These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.
- Presented by: Michelle van Wijk & Geraldine Lissalde-Bonnet
- Presented at: Online webinar
- Presentation date: 21 September 2021
- Presentation summary: Issuing Agencies are responsible for creating unique device identifiers according to globally recognised standards. This session will provide information on the creation of UDIs and the role of an Issuing Agency.
Recording of online webinar
Michelle van Wijk
Good morning, everyone, thank you, Rachel, for the introduction, and welcome to our UDI webinar, which is the fourth in our series around the implementation of UDI in Australia.
Today, we are going to cover off... We have an invited guest speaker, Geraldine Lissalde-Bonnet, so I'll talk a bit more about Geraldine's background. Really, to provide us with some information about the role of an issuing agency and the generation of UDIs and how that process works. But also, some experience from a global perspective, in terms of expectations and observations from other implementations.
As usual, we'll give you a progress update on what's happened in the last month, and I have some answers to some of the questions we've already received. So, we'll talk through some of those ahead of time.
We'll, also, at the end, if there's time, have questions and answers for either myself or Geraldine. And any of those we don't get to, we will capture, and we'll continue to make available as part of our process. And we'll publish those on the website.
So, before we start, I'd like to acknowledge the traditional custodians of the land on which we meet today, which, in my case, is the Ngunnawal people. And pay my respects to Elders, past and present, and extend that respect to any Aboriginal Torres Strait Islander colleagues attending today.
Now I'd also like to introduce Geraldine. So, Geraldine Lissalde-Bonnet is a Public Policy Director in Health Care for GS1 Global Office, based in Brussels. And she works with her local GS1 colleagues in 115 countries across the world on regulatory harmonisation through the implementation of GS1 standards in the healthcare industry.
She leads the GS1 Health Care Global Public Policy work team, which has the mission to interact with decision-makers globally and to provide strategic leadership on the use of GS1 standards in the healthcare sector.
A lawyer by training, Geraldine started her career in the private sector, complemented by several years in the European Commission in the Directorate General for Health and Consumers.
She has developed expertise in public affairs at both the EU and international levels and has sound experience in the fields of technical and regulatory affairs related to traceability and to product identification systems. and we are very grateful for Geraldine for making the time to come and talk to all of us today. So, I will hand over to you, Geraldine.
And starting, also, with a disclaimer, explaining that GS1 is a standard government organisation, we are not a regulator. And so, we don't interpret or explain regulation, we just focus on the use of the GS1 system on which we provide, of course, implementation support.
We start first with an overview of the importance and the benefits of global harmonisation, when we talk about UDIs, this is really key. Then I will go into the details of how to get UDI numbers, and that's the role of GS1, and that's all based on collaboration across different stakeholders, but also across different issuing agencies and with regulators. And last, but not least, I will share with you the benefits of UDI, as we have seen implementation and adoption of the UDI system in other countries.
Let's start. When we think about harmonisation and UDI, it's quite natural to refer to the IMDRF, the International Medical Device Regulators Forum because this group of regulators has, a few years ago, already, defined the global framework for UDI across the world. And this global framework is divided into three parts. The three parts that you can see on the screen now.
If you have to, really quickly summarise everything, starts with a globally unique identifier for your medical device, and that's what you see in blue here, which is captured in human readable and in machine readable format on the device, on the labelling, on the packaging of every trade item. Logistic units are not covered by UDI. And that's the pink part, here, on the slide.
And last, but not least, the idea that every manufacturer will have to upload and register data into a regulatory database with all the UDI information. If you look at the GS1 system now, and that will really highlight the fact that GS1 is key for UDI implementation. The UDI system, again, the GS1 system, again, very summarised. It is also divided into three parts and, also, the same complement.
The first one is the idea to identify globally and uniquely all the things that you need for supply chain management, from logistic units, to location, trade items, and patients. Once you have identified, you need to capture this information in different data carriers. And you see, here, a list of them.
And last but not least, you need to share that information among your trading partners or with regulatory database. And that's, really, the same colours, but, also, the same ideas as the UDI system, as defined by the IMDRF. Identify your device, capture that information into a machine-readable format, as well as human-readable format. And share that information with the UDI regulator, with the UDI database.
If I look in practice, now, how this is translated today in different countries and in order to support different regulation. First, GS1 is supporting the IMDRF, and we are also a member in the Asian Harmonisation Working Party.
