Part 2: Navigating the Challenges of UDI Compliance in Europe's Evolving Regulatory Landscape
Highlights:
Richard Houlihan is the former IT consultant for the European Commission during the creation of EUDAMED, and today he supports medical device manufacturers with their submission through his company, Eirmed.
Dr. Christiana is an Executive Consultant and Business Development Manager at Anteris by Kymanox, and formerly Regional Manger at TUV SUD.
Memorable Quotes:
“I think the starting point is way before. So assigning the basic UDI, I think you really have to have in place a really good strategy. ” - Dr. Christiana Hofmann
“Some of the companies in Europe didn't have UDIs. So they have to go through that whole process. But to get all the data together for the FDA is far easier than EUDAMED. EUDAMED requires an awful lot more.” - Richard Houlihan
Show Links:
Contact Richard Houlihan: https://eudamed.com/
Dr. Hofmann can be reached at: anteris-medical.com
Watch Part 1: https://youtu.be/yAZWBXP3-hs
Transcript:
Voiceover - 00:00:04: Welcome to The Factor, a global medical device podcast series powered by Agilis by Kymanox. Today's episode is hosted by Shannon Hoste, president of Agilis by Kymanox, and Assistant Professor in the Quality Education Program at Pathway for Patient Health. Dr. Christiana Hofman and Richard Houlihan are back for part two. And if you haven't listened to part one, do that first and come back to this one. They chatted about transparency challenges and opportunities brought about by the EUDAMED requirements and how the delay in MDR implementation has impacted the industry. Today, they continue the conversation, discussing the complexities of UDI compliance and the impact of AI on Data Reporting.
[AI for the EUDAMED requirements]
Richard Houlihan - 00:00:50: I think the AI side would be very, very interesting on the data after the fact, like for the reporting and the statistics. And one of the things that we spoke about in the Commission was open data sets. Now an open data set is just a dump of all the data. allowed public. And it would only be around the UDI data, never the clinical investigations or the vigilance. We had that discussion before I left the Commission and I contacted them two, three months ago and they now said they have absolutely no plans to release open datasets, which I think is an awful shame. I'm hoping that they will in the future do it because from the market intelligence, from the statistics, imagine letting a really good AI engine loose on that. You could have great fun with it. But at the moment, there's no plans for it, which is a shame.
Shannon Hoste - 00:01:49: So you mentioned earlier. Minimally viable. What do you think the functionality difference will be between the first release or I guess through to mid three and subsequent versions that we're following on right after that.
[Version variations]
Richard Houlihan - 00:02:05: I can't go into the details of exactly what the individual module requirements will be. I'm kind of caught on the commissioner, very, very fussy about some of this. I don't know why. It's a database that everybody's going to get anyway, but I was going to say politely warned, but I'm not sure if that's the correct phrase or not. But the statistical side, the reporting side, none of that is going to be in version one. None of it, there's nothing. But that will come as we go along. One of the things I had hoped for and had requested was a cloning function. Because when you're entering your basic UDI, that's fine. You go to your first UDI-DI and you have another 100 to add tiny changes on each one. There's no cloning function. We put it in our software, but the Commission wouldn't do it. At the time they said it was, would have been the Commission entering data on behalf of a Medical Device Company. Which I think is a bit of a stretch, but anyway, something like that would be fantastic if they did it because it's such a time-saving thing. And at the moment, you have to enter every single field for every single UDI-DI, and the application was designed as a pretty application. So you do a little bit, save and next, a little bit, save and next. Whereas, when you're entering data into things. You want to reduce amount of clicks I did have this argument and I said, look, this is meant to be a data entry system. It should be a long form that you've got the data beside you and you can go bang, bang, bang, save, bang, bang, bang, save. That's two of them done rather than another seven ticks each. Little things like that. I was told I didn't understand modern applications and I thought that's very nice after 25 years experience. But hey. Some arguments I won, some I lost. Yeah, I can't go on too deep into that one. But like I said, a lot of it is gonna be around the reporting site.
Shannon Hoste - 00:04:16: That makes sense.
Richard Houlihan - 00:04:17: But be careful because there might be more mandatory things coming in.
Shannon Hoste - 00:04:23: So you've started EirMed to support this. If I'm a manufacturer and I'm thinking about what I need to do for EUDAMED just to enter in the data, what kind of things are required in that and what are some of the hurdles that you see with that?
Richard Houlihan - 00:04:41: Um...
Shannon Hoste - 00:04:42: Other than the line by line entry.
