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UDI and the Current State of Global Implementation

August 17, 2022

What is the current state of unique device identification (UDI) in the United States versus the European Union (EU)? What are the current deadlines, complexities, and differences, as well as the four quadrants of UDI that companies need to be aware of? Don’t underestimate your time to comply because it always takes longer than expected.

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Gary Saner, Senior Manager of Information Solutions for Life Sciences at Reed Tech, about UDI and the current state of global implementation.

Gary has been helping companies achieve UDI compliance on a global scale for years.  He is considered to be a thought leader and recognized authority on medical device UDI compliance.

 

Listen now:

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Some highlights of this episode include:

  • As the U.S. FDA Class I UDI deadline approaches, companies should refer to the FDA’s final guidance, which describes the compliance policy regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products.

  • Delays seem to be a part of the history of UDI. Manufacturers face challenges and pitfalls from UDI being rolled out easily. There are a number of issues with the brand new requirement in the United States.

  • The four quadrants of UDI are identifying a product, reprocessed/reused products, reporting attributes, and documenting standard operating procedures (SOPs) in a quality management system (QMS).

  • The EU has a complicated UDI implementation schedule, as well. Delays have been announced, but the impact was due to the European Commission completely revamping the regulatory platform. 

  • In Europe, UDI becomes one of the many things that a manufacturer has to learn, be educated on, and respond to. There’s no grandfathering of products, notified bodies, and patients. Portfolios are re-evaluated to meet new regulations.

  • With the FDA and EU in place, the regulatory landscape typically uses one or the other as a precedent. Some health authorities around the world base their policies on one or the other. However, good global harmonization is not in place.

Links:

Information Solutions - Life Sciences at Reed Tech

Gary Saner on LinkedIn

The Ultimate Guide to UDI

FDA - Unique Device Identification (UDI) System

FDA - Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices

Center for Devices and Radiological Health (CDRH)

European Union Medical Device Regulation (EU MDR)

EU In Vitro Diagnostics Regulation (IVDR)

EUDAMED

Greenlight Guru Academy

MedTech Excellence Community

Greenlight Guru MedTech Lifecycle Excellence

Greenlight Guru YouTube Channel

Etienne Nichols on LinkedIn

Memorable quotes from Gary Saner:

“This is a challenge in that this particular dataset has never really been assembled before. So, there’s no precedent for this.”

“The other issue is sometimes you find the data and it’s not accurate or it hasn’t been touched for a while. It’s not current. It’s obsolete. There’s issues with formatting. Sometimes, the formatting of that data that’s held for internal processes is not the format that actually gets submitted to the FDA.”

“There’s a little bit of a nuance about making sure the acknowledgements that come back from CDRH, there’s three acknowledgements, and making sure that they’re all complete for every single record.”

“UDI becomes one of the many things that a manufacturer has to learn and be educated on and then respond to and there was no grandfathering of products.”

“With the FDA and EU in place, the regulatory landscape typically uses one or the other as a precedent. Some of the other health authorities around the world will kind of base their policies on one or the other - US or EU.”

Transcript

Announcer: Welcome to the Global Medical Device Podcast, 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.

Etienne Nichols: Hey everyone. Welcome back to the podcast. My name is Etienne Nichols, and I'm the host of today's episode. In today's episode, we spoke with Gary Saner on the topic of Unique Device Identification, or as it's commonly known as UDI. UDI. Gary has been helping companies achieve UDI compliance on a global scale for years. He's also considered to be a thought leader in this part of the industry. Gary is the senior manager of Information Solutions for Life Sciences at Reed Tech. And he is a recognized authority within the Life Sciences community on SPL, FDA, Electronic Drug Registration and Listing, that's EDRL for those of you interested in acronyms. And he's also a leader in recognized authority on medical device, UDI compliance. I also want to mention that we've been working with Gary to create the Ultimate Guide to UDI. This is a free resource for you, our listeners. So be sure and check out the show notes, find out where you can access this guide. We covered a lot of ground in this episode, we talked about things like what is the current state of UDI in the US, gave a brief history and current deadlines. What is the current state of UDI in the EU and what are the differences for UDI for EU versus US. We also talked about the four quadrants of UDI that companies need to be aware of. So pay attention for that. And we talked about much more. Seriously, if we need to do another episode with Gary, please email me and let us know. So without further ado, please enjoy this episode with Gary Saner on Unique Device Identification. Hey everyone, welcome back. This is Etienne, the host of today's episode. I'm excited to be with Gary Saner today. He's from Reed Tech, and we're going to be talking about UDI, Unique Device Identifiers. And some people call unique device identification, but both with the FDA and the EU, we'll try to cover a lot of ground here. So we'll just go ahead and get started. Gary, I don't know, how are you doing today by the way?