The idea behind this support is, really, for GS1, for example, to provide concrete example of how the GS1 system has been used on labels to implement the UDI requirement. And to provide it to the IMDRF so that when they release their UDI application guide, they are able to produce annexes. Where you have real examples, and you visualise what the requirements are about when you think of the packaging or a device.
It's also attending meetings, where we are able to help the IMDRF in, also, understanding the challenge of healthcare providers, etc..
If we look now beyond this regulatory forum, but in specific countries. So, in Argentina, the system for traceability of certain devices is based on the GS1 identifiers. That's also the case in Japan, where you have, still today, before the regulation enters into force, a guidance, which is inviting manufacturers to identify the device.
The NHS, of course, in the UK, is one of the examples of implementation, and successful implementation of the identification of medical device using global standards.
And then, if we look at UDI regulation, we have, today, examples in China, EU, Saudi, South Korea, Singapore, and the US, and more others to come where GS1 is going to be used as a basis for the implementation of the UDI system. Turkey is another example, where medical devices are widely marked using the GS1 system.
So, all these to make you visualise, or to help you to visualise the parallel between the IMDRF framework and the GS1 system, identify, capture, share. And some examples of concrete collaboration, in order to work towards harmonisation with regulators from across the world.
If we go one step further and we dig into each of the parts, we start with identify. And on this slide, you'll see the translation of the UDI regulatory requirements as of today, and the GS1 standards.
In Europe, we have a specific level of identification, which is the Basic UDI-DI. In a nutshell, the idea is identifying a device through the entire lifecycle of this device, from market approval down to use on the patients, vigilance, etc..
And for that, GS1 has developed a specific identifier, which is called the Global Model Number. And the idea is also to group devices and be careful that identifier, at least, in Europe, is not used in the supply chain. It's really used on documentation, in the database, etc., but you don't find it on the pack, and you don't use it to help moving your product across the supply chain.
And then, the other part of the table is, really, the IMDRF framework that we see translated with the Device Identifier, which is in the GS1 system, the global trade item number for this global unique identifier that you apply on your devices, together with Production Identifiers. And here, again, in the GS1, terminology, we call it, Application Identifiers. And you find one of these Application Identifier, depending on what is on your packaging and what is on your label and what you need, in order to ensure that your device is properly identified for supply chain management and for patient safety.
Expiry date, manufacturing date, lot number. And for certain device, serial numbers are the usual suspects. So, the combination of your Device Identifier with your Production Identifier make your UDI number, the combination of your
GTIN with the relevant Application Identifier are making your UDI number in the GS1 terminology.
TGA Webinar team
TGA Webinar team
Sorry, it's just that the sound quality isn't coming through very good at the moment. It's still clear, but how difficult would it be to relocate to the room that you were in the other day, speaking? Did it seem to come through a lot better there? If it's too much of an issue, we can definitely get through this still this way.
Let me switch my... I will switch to another network.
TGA Webinar team
I think it might be the room.
It sounds better?
TGA Webinar team
Look, just keep pressing forward, that's fine. Yes. Sorry about that.
Just changing the room will be a catastrophe for my daughters, I'm sorry.
TGA Webinar team
No, that's all good. Keep going, thank you.
Okay, fine. Just tell me if it's really bad, I can go downstairs.
TGA Webinar team
So, I just show you the parallel between the UDI requirements and the GS1 system. And in practice, how does it work? You have two sets of rules, so the rules of the issuing agency in one hand, and the rules of the regulation in the other hand, and how do you articulate that together?
So, the idea is very clear. The rules that are defined by the regulator always supersede the rules that the issuing agency are going to propose or develop, in order to implement the UDI system.
There is then two layers, and you always start to apply, first, what is in the regulation. And if there is nothing, or if there is a delegation to the rules from the issuing agency, then you apply these rules.
In the GS1 system, the rules that you apply for UDI are called the... Sorry, GS1 has GTIN allocation rules. And on the slide is a hyperlink so you can find directly a link to these rules.
Concretely, and if I have to take an example, these are the GTIN allocation rules. And you will see, here, that these are the same rules as we have in the regulation for UDI. So, one trade item, one globally unique identifier. And you're not allowed to reuse that identifier. If you have change in your packaging, you need also different functionalities of your product, you need to change your identifier.
