UDI and EUDAMED: Past, Present and Future State

In this episode, we discuss the past, present, and future state of EUDAMED. EUDAMED is the European Database for Medical Devices, and is part of the European Medical Device Regulation.

While the EUMDR may have been published in 2017, many companies are still unsure how to handle the submission of their UDI (Unique Device Identification) data.

Joining us to discuss this topic is Richard Houlihan, an international speaker and guest university lecturer on EUDAMED.

His time running the European Commission IT teams developing EUDAMED has given him unrivalled insights into how EUDAMED affects the MedTech industry. This EUDAMED experience and his 28 years in IT give him a real advantage when helping companies prepare for EUDAMED, FDA GUDID, and other regulatory submissions.

His company EirMed with the website eudamed.com provides ongoing EUDAMED and regulatory submission support, training, an EUDAMED mobile search app, and software to help Manufacturers, Importers, European authorised reps, and Distributors meet their EUDAMED obligations.

To date, Richard and his team have trained over a thousand people on EUDAMED and helped hundreds of companies with EUDAMED consultancy and their regulatory data submissions to EUDAMED.

We hope you enjoy this episode on EUDAMED!

Listen now:

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Some of the highlights of this episode include:

• After the European Commission's EUDAMED working group meeting in June 2023 and the publication of the minutes, we know that the legally required audit of EUDAMED will now take up to nine months and is to be completed in Q4 2024.
• Six months after the OJEU publication, EUDAMED will be deemed fully functional and EUDAMED will be mandatory. EUDAMED vigilance reporting for serious incidents will be mandatory from that point, Q2 2025 - the day after EUDAMED is fully functional.
• EUDAMED’s fully functional date is now expected to be Q2 2025. Ireland and France have already made EUDAMED mandatory for new products.
• For most medical device manufacturers, EUDAMED’s Actor, Device, and Certificate modules will be the only modules they'll use. These modules are already up and running.

Links:

• Richard Houlihan
• EirMed (eudamed.com)
• GG Academy - use Promo Code "podcast25" for a 25% discount
• Greenlight Guru
• Brittani Smith on LinkedIn
  
  
• Etienne Nichols LinkedIn

Memorable quote:

"...it's a hugely ambitious project. Now, the device module and the certificates module, they're both huge in themselves. The vigilance module, that's a whole ecosystem in itself and the clinical investigations for any poor devil involved in clinical investigations, this thing is an absolute monster, it's huge. But what they've done is they're putting them all together and they're connecting them all - in the real world, we would call that consolidation in a marketplace... I was told it was the second biggest It project ever undertaken by the Commission." - Richard Houlihan

Transcript

Etienne Nichols: Across the globe, visionaries and innovators are building the future of medical devices. Devices that redefine boundaries, extend possibilities, and improve the quality of life for millions of people. But every innovation encounters obstacles.

Regulatory complexities, data management hurdles, evolving quality standards, transitioning from prototype to the patient is filled with challenges. There are a multitude of regulations and requirements that can get in the way.

Many teams have inherited or relied on legacy tools, outdated systems and manual processes that can move the product lifecycle backward rather than forward, turning potential medical breakthroughs into nothing more than long held ideals that just couldn't quite make it.

Time is of the essence. And with every delay in getting to market, the potential to change real lives for the better gets diminished. And this is where Greenlight Guru can help.

Our suite of purpose-built solutions helps companies modernize quality management, streamline design and development, improve clinical trial operations, and keep up with industry trends and changing regulations. Ultimately getting high quality medical devices to market faster and keeping them there.

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So that in every innovation, every device reaches its full potential, improving lives around the world and setting new standards in healthcare. Greenlight Guru moving MedTech forward.

Hey, guys. Welcome back to the podcast. Today we're going to be talking about Unique Device identification, or UDI for short. Specifically for the European Commission. Today we brought on Richard Houlihan.

Richard Houlihan is an international speaker and guest university lecturer on EUDAMED. His time running the European Commission It teams developing EUDAMED has given him unrivaled insights into how EUDAMED affects the MedTech industry.

And by the way, if you hear me flip flop back and forth between EUDAMED and EUDAMED, I'm really not exactly sure how it's supposed to be pronounced, but I hear it both ways, so I kind of dabble in both directions.

But Richard's EUDAMED experience in his 28 years in It, it gives him a real advantage when helping companies prepare for EUDAMED, FDA GUDID, and other regulatory submissions. His company EirMed with the website Udemed.com, which how did you get so lucky to have Udemed.com, provides ongoing EUDAMED and regulatory submission support training and EUDAMED mobile search app and software to help manufacturers importers European authorized reps and distributors meet their EUDAMED obligations.

To date, Richard and his team have trained over a thousand people on EUDAMED and helped hundreds of companies with EUDAMED consultancy and their regulatory data submissions to EUDAMED. So, we kind of talk about the history of EUDAMED, what it took to get there and where it is currently, and what the near- and long-term future of EUDAMED is.

Hope you enjoy this episode. Last little note that I'll throw out here is my co-host, Brittany Smith. She's new. She's new to the podcast. You may have heard her. Actually, we've done a podcast in the past with her. She's my stand in co-host. I'm hoping to do more episodes with her. So, love any feedback you have on if this works.

If it doesn't work, I think she's pretty great. You'll really like listening to her. She's a medical device guru. She has UDI experience. So that's one of the reasons I wanted to bring into this episode.

But hopefully we'll have her on more episodes in the future. So, let's get to the episode haven. Welcome back to the podcast. My name is Etienne Nichols. I'm the host of today's episode.

With me today, I actually have a couple guests with me. Well, not a couple guests, one special guest, Richard Houlihan from EirMed. We're going to be talking about EUDAMED first of all.