[Tips for inputting data]
Richard Houlihan - 00:04:47: Even before you get to the line-by-line entry, the collating of the data is an understanding of what you actually need. One of the biggest questions that we ask or were asked and never cease to amaze with is the people panic over it. There's one field in there. it's basically the first market you put the product on. within the EU. That's fine, there's 27, used to be 28 countries. So... They said, we put it all on at the same time, what do we do? So pick one. There's a book, but which one should we pick? Because... And I said, look, if you really want to keep people happy, pick the first one where your competent authority is in. And I said, nobody's going to shoot you if you get it slightly wrong. And they said, but this product has been there for 20 years and we don't have the exact date. That's what. Do you have an idea of the month? And that's about, yeah. ask, well, put the forest in the month. I said, if it's... two weeks early or? I said, nobody is going to kill you for that data. That's more for historical reasons. And then they go, well, what do we do with the other countries? Well, that's voluntary. only have to enter one country and it's the first country. Now I said if you want to enter all the other countries there's a section for the markets. And you can put them all in at the same start date. And as soon as you take one off the market, you can put in the end date and that takes it off the market. And as far as EUDAMED is concerned, each time you do things like that, your markets get a new version.
Now the market's getting a new version. Not a big deal. Your packaging is getting a new version, not a big deal. The only ones you need to worry about are your basic UDI and your UDI-DI. They're the two things you need to do. So... from the manufacturer's standpoint. Don't go out of blind. I've seen some absolutely horrendous data. being sent to our systems and they're using our templates. And in our templates, we highlight the mandatory fields. If you click new in this spreadsheet, it highlights in orange the fields that are mandatory. and it tells you what. type of data should go in there. and people still don't do it. Bit of education. of a training session, it will frighten the life out of them.
When I first started doing the training sessions, there were eight hours. We start at about 8.30 in the morning and end around 5.30. and the people's heads, they used to leave and they were sore. And I can understand that because it really is humongous. We split the content to make it less... IT orientated, but it's still IT, but you can dilute it down very well. So we cut it down to four hours, which gives them the core information that they have to know. and they're still stunned at the level of information and how big EUDAMED is. And this is only the UDI-DI model. This is just the device module. So. They need to collect the data. They need to figure out. If they don't have their UDI system in place, that's a Project that they have to do. You have to do that. If they're entering legacy devices and they don't have UDIs on that, we have a... free spreadsheet that allows them to create all those for the just a generator based on an algorithm from the Commission. but they have to lay it out. clearly, bit by bit. You have to get this data from the Marketing, you have to get this from R&D, you have to get this from regulatory associates. It's not going to be. everything from the technical file, but there'll be bits. And within the MedTech industry, spreadsheets seem to be the the choice. Which, on my background and my education just has me screaming. You lose a spreadsheet, your data's gone, get it into a database and back it up. It's just terrifying. But you can collate all this data in spreadsheets. But if you are going to do it like that. You also have to remember there's a lot of sections in EUDAMED where you can repeat data, where you can have multiple entries, trade names, clinical sizes. and the crime substance. There's so many where you can have multiple entries. So. you then have to put those into separate tabs. because you don't want to repeat. all the data. So one guy commented on our templates. He said he's never seen a relational database in a spreadsheet before. that's what you have to do because they have to connect.
You've got your UDI on tab one, you have to refer to that on tab two, on tab three, on tab four. So the whole collating, is huge, do not underestimate how long it actually takes to put this data together. And if you want to bring in consultants to do it, because your guys are all flat out busy. You could do that. But it takes time. It's not something that Mary from QA can do one day a week, spending four hours in the morning, because by the time she's caught up with where she stopped last week. The four hours are going to be gone. This thing needs concentrated staff. What you've done? You're clear. Then you just need your procedures to keep it updated and update EUDAMED afterwards with the new versions, etc. But to get it started. Really need to have a very clear view of what you're doing. It needs to be a full Project, does change management in it because, the RAs who may be filling in the data, they also need to understand a little bit of the IT side because when they're talking to the IT guys. this failed because it was. related to some other business rule that connected to this piece of data. It is a quad wire, it really is.
[UDI Strategy]
Christiana Hofmann - 00:10:59: But actually, I think the starting point is way before. So assigning the basic UDI, I think you really have to have in place a really good strategy. Because if you're kind of grouping a family and you decide on that, and then you recognize, oh, it's not working, I have to change something, then it's a real mess. Or then you have to upload everything again. So do you also consult in this way? Because I think this is a very big or huge challenge for the manufacturer to at least define the basic UDI and to assign a family or whatever.