Gary Saner: Oh, really good today. Trying to keep up on the various changes. So we'll touch on those later. I thought we had this figured out three or so years ago and it keeps changing on us. Literally, there's things to share from literally a week ago. So there's a lot to talk about and keep fresh, up to date with the info.

Etienne Nichols: Yeah. Well, we'll talk about those states here in a little bit here, but I also want to talk about maybe some of the complexities regarding UDI. But before we get into that, maybe let's just go ahead and talk about one in particular because the US FDA class one UDI deadline is coming up. What should companies, if they're those class one companies, that date has been moving, what should they be thinking about and what should they be doing right now?

Gary Saner: Yeah. This is starting to cry Wolf and then now you don't believe it anymore, but this is like the third to fourth date that's been set out by the FDA. And some history on that, we understand what the FDA has been challenged with in coming up with that. Originally class ones were due back in 2018. And then prior to that class one deadline, the FDA had a lot of feedback from industry about the previous classes of devices that were already sent in. So the class threes and twos downstream users started to search that data, look at it and implement it in various downstream systems. And there was a lot of feedback that said some of these fields are either not correct or they're not complete. There were some fields that were marked optional and industry kind of took that as a free opportunity not to submit anything, when really the FDA kind of intended that to be conditional. So if you have it, please submit it sort of thing. So anyway, the FDA extended the deadline in 2018 out to 2020 and asked companies to take that additional time, go back, clean up the data that they had already submitted and prepare high quality data for class ones. And then as you know, 2020 hit and COVID was interrupting all of our processes, right, and timing. So the FDA responded to that. They had internal staff that was dedicated to responding to the COVID and were diverted. There was also a realization that industry had other issues, had remote users, people weren't present anymore in the office and whole infrastructure had changed. So they pointed that COVID issue as pushing the date back again from 2020 to 2022. Now September of this year, September, 2022, we have this class one deadline and just a week or so ago, back in July 25th, a guidance document came out that I believe that think you were referring to. And that had two important bits of information. One is that the September deadline remains in place for complying with class one labeling and if it's applicable, direct marketing. So that did not move. So September 24th of this year for those particular attributes, but they did extend the date for the class one GUDID submissions. So that is now December 8th of this year 2022, they moved it out 75 days. And the reasoning for that was they felt they were, I guess, late in advising industry of particular exemption for GUDID submission. Now this particular exemption has a little bit of history. It went back to October of last year where the FDA put a proposed draft guided sale and basically said that your class one is 510( k) exempt and most are. And you only sell to the retail over the counter market. Then with a little bit of exceptions, you do not have to submit a GUDID record. So they basically took the submission aspect out and that draft guidance was in place, industry knew about it, but they were in limbo. They really couldn't depend on that and point to that as a legal exemption, it was draft, non- binding and time marched on. And literally up to a couple weeks ago, here we are about two weeks before September 24 or two months before September 24. And finally the FDA responded and with a final guidance that confirmed that exemption. So if you do have class one 510( k) exempt and retail sale only, then you don't have to submit a GUDID record. And there's a couple exceptions built into that. So I think the FDA felt that, you know what, we're kind of late in responding because some companies had held back on not knowing what to do. They might have tens of thousands of records that would be in play here. So either to start preparation and go ahead and submit those records, or cross your fingers and hope to die that the FDA is going to come through with some kind of confirm. So anyway, that's the quick little story on that guidance. So we're looking at December 8th of this year for GUDID submissions and September 24th for the other labeling document or direct marketing and any document updates and quality management systems. By the way, there's some UDI touchpoints inside all those documents SOPs and so on, and reports and so on that has to be provisions to accommodate UDI where it's applicable. So that's a little bit of a long answer, but-

Etienne Nichols: I love it.