So, Richard, how are you doing today?

Richard Houlihan: Hey, good to see you.

Etienne Nichols: Great to have you with us today. Also with me is my co-host, Brittany Smith, and I dragged her onto this episode because she and her past life had to deal with UDI.

And it is kind of funny, and I'll let you speak to this a little bit, Brittany, but it seems like anybody in a medical device company, once you learn what that acronym stands for, you are suddenly in charge of the entire initiative.

Is that kind of what your experience was?

Richard Houlihan: You're in trouble?

Brittani Smith: Yeah, absolutely.

Once I learned the process, I was the UDI person and didn't matter if it was FDA, EUDAMED Prep, I was the go-to. So, I was educating the team. I was managing our UDIs, the GMDN, all of that.

So, yeah, once you become that, like, you've got it. So, you got to learn all the acronyms because UDI has a lot of them.

Etienne Nichols: They really do.

And so, I want to talk a little bit, Richard, about your journey to where you are today, because you've been involved, whether peripherally or directly with EUDAMED for a long time. Isn't that, right?

Richard Houlihan: Yeah, for my sins, I started with EUDAMED in 2011.

Etienne Nichols: Wow.

Richard Houlihan: And I had a working group in 2012. I was in Ireland. I was in the European Commission office in Ireland, and my clients effectively were in Brussels. So, I would just talk to them like this on video before it was fashionable, right. But it was good. But I would talk to them once a week, we'd go through what was happening with EUDAMED 2.

And I was running that. And then I went to a working group in the march, give or take. And this was just after the PIP case, which was the industrial silicone in the breast implants from France, caused a whole load of pain for people. It was a horrible situation.

But at this meeting, they started talking about the new version of EUDAMED that they were going to start on and the new regulations. And I made it my business to get stuck into the middle of the regulations.

So, from a nerdy level, I managed to follow it from thought all the way through to the trial logs, all the way through to the delivery and the enacting of the medical device regulations.

But on the EUDAMED side, I thought naively, I thought coming from the private sector, that they're talking about creating a piece of software, year and a half, two years, we should be live.

And the people, the commission kind of laughed my naivety and they went, no, we think maybe 2016, 2017. And this is 2012 now.

Etienne Nichols: Yeah.

Richard Houlihan: I thought, Jeez, that's a long time away. So, I thought okay, eureka moment. EUDAMED is going to be big. EUDAMED is going to require a lot of help. Because the working group I was at, it was one of these really nice ones with all the little country flags in front of the delegations and really intimidating.

And I was supposed to do a 20 minutes presentation and walk away.

But the competent authorities that were there, they didn't want anybody walking away. They wanted anybody who could answer their questions. So, I got verbally attacked and battled for an hour and a half with the member states and with these competent authorities.

And I thought, wow, if these guys don't understand what's going on, I'm in a great place here. So, I decided then that I'm going to chase this EUDAMED thing. And I still thought 2016, 2017, there was going to be something. So, I was running EUDAMED.

EUDAMED 2 at that time.

It does exist already.

It's only available to competent authorities and the European Commission. But the notified bodies have to provide the competent authorities with all the data and all the incidents, all the big, serious vigilance incidents, and they then upload it to EUDAMED 2.

Data is awful. Absolutely horrendous.

It allowed duplicates of everything. We had one actor in their separate entries 379 times, and some of those 379 times had multiple versions. And they all owned different devices, but they were the same company.

Etienne Nichols: Oh, no.

Richard Houlihan: So, the data just absolutely abysmal.

But then I pushed my way into this EUDAMED that you guys are talking about, because this EUDAMED is really EUDAMED Three. Commission don't like to call it EUDAMED Three, they just like to call it EUDAMED. They're a bit funny about their naming, but they didn't want to transfer any data from the old one.

They didn't want legacy devices.

Etienne Nichols: Now why is that?

Richard Houlihan: Because the data was awful. Okay? The data in EUDAMED 2 was awful. That was the first thing. So, you couldn't transfer it. And because there were so many more fields that were required, things like that.

But early on, there was a conscious decision made. No legacy devices. This is for the new devices, the new certified devices. We're not going bringing any legacy stuff with us.

So, we designed EUDAMED to act like that. Basic UDI. UDI, that's the composite key. A database has to have a nice key. This was the key.

Then the MDCG. Now there was various meetings, the MDCG and the commission had a bit of a back and forth at their meetings. And eventually the MDCG decided with the member states that you are going to take in legacy devices.

Etienne Nichols: And time out.

MDCG just for those listening the medical device coordination group.

My wife told me she listens to my podcast, but she will not listen to it if I don't define the acronyms. So, there you I have the first.

Richard Houlihan: Slide I do in my presentation is a list of acronyms. Because I was doing a speech with the Medical Device Writers Association, and they were seen some of my earlier stuff, and they said, you cannot use acronyms if you don't give us a list of them. So, I've kept it in there.

I can send you the list.

Etienne Nichols: Apologies for the interruption but go ahead.

Richard Houlihan: So, the commission then came back to us, the It team creating EUDAMED, and they said, you're going to have to figure out some way to bring these in. So, the whole idea, and the commission don't like calling it this, but the whole idea of a fake basic UDI and a fake UDI for those who didn't already have UDIs, we had to come up with that. And I know I've kind of dived really deep into the EUDAMED bit there. But the main point about it is because the data in EUDAMED 2 was so bad and at one stage, I had some coding put in to block the duplicates with three member states throw the toys out of the pram and say, you've no right to do this. You don't have a legal basis. Yada, yada, yada. So, we very delicately pulled it all back because it's more than your job's worth to keep it there.