And in particular, for that, because it's very often a question we get from users, when do I need to know if I have to change my UDI-DI, and what is going to trigger the new UDI-DI? The rule is clear, you always look at the regulation what are the cases where you need to change your UDI-DI. And if it is not covered in the regulation, then you look at the GS1 rule. And to help in making the decision, we have developed a specific guiding principle tool that you can find, also, here on the slide.
The idea is that you first look at the product, which is marked in the package, and if it is something changing, then you look at your packaging, do you have any regulatory requirement for changing it? And then, if not, then you look at your supply chain management. And this is, really, like a decision tree, so you go yes, no, yes, no, and finally, you have the answer.
And this is just to show you, really, the dynamics. So, first, you look at the regulation, and if there's nothing, you look at the GS1 system, and you always find a parallel between both regulation.
Looking at capture now. So, we have looked at the identification part. We show the need for harmonisation, and how GS1 is enabling to use the identifiers for whatever regulation you're trying to implement. How does it look like on my pack? First, the type of barcode, you can choose any type of barcode for UDI purposes, and that's very important to leave that flexibility for the manufacturer to decide which of the data carriers is the most appropriate.
Why? Again, it's kind of common sense. If you think of surgical instruments, like you have on the screen, you will not apply a big, long linear barcode on these instruments. However, if you think of a big x-ray machine, likewise, you're not going to put a super-small data matrix on the x-ray machine, where you will spend hours, in order to find your data matrix.
So, first, flexibility in the barcode is key. And then, in regards to capture of the information, it's really like in normal barcoding process, I would say. So, you follow the rules of the issuing agency. And you see here on the screen that for every level of packaging, you will have a different identifier and, potentially, a different type of barcode as well. But thanks to the UDI database, you will then be able to build up the hierarchy in your packaging and the relationship between all the devices.
So, in blue, you see the device identifiers, which are captured here on the packaging, these are the GTINs. And in kind of orange, you have the production identifiers, which are also included here in numerical format. And if you're scanning the barcode, you will find them in the machine-readable format.
Be careful, and there are specific rules that I'm not going to cover, for direct part marking, and in that case, you have, also, some exemptions for the human-readable format not to be captured. And this is changing, depending on the regulation. And so, it is the first time that I mention the fact that, yes, harmonisation is important across the world, but nevertheless, we are starting to see differences across the different regulation.
Identify, capture, and the last part is share. And this is one part where we see a lot of differences between the different regulation. First, if you look at the structure of the UDI database. The UDI database in all the different jurisdictions with UDI requirements, today, is focusing on UDI information, except in Europe, where, as you can see, EUDAMED is covering the entire lifecycle of the product, from market approval down to market surveillance.
Another point of difference is related to the data elements. And it's needed because you need to have some local specificities, which are captured in your database. But hopefully, a maximum of alignment will be seen by focusing on the minimum viable elements, meaning that only the data elements which are needed will be required to be registered in your UDI database.
So, in the end, you try to limit the room for differences between the requirements. And if you think of manufacturers, this is then making the burden of having to register devices much easier to deal with.
And last but not least, data submission. In principle, you have, in the IMDRF the call to open the possibility for machine-to-machine submission. This is important not only to be able to capture a large volume of data, but also, for data quality. Because when you do your machine-to-machine submission, you have, in principle, some validation rules, which are part of that process and which help to avoid that you have errors in the submission and, also, in the data.
However, we see that in some countries, it's challenging and it's, also, not opened. And so, really, here, another point of difference, where harmonisation is going to be key in order to ensure that data across the world when we move forward with more and more UDI requirements implemented, is still reliable and of good quality.
So, if I have to conclude on that section, and I hope the sound is better, there is a need to align on the global UDI framework. IMDRF is a reference. In that case, even if it's normal that you will have some local and regional specificities, really driving the maximum of alignment is going to be critical, in order to ensure patient safety beyond the national borders. And to, also, ensure that the purpose of UDI is met. You have, here, on the slides, a reference to the IMDRF document that I mentioned as I was going through my presentation.
Second part, now, is related to the collaboration. And, really, the idea of sharing knowledge across the different stakeholders and learning from each other. If you look at the map today and you try to put a pin on every country, or every region, where you have medical device identification requirement, you realise that it's everywhere across the world. And you also realise that if we really want to have the globally unique identification system for medical device, the only way to make it work is to work together.
If we look at this map, but with a clock and a timeframe, we will realise that some countries have started to implement, while others are still in the process of developing the UDI requirement. There is also an opportunity to learn from what others have faced in regards to challenge and benefits.