Gary Saner: ...it's where we're at on that guidance.

Etienne Nichols: Yeah. The details are important. So there's a couple things you mentioned there. Before we get too far away from this, when we talk about these delays, September 24th is a date that is forever ingrained in my mind because when I was working in direct marketing, that was our drop dead date that we had to make it too. So anyway, that September 24th date, things get pushed, it seems like that's kind of the history of UDI, but why is that? And I wonder if maybe you can speak to some of the challenges that manufacturers have faced. Maybe are there certain pitfalls that have sort of prevented this actually from being rolled out easily? Anything come to mind when you hear that question?

Gary Saner: Yeah. There's a number of issues, and it's a brand new requirement. So we already had in place in the FDA, the establishment registration and a product listing. And that still remains in place, no change, but what the FDA did was layered on top of that, this UDI requirement. And there's four quadrants that we like to talk about. One is identifying your product. So putting UDI on product label and packaging. And then there's a subset of products that are reprocessed and reused. They need to have direct marketing. And that can be a technical challenge. Sometimes you have to go back and redesign your manufacturing process. Some companies engage a laser etching or chemical etching or something, but anyway, it takes a design effort in many cases and then testing to see if everything is still safe and effective after applying that particular mark. The third quadrant is this reporting to the FDA. There's a lot of attributes, 57 attributes that need to be reported. And is it a challenge in that this particular data set has never really been assembled before? So there's no precedent for this. And when we talk to manufacturers, they find bits of data throughout the countryside here and disparate systems, maybe labeling systems over in a master data management or a product cycle. It's just kind of scattered about. So collecting that information, finding it, collecting it and then determining is this a full set. And many times there's some fields that are omitted, you have to go search for those. The other issue is sometimes you find a data and it's not accurate, or it hasn't been touched for a while, it's not current. It's obsolete. There's issues with formatting. Now sometimes the formatting of that data that's held for internal processes is not the format that actually gets submitted to the FDA. So there has to be some transformation done. And then unfortunately it continues where this is not a one time activity and then it's done. There needs to be maintenance and making sure that the content is updated in the event there's changes. So making sure there's data owners and there's some stewardship in trying to find these values. The original data owner might have left a company by now, and the information might have been on their laptop, which is now repurposed. So it's a little bit of an issue in working with the data. Now that's a little bit of discussion about the actual collection of data, but another challenge then is how do you actually submit that data to the FDA? And there's two basic option. One option is to put a manual entry approach in place and keep data in. The other option is to submit the data electronically and use something called the Electronic Submissions Gateway into the FDA. That's the only two methods. So when you think about what's best for your company, manual entry, there's some established inaccuracies when you transcribe data and simply type it in. So some companies go ahead and have a quality control check of the data that was actually submitted. So sometimes a perception that this is a free option to go with a manual entry. And what is not under consideration is there's actual time and effort to make the data entry, check it. And then in the course of setting that up, you might have to have some consultant, information about trading and education. So those particular items all come into play when you think about the manual entry option. It's a lot of what I would call hidden cost. You think it's free, but surprisingly there's actual direct cost. And then your other option is if you go to a electronic submission, there's options there where you can either build internally a system, you can buy a system and have it installed or you can rent a system. And we here Reed Tech actually are the third option there where we provide a system already in place and available. It's basically Airbnb, you move in and everything's furnished, ready to go.

Etienne Nichols: That's cool.

Gary Saner: You had a question?