Richard Houlihan - 00:11:40: We don't directly do it. We have partner companies that we pull in to do it. We. currently manage the data side of it. the consultants that we work with, they will go in and do everything. They will run the basic UDI Project, then there's a group that'll go in and collate the data for you. And then afterwards, how do you manage the data? Because the Notified Bodies also ask, what's your EUDAMED strategy? And if you don't have a strategy, some of them are being very... Where are you picking it up?
Christiana Hofmann - 00:12:12: Do you have the feeling the Notified Bodies are kind of aligned or aware of really entering this data than in EUDAMED? What this means for the manufacturer?
Richard Houlihan - 00:12:23: The Notified Bodies are being treated in the same way as the manufacturers by the Commission, the private companies, mission is not giving them as much assistance as they should, or at least that's what I believe. Competent authorities, they get everything they want. That's because the legislation said they had to get full support. But in a lot of the cases, the Notified Bodies. They're waiting for the same publications as you are from the Commission. And then you go back to the Commission and go, well, what do you mean by this bit? I've had the response of the Commission. We are not your regulatory consultants. Go talk to them. And it's the regulatory consultants that have actually asked the question, there is an information deficit. There is an information overload on how they've given some pieces to such an extent they presumed that was all gonna be IT Teams. I was at one working group meeting where they actually asked, is there any chance you could produce an Idiot's Guide to EUDAMED? And they said, no, it's software. Talk to your IT Teams. I had one German company and I said that to him, that this is what they said. He says, I've got 4,000 UDIs. He said, I've got three guys that fix the PCs. He said, they don't know XML or putting this data together. He said, they don't know about that. He said, what am I to do? So I can have my card. There's nothing else I could do.
Christiana Hofmann - 00:13:50: Absolutely, very difficult. So in the medical device combination area, there is now established a kind of advice group, where also Notified Bodies are included. They have to define now how this can work because they are not allowed to consult or give any advice that leads to manufacturers. But this is existing. Would you think this would also be helpful to have this in place for EUDAMED, a group really working manufacturers, European Commission, Notified Bodies in a working group together, and really to have all the challenges addressed from all sides?
Shannon Hoste - 00:14:30: Like a community of practice.
Richard Houlihan - 00:14:32: The Commission do have working groups and they do invite. in these groups. What the problem is, If you're an invited guest by the European Commission and you make too much noise at the working group, you're not going to be invited next time. On the outside, you've got your team MB, you've got the PRRCO groups. on, everybody's kind of looking after their own corner. but there should be something in the middle that explains everything, and it cannot be run by the European Commission. Because, then it's their agenda, then it's their discussions, and at the working groups, then you listen to them.
Christiana Hofmann - 00:15:18: But hopefully it will work because if you then recognize the is established, it's not visible for the manufacturers.
Richard Houlihan - 00:15:30: So far, we're three years late.
Christiana Hofmann - 00:15:32: Yeah.
Richard Houlihan - 00:15:33: And we've pushed out dates, and with the sell-off periods, if your product doesn't have an expiration date on it, and you manufacture it before a certain date, you can fill a warehouse and sell these things for the next 100 years, perfectly legally.
Christiana Hofmann - 00:15:48: Two questions. It's with regard to FDA. So FDA also has the kind of UDI system. Is there any chance of synchronizing that? So most probably not because they also have included the combination devices. And yes, second question is how to deal with the DDC, is the Drug Device Combination Product. So there was a special group I'm working on, it's article 117. It's actually a medicinal product, but it's a combination three-fold syringe. So there mustn't be a sign of course, a UDI, because it's a medicinal product. But anyway, it has a medical device component. It does not track the mutamate,
Richard Houlihan - 00:16:33: That second question is probably one of the things that will be dealt with in 2027 when they start doing this review. And then they'll take that little bit more control. They'll bring in more things. But that's moving into too much of a regulatory. But I think the review will work on that. You know, I've forgotten the first part.
Christiana Hofmann - 00:16:56: The FDA and synchronizing with us.