So, what does collaboration look like when we are a standards development organisation like GS1, and you have to implement the UDI system in a globally organised way.
First, you have to work with your peers. You have to work with other standard development organisation. And you have a list, here, of some of them. And luckily, there is this joint initiative council, which is the consortium of these organisations who are coming together in order to help to build the future digital health ecosystem.
The idea is we need to make sure that if GS1 develop a standard, it will work together with other standards that are used across the supply chain and, also, in hospital environment. To ensure that there is no break and there is, really, bridges across the different system, and they are interoperable together.
I won't spend hours on the JIC, but just for you to know, if it's a topic that is of interest for you, webinars are organised on a regular basis. We had, already, two on different topics. And next one is coming beginning of December. They are open, and you'll find the details clicking on the hyperlink on the slide, here.
When you think of collaboration, and GS1 in particular, you must think about the GS1 MOs, the GS1 Member Organisation. These are the local office of GS1, which are, really, the voice and the face of GS1 on all the markets across the world.
GS1 Australia is yours. And the idea is, really, that by working with the different MOs. And with having MOs which are able to understand and translate the local needs into a global system of standards, we make sure that we are, effectively, supporting implementation in a harmonised way in every country where you have a little orange dot on the map, here.
So, like I did before, that was the theory in practice, what do I do if I need to implement GS1 standards for the UDI system. The first part of the implementation journey goes without GS1, actually. It's up to every manufacturer to assess which product is falling under the scope of the different regulation.
So, you have, in one hand, your UDI regulation, in the other hand, your catalogue of product, and you need to do a mapping, which of these products will have to comply with this requirement. And you have to do that for every regulation across the world, even if the scope is kind of harmonised. Again, you may have little discrepancies, also, in regards to which class is my product related to.
The class is a way to identify the risk posed by a device for a patient. And depending on the country, they are identified with numbers, so Class 1, 2, 3, or letters, Class A, B, C, but the idea is always the same. And in regards to implementation, what we have seen is we are trying to, of course, start with the implementation for devices which pose the highest risk for the patient.
So, first, are my product falling under this scope of the UDI regulation? Yes. Which class is my product falling under? And then you can already map the deadline that you will have to meet, in order to implement your requirement.
And then, GS1 is coming on board. Define your issuing agency. Because one of the steps to implement is identification of your devices, you will need to see if, on your product, you already have identifiers. Do you already have barcodes? If so, who is providing you with support to generate your identifiers?
Which member organisations, which of the little orange dots that you see on the map just before is the relevant one for you? You may have more than one, so you have to really do all these assessments and all this mapping, in order to be able to visualise exactly what the UDI implementation will mean for you. This must be done by every manufacturer and for each product.
Then, once you have done that first mapping, you can start to work on the identification itself. So, generate and assign the Basic UDI-DI if you're planning to suppy Europe. Or the UDI itself, so the GTIN and the relevant AIs for the rest of the world today.
Once you have identified your product, you need to encode this information in the machine-readable format and human-readable format. Here, in principle, the deadlines depend on the risk class of the product. And then you need to, also, work on data.
This is presented with numbers and by order, but more and more we see that, actually, data is not last. In principle, you need to, as you think of the identification of your product, already, you have a process to ensure better management and data quality in place or being designed in your company. Because this is the part which has been, at least, the most challenging. And one of the most important one, as well.
So, really, try to think of, first, assessing the scope, identifying the class, looking at the issuing agency and what is already on your product. Start to look at the identification and marking. And in parallel, look at the data and get ready for your data management process to be in order.
Once it's done, you just put your identifiers and your barcode, you register your data, and then you only have to keep this data up to date, and to make sure that information is still of relevance.
If we look at the part related to the assignment and generation of the UDI, that's where GS1 can help you, actually. And that's a role that has been given to GS1 and the UDI issuing agency by the IMDRF and, also, by the regulators, today.
So, in practice, and we receive many questions on that, how can you provide me with a barcode. No, we don't provide a UDI barcode to manufacturers, but we can help you to get there. You need to knock at the door of any of the GS1 member organisation, and this will be the first step for you to obtain your UDI. You will need to ask this member organisation to get license for a GS1 company prefix, and that company prefix will be assigned to your company, not to the product.
