say, from the parts of our organization within the eight partners that can bring that regulatory expertise to program management, to then the execution as well, and setting up the post-market side as well.

Ron Freeze:

But yeah, I don’t have any other questions at this point of what you’ve covered. So I’ll let you go ahead and get through the other part. We have another Q and A at the end. So please post questions and I will post them to Rob at the end as well for him to answer live. I’ll let you continue on, Rob.

Rob Turner:

Cool. Thank you. All right. Topic number six, so partner alignment. A number of our clients and a number of us don’t work in a silo where we’re working on MDR/IVDR requirements, or just in general. You have partners that either help with supporting the replacement devices, or they make maybe accessories to your device or your diagnostic. Because that’s the case, you really need to be working in lockstep with your partner on what they are planning to do with regards to MDR, because if not, you could say, “Well, we’re moving to MDR,” and they’ll say, “No, no, we’re good.”

Well, then what do you do? A really good example of this was a client that I knew where they were dependent. They created the drug. Their partner created the device that delivered the drug. Their partner decided, “Yeah, we’re not moving to MDR.” Because they didn’t want to move the MDR, that would basically cause the first companies a potential loss of easily eight figures in revenue from the EU market. So they thought, “Okay, well, this is not good.” They actually had to end up starting up a whole other program to address that.

And so, knowing what your partner wants to do, and that’s probably the more extreme, but there’s been other situations where people have had different classifications. So they say, “Well, I think this device is class 2A.” They’re like, “Well, I think this is class 2B. If you know the regulations for MDR, there is different expectations for 2A versus 2B, especially with 2B implantable. So it’s like you sit there, you look, and go, “Okay, well we need to have these conversations or come to some level of agreement on why this is the case, why you’re defining it your way, and why we’re defining it our way.”

The real core of this is just to make sure you have very, very, very clear understanding of what your partner is doing to ensure that you both are working together in a consistent manner. The other piece of this too, is that you want to understand how your partner is going to move through and move to the MDR process, because some companies are rather small or mid-sized. They may not have a level of maturity that you have.

It really goes back to what Ron was saying. Some may not know how to start in moving this process along. It may take you either introducing somebody to them or coaching them or something. It may take something from you to help guide them down that path to ensure that they get started effectively with MDR and that their timing aligns to yours. The last piece is just making sure you’re understanding when your CE certificates under NDD or IVDD expire, because you do have a little bit more time to play with.

But it’s really critical to know that going in because that will impact how you’re able to work through all these other things. So really, you don’t want to ignore this because you want to be as proactive as possible. This is something that we’ve done in a few of my projects. We’ve taken the list of every single partner that we could think of, how they’re a partner to us, what they’re doing, what role they play, whether they’re an importer, whatever. We went through all of them.

I highly recommend that because it’s a good amount of time worth spent because then you can mitigate the risk of knowing what’s happening with your therapy, because if you don’t, then it will have to escalate to your senior leadership. You’re going to have to figure out, well, do you make the device, make the diagnostic? Do you partner with somebody else? And how fast can you get that replacement to market? That is a truly painful path to go by not working proactively.

Reg intel effort. One would think that this is easy, but it’s not. There’s a lot of companies that don’t have a structured team that is effective at staying aware and disseminating all relevant information for any regulatory guidance. But in the context of what we’re talking about, is MDR and IVDR, we know why this is the case.

Remember all the different sets before pandemic, all the different updates we received, all the different guidances that came from MDCG, or just the number of meetings or symposia that were being held, or just the unending set of information we received about article 117 on the MDR side.  Without  a reg intel group that’s there and functioning as that central piece to capture that data, distill it, send it out to the right team, you’re really swimming in a ton of information that’s coming to you every which way.

And so, it really, really, really helps to have that group in place. They’re staying on top of things. They’re the people that they’re going out to these meetings, asking those questions, helping to really resolve and address some of these key issues that even the team is struggling with. There’s been several times where we’ve worked with our reg intel group as they were going out to some meeting to talk about some MDR area, and we’ve given them a list of questions.

At the same time, we’ve also had them present at our ongoing team meetings about what they’re learning with regards to regulatory intelligence, the types of meetings that are upcoming, and just other things that we should stay aware of, like getting draft comments for white papers that are in development. So that your reg intel group is incredibly critical. I cannot understate how important they are, and you really want to have that group positioned to do a lot of that key work. It is especially important because we still have a number of guidances that are still in development. We’ll talk a little bit about that in the sustained area.