Etienne Nichols: Yeah. I had a question about that. So the manual entry, I assume that's just transcribing. In my past, I saw Excel spreadsheets with all of this data for however many hundred products we had and manually entering that into the FDA or the GUDID access database. But the other option you're suggesting, the electronic option, is that building out a CSV of the existing information and uploading it to that third- party software, or how does that work exactly?

Gary Saner: Yeah. The electronic submission has to be done through a particular format the FDA has approved and recognized. So rather than creating their own internal standard, the FDA has pointed to a standards developing organization. So this is an industrywide company, organization Health Level Seven. And they have a specification referred to as Structured Product Labeling that happens to be an XML specification. And the FDA provided some guidance about how you capture all those fields, those 57 fields into this XML format. And understanding that, being technically savvy and figuring that out is a little bit of a challenge. I was actually in this conversation with a company last week that had embarked on that on their own, and they made some very significant progress, but they were never able to have a successful submission and kind of went back to meeting the particular guidelines of building that XML file and meeting the schema that's required. By the way, once you finally figure the build of that file out there is what is referred to as Electronics Mission Gateway. This is an FDA portal to receive a lot of information. And it turns out that CDRH pointed to this particular pathway to receive the data. So you need to set up a gateway account. Now one of the advantage of going with the rent model with a particular vendor is that that vendor has hopefully figured all that out and built a gateway. So that's all hidden, and really you just need to supply raw data to that rented system or many times referred to as software as a service, a SaaS model, where you simply subscribe to it and then deliver raw data. Internal policies take care of packaging it and sending it. And there's a little bit of nuance about making sure the acknowledgements that come back from CDRH, there's three acknowledgements and making sure that they're all complete for every single record. We've seen issues where sometimes the FDA does not respond, so it never gets published. And unless you're very vigilant and keep down to the individual record, you'll never know it unless you have a good process to go back and check all that. So it doesn't come with some challenges, but I would highly recommend that you find a vendor that is experienced and capable in submitting that XML file.

Etienne Nichols: Okay. Makes sense. So you talked about the first, second and third quadrant, you mentioned there were four. What's the fourth quadrant? The documentation SOPs, go ahead.

Gary Saner: Yeah. So there are a number of points in the final rule, and off top of my head I think there's about six or so additional CFRs, coded federal regulations, that are affected by UDI. So there's a policy requirement that a labeling person makes sure that UDI is properly administered and designed and placed on the label before that label design is released. So putting those procedures in place would most likely be held inside a quality management system. There's other procedures about receiving complaints. So if a medical device company receive complaint," Hey, I don't like the color blue of your product." And the UDI is 1, 2, 3. There has to be provision to track that UDI 1, 2, 3, with that complaint. And then if that becomes escalated to be an as adverse event, it's like, I was using your product. And now I had this adverse event, something broke and I was injured or whatever. Again, UDI needs to be tracked if it's available. And then for recalls, again, there needs to be some tracking along the UDI. So there is a various touch points for the documentation. It doesn't establish new documentation or policies. It really affects the reference to UDI, making sure that you have provisions for UDI in the event that it's available. And we've seen, I don't know, you can go to the FDA, there's some warning letters. Now the inspectors are actually checking for this information that UDI was not properly handled. So you don't want to go down that road, make sure you're aware of some of these touchpoints. They're into final rule, or I'd be glad to share those in additional information or something like that. So that adds the good policy best practice here in the fourth quadrant.

Etienne Nichols: Okay, great. No, that makes sense. It's very comprehensive. So when you're talking about, well, we've been talking about the US, the FDA, that being said though, the EU has a complicated UDI implementation schedule as well. Now, EU MDR is in place. There's a requirement for UDI and the EU. So recently they announced some delays as well though. Is it a similar situation? What should companies be doing or expecting in regards to EU?