That company prefix is the first component of your UDI-DI of your GTIN. So, once you have your company prefix, you will be able to generate UDI-DI. The first part, the company prefix, is given to manufacturers, by GS1 member organisation. And the second part will be generated by the manufacturer, according to the GS1 rules, and this will make your UDI-DI.
Next, for your UDI-DI, you will need to add the Production Identifiers, so the PIs, in order to have your full UDI number. The company prefix can be used for the GTIN generation, so the UDI-DI generation, as well as the Basic UDI-DI generation. And also, type of identifiers which are used for location identification, which are used for logistic item identification, etc.. So that's, really, the basis and the foundation for all the different identifiers that you will be able, or you will have to, develop, and generate based on the GS1 system.
And as I said, you need to go to a member organisation in order to have this company prefix, and you need to follow the rules of the GS1 system to know the sequence on how to create your number. You always start with your company prefix first, then you add a suite of numbers, this is your UDI-DI. And next to it, you need to add the Production Identifiers to have your full UDI.
Concluding on this section related to collaboration, I had to mention the pandemic we went through, and we are still in, actually, and the need for harmonisation, again. Because we have seen, over the last year, even more than before, the need to have efficient supply chain. An efficient supply chain which are working beyond borders, and for that, UDI is key.
If you are able to identify your device in more than one country. If you are able to know where it is, exactly, where is it going, and maybe where is it available today because you don't have any more in your country, but you need it, then you already managed to make a difference for patient safety.
You can also help to prevent substandard and falsified product, and again, unfortunately, with the pandemic, we have seen a tremendous increase in the number of falsified product that has been supplied. And you need, also, to ensure that you have the resource that are needed in your hospital who are effectively able to treat the patient and not to spend time in looking in cupboards to find the right product.
And so, this is really where we have seen that the GS1 system can make a difference, or any global standard can make a difference. And the UDI system could really help, also, in knowing that in this country, in this hospital, these ventilators are available. In knowing that this mask that are coming to my market are not fake ones and they are going to, effectively, protect the patient against the virus.
Moving forward with the last part of my presentation, the benefits of UDI. So, beyond harmonisation, beyond collaboration, really, UDI is making a difference for many different stakeholders.
I start with regulators, and the benefits of UDI, globally, for regulators is, and these are just examples, it's not an exhaustive list, the idea to be able, as I said, to just know where your product are and what is available in your country. So, you are able to, really, anticipate on the need for more healthcare products to be supplied to your market. And also, be able to assign the different product when they are needed in the different parts of your country.
It's also the possibility for you to have an integrated healthcare system, where you can leverage the use of a global unique identifier for insurance, for price control, for tender requirements. You can also leverage the use of UDI for market surveillance, and prevention of counterfeited products to be supplied to your market.
And last but not least, as mentioned, I don't know how many times, already, global harmonisation. This is really the key for you to be able to have a system of identification, which is not only working in Australia, but in any other country.
Referring to Australia, not all the system... Not all the benefits are of relevance, sorry, for TGA. For example, price control is not something that is done. And so, these are the benefits for regulators globally, but it's not only for one agency or for one part, it's really for the entire scope of the decision-makers, governments, and the healthcare system.
Looking at manufacturers now. So, here, again, the idea of being able to know where your product are. The idea of being able to ensure that they are the right product, and they are not fake ones.
The idea to be able to capture information on the use of your product and the impact on the patient. Is this hip implant causing infections to all the patients, maybe there is an issue with this product, and I'm able to know exactly which product, which lot, because they are properly identified. And last but not least, the possibility to build trust by making sure that the patient are seeing your product as effective and trusted ones.
And last but not least, healthcare provider. Because ultimately, the idea of the UDI system is to enable the healthcare providers to make sure that they have the right product to treat the right patient. So, Mr Jones is not going to end up with the right hip implant when he's needed the left one.
So, having the possibility to globally and uniquely and ambiguously identify your device. Having the possibility to have more effective recall in case there is something wrong, it's quick enough so that you're sure that your product are not going to be used on the patient.
You have access to accurate information and data, and you are able to, potentially, link it to the electronic health records. You have the possibility to report, also, effectively, on adverse events, on errors, etc.. You are able to monitor the use of the device and to assess the cost allocation, and to, potentially, optimise that.
And last but not least, for all the process related to the administration, to the invoice, to the ordering, etc., you are able to leverage, again, the use of these global unique identifier, and all the data that are behind in that UDI database.