Because the commission weren't allowed do this this time with this amount that's been created. Now, the rules are so tight, you can get nothing in there. And because they've made the rules so tight, this is why we're taking so long. This is why things are being so slow, because when I left the commission in April 2019, everything was on target to have EUDAMED released in March 2020. Everything was on time. Even the commissioner spoke to the parliament in the August, and they said, yes, everything's on time.

Etienne Nichols: Interesting.

Richard Houlihan: And here we are in 2023, and I'm still saying, yeah, it's coming.

Etienne Nichols: Yeah.

Well, I suppose if you look back on the timeline, I guess 2020 was the world's longest year, and then followed by the world's shortest year of 2021. But 2022, we still should have gotten there.

Richard Houlihan: Yeah.

When I left, we had a team of 23.

Now the team is around 50.

When I left, we had two people running the project, one looking after the business, one looking after the It side, and there was a good crossover. Obviously, I made sure there was a crossover because I wanted to get as much information as I could. So, I went to as many of the business meetings as well. Information is always key to these things.

And now I believe there's half a dozen different managers and we're even later.

Etienne Nichols: So how does that affect the actual companies that are out there who are watching this happen, thinking, okay, well, I know I've got to do something at some point, and Brittany, feel free to jump in with your experience as well.

But how do you see that impacting companies?

Richard Houlihan: They're now complacent. They now cannot be scared. When I left the commission and I started talking about this in 2019, some rather large companies came to me straight away, oh, you know about EUDAMED?

And I says, yeah, and I tried to explain it, and they kind of glassed over and fogged over, didn't understand any of it. And that led to a whole other situation with training courses, et cetera.

But the commission's approach is they believe everybody is just looking at their web pages, waiting for something to be published. So, they've communicated. They put up a little link in a page that's maybe four or five four pages long, and they go, well, we've informed them.

They're all ready. Now the reality, most of the companies don't know anything about it. Oh, they know about MDR, they know about IVDR, they've heard of EUDAMED, but we have our data in GUDID, so what's the big deal?

We'll get it done. Chalk and cheese. But for the companies now, a lot of our clients have data in there already. Obviously, there's a whole raft of clients who have got their budgets, but they've pushed them back till January next year, and next year they're doing it. But because of the latest, there's another cohort then that are doing nothing, absolutely nothing, until the commission says, this is fully functional. Now get your data in. They're not even preparing the data, and this takes a lot of time.

Some of the companies in Europe, they didn't have UDIs. They were just selling in Europe. They weren't selling in the US. So, they didn't have UDI. So, they've got a whole UDI project to go through.

Then once they go through that, they've also got their basic UDIs to figure out how these things group together. The basic UDI is like a family of UDIs, basically. Yeah.

And there's another twist to that coming with what's called the Master Udi, which is going to be for the likes of contact lens companies.

Etienne Nichols: Okay, this is new to me. Brittany, are you aware of this?

Brittani Smith: No, but probably because I wasn't in the contact lens space. So, I'm going to say that's okay, that I haven't heard of that one.

Etienne Nichols: You're blowing our mind, but go ahead, Richard.

Richard Houlihan: It's a new one coming down the road, and what it's going to allow them to do is to group their lenses. We had one lady come to the working group, and she said to the commission official running it, I won't give his name. I'd love to, but I won't. But she said to the guy running it, we have a choice if we can group the contact lenses under one ID, and they're the exact same thing, exact same rules. Everything is identical. A slightly different diopter size, just a slight difference in the sizes, so you can actually see something.

If we can group them together, we have a few hundred.

If we cannot group them, we have 60,000 separate UDIs we're going to have to put in. Now, some of them run into hundreds of thousands.

And the guy laughed at her. He went, well, guess you're 60,000 then.

But this is the whole idea of this master di. Now, there's still talks going on about how the implementation, et cetera, but this is another thing that's going to be part of all this.

But with the basic UDIs, it was there to group things. Nice family of products, you're all the same. You have a different color, a different size. There's something small. There's only a tiny difference between all these UDIs.

But you've got your UDI project to get everything together from the US. You've got UDIs all over the place or jeetens all over the place. And now you've got to group them together and you've got to figure out, oh, is this the right group?

Does this one fit in under these rules, or do I need a different group? So, there's that side of the project everywhere. But then for EUDAMED, you've got to get your marketing data.

You've got to get when you put it on the market, is there latex in it?

The good idea has two questions around latex.

EUDAMED has one question around latex. You can't even look at the exact definitions on the GUDID side and go, well, that fits exactly there. So, we're one for one.

And the reason I know all this is because we've actually added the GUDID to our system. As well. And we thought, hey, we know this stuff inside out. We're just going to figure out where the crossovers are. Even when I was running the EUDAMED team, I had two analysts look at the GUDID to see could we name things similar, or could we keep things really tight so that there could be savings along the way?

There isn't.

Brittani Smith: That's the big thing that we ran into. And we were definitely in the boat of what you were talking about, of like, well, we can do some prep, but I was pretty adamant of I don't want us to put in our data.

The database could change, and then we have to do a remediation action to get everything that's changed. There was just too much variability to risk putting things in because we're talking about like 9000 SKUs.

At my company, we had a lot of SKUs, and basically, we were like, okay, we're going to be able to group. And we were running into yeah, we could minimize and there were groupings, but we had screws.

Yeah, we had various sizes, but there were two sets of screws that had different materials, so we couldn't group them together because of the material properties. And we were running into so many we were trying to and there was not a lot of overlap.

Like, it was its own separate group outside of the MDR transition team because there was so much to focus there. And EUDAMED was the one thing that we could push to focus on the other things, the lifetime testing.

And I don't know where it stands now, but I was pretty vocal of let's prepare what we can. What is the most important when the time comes that it's ready to flip the switch, let's focus there and then let's learn from what we can.