Gary Saner: Yeah. Now the timing for the EU is a quagmire, to be honest with you. I mean, I have a set of timelines that I present and I think I've redrawing it probably a dozen times so far. And to understand what the impact is, you have to understand a little bit about what happened in Europe. So the quick little history lesson is that the European Commission completely revamped the regulatory platform. So the full infrastructure is now changed from directives over to regulations, and now coming into play as a medical device regulation and a in vitro diagnostic regulation. And this is quite different than what happened in the US. In the US, all your approval process and establishing registration and product listing, that was all untouched and remained in place since UDI was simply a new requirement. Not so in Europe, UDI becomes one of the many things that a manufacturer has to learn and be educated on and then respond to. And there was no grandfathering of products. So basically your whole portfolio now has to be reevaluated to the new regulations to see if they meet. And when you think about that, if you go back to the medical device class ones, which most of those are self- certified, that was May of 2021. So there was a lump of activity there for companies to go through their technical evaluations, they might have had to do some further evaluations and analysis and testing, but basically they had to come up with this self- certification and put their name on the declaration of conformance to say, yeah, we're okay. We meet all the regulations. And that was a huge challenge. That was a big challenge, just for your class ones. And most recently in May of 2022, a similar deadline took place for the in vitro diagnostics. So those now class A products that are self- certified as of the date of application in May. It was another bundle of energy that had to be put together and meet all that. Now when you get beyond the class ones and you start to get into class twos and threes, the two A's and B's so on, and now you need to engage notified body to evaluate your documentation. Just like products were not grandfathered into the new system, the notified bodies were not grandfathered into the new system. So there was a re- certification, if you will, of the notified bodies to make sure that they were qualified to evaluate MDR and IVDR regulations. So there's a bottleneck. There's less notified bodies than before. And the level of effort is huge because remember, it's the whole industry has to now be checked, all the devices. So this is producing a real significant problem with engaging a notified body. So one of the things that you might highly recommend is that make sure you engage with a notified body that, first of all, has made commitments to review products under the MDR and IVDR, as appropriate. And get on their list and start to collect your data according to the MDR so that when your schedule comes up in their timing, you're ready to go. Because there's some deadlines, legacy products with old certificates. And again, sometimes they expire over the course of time, but if you're able to use them without a design change and the certificate's still valid, there's a deadline for those. So if it's a medical device, you have till May of 2024 to continue to place that legacy medical device on the market. And then a year later, May of 2025, if you have a in vitro diagnostic certificate. So there's a deadline looming ahead, if you don't comply with the new regulations, you will not be able to put products on the market. And I know the European Commission and industry is a little concerned about this because some responses that made some changes in the regulations and timing and so on. We'll see how that plays out, but many companies are working feverishly to prepare for this because they know there's a cliff ahead and it's going to drop off and now you have serious issue. No revenue coming in because you can't sell product. So that's not good. You want to certainly avoid that. And as well as patients, patients in industry would not have access to products when they need them. So the shortfall is certainly something to be avoided at all costs. Now there's a couple things that can be done right away. I would suggest, the EUDAMED has three of the six modules up and running even now. So EUDAMED is this new database platform that handles all this data related to medical devices under in vitro diagnostics.

Etienne Nichols: The EUDAMED is to Europe as the GUDID is to FDA?

Gary Saner: Yeah. That's a good analogy, except the GUDID here in the US only handles UDI data. And that is directly corresponding to a single module in one of the six modules inside EUDAMED. So there is a UDI medical device registration module. And you're right, that's a pretty tight correlation. The other modules, there's another module for active registration. So if you're a stakeholder like a manufacturer or system and procedure PAC provider, those sort of thing, you can register even now in that module. That is up going back to December of 2020, it actually started. So you can do voluntary submissions of your company information and receive something called a single registration number. So an SRN is very critical in moving forward and identifies you in this system. And you can do that now. There's no charge for that. I highly recommend you start your pathway with that first module. And then the second module is this UDI and device registration that's also voluntarily, able to be used. It was opened back in October of 2021. And I checked a couple weeks ago, it has 96, 000 records already in it. So people are making use of it. They're putting data in and you can walk down that. And again, that's voluntary at this point.