I have included some examples of concrete benefits that we have seen as UDI has been implemented in some hospitals. And you see here some numbers, and I'm not going to read you the full story, but the idea is that you manage to save time in ordering your device. And the scanning rate, yes, it's a question we often have, is quite high. More than 90% of the staff in the hospital was able to scan and was scanning after only two months of implementation of unique identification of certain implants in this hospital in Chinese Taipei.
Looking at Denmark and, again, I'm not going to tell you the full story, you will have the slide, and you can read, but focusing on the result and the benefits. The nurses were able to spend more time next to the patient, instead as looking for devices.
There was no cancellation of the procedures because product were available when needed. People were, of course, more happy, and you were able to reduce the stock because you were able to map what product are needed for what procedures and what product are then available in my inventory.
And to conclude, let's look at what we've learned from working with others across the world on supporting implementation of UDI system or readiness for adoption of UDI system.
And I will repeat myself, but it cannot harm. So, the identification and the barcoding requirement must be aligned with the IMDRF. Really, the beauty of the UDI system is that it works beyond border, and this is key.
Following the rules of the issuing agencies of UDI are one of the way to ensure this global harmonisation because with one identifier, you can identify your device for many countries. And the system is consistent and coherent and interoperable with other systems that are, potentially, used in hospitals based on other standards.
Flexibility in the barcode choice is needed because, remember, the example of the surgical instruments and the x-ray machine, you don't need to have on both of them the same type of barcode. Space constraint is one of the driver for the barcode choice and supply chain management process, as well.
The UDI database is managed by the regulators. And really, focus here on what is needed. Don't try to have an exhaustive list of all the data elements that could be used one day for one specific purpose. No. Go with what is needed and ensure that data quality is high.
Validation rules can be included in the database function or specification. And it's also a good practice, a good business practice, actually, for the industry to include some of this rule as part of their data management process.
Machine-to-machine submission is making a difference, in terms of data quality, in particular, for large volume of product to be registered with the database. Work together, so look at what has been done by other companies in other countries, in other hospitals, and learn from others. Ask for their views and get the feedback on both, in order to improve the system. This really is critical. And as we are all moving forwards towards a UDI journey, it's time now to do it. Once everything will be implemented and running, it will be much more difficult.
And last but not least, think about the different type of device. If I draw the parallel between medicines and medical device, the variety of product that we're talking about, and the differences in manufacturing processes, supply chain processes use in the clinical process, as well, between devices, is very wide.
So, if you think of kits, if you think of software, if you think of combination product, if you think of devices which are sold in retail, if you think of implants, etc., these devices will require specific requirements, or specific guidance. In order to make sure that UDI is effectively meeting the purpose of patient safety and supply chain management efficiency.
And with this, that's the end of my presentation. So, really, if I have to summarise in three words, harmonisation, collaboration, and optimisation would be my three last key words to conclude.
If you have any questions, you can find, already, some answers here, and I see that you have been busy filling them in the chat. Michelle, I turn back to you.
Michelle van Wijk
Thank you so much, Geraldine, for your presentation. And for those of us who are in Australia, you might not realise it's actually 3:00 am for Geraldine. So, appreciate her offering to answer our questions, to come and present today, but also, that it's such a difficult time over there, in terms of not a normal day. So, thank you so much, Geraldine.
We do have some questions in the Q&A, thank you. We will go to those at the end if we have time, but if we don't, we'll make sure we respond to those and put them on the TGA website.
So, what I'd like to do now is just give an update on where we're up to on our UDI project in Australia. And then provide some questions and some answers, actually, to the questions that we've already received.
in terms of international alignment, there was a workshop on 9th of September, between the DITTA Organisation and the International Medical Device Regulators Forum to look at UDI in a couple of lenses.
One of where presentations and implementations were up to for countries. And then the second, from a manufacturers' perspective, in terms of the range of regulations that are now coming into force. If you wanted to have a look at any of those presentations, they are on the DITTA website. They are going to make the recordings available, as well. The last time I looked, they hadn't yet done that.
In terms of our early adopter work, so, really key to build in where we can, the use of the codes through the system, in addition to the work we're doing to establish the database and the regulations. So, the business case for that project with Queensland Health is now approved. And there's work continuing to go ahead on scoping which hospitals and which devices will be part of that early work.