And it's so hard because there's not a lot of translation and it's a whole project, even if you have really.

Etienne Nichols: Good and Richard, I've got a question on that. So, and maybe, we need to go through some dates because it'd be good to just kind of get an idea and feel for where we are and what's coming.

But you mentioned this talk about potential Master di, and I'm curious.

At some point, are we going to draw the line in the sand and this is when it's fully functional, and then we're going to make additional improvements or streamlining? What have you seen or heard about that?

Richard Houlihan: So, before I left the commission, I know I keep saying this, but it was before I left the commission, I had already started lists for version two and version three.

We haven't even released version one yet.

This is going to be the MVP, the minimum viable product, right. There is a load of stuff that's going to come afterwards. Now, I'm gone four years, so I'm fairly sure those lists are a little bit bigger now, just a little bit. But there are huge amounts that are not going to be fully ready when we're there.

One of the bigger things that looked like it was going to be pushed until the next version was the mergers and acquisitions.

What happens if you merge with a company?

Company A has their UDIs.

They all belong to Company A. Company B also have their UDIs. They all belong to Company B. But now Company B is going to be trading under Company A.

What do you do with the UDIs?

Because in EUDAMED they belong to company B.

There's no transfer.

So, does Company B now have to issue all brand new UDIs and start the whole process again?

Because the whole idea of EUDAMED is that it's going to keep the data. It's not going to delete stuff and add new stuff. It's going to keep the data. So, all these UDIs, then all of a sudden, you've got a duplicate situation because if they go to Company A, it's a duplicate. But EUDAMED says you can't have a duplicate even if you've started a draft in EUDAMED and then you try and upload your data in XML, it'll block you because that UDI is gone because you have it as a draft.

So now you've got all this merger and acquisition stuff and demergers and company splitting, and it's a massive piece of functionality that is going to be pushed back a bit.

They even mentioned it in the only reason I brought it up is because they mentioned it in the minutes of the meeting. Because one of the lovely things about my position with the commission is I was warned in no uncertain terms, do not mention anything confidential.

They said, I mean, all this is going to be public anyway, but I was very clearly warned we prize confidentiality, so when you get out there, shut up.

Etienne Nichols: So, you got to extract the confidential.

Richard Houlihan: Okay, so I have to wait until they mention something and they just in there and I'm pointing to the other screen. But in their minutes of their last.

Etienne Nichols: Meeting OJEU, the Official Journal of the European Union, or is?

Richard Houlihan: No, this was a different one. This was the minutes of their EUDAMED working group meeting.

Etienne Nichols: Yeah, yeah.

Richard Houlihan: And this is also where they've mentioned another potential delay. I'll get to that in a second. Okay, but there were two things you asked going back to the first one, the companies and how they're approaching it now.

A lot of them are being very complacent because they think they will have time because of the UDI project. Even if they've all this bit done, the UDI project and their basic UDIs, even if they've all that done, collating the data can take months.

It's a project in itself. So, you either bring in external consultants from the likes of ourselves and they will go in and collate all the data for you so that you can leave your Ras and QEAS doing their day job which has to be done anyway.

Or you take them away from their day job and you don't count them as an expense, even though you still have to pay them. And all the other work is piling up in the background, but it can take them months away from their day job to collate the data. Then after you've collated the data, you have to make sure that that data actually passes all the EUDAMED rules.

And the EUDAMED rules are extensive.

Believe me, I've slept with them. Jesus, they're really extensive.

We have a very clever rules engine that bounces off the data and gives you a list of what's wrong with your data.

So that bit's fine. Then you have to create the XML.

Then you have to submit the XML. But submitting the XML is not just select that file and push it because there's sequences of things that have to go up there.

You have your version one of your basic UDI and its first UDI.

Then you have a different service for version two of your basic UDI. You have a different service for version two of a UDI. You have a different service for version one of a UDI, for an already existing basic UDI.

And then you have the same for the markets and the packaging, right? So, lots of pain in the *** tied into this thing, but it takes time.

And one of the things some companies have done, which personally I think is absolutely crazy, they've invested in building their own system, right?

For half a million dollars you will get the most basic system on earth.

I spoke with one big company from Texas, and this is early on, and they had built their own system for the G Ten, which is a lot simpler, but they had built their own system, or, sorry for the GUDID, and it would put together the XML files and deliver them, et cetera, same as any good EUDAMED system would.

And I said to you going to he was at one of our training sessions for EUDAMED. I said, you're going to do the same for EUDAMED. He said, not in a million years.

He said, we spent over a million dollars preparing this system and now we have to keep a permanent team managing it.

If companies outsource to me, if your company are doing the EUDAMED stuff, or some of the other companies that are doing the EUDAMED uploads, they could run those systems for 1020 years and still not get to the same costs.

A lot of the companies are making very foolish decisions on delaying collating of the data and other ones on designing their own systems, even though they're going to be paying for this for years to come.

Because your version twos, your version threes, all those new things that Brittany and yourself are concerned about, they're going to come. And as soon as they come, somebody has to go back in the code and make your system match.

But one thing that Brittany, sorry, I know you're trying to get no, no, go for it. One quick one. Brittany mentioned that one of the reasons that they didn't do anything was she wanted to hold back because EUDAMED might change.

The UDI device module. Now, from the beginning of this year, say February of this year is fixed.

It's not changing. The bugs have been fixed. Now, every now and again, you get a tiny little bit of what's called regression, where they put in a new version and something small trips up.

But that's software. It's like the old blue screen in Microsoft. Everybody thought it was brilliant. It's a pain, but it happens.

But the UDI device module now is 100%, and there's absolutely no reason for any company to delay.