Certification preparedness. Really, what this is about is that we know that in May, a number of us who are on the MDR side and then a year from now on the IVDR side, will be going through our audits. This is a significant moment for us. What we’ve decided, what we have learned and observed and found to be the best approach was that, number one, you need to definitely do your pre-work. It’s almost like when you were in college and you had the old exams and you went through the old exams to test yourself to make sure you were ready.

Well, we have a lot of tools that we can utilize on our end to make sure that we’re ready. And so, one of the key things that we always want to use is your internal QA group. These people are talented, smart individuals who can come in. They may not understand MDR or IVDR the same way that you might, but they understand what good QA is and what should be expected. So they can come in, kick those tires, and give a first round set of assessments. We, in my teams, have learned a fair bit from just that.

But then the second piece was that we went through and put together our own internal checklist based off of things that we’ve learned, different colleagues who’ve been at different places, and we’ve had a pretty healthy list. I think we have roughly a hundred or so questions that we worked from to make sure that we were ready for any audit or anything like that. By us doing that, we really did uncover… I think we covered like, our first go-around, like 15 or 20 gaps, which was great, because, I mean, we would have wanted zero, but it was great because we did it within the context of our group.

We were able to address that fairly quickly, and there were literally some things we just didn’t think about. 

The other piece too is that we had an external mock audit. We brought in a group who was actually very experienced in MDR, and they conducted an assessment on us. The great thing about this was that we were able to really test, like, “Are we ready for this? Is our documentation up to par? We have identified all of our new roles and people are sitting in those roles. How are they doing? Do they really get it? Are they comfortable in their roles? Can they speak to things effectively?”

That was a really, really, really good check for us because it gave us a sense for whether we were ready or not. Typically, when you do those types of audits, hopefully, what you’ll get are your major findings, if there are any, your minor findings, and then some suggestions of what you can improve going forward. All these three pieces are critical because you figure, as you go through each set of assessment, you get a little bit better each time, and you get a little bit closer to where you need to be in terms of readiness for your May audits.

And so, the key recommendation here is that after you’ve done all this, definitely conduct extensive debriefs, lessons learned, and make sure that you have someone that’s on tap to track status to ensure that all those items that were identified were addressed. The last piece is that you really want to be sure that you give yourself some time. So if you’re MDR role, you’re pretty much there at it. Maybe you can do like a quick pre-check over the next couple of weeks.

But if you’re IVDR, I would highly recommend that in Q4, making sure you do all three of those pieces, so that way you can be ready for certification. 

Finally, sustainability. I have a couple of slides for this because it’s an incredibly important piece, because let’s think about this. Whenever you’ve been on a project, has this been your journey? You find out that you’re on a project. You go through the stages of grief. You work your butt off on a project, you get it done.

Then the team has cake. Then maybe some people get some awards, and then you all move back to your regular jobs. That seems to me the typical life cycle. Maybe there’s one or two people left over, but you go through those stages. You’re working a project. For something like MDR and IVDR, they’re so transformational that you really need to make sure that there is some version of a group or something that’s around to make sure that this entity, this set of work that you’ve done, continues to exist, and that all the pieces that you need to have are in place.

I’ve broken this out to five areas. First is the people in governance. Right now, if you’re a very large company, you have these massive teams. You don’t really need a massive team for sustainability. You need just a relatively small team with key representation to ensure that everything is running smoothly. My main recommendation is to make sure you have this for at least a year after.

You don’t need to meet every week or every two weeks, like you’ve been doing during your project team. But maybe monthly you’re checking in to make sure that things are going fine, if there’s no key issues, that you’re just on top of things. That really provides a level of comfort to the rest of the team and also to the senior leadership group.

The other piece around this is just making sure that your senior leaders are aware that everything is running as expected and that there’s no major hiccups or issues. But with this sustainability in the companies we’ll talk about, we’ll be on top of that.

The next piece is really around ongoing activities. Just because you’ve gotten past your May audit doesn’t mean things are all done.  Because remember EUDAMED?   It has modules coming up in September. It has modules coming up next year, sometime in 2022. And then, there’s still a ton of guidances that we’re still waiting on. The general expectation is that even though they’re called guidances, there tends to be an expectation that these guidances are worked into your quality management system.

You’re going to want to make sure that you’re still executing all the things that you need to execute, and then you’re also producing a brand new set of reports that you never had to produce before. So you have a lot going on. Even though you’ve gotten past your audit and you’ve had your cake and you’re celebrated, you still have a lot to do. 

And then, regulatory intelligence. That group that I talked about earlier, don’t disband them. Keep them there.