We're also continuing to have discussions with registries, software organisations, healthcare procurement, and other states and territories, around, potentially, being involved in early adopter work. And so, we're going to maintain a list of all interested organisations. And once we're established enough, in terms of our framework, then we'll be reaching back out to start further discussions around that.
So, if you are considering being part of an early adopter project with us, please let us know. And the best way is via email, and we'll give you those details at the end of the presentation.
We're also very excited to be kicking off our first triggers working group, or our first working group, which will be focusing on triggers. So, the circumstances under which a new Device Identifier might be required. You heard Dennis talk last week. So, Dennis Black is from Becton Dickinson, he's got a lot of experience globally in implementing UDI. But also, in working with these style of groups to try and really improve, increase, the uptake and the use of those devices.
So, Dennis has very kindly offered to chair and bring his expertise to that work. And we have a number of registrations. The kick-off meeting is next week, and so we're sending out invitations and details as we go. If you'd like to be included and you haven't yet let us know, please also let us know via our email.
In terms of next steps, so we're planning for regulatory consultation early next year, to really start to map out what the regulatory framework will look like in more detail. We're connecting a beta version of the National Product Catalogue, so for anyone that's overseas, that's the Australia equivalent of the Global Data Synchronisation Network. We're connecting that up with our sandpit UDI database to look at whether that's going to be something we might use for providing data to the Australian UDI database going forward.
And we're continuing to develop functionality on our Australian UDI database and test that with user groups as we go. So that is evolving very rapidly, the database technical aspects.
What I'd like to do in the last ten minutes that we have is start to talk a bit about some of the questions we've received to date. So, we're really excited, there's been great questions, great engagement. We've had over 150 questions to date, either directly from webinars or to our email address. But really, they're focused on ten themes, so what we're seeing is timing is the key one. A lot around international alignment, and then the scope of devices.
But then we're seeing questions around alignment with our existing processes and the Australian Register of Therapeutic Goods, our Australian device database. Also, around the Australian UDI database, the provision of data to it, the Global Medical Device Nomenclature, and its use. The generation of UDIs and issuing agencies. So, hopefully, you've got some better idea from Geraldine's presentation today, as well.
Labelling requirements, the use in clinical systems and patient records. And then, some around collaboration and engagement. So, I will start to go through these, and we'll see how we go for time.
So, we're still confirming our transition period and the details, but we will, like most of the other countries that have implemented UDI, begin with those high-risk implantable devices. Our first compliance dates will focus around those.
We got a lot of feedback from, particularly, our second consultation, to suggest we should be able to explore opportunities, to, perhaps, transition more quickly. And perhaps, we could already use data and devices that are compliant with U.S. or EU regulations. So, we're continuing to explore that.
Other feedback is that we should allow 12 months from finalisation of regulations to our first mandatory compliance date. And also, that we should consider voluntary provision of data prior to those mandatory compliance dates.
So, I wanted to share this with you now, which is more direct feedback, in terms of our timing and our planning around that. So, we have four key dates that we are currently working towards. And the first one is the provision of a sandpit or a beta version of the Australian UDI database that's available for use and testing.
So, beyond our early adopter projects, but for machine-to-machine connection, direct entry of UDI data, using our portal interface and other testing of downloads, for example, should be available by the end of June 2022.
In terms of putting the regulations and the guidance together, we're anticipating that will be completed by June 2023, which will allow, then, a full 12 months before the first mandatory compliance date for implantable devices, which would be July
And in between there, we have a voluntary compliance date of December 2023, which we're working towards for provision of data for device of any class prior to that first mandatory compliance date of 2024.
As I said, the transition period we're still working through how that might look, but that will obviously then follow from July 2024.
Questions we've had around the scope of devices. So, we've separated the rest of these into what we already know and what we're still exploring. So, in terms of the scope, we know for example, that where software is a medical device and it's regulated by the TGA, it must meet the UDI requirements unless its exempt or exceepted.
The UDI will be required for every model of device, which will be different to the ARTG, Australian Register of Therapeutic Goods, which also enables a kind of device level of granularity. Which, in some cases, will be higher than the model, which will be in our Australian UDI database.
Some of the questions we've had, we are still exploring. Will non-ARTG registered products be eligible to utilise the UDI? Will Class 1 be in scope? Will legacy devices be in scope? What are the rules around kit systems and procedure packs? And what will be exempted or accepted, and that might be around patient match and custom-made devices?