Etienne Nichols: Okay, I'm going to take a quick time out because you've fuzzed out on me. I don't know if you can refocus your camera.

Richard Houlihan: All right.

Etienne Nichols: No, that's okay. That's just me wanting to see you. So that's great.

Richard Houlihan: Well, what happens with the camera is I keep waving my hands, trying to block out the sun, and the camera is trying to go, I need to sit in my hands.

Etienne Nichols: No, I know. I do the same thing. Okay.

And that was my understanding, is that the Udi portion is locked down. And so, when we think about that and you know what? Basically, before we go down the road as to what companies should do, maybe we should talk a little bit, because we've talked and mentioned GUDID, which the Global Unique Device Identification Database.

Richard Houlihan: I believe that's one for Brittany. You're better than me on that acronym.

Etienne Nichols: That's the FDA's UDI database.

And you also mentioned GTM, which I believe is a global trade item number. That one was burned into my brain, and that's part of what you put into that GUDID.

But the differences as far as EUDAMED and GUDID and their requirements are Brittany, have you got a and maybe you know this, Richard. The different numbers of pieces of information you have to have for each I can't remember, it seems like it's 15 versus 54 or what are the and.

Richard Houlihan: I could be wrong on this, Brittany? From my memory on what we did, I think there was 64 data points in GUDID if you use them all. But in EUDAMED, there's 104.

Etienne Nichols: Okay.

Richard Houlihan: But within EUDAMED, there is a lot of sections where you also can have multiples. There’re a few sections in good idea. You can have multiples as well. But in EUDAMED, there's a lot of sections where you can have multiples.

Etienne Nichols: So, on the one hand go ahead, Brittany.

Brittani Smith: I was just going to say, I'm visualizing the spreadsheets that we had to work with for Uploads, and the G ten one was very straightforward. I could probably fill it out in my sleep.

By the time I did about a couple of hundred. And the Utah Med spreadsheet had two tabs, and it was much longer than the GUDID.

And with the multiples that's the kicker with EUDAMED is there are a lot of columns where you can have multiple inputs for the one column.

Richard Houlihan: We designed our templates for companies.

One of the first things we did, we put together a template. It's like a relational database in a spreadsheet, for want of a better way of putting it. For MDR, there are 20 tabs.

Now, not all of them are mandatory, but you had to have a tab for the emdn codes because you could have multiples for the trade names, for the additional descriptions, clinical warnings, blah, blah, blah, it goes on and on.

But there was 20 tabs.

Etienne Nichols: Wow.

Richard Houlihan: Now it is a monster.

But when it's up and running completely, when it's all there and angry, angry or in anger, rather move forward maybe five years, the level of statistical data will be just phenomenal, right? Because they have been such a pain in the *** with the rules, the data that comes out will be absolutely pristine.

Etienne Nichols: That's a really good point, actually. And we talk about how difficult it is, and I actually want to touch on that one moment before we leave. That 64 versus 104. You might think it's just a little less than twice as much.

Shouldn't it only be twice as much work? But that's not thinking about the different permutations that result from those additional columns, because that does almost become exponential at some point.

Richard Houlihan: There was one piece that two years ago,

all you had to enter was your first market in Europe. What was your first market, and that's all you had to tie to the UDI.

But I don't know when exactly they did it, but they slipped it in that with the exception of Class One and Class A, with the exception of those two, you have to put in all the EU markets, whether they're on the market now or you plan on having them on it. And they made that mandatory.

And that was something that was just slipped into the user manual. And when I followed them up, they no, no, this was always mandatory. I said, no, it wasn't. I was there when this was done.

Etienne Nichols: Well, to your point, though, you talk about the cleanness of data, or if the rules are as strict as they are, the statistical data is going to be going to be a big benefit. And I want to maybe talk about that, because sometimes we only focus on how difficult it is.

If you compare, I remember this is back, I'm going back five years, six years. Looking at the good idea, I thought, wow, the good idea is kind of a mess.

I mean, it didn't seem like very clean and please, FDA, don't listen to this, just ignore me. But that was my feeling at the time, and I don't know if that's still the case.

I haven't looked at the good idea in a few years now and I'm curious what your thoughts are and maybe what the benefit is from having all that clean data.

Is there any specific goal or use that they're planning to have the industry utilize for?

Richard Houlihan: Yeah, the use is a big one because when I was there, we discussed open data sets. Now, an open data set, for those who don't know, it's just a big dump.

All the data that anybody can import to their own database, it really is just a big dump of data. But when you get all this data, you could run queries on it, you couldn't run reports on it, you can get nice, pretty graphs of certain things, but you can also see trends.

But the Commission had said and had agreed that we were going to publish open data sets because the European Commission as a whole, they're really keen on this, they're keen on the transparency.

And for the UDI device module, every single bit of data is public.

Everything.

Now vigilance, clinical investigations, post market surveillance, there'll be summaries because there's confidential information, there's commercially sensitive information in those, but every single thing on the device module is public. So, this was the one that we wanted to, or I wanted to publish the open data sets on and it was going to be done.

But I contacted them six, eight months ago and I says, right, when are we going to get these open data sets? And they said, what open data sets? And I said, well, the ones for X.

And they went, we don't have any plans to do so because the data can be used for market intelligence.

Company A can spy on Company B. Company C can go, well, which direction should we go in? Oh, there's a trend there. Maybe we should look at that product. It could trigger something for startups.

I want to do some sort of a heart monitor that you look at your phone for 2 seconds and it works. Is there anything like that on the market?

But you could find other things.

When I was with the commission. I sat with the commission. auditors. Now, the auditor now, I know I digress a bit on this, but I come back. The auditors, they are the ones who visit the notified bodies.

