Episode 4 – UDI for Unique Device Identification
On this Episode, I will provide you some information on what is the UDI for the new Medical Device Regulation EU MDR 2017/745 and IVDR 2017/746.
All this is important for the UDI medical device labeling. You´ll understand all the requirements for your medical devices in Europe.
I will tell you what means:
- UDI-DI: Static part of the UDI code
- UDI-PI: Dynamic part
- UDI carrier: The way you are seeing the code
- Basic UDI-DI: The code for a group of products with the same intended use, classification, design, manufacturing characteristic.
- AIDC: Automatic Interface and Data Capture
- HRI: Human Readable Interface
I know it looks a lot but these are important information for you to be able to implement this new requirement.
Additionally, I will provide you also the information on the timeline to implement the requirements.
Below are some resources that are mentioned on this episodes. You can also scan the QR-CODE to get the link to my blog article.
Infographic
Have a review of the information regarding this infographic on my blog article.
Resource
- Free Mini-Course MDR 2017/745: https://easymedicaldevice.com/mdr
- Easy Medical Device Article – UDI: https://easymedicaldevice.com/udi
- GS1: https://www.gs1.org/healthcare/udi
- HIBCC: https://www.hibcc.org/udi-labeling-standards/
- ICCBBA: https://www.iccbba.org/subject-area/medical-devices/udi-labelers
- FDA resources: link
- Podcast Episode 2: Medical Device Regulation EU MDR 2017/745: https://podcast.easymedicaldevice.com/002/
Video
This video is an audiography of the podcast. On the side, you can see all the places where you can subscribe to my podcast. If you are using Alexa, you can also call the Alexa Flash Briefing “Medical Device Podcast”
Podcast Episode 4 -UDI
Transcription of the Podcast – Temi.com
00:00 IDi this means unique device identification. Are you an expert on it? Do you know exactly what it is? So I will try to provide you all the information regarding the new feature that comes with the new medical device regulation MDR 2017/745 and also the IVDR 2017/746. So let’s dig in.
00:37 Hey, welcome everyone to the medical device made
01:33 But just disclaimer, what I will tell you today may change. I think, I don’t know because there is so many unknowns now from the MDR, the platform that should be used with the udi is called EUDAMED and it’s not in place. There are maybe some other draft guidance that should be implemented and maybe they are not. So, what we’ll do today is that, I will try to explain you what I know for now. Maybe I will create another episodes for… If there is any new information that, that should, that should come. Okay. So let’s put you now in context. The, as I’ve said the UDI is new for the medical device regulation, but this is already something that is existing in the USA. FDA already implemented the UDI for the products sold in the USA. since, I mean, since the requirements started on 2013 but there was, there is a transition period, like what will come or, so for the European Union and Europe, this will be starting with the implementation of the new medical device regulation by the May 26 2020.
02:54 But I will also
03:53 So I created a free
04:52 So what I can say is that Udi, sorry. It looks like really any, I mean it looks like it can look like any barcode that you see on, on the grocery store. When you have a product, you have the barcode, which is some lines if I can say and you have the numbers that are just below the, this barcode. So this is the way the UDI is looking like, but, to be more specific. So the Barcode is kind of the
05:52 So it’s a bit difficult for the scanner to, to read the Barcode. And at the end the person is using the human readable part which are the numbers to include that in the, in the, the machine, the computer, then the machine recognize the product. And then you can have it on your, on your list if I can say so this is the way, the UDI is working. The only thing is that now I’m talking about Barcode, but it can also be a datamatrix. You know it’s those specific, 2D barcodes. So it’s not on one line. It’s two lines. So, and you have also RFID tags. you have, I mean you can have many forms. So this is what we call the human readable parts. Uh, oral, the, in the UDI vocabulary we call it the AIDC
06:46 So it stands for automatic interface and data capture. So this is the machine readable part and the human readable part, which are mainly the numbers is called the HRI, which stands for the human readable interface. And to be more specific, all this is called the UDI carrier. So the UDI carrier is the way you are seeing the UDI, the way it’s carried. So it’s to, if, if you want to be more, more specific. So the way it could be carried is as we’ve said with many forms, RFID, Datamatrix, Barcode, etc. But you are free to define the way you want to carry the Udi. So it’s not, um, it’s not defined clearly. Okay. Now we, covered the UDI carrier. You, we covered the AIDC, the HRI vocabulary. So I hope it’s clear for you, but all this means the same thing it is how visually we are seeing the UDI.
07:54 And then what we can say is the fact that the UDI itself is composed of two parts. So the numbers below all the Barcode has two components. The first component is the UDI-DI. So the UDI-DI stands for the Unique Device Identification for the Device Identifier. So this is a static part of the UDI. It’s the part that is representing the device itself. Every device has its own UDI-DI. And so let’s go, come back later on that. And then you have the second part, which is the UDI-PI, which stands for Unique Device Identification. PI for Production Identifier. It means that it’s specific to the production, that you are running. So it’s a dynamic parts means that if you are producing today or tomorrow or after tomorrow, it can, it’s changing for sure. So the UDI-PI is the dynamic part. It’s always changing, but the UDI-DI is a static part so it’s never changing if I can say, but I will explain your also that later.
09:09 Okay. Let’s come back with the UDI-DI. So as I’ve said, you have a UDI-DI specifically for each product, but let’s be clear on that. We have a UDI-DI for each stock keeping units. So Sku, it means that if you have the same product, let’s say for example a Syringe, a syringe can be delivered, non-sterile can be delivered. Sterile can be delivered in a package of 10 or in package of 100. For each of those categories or we can say for each of those Sku you should have one different UDI-DI. It means that you have a specific UDI-DI for a syringe packaged out of 10 and a different one for the same syringe packaged out of 100 pieces. So this is really important for you because you should not think that because you have only one product like a syringe, it should be only one UDI.