They’ll just probably focus their energy primarily somewhere else, but definitely keep them intact to make sure that they’re basically hearing a lot of the information and the data coming out around MDR/IVDR. Because like I said, there’s still a lot of guidances coming out. There still be people after we’ve gotten past our May deadlines, talking about, “Well, what is the impact of MDR? What pieces of the regulation have been sustainable. And now that we’re living this regulation, what parts of it are unsustainable that may need to be adapted?”

And so, between your peers that are on your core team, your reg intel group will be the other group that should be able to help you and keep an ear to the ground, to see what’s happening with regards to that. 

Communications. With communications, as I’ve said before, you just want to have some way of keeping individuals updated. One of the things I didn’t mention earlier was that we send out…

One of my project teams send out a monthly update to a huge swath of stakeholders, because part of it was, with a lot of these types of engagements, you started off with just a few people, and then next thing you know, it just grows and grows and grows. We didn’t want to have like a hundred people at our project team meetings, but we didn’t want those 100 people to be aware of what we were doing. So the compromise was to send these monthly check-in, but it was monthly check-in newsletters or things to everybody so that they knew what was going on, what we’ve achieved, and where we’re going next.

That’s one of the key things I think would be useful for the sustained world. It’s also important too, because you may have a need for more resources or whatever project needs come across. And so, as you’re building out that story of how things are going and where the needs may come up in the future, this is a good way to do that. 

And then, finally, continuous improvement. You’ve built this brand new process, or you’ve enhanced this process based off of the regulation. But there’s this concept of evolution that always comes about when you’re doing something of this stature.

You’re definitely going to want to keep an eye on how you evolve and build out and improve what you’re doing based off of how things have been going previously. So having those detailed lessons learned sessions, will be really critical to making sure that you talk about how you improve your project or related projects or the things related to this. The other piece of this is just understanding, well, how do you improve, how do you measure effectiveness and report that what you’re doing is truly having an impact? It’s not just about being compliant. It’s actually showing that you are truly benefiting the organization.

Those elements are typically common with continuous improvement. 

So I do want to reiterate, sustainability is incredibly important, and please, don’t eat the cake, get the award and forget that this exists. There’s still a lot of work that you need to do, but it’s just not the same scale. It’s not with the same set of urgency. But you still need to be able to have some sort of functioning team that exists, that’s keeping an eye over your MDR or IVDR implementation after it’s largely wrapped up.

Nine parts. I cannot believe that we made it through. Hopefully, you’ve all gained something. But the key thing is that this is a really challenging project, whether it’s MDR, IVDR, whether you’re a small, mid-size, or large company. This is not an easy one. This is a tougher one. But my personal belief has always been, you need really good or strong project management, and then you need people who really understand the regulation. You have those two pieces together, you’re going to be successful. There’s just no ways around that.

What I wanted to do was really provide nine considerations. There’s probably tons and tons of considerations, and really I could have taken one topic instead of an entire session, just going through one topic. Although, some would have been more exciting than others. But I could have really spent an entire hour just talking about one. But I wanted to make sure that you all heard the nine that were really critical.

I really do hope that if you’ve been through the MDR piece and you’re pretty close to your audit, that you really feel a sense of comfort, that you’re like, “Yes, I’ve done almost all of this,” or, “I’ve done all of this.” But then, for those of you who are on IVDR, my real hope is that you look across these nine areas. These are things that you’re thinking, “Oh, wow, these are some good things that we should really make sure that we do,” or, “Oh, crap, we didn’t do this, but we still have time to course correct.”

I did want to say, MDR and IVDR are two primary examples, but if you’re doing other regulatory related initiatives, you can really follow all of the same nine steps. What I wanted to do is give you all something that is very useful for MDR/IVDR. But if there’s other regulatory related projects that you have, the same nine steps align. Thinking about your Brexit regulatory projects, same nine steps. So hopefully that was really good. And as a result, I just want to say, thank you all for listening and paying attention. Are there any questions?

Ron Freeze:

Yeah, Rob. I actually have a couple, one from Mitchell, and then I’ll circle back to the previous one that I had queued up as well. But Mitchell, and I know you mentioned it, you mentioned the September date, was just looking for anything more specific on the latest updates on EUDAMED and the status where that is. I know you monitor that. We keep a close eye on where that is, what companies need to be doing, and the expectations.