Under the old legislation, they had to be asked. Under the current system, they can turn up and go, give me all the CVS for everybody involved in this certification process. Why can that person say, yes, this company is correct, and we can certify them? So, they really delve deep into it.

But what they couldn't do is they couldn't see the trends as to which notified body across Europe was putting out more hip replacement certificates or knee replacements or screws for your jaw, something like that.

They couldn't see that. But with this new system, with this new … coming up, they will be able to go a screw of this diameter of this metal, how many of them are on the market?

What countries are they being sold in?

Who's certifying the most of them?

Which person within now they'll have a little bit more access to the certificate module, which person within that notified body is the one that is signing off on most of these?

And what gives them the right to do so? So, they will be able to drill down and down and down and what they can do if there's a cowboy notified body. And they did exist, not under the new system, but under the old system they did exist.

They couldn't de designate them previously, not without the whole European Commission health ministers signing off and the whole thing. But under this new system, they will be able to shut down a notified body if they are cowboys, and it makes the whole thing safe. So those kinds of statistics, from the public point of view, you're going in for your hip replacement, you want to see, well, doctor says you're getting number one, you go, I'm not sure, you can go in and have a look and then you can drill down and see what other ones are available.

Were there any incidents with them? How come three people died using that one and nobody died using the one I'm not getting?

I'm actually a big fan of EUDAMED, in case you didn't catch that piece. But it's the data now, my background is it I'm 28 years It, I have my bachelor's in IT and I have my MBA in information management, so I'm all about the data.

Etienne Nichols: Right.

Richard Houlihan: Nerdy but for this, IT is just going to give so much good data. And I know there's a lot of people really irritated with the commission, really irritated with the delays, and again, I'm irritated myself.

But it's a hugely ambitious project.

Now, the device module and the certificates module, they're both huge in themselves.

The vigilance module, that's a whole ecosystem in itself and the clinical investigations for any poor devil involved in clinical investigations, this thing is an absolute monster, it's huge.

But what they've done is they're putting them all together and they're connecting them all in the real world, we would call that consolidation in a marketplace, which is another story and I do think there's going to be a whole heap of that on the It side for these medical device things, but it is hugely ambitious. I was told it was the second biggest It project ever undertaken by the Commission.

Etienne Nichols: Interesting, right?

Richard Houlihan: There's a lot of problems with it, but a lot of that might be down to lack of experience, but it's consolidated and it's put together software the way the market wants it.

Now, my experience so far with the marketplace and the medical device, people want to use a system that has lots of things in it they don't want to use a QMS here a new med supply, there, inventory. They want to put it together.

Etienne Nichols: Yeah, they want to sweep.

Richard Houlihan: But this is what the commission have actually done. Now, people don't see it like that yet. They just see it. So, it's delayed. It's a pain in the ***. We have to do all this work.

But this is what it's actually done. It has consolidated everything, and it's put it all under one umbrella, as it were.

Etienne Nichols: It's almost as if we're expecting a step jump in the quality of data. And that step a, that's a cliff to climb for the industry.

Richard Houlihan: Sure.

Etienne Nichols: Go ahead, Brittany, what were we going to say?

Brittani Smith: Yeah, I was just going to say, as it relates to the delays I had seen, like, the last date, unless it's changed, was like Q2 2024 was when all right, this is when you are mandatory to use is that the right date?

Is that what's currently posted? And then I heard you mention some delays.

Richard Houlihan: Yeah.

Brittani Smith: What is the delay? Do we know what the new date is?

Richard Houlihan: Okay, well, we do the date for fully functional.

And the fully functional is very important because that's after the audit. After the audit signs off, after the commission publish in the official journal, six months after that, then it's officially fully functional.

Right.

So up to a few weeks ago, Q4 2024 was the fully functional date.

And now when the commission give you a queue, it's the last day. It's never up near the beginning. It's the very last day. Right. So that's what was there in their minutes for June.

There was an EUDAMED meeting in June and a working group meeting in June. And what they said there was that they need to have a longer audit.

Right. Yeah.

It's a good excuse. It's a good excuse. So, they need to have a longer audit that may take up until may take up to about nine months rather than the six they first thought of.

But then they said they need to move the start date of the audit a little bit as well, which gave them another three months.

So, on my calculations, the publication in the official journal will be either the end of Q4 2024 or the very beginning of Q1 2025, which makes the fully functional date Q2 2024. But I have a funny feeling it might be Q3 2025.

Etienne Nichols: Do you have a funny feeling that it may be Q3 of 2025 for fully functional?

Richard Houlihan: Yeah.

Etienne Nichols: Okay.

Richard Houlihan: Now, the fully functional is very important because that's when EUDAMED becomes mandatory.

The day after it's fully functional, any serious vigilance incident has to be reported through EUDAMED, not through the competent authorities, as you currently do. It has to go through EUDAMED. Mandatory, legally binding, do not pass Go and get your 200, probably more than 200 now in monopoly, I don't know. But the fully functional date.

And this goes back to one of your earlier questions. A lot of companies are looking at that and going, that's when we're going to start.

It is nuts, absolutely nuts to wait until then for a few reasons.

What if you have a vigilance issue? If you've no data in EUDAMED, if you've known device data in EUDAMED, you cannot do a vigilance report because you have to select your UDI and then it'll prepopulate certain things.

There's a massive form called a mirror form, and it runs to about eleven four pages.

That's the vigilance report you have to populate, but it prepopulates based on your selected basic UDI.

But if you're IT guys on holidays, and the It guys are always the Porsche mocks who have to pull this data out and oh yes, we've got all the markets, we got this now we can put it into EUDAMED.

If you're very lucky, you'll get that one basic UDI and UDI into EUDAMED.

But if it's a serious incident, you've only got two days.