[FDA & EU MDR Synchronizing]
Richard Houlihan - 00:16:59: FDA, right. I've had this conversation a few times with people. We've just updated our system to handle the good idea as well. There is such a divide between the two systems. Even when I was in the Commission, we'd put some analysts, business analysts on it to see what can we do to keep EUDAMED's close to it and still obviously stay within the regulations. They spent a few weeks on it. couldn't do. So that's the first part. But if I use my crystal ball. and I look forward 10 years. EUDAMED at that stage will say it's working perfectly for at least five years, at least. And with all these wonderful statistics and trends that we can now very easily see and keep track of. I can see the FDA. trying to go beyond. Europe. so they will drag in even more. And then the next evolution, the EUDAMED crowd will look at and go, oh, that's nice. and they literally just jump back and forth. Now, it might be 10, 15 years between each of these jumps, but if one side sees that the other is... absolutely getting fantastic data and fantastic market intelligence out of it. then the other side would be very, very foolish not to adopt. they probably won't admit. that's what they're doing. But even within the Commission, the FDA were still having conversations with the Commission side during the time the regulations were being put together, during the time the EUDAMED is being put together, they do still have a quite a close relationship. There was that attempt to try and get the, oh, what was it, the... DMDRF?
Shannon Hoste - 00:18:50: I am, yeah, I am D.R.F.
Richard Houlihan - 00:18:52: They tried to kind of bring everything together. And now we've got five or six different big systems and things. Unfortunately from the manufacturer's point of view. they're still going to have to have all these labeling teams sitting there checking the regulations in different place. It's got to continue being an expense for them.
Shannon Hoste - 00:19:12: Yeah, and I've seen that as you talked about that being a crystal ball, I've seen that that theme play out over the years. Like 25 years, you know, whether one thing or another kind of tick tocks back and forth back between European and FDA regulations.
Richard Houlihan - 00:19:29: I spoke with one guy from California, not California, Florida, and he helps startups. And he said, 10 years ago. He was helping all these startups move from the US to Europe. And he said he was very busy. started laughing. He says, now I'm sitting with more or less the same people or the next evolution of them. I said, I'm helping to go from Europe back to the States because at least the starting point is a little bit easier now in the States. They get up and running in the States, then they'll come back to Europe, where it was the other way around for a while.
Shannon Hoste - 00:20:02: Tick tock.
Richard Houlihan - 00:20:03: Oh yeah, it's like that thing for the piano that goes back and forth.
Shannon Hoste - 00:20:07: Yeah, like a metronome. Yeah. That's the one. Yeah. So I have a question and I'm admittedly a bit FDA centric. I'm former FDA. So I'm a little more aware of some of the things on this side, but you know, there are several, groups like, AdvaMed and Combination Products Coalition and ISPEC that have communities of practice. And these groups are industry and consultant groups, that provide feedback to the FDA on certain items. They'll collect information from their members and kind of co-lay that into a white paper to report to the FDA on, you know, trends and things that they're seeing. Is there an equivalent to that, the European side that can provide feedback as this is evolving?
Richard Houlihan - 00:20:52: Before I answer that. I'll ask you a quick question. Does the FDA listen?
Shannon Hoste - 00:21:00: I think so. I'll answer it from having than when I was at the FDA. I know when that information was received. We always had a task force to review that data and investigate that feedback and respond.
Richard Houlihan - 00:21:17: Okay. So, and I'll tell you why I asked that.
Shannon Hoste - 00:21:20: But we also have MDUFA and PDUFA and things on this side where, there's some now then some contractual agreements between essentially industry and the agency, right?
Richard Houlihan - 00:21:30: When the Commission were looking at doing this extension? they opened up a little place where you could go and put your feedback. And there was a lot of feedback. Some of it was rubbish, like, oh, get rid of MDR, which was never going to happen. So some of it was just not useful. But there was a lot of very useful things in there. Like for one instance, your legacy device certificate is expired, but you have got a letter from your notified body saying that you've started the process, so you can continue. in EUDAMED. Your medical device certificate remains expired. One of the suggestions that we put in was that, how about you add a simple field or a simple section where that notified body letter can be uploaded, that if you're selling to a Middle East country or an Asian country or something else that wants to see what the C.E. Mark status is, they could go to EUDAMED click on that little file and go, oh, they've got the extension. So that's just one thing that we had suggested. There was dozens of other brilliant suggestions in there from people. The Commission thanked everybody and said they will add those to the review in 2027. They don't listen, though. There are the industry groups that you pay to join, like the MedTech Europe and things like that, they will communicate with the Commission, but you have to pay to join. There's, to the best of my knowledge, other than the working groups or emailing directly to someone you might have met along the way that might listen to you, there's nothing official, can publish everything under the sun. I mean all these people who come out and do these, an open letter to the European Commission. They're dauntless. They never do. The European Commission is this giant wall. But there should be something, there should be an ongoing feedback. It shouldn't be left to, reviews every five, ten years. But it also requires buy-in on the Commission side, that they're not being conned by the industry. There is that suspicion there always as well and I'm a great fan of the whole European Commission, the whole project. But having been on the inside as well. I'm also very wary of some of the things that have been done because someone passed an exam. There should be more communication and more trust-based communication. How's that for an answer?