10:22 No, it’s one UDI per kind of format or category. So, this is also important that the UDI-DI is specific to this product. But if you are changing something on this product itself, you have to ask for a new UDI-DI. If you want to change, for example the name or trade name, you need a new UDI-DI. If you want to change the version of them or the model if you want to label now with this product as a single use, or to label it as a sterile products, or if you have now a new request that this product should be sterilized before use, etc.. So they are a lot of, those requirements that are existing for, the change of the UDI-DI. It means that a UDI-DI is not for life.
11:18 It can also be different out of all the changes that you are performing with, with this product. And if we are looking now at the barcode or the number on the Barcode, on the
12:22 So this is important to really identify; at which time this product was manufactured or which lot number it is, etc… etc… So it’s really for, for traceability. So the same here you have also, some possibility to identify those information on the
13:24 Okay. I think we are clear now about the
14:32 And what is great is that those companies that are for now, I want to be really specific for now, accredited or designated, are the same as the ones that the FDA already accredited. And you can see there names on the Article 120, paragraph 12, because it says specifically that, if the, the European Commission didn’t finalize the designation of the all those entities, for now we have three companies that are mentioned, which are the GS1 company, the HIBCC and the ICCBBAA, no, sorry, the ICCBBA there was too much double, double letters here. Okay. So those three companies are the ones that for now I say for now because maybe later there will be new ones that for now are capable to provide you with this UDI-DI. So it’s the number that will be registered on their database that will confirm that you are the owner of this number and of this product.
15:46 And a, yeah, it’s kind of a place where you register, like your car, you register your plate and this and that, so this is the place where you should register your products. So these companies are known. I will provide you the link on the, on the show notes so that you can also visit their site. There are providing also information about, about the UDI. What is now confusing, is about, uh, the next, vocabulary or the next, the next Wording that I want to explain. There is the UDI-DI. There is the UDI-PI and now we are talking about a Basic UDI-DI. I know this one was really confusing because a lot of people were asking me the question, what is exactly that? We were already confused by the UDI-DI, the UDI-PI. Now they are including the Basic UDI-DI.
16:42 What’s this? Okay, so let’s be clear to make it easy. The basic UDI-DI is also a code. It’s also a number, a static number that is defining a group of products. It means that if in your portfolio you have some products that have the same intended purpose, the same risk class, the same design, the same manufacturing characteristics, then they will be categorized under the same Basic UDI-DI. Okay? So I hope it’s not confusing more, but you have one. Basic UDI-DI that you will request also from those entities gs1, HIBCC, ICCBBA, to define one of your product category. If you have for. Let’s, let’s make, let’s make it more as an example. If you have, for example, the example of the Syringe, you have the syringe A that has maybe a plastic, with the, with the metal part for entering the body and the piston, but it’s a six milliliter syringe and you have a second one which is a 10 milliliter syringe.
18:05 So different Syringe, different
19:05 So this is some, some numbers that are mainly visible by the authorities or by the manufacturer but not really by any consumer. So it’s really important, that you, you are seeing that. Okay, one last thing. Now let’s talk about the UDI timeline because many people think that by May 26th, 2020, everything should be in place. But to be honest, it cannot because, first you need the EUDAMED database, to be, to use it for registering the products and you need also the UDI for the registration. But we are not sure first the database will be in place, at the time of the implementation of the, medical device regulation. And it’s it also, so we have also on the, on the medical device regulation, it was also mentioned some kind of UDI transition period. I hope this is making you smiling because yeah, maybe it’s people who are stressful and say, oh, I need to put that in place.
20:17 But, but this and that. So, so what is the rules for this huge, transition period. I think it’s the same as what made what was made for the US for the FDA. So the rule is for products with high risk. they should be putting in place a UDI, not long after the implementation of the medical device regulation, but for products with lower risk. So class I to be really, really later. But let’s be specific with dates. Okay. I will provide you the dates now for products with class one, you have to put in place the UDI-DI before the 26th of May, 2025. So it’s five years after the implementation of the, of the medical device regulation. Then for class two A and two B, you need to do that before the 26th of May, 2023 okay. Then for class three it’s the 26th of May, 2021 and specifically if you have implantable devices, they should be done by the 26th of May, 2021 so, you see that it’s really dependent on the, on the risk for class three and implantable devices.
21:33 So we estimate that the risk is higher. So it should be done nearly one year after the implementation of the medical device regulation. And you have a last one, which is products that are reusable. So for products that are reusable, they should be put in place. I mean the UDI should be marked on the product itself. And this, because it, can take maybe more time for that because you are reusable products are already on the market, so it can be difficult to ask them to come back and then to exchange them. So they give you two years more. So it means that if you have a class three reusable device before a class three should be put in place by the 26th of May, 2021. But as it’s reusable, it has two years more delay. So it can be put in place by the 26th of May, 2023.
22:28 Okay. So yeah, it’s, it depends on the class. So if your class is class one, count two years more. If it’s a reusable product, WoW, I don’t know for you, but for me it’s, it’s hard episode because with all this vocabulary, so UDI-DI, UDI-PI, UDI carrier, Basic UDI-DI, UDI timeline, etc. So it’s a lot of UDI I think. But I hope this is clear for you now, but if not, please send me a comment. and, I will try to make it clearer just to answer, answer to your question. To finish. I will try to summarize again just for you because I know it’s this difficult one. So first you have the Basic UDI-DI, which is the highest UDI code on your kind of pyramid. If I can say it reflects the products inside the category which has the same characteristic, the same class, the same design.
23:26 So you can have one Basic UDI-DI, with many
24:35 You have also to be able to read it with your eyes. So to read the numbers and you have
25:54 Bye, Bye.
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