But he just asked specifically, they’ve said over the last couple of years that it’s going to be ready. Of course, as large technology implementations, we all know can sometimes go a little bit over time and over budget, that it is not all ready to go. But he just asked, “What is the latest that the EU has shared as far as updates on EUDAMED?” Rob, I’ll make it more difficult for you. I guess, there’s probably two ways we look at it, what is actually available? And then, the second is, what are the expectations? What flexibility has been given to manufacturers as well? I’ll hand that back to you.

Rob Turner:

Sure. Right now, the only module that you can do anything with is the actor registration module. That’s where you register your authorized rep and your PRCs. You’ll be able to get your SRN number and you’ll have your basic UDI. That’s right now the only real major thing that you can do with the EUDAMED. They provided their user guide, 60 some odd pages, that walks you through the process. So that’s really it.

And then, what was originally supposed to happen in May was the actor… I mean, the UDI device registration, and then also the notified body module. And so, those were supposed to happen in May, they got pushed to September. For right now, there’s not a ton you can do other than just wait for… Because similar to what they did for the actor module, I’m sure they’ll put out yet another user guide.

So, for a lot of companies, what they’re doing is that they’re putting together their SOP for EUDAMED in general. Some are just basically putting in everything. Others are going, “Well, we’ll do the step-wise process. We’ll put in everything we need to do for the actor module. And then when the next modules come out, we’ll put in the next set of stuff for that within our SOPs. We’ll train everybody, and then we’ll just bring all these people on step-wise.”

Then there’s those modules. And then in 2022, the remaining, the clinical and then the post-market surveillance system modules are coming out next. So that’s the general timing. In terms of expectations, the most that we can really do is start to think about, for instance, if you’re going to be registering your devices, if you have a huge number of devices… I mean, by huge, I mean like thousands, tens of thousands, well, then, what is your approach? You should be building out your approach now.

Actually, I’ve heard that they have a sandbox that they can make available to manufacturers so they can see what everything looks like and how it’s changing. And between the sandbox and the final iteration, there’s only been minor changes. So I would recommend that if your company can get access to the sandbox, you can start to work up, how are you going to do various things? That is one thing that you can certainly do right now that will help position you better. Did I answer everything, Ron?

Ron Freeze:

Yeah, I think so. I’ll summarize a little bit and give people any other chances here to give questions. I’ll talk for just a minute. But did want plug I think you did a great job, Rob, of focusing on sustainability. This is something we talk a lot about internally, and throughout my career. I’ve always talked about, it’s almost the easy part. I like when you say you have your piece of cake of you’ve succeeded, but when the entire team is together executing a focus project, but then when that team disbands, really sustaining that year on year and making it the normal.

I think, Rob, you’ve done a great job of just summarizing, the way that you drive good sustainability starts at the beginning with what you focused on. What’s your process? What are your processes? What are your improvements in your quality system? What’s your communication plan? But then, throughout, always making sure that the organization is prepared. There is an incremental complexity that is coming, after this, that we’re not going back to the way it was, that there is not a reverse button on this. We are moving to a new paradigm, and it’s preparing the organization for that. So, really, I think you did a nice job there.

I don’t see any other questions. I guess, I would say, and I think you’re going to cover this as well, we definitely make sure to let people know they can email us directly. We’re very happy to fill those questions always within Treximo. We don’t want to make these into a sales pitch, but the nice thing, within Treximo, I’ll do just a little bit of that, just to say, we have very focused organizations.

If we start working with a client and they want to get quality expertise pulled in, or they want to get managing a notified body, we go to Rob. If we need project management, we pull in people that are very skilled in the project management. I have the quality of the medical writing organizations that we can support. Last year as well, we had NDA partners that became part of our organization, in-depth, unsurpassed, I would say, regulatory knowledge, being able to put that regulatory strategy together as well, whether it’s navigating the notified body and the EU regs or the FDA or China or anywhere else.

So there, I made it into a sales pitch. I didn’t want to do that. I’ll stop now. I’ll hand it over to you, Rob. I know you have maybe one or two more slides just to wrap things up and do final thank yous. So thank you so much, Rob, for the time and the preparation for this. It’s all yours.

Rob Turner:

Okay, cool. Thank you. Well, thank you all again. We have another session set for May. Now what we wanted to do was not focused on MDR because I know that the MDR people are going to be busy, very busy. But you IVDR people, what we want to do is we want to have a discussion around roadmap for a successful transition. We’ll have a cross-functional discussion with key areas of focus.

More details will come out about that, but we’re scheduling that for May 18th, another Tuesday, 11:00 AM, so same bat time, same channel. We will look forward to talking to you all again in a few months, to talk about IVDR exclusively. Thank you all and have a wonderful morning or afternoon.