There's another version of it where you've got 15 days, but for the serious incident, you've got two days to get this reported, because then it gets pushed out to all the competent authorities.

If you don't get it out and you're late, then you're guaranteed a very long conversation with a competent authority that you really don't want to be having.

That's the first thing. The second thing, if you underestimate how long it's going to take you to get all your data together and get it into EUDAMED. And I've got some companies that are just mental, that think they can type in 10,000 devices and it'll be just fine.

It'll only take us a couple of weeks. Just out to lunch, some of these people. But if they miss the date, if they miss their transition date, then they can't sell their devices legally in Europe.

So how do you go back to your managing director, CEO, board of directors, shareholders go, listen, funny story, we haven't been able to sell in Europe for the last month.

It's not really a career enhancing move, right?

But then there's another twist.

And this is to do with the MDR extension where you could extend your certificates. And this was done to help notified bodies, not to help manufacturers. Some manufacturers think, oh, this is great, now we don't have to do anything.

We just get our QMS in place and send a letter to this competent or the notified body and we're all good to go.

Now, there is some good things in it. I'll digress for 1 second. Sure, there is some good bits in it. If your device doesn't have an expiry date or a use by date or anything that limits when you can actually use it, you can fill your warehouse, and I mean fill your warehouses to the gills. Then they're in the supply chain. Once they're in the supply chain, you can keep selling them under your MDD certificate.

And we checked with the commission, and we said, look, you could fill a warehouse in of 80 years’ worth of these. We'll say, Scalpels, just for example, you could fill your warehouse in of 80 years of these.

And they went, yeah, still sell them under the old certificate. So that's a bit of a weird anomaly. But because of this extension, other jurisdictions are now contacting the competent authorities and going, is this device still okay under this certificate?

Yeah, but we're not seeing it EUDAMED.

And there's so many permutations on it because a lot of companies that we're dealing with had decided they were not putting in their legacy devices. Not a chance.

Don't need to. We'll just wait for the certificate and put in the new ones. But because of the extension, these guys are now going, oh, we kind of have to put them in just in case you then have some importers and distributors, they're saying, well, we're not going touching your device if we don't see it in EUDAMED.

It's been explained to them. And I had actually had this conversation, we explained it to these guys that, look, EUDAMED is not mandatory at the moment.

And they said, we don't care if that American company that were selling IVDRs, that over a thousand IVDRs.

If that company wants us to import their goods, we want to see it in EUDAMED because we have a lot of legal obligations. And one of the things is we got to check EUDAMED, so even if it's not mandatory.

Etienne Nichols: So, it's interesting that you bring those up because a lot of times we look at the one milestone and you're like, okay, well, what's the date on that? But you might not think, well, the milestone after that.

Vigilance reporting, for example, requires that milestone actually to have been met three months prior or whatever the month is. You think about project it's really just project management. Or looking at your Gantt chart, what are the preceding factors that have to happen?

And that's really how companies need to be looking at this. That's the way I'm kind of interpreting this.

Richard Houlihan: Absolutely.

Brittani Smith: No, I was just saying what I'm hearing, too, is where EUDAMED is now, it's a good business decision to start to put in your EUDAMED.

And if you don't know who's going to be helping you, don't build something yourself outsource where you can start to build it now, set yourself up for success, because it's about this is the good time to get it in because the database itself is stable.

Richard Houlihan: And you've also got all the other regulatory things, the Australians, the Canadians, the Chinese, everybody's changing things.

And if you wait until next year, suddenly you have all these other headaches coming along.

There’re certain markets that are looking at EUDAMED as the starting point. To get into their market, you have to have your Ce mark. And we want to see your data in EUDAMED, then we will do it.

Then you can start looking at coming in here and selling your products here.

We've also come across which a very bizarre one and goes back to the whole thing on the data distributors and importers, using it as a product catalog, what's available out there. We're looking for something new. Let's search for this class, this device, because we have some clients that are looking for that, and they can go in and search for it because all the data is there. Now, at the moment, we only have, and I wrote these down, that's why I'm looking at it.

At the moment, we have 147,000 MDR devices, 82,000 UDIs, 82,000 MDD, 18,000 IVDR. Twelve and a half thousand IVDD, and that adds up to less than half a million.

We were expecting well over 2 million. GUDID has something like four and a half million.

Etienne Nichols: Yeah.

Richard Houlihan: This hasn't even started yet. Yeah, we're expecting over 80,000 companies. Currently. There's about 22,000 with SRNs.

We did a survey yeah, we did a survey with KPMG, and we went out to the market and spoke to our clients and their clients, and 10% reckoned that they were in a good place, 30% reckon, no problem, we'll easily get there.

But that's count of companies, not of devices, some of the smaller companies seem to be far slower, and by smaller, I'm talking less than 10,000 devices. Some of the huge ones are miles ahead, but they've also invested ridiculous amount of money.

Etienne Nichols: Yeah, but as a Fortune 500 company, that was the big focus. Obviously, this is going to inhibit our ability to market in certain areas, whether that was GUDID or EU MDR.

So, I think sometimes maybe the awareness might be an issue. There's a lot of buzz in the industry about extensions and delays, and so a small company might just say, okay, cool, I'm good for a while, which is not really the case necessarily, but.

Richard Houlihan: More headaches are coming around the corner. Yeah, there's so many regulatory changes coming.

Etienne Nichols: Quick question. So, you deal with so many companies, and you've been in the weeds with EUDAMED for so long, I'm curious if you have any piece of advice for smart companies.

If they are looking at this, they're just tearing their hair out. Maybe they have let's just pick out a number. Maybe they have ten devices.

What would you recommend? Is there any advice you give them to just this is how you start, maybe don't attack at all, all of your devices, or do I don't know what your advice is.