Etienne Nichols: So question about that, the FDA, you mentioned those 57 pieces of data and the different ways you can input those pieces of data. What does that look like for the EU and this specific module on the EUDAMED?

Gary Saner: Yeah. Unfortunately, I've bad news for you. So you thought 57 was pretty tough for the US, the numbers are up around 111 attributes for the EU. So basically it's twice as many attributes you need to collect and only a few of them are able to be reused. The other complication is the structure of that data is quite different than the FDA. So the FDA had a single record, model if you will. So your reference to a spreadsheet was very common. You had a single grow in there that had a particular device identifier on it. And a lot of these other attributes, is it a prescription? Yes, no. What's the MRI condition? What's the packaging level, and so on. When you go over to the EU, European Commission rolled out a two level type of data structure and I think industry was caught by surprise. They weren't sure what this was going to be, or in many cases they're still trying to figure out the implication. But there's a concept of a device identifier at the device level, but then the European Commission rolled out this grouping concept referred to as a Basic UDI- DI. So the Basic UDI- DI, it's real mouthful. People use a little shortcut for it, refer to it as BUDI. I'll use our term BUDI. And it's not very friendly, believe me, but it's a BUDI.

Etienne Nichols: So I have a question about the BUDI, and maybe you can correct me. I heard someone say the BUDI or the BUDI-D is similar to the FDA product code for the EU, but where am I missing the mark when it comes to that?

Gary Saner: So the BUDI can be broader than a product code. So a product code would identify very specifically a scalpel, for example, and a BUDI can be a little bit broader. It points back to a grouping that has some parameters. So we have to have the same risk level, the same class, the same certificate. And there's some other attributes, but it can be a broader scope. For example, it might be a, I'm making this up, let's say it's a stainless steel scalpel and also a plastic scalpel. Where in the US, you might have two different product codes. Again, conceptually in the EU, you might have both of those under the same BUDI. So you do have all the issuing agencies, by the way, provide specifications on how you create a BUDI. It does not appear on the label, but there's some requirements about how you create it and report it as a separate row in your spreadsheet. Now you have to create basically another tab, different sheet for all your BUDIs to be recorded because they have different characteristics and then you need to relate them back together. Basically build the family. So one BUDI might have at least one, always one, or it might have a 100, 1000 different devices associated with it.

Etienne Nichols: So is there a predetermined list of BUDIs already, and if you can't find one that meets, how do you create one? I don't want to get too far off on the weeds, but curious about that.

Gary Saner: Yeah. Yeah. So that's the other difference when you talked about the FDA product code and was looking at that analogy, the FDA established product codes and they defined what the scope is and the definition and the identifier, the three letter identifier. Not so with a BUDI. A BUDI is determined by the manufacturer and it's unique to their portfolio. So it's not across industry, not across, if you had a BUDI and I actually made the same product as you, I have to have a different BUDI. So the analogy kind of breaks down when you look at some of the details there. So each manufacturer has to create their own BUDI and put their devices inside that BUDI. There's some other codes. And again, this is one of the challenges, I just quickly mentioned it. The European Union has established something called a European Medical Device Nomenclature. So that would be a pretty good analogy to an FDA product code or more accurately what we have used here in the US, the Global Medical Device Nomenclature, GMDN. So the Global Medical Device Nomenclature is used in the US in a lot of different other health authorities. European Union elected not to use that and create their own. So you would find, for example, a scalpel in the EMDN. So to answer your question, if you wanted to do some data mining inside EUDAMED, you could search for that EMDN code for a scalpel and find your product and my product, but both of those products would be associated with different BUDIs.

Etienne Nichols: Okay. That makes sense.

Gary Saner: Yeah.

Etienne Nichols: Okay. I know we're sort of running a little bit short on time. This has been really helpful. I have another question I want to get to, but I also want to plug something while we're at this point because if you're listening to this episode, you could tell Gary has a lot of knowledge when it comes to UDI and we're on the tip of the iceberg here. He is building out something called the Ultimate Guide to UDI. And we're kind of a joint effort building out that Ultimate Guide to UDI, where we talk about the FDA and the EU to a certain extent. So I'll put a link in the show notes to that. So if you want to go check that out, we'll have links as well to get a little bit more information from Gary as well. If you went to get ahold of him directly as well too with specific questions. Because in my experience, when I was working UDI, I had very specific questions and I think everybody will.