Shannon Hoste - 00:24:14: Yeah, I guess international standards give an opportunity for some of that collaboration. Again, that doesn't directly address it. That model pulls together the input from different stakeholders.
Richard Houlihan - 00:24:28: Certainly helps.
[Conclusion]
Shannon Hoste - 00:24:30: Alright, so I'm going to wrap this up. We talked about a lot of things. We talked about, things that potentially seem insurmountable, the building of the system, but then also the integration into the system. So before we wrap up, what's some general advice? How can people scale the mountain and move fast?
Richard Houlihan - 00:24:50: Literally, it is very, very simple. Don't do it on your own. It will cost you an awful lot more money. What seems like expense of outsourcing some of this. If you look at the bigger picture and you look at how much this is going to cost you long term. it will save you a fortune. We had one particular conversation with someone who had 43,000 devices. UDIs, were lining up to help them. The guy asked the young lady who called the meeting, how long does it take you to do one of them? She said, well, the first one maybe 35-40 minutes and then each UDI afterwards, 5-10 minutes. Richard, we don't need you. She can type them in. It's an awful thing to do to someone. But that time that she will spend, leaving aside the horrible job. But the time that she will spend doing that will cost an awful lot more than bringing in a system. So the only piece of advice I can give people. Don't do it on your own. It'll cost you so much more in the long run.
Shannon Hoste - 00:25:59: For scaling questions, so I know I was involved when everything went to the UDI, when all of those systems are being implemented. Is it that same level of effort? Do you think that companies went through? What was it now 10 years ago, to build up their UDI systems? Is it the same level to then take that to the EUDAMED level?
Richard Houlihan - 00:26:20: For some people, it's two separate projects. Some of the companies in Europe didn't have UDIs. So they have to go through that whole process. But to get all the data together for the FDA is far easier than EUDAMED. EUDAMED requires an awful lot more. So if companies are coming at this thinking that, oh, look, I did the FDA, we've got all the data there. It's not the same. First of all, the fields aren't the same. There's a few that are similar, but they really are not the same. I think they should consider a completely separate Project. There might be complimentary bits in the middle as to how your processes work. but don't underestimate it.
Shannon Hoste - 00:27:03: Gonna come a mountain, you have to have a plan and a sherpa. That's a big movie roll. Yeah. Excellent. And Christiana, any advice on your side for companies that are kind of looking at? their MDR plans and their. their EUDAMED plans.
Christiana Hofmann - 00:27:20: I think it's the same if you don't have in place the resources. I think kind of outsourcing some topics might be helpful, yeah, if you don't have the specialists, because you must start now. You do not have the time, you do not have time to waste again. So the transition period will definitely end. I think there will be no more transition periods. And then it's more or less done. Get your notified body. Actually, you must have registered already to have a chance to get MDR certified. Yeah, start now. Please start now. And if you need help, there's Richard for EUDAMED. There are several consulting companies like Kymanox and anteris Agilis. Take the opportunities for support. You must start now. And the notified bodies, yeah. I'm not sure, but I think might be they have a leg also at the moment. Start now, take your chance. And also for all this Biocom testing, colleague of mine told me, There is also a lot of capacity at the moment. Start now for your MDR replication and efforts.
Richard Houlihan - 00:28:38: Definitely.
Shannon Hoste - 00:28:40: Excellent. And I'll share it. We'll share in the links below in this podcast for your companies for EirMed and for anteris for folks to get some more information. Thank you both for coming on the show and chatting with me on EUDAMED. This has been an insightful look into this requirement for medical device manufacturers. And we want to thank our audience for listening and or watching this episode. Thank you very much.
Christiana Hofmann - 00:29:04: Thank you for inviting us. It was a pleasure meeting you all.
Voiceover - 00:29:12: That was Dr. Christiana Hofmann and Richard Houlihan. Be sure to check out Christiana and Richards websites at anteris-medical.com and eudamed.com. That's EUDAMED.com. Thank you so much for listening and watching this episode. Please subscribe or follow this podcast and whatever app you're using right now. or follow Agilis by Kymanox on LinkedIn for all updates. This Episode was edited and produced by Earfluence. We'll see you again soon on The Factor.
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