Richard Houlihan: Our smallest client has seven UDIs, okay? Seven. And I said to him, I said, look, go to EUDAMED, type them in.

He said no. He says, I don't want to touch it. And I said, look, honestly, I said, there's certain steps, you'll be fine. I said, look, it might take you a little bit of time getting the data and that, but you've only seven devices.

Just type them in. He said, no, but I'm going to charge you X amount of money to do it. And now our charges are far less than some. But anyway, he was still going to get charged and he said, I'll pay.

Yeah. So, some of it depends on if you have the people with the time. That's one thing. And a lot of companies don't include when they're pricing their project, they don't include staff.

If they have to bring in consultants, they'll include those in the budget figures. But the ten staff that you have sitting there that are working on this full time, well, we're paying them anyway.

But it's still a cost because it affects the whole thing, right. People can go and read all the documents, right? The documents were written for it.

They were not written for the likes of non-IT people.

Etienne Nichols: Right.

Richard Houlihan: I didn't take that decision.

At one of the working groups, we were asked, is it possible that you could produce an idiot's guide to it for the regular people, the ones that do the actual medical device work, who still need to do this bit?

And the head guy, the commission guy, because there has to be a commission guy in the top of all these things. He said no. He said EUDAMED, is it? EUDAMED is software. Get your It teams to explain it to you.

Most of the It teams fix the computer if it goes down. They'll install a new piece of software, they'll add a new user. They are not heavy-duty developers. Yeah, I mean, Greenlight would not have an RAQA creating the next module.

It's a developer's job. The RAQA can guide them as to what it should actually do, but they will not do the hardcore coding. It's a different world.

So, the documents that these companies are looking at, the commission have published so many of them given the exact same information in different formats.

It has confused the life out of people. We've had people come to our training that have spent six weeks going through all the documents, and this is true. The guy came with a list of 18 questions, and by the end of the training session, I never saw those bits. He said, I never got that. That's not in the documents. And this was all fresh because he had really and it was a guy that worked with labeling and the traceability side of things, so he knew his business inside out.

But the documents didn't have these little nuances in there because they're not written for regular people.

Right?

Etienne Nichols: That's the first thing, yeah.

Richard Houlihan: The training we put together, the only reason we put the training together is because nobody had a clue what I was talking about.

And I blindly said, hey, how about I throw together a training session? I'd never done it before. So, I thought, how hard can it be? It took me nine weeks, evenings, weekends, because I'd committed to giving a course on it so people could come to our training. They can find other training. We've got self-based training. It's €400. You'll save yourself weeks of pain.

Yeah, but they have to start.

They can't just keep pushing it back because this is one of these things, it isn't going away.

Even if the software is not 100% perfect and doesn't meet everybody's expectations, the commission doesn't care because legally you have to use it. Yeah, it's not like your Microsoft Word against some other version. Oh, I'm going to use the other version because I prefer that.

You got to use EUDAMED. Yeah, there's no choice.

Etienne Nichols: I love your example of the company with the seven SKUs, and they just put it in yourself or directing people to training. Because I think to myself, if you're staring at an insurmountable task, it's kind of like the first time I ever did my taxes as an engineer. I thought I could do this on my own.

And there was a deadline, I had no choice. And so now I just said, okay, I'm going to get curious about this. I'm going to follow this form, to this form, to this form, to this form, and just read them all.

And I don't necessarily recommend that, but the other piece of advice that you gave or piece of information I think is powerful is to know who this is written for so that you can put that pair of glasses on.

Is this for it? Okay, well, I'm going to look at this through that lens and then just start learning from that perspective.

Richard Houlihan: Yeah. Even with the It side, it's a very niche area.

Etienne Nichols: Oh, yeah.

Richard Houlihan: No, I sat with the guys doing the whole machine to machine and preparing the XML and everything. You ask any IT person under the sun; can you do XML? Oh, yeah, okay.

But it's very different looking at an XML file and going, oh, okay, if I put that here, this will work to creating a system that will take those 5000 devices, convert them to the correct XML that passes all the rules. There's a big difference between the two things.

And then when it came to the services, that the sections of EUDAMED you target depending which version of the device you're uploading. I'd never come across some of this stuff before.

Like I said, I'm 28 years, say I was 24 years at It at that stage. I'd never come across this machine to machine. The automated processing, it's a real niche of a niche of a niche.

And if you try and read these things, if you suffer from an insomnia, they're brilliant. 2 minutes, you're gone.

Etienne Nichols: Well, very cool. We'll have to put a link in the show notes to the different trainings you mentioned. That sounds really helpful.

One of the things I always think of, even sometimes I would go down the path trying to do something and then finally as a project manager or whatever role I was doing, and finally I'd outsource it.

At least at then I knew what I was doing, and I appreciate it so much more and I could direct and delegate so much more accurately. So, this is good.

I really appreciate it. I know we're kind of at the top of the hour, so I appreciate you hanging in there with us. Any last piece of advice or thoughts you have before we leave?

Richard Houlihan: Start.

If they leave it too long, I mean, we're in budget season now where they're their budgets for next year, if they miss it, if they leave it too long, the pain that they're going to have because of all the other systems coming in as well, it's not worth it.

Just get this headache out of the way, tick the box, move on. Yeah, that's really the only piece of advice I have.

Etienne Nichols: That's a good point. With budget season, it's early enough that maybe you could get it in next year with your budget. Definitely need to do so. All right, thank you so much, Richard, I appreciate you coming on to the show.

Brittany, thank you for joining us as well. I really appreciate giving us an hour. We will see you all next time, and until then, get your UDI and get your EUDAMED altogether.

We'll see you next time.

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About the Global Medical Device Podcast:

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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