Gary Saner: I'm excited about that guide, your team, and the other team members over here Reed Tech, working together, putting that together. I think it's going to be very helpful, especially coming into this particular topic. And it does cover things generically, basic education. And there's specific information about the FDA, there's also some information about the EU and some other health authority. So yeah, I'm excited about rolling that out, but anyway, what was your question there?

Etienne Nichols: Yeah. I'll say one other thing, we keep adding on to each other, but that's a free guide. So if you're interested, definitely check out the show notes. Okay. My last question. There's other regional health authorities. We talk about FDA and EU as if they're the only ones sometimes, but there are other regional health authorities and they have current, maybe they have planned UDI requirements that haven't happened yet. What's your suggestion or recommendation to manufacturers? Can a single global UDI management approach, could it help the bottom line if we look at these as a holistic? Is it even possible? What are your recommendations?

Gary Saner: Yeah. So we have found that with the FDA and the EU in place, the regulatory landscape typically uses one or the other as a precedent. So some of the other health authorities around the world will kind of base their policies on one or the other, US or EU. That said, we have yet to see any really good harmonization. So sometimes the policies are pretty close. You read them and there's a lot of similarities, but we have yet to seen a cookie cutter where it's like, what you have in place for the US, we're going to do it the same here. Or even what you have in the EU, just duplicated here. So you can look at South Korea, and they started to roll out the requirements, actually back in July of this year. They had their final way for class one. So well along the implementation process. China is also one of those countries that has UDI requirements. June of this year, they completed a second round. They did some high risk class threes early on and then the rest of the class threes were due in June of this year. So they have yet to schedule the class twos and ones. But in both those scenarios, South Korean, China, there's a lot of similarities with US and EU, but they made very specific differences in their policy and also the data that they collect. And at ANM, you're aware of this international medical device regulatory forum where there was some guidance put out and their regulators kind of sat around saying, okay, what's UDI? And what are some good guidance and practices and what should be done? And then unfortunately, each implementation as it is implemented by a particular health authority deviates from the core guidance and they layer on some additional custom things. So it makes it very difficult. So when you start thinking about a global approach, you have to realize that even though it kind of sounds the same, hey, it's UDI. UDI for Australia is coming up, or UDI for Saudi Arabia has a deadline in September of next year. And oh, okay, I already did it for the US, it'll be good. Not true, unfortunately. I mean, I had this dream that there'd be this one big global database of UDI information. And I think others might have thought that initially, but it has not happened. Even UDI databases are totally independent. FDA GUDID has no connection with the European EUDAMED and we don't see it happening anywhere else. So the policies are different. The data structures are different. And so it makes it very tough. Now that said there are systems, and actually that's one of the activities here Reed Tech is to take a very close look at each of these different health authorities. See where they are common. See where they're different and build a single central database that is able to apply attributes as they are able to be reused to each of the different health authorities and collect data and validate data per each of these independent health authority business rules. So it is able to be done. We're doing it and have in place US, EU, China and South Korea. And very far along in Australia, or Saudi Arabia, I meant, and working with the technical group down in Australia. So it is able to be done and there's significant advantages. When we talk to the clients, they want to be able to have governance of this data in a central repository, common reporting for each of the different regions and have a master source of information and then be able to reuse it where possible, have the same common interface, alerts and messages and just be able to maintain the data elsewhere. The other point is that by going to a single system, usually that will be associated with electronic submissions as well. So there are machine to machine submissions to each of those four regions that I mentioned. They're all different. So we build a different custom gateway for the FDA, EU and different APIs for China and South Korea, but let a vendor take care of that. And the concept of is a data hub. So you have one particular data pipe sourcing the data into the system and then let that management system act as a conduit and take care of validation for each of the specific health authorities and the gateway and the acknowledgements coming back. So it's able to be done, and has significant advantage over obviously manual submissions and trying to keep track of what's going on, but there are some, anyway, significant advantages in that.

Etienne Nichols: That's fantastic. I mean, you mentioned the hidden costs and I would hope that companies are starting to recognize those aren't hidden costs when you have somebody manually typing something in, because you also have the risk of mistyping because I know we've all fat fingered something, so yeah. That's fantastic. I'm glad someone is... That was actually going to be my next question y'all. How do we collect all this data in a uniform way across all the overlap in doing those things? So that's really good, I'm glad you're doing that. We'll put a link in the show notes. So if anyone wants to look up, see how to find Gary, how to find things that he's doing with Reed Tech and so forth. You could tell Gary lives and breathes this. He probably has a whole nother episode, but we've got a hard stop. So any last words, any recommendations you have for our listeners before we close it down?

Gary Saner: Well, I would highly encourage those to realize that time is short. And one of the takeaways that we have always walked away with, whether it be the US or EU, China, South Korea, is that unbelievably underestimated my time to comply. And there's a number of things that go into that, learning the regulations because now they are different. You can't just simply cookie cut what you knew for the US. And many times the data is not as clean as you hoped it would be. And there are some nuances when you go into China, South Korea, there's a local representation that this organization needs have a physical address in that country. So that comes into play, making sure those users are in place. Many people think, oh, okay, I'm going to put UDI back on the shelf because for example, the EU deadline has moved out a year. That is really a risky play. Some companies do the opposite of that. They want to keep their momentum in place, keep rolling. They don't want to lose people through attrition, the knowledge- base. And once they get into it and realize that there's lots that can be done in complying with the regulations, making sure that you meet the certification. And also in regard to UDI data, you can collect data. Actually we provide a platform, a lot of companies just load the data temporarily into our system and cleanse it, which is 80% of the effort loading and cleansing the data. And then knowing that later on, they'll just select it, push a button and submit at some later date. So I recommend you to make use of the time.

Etienne Nichols: Yeah. No, you said it, it always takes longer than you think it will. I was in project management and that was like, number one, you just put some buffer in there, start early. So that's great. I appreciate it, Gary. Thank you so much for being on the podcast today.

Gary Saner: Love it.

Etienne Nichols: For those of you who've been listening, you've been listen to the Global Medical Device Podcast. We've been powered by Greenlight Guru, the only medical device MedTech Lifecycle Excellence platform that provides end- to- end traceability for your medical device development needs. Definitely check us out at Greenlight. guru, www.greenlight.guru. And we'll see you next time. Thank you so much. Thank you so much for listening. Just a few of the points I personally took away from this conversation where the EUDAMED requires nearly double the attributes as the US's GUDID, but there are tools out there to make that transition much smoother. Number two, if you understand why this initiative took place for UDI, it becomes much easier to implement. The user of this product should be able to clearly and easily identify the device. And while there is complexity with manufacturing, you aren't the first one to go through this. It can be done. Third, there is an Ultimate Guide to UDI on the horizon. So definitely check out the show notes. If you enjoyed this episode, reach out to Gary on LinkedIn, let him know. Also, I'd personally love to hear you via email at etienne. nichols @ greenlight. guru or look me up on LinkedIn. I'd love to hear from you. You can learn about all that we do if you head over to www.greenlight.guru, we're the only MedTech Lifecycle Excellence platform out there and on top of that we've built both a community and an academy where you can go to join the conversation or learn more about the things that we discuss on this podcast. You can find those at community. greenlight. guru or academy. greenlight. guru. Next week, we'll be speaking with Mike Bacca on the topic of playing the long game with your career as a MedTech professional. It's one I'm looking forward to, so stay tuned for that. Finally, if you enjoyed the show, please consider leaving us review on iTunes. It helps others find us. It also lets us know how we're doing. So thanks again. You're the best.




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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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Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...