In terms of international alignment, we're looking at alignment with the USA in the first instance. And then looking at bringing in the EU requirements there as well. Obviously, that will all be underpinned by the IMDRF regulations to help make us globally compliant.
We need to do some analysis now to look at where the differences are between the IMDRF, the U.S., and the EU, to understand what lessons we might have learned from the U.S., which has been in production and mandatory from a compliance perspective since 2014. So, there are some lessons learned from that, and look at the differences.
In addition, there'll be some minimal TGA Australia-specific requirements, which will include ARTG-ID to map the ARTG-I with the UDI, those two datasets, to make sure we can match those. Production information leaflet, a URL for those. A product information leaflet, and also, looking at the prosthesis billing code, again, to make some of those connections with the UDI and existing systems, particularly around device billing and payment.
If I look at the Australian Register of Therapeutic Goods, we have said that each device record is the UDI will also include a list of all of the ARTG-IDs that relate to that model of device. And under the current regulations, UDI is already mandatory for the patient implant card if the device has a UDI in Australia.
We are still exploring whether the sponsor will be required to submit a variation for each ARTG to provide a copy of the updated labels with the UDI. And also, linking, of more broadly, of the data across the TGA, for ARTG UDI adverse events and recalls.
And I'm going to stop at the end of this slide because we're just running out of time. So, from an Australian UDI database and data provision perspective, we know that the majority of the UDI data will be made publicly available throug a wheb interface and through data downloads.
We'll provide machine-to-machine capabilities for data transmission to the Australian UDI database from day one. MRI compatibility is included in the IMDRF dataset, and we're planning to capture it as part of the Australian UDI database. And we'll provide a web interface to allow for the entry of data, one device at a time for those organisations that need to do that, that aren't mature, in terms of their digital systems and capabilities.
Some of the questions we've had that we're still exploring are should the manufacturer be able to provide UDI data directly to the TGA? The use of the National Product Code, or the Global Data Synchronisation Network for the provision of data?
Is the TGA considered the practical... Or has the TGA considered the practical elements where a sponsor of a system of a procedure pack might supply multiple devices? So, again, we need to look at that.
The final dataset is still evolving, and does it mean that the manufacturer will have to create a new UDI and packaging for each device that might have multiple sponsors?
So, I'll continue with the questions and answers at the next slide. At the next session, sorry. And we might quickly do our polling, and switch across, if Geraldine's got a few extra minutes to... I think there's a couple of the questions that we received that I'd particularly like to cover if we can. So, Rachel, back to you for the polling. And then, Geraldine, there's a couple of questions I'm hoping we can just cover off before we close.
TGA Webinar team
Thanks, guys. Thanks, Michelle. Thanks, Geraldine. It's important that we do get your feedback so we can move forward with some further webinars. So, we really do appreciate your input.
Geraldine, and Michelle, there are some questions that have been popped into the Q&A, so if you're familiar, to go back and have a look at those. And I believe that you'll take over reading those questions, and I'll just take over the control of the slides if you like? And when you're ready, while the audience are filling out the live poll, just get through a couple of those questions, that would be lovely.
Michelle van Wijk
Great, thank you. So, Geraldine, there's quite a few questions here on, particularly, the GS1 aspect of it. I'm hoping that you might be able to answer a couple of those. So, one of them was from a GS1 perspective, do you track the usage of a UDI-DI, by the device manufacturer? And does the manufacturer have any obligation to supply the information regarding the usage of UDI-DI back to GS1?
Thank you. So, in practice, no, we don't collect the UDI-DI. However, for the U.S. FDA purposes, we need to know if a device manufacture is using, or not, the GS1 system for implementation of the U.S. FDA UDI requirement. So, it's not the number of the exact identifier that we need to know, we just need to know if the GS1 system is used by this manufacturer, in order to identify a device supplied to the U.S.. this is in order for us to be able to compile the electronic list of labeller that we have to submit every year to the U.S. FDA, based on the U.S. FDA UDI regulation.
Michelle van Wijk
Great, thank you very much for answering that question, Geraldine. The other question that we have here, which has more of an Australian flavour, which I'll take is, if an overseas legal manufacturer company does not have a GTIN and assuming, then, UDI, and if us as the sponsor request a GTIN from GS1 Australia, are we, as a sponsor, with the help of our third-party warehouse, allowed to label the products with this GTIN?
So, it's a really good question, and it speaks to the role of the manufacturer and the role of the sponsor, in terms of labelling and allocating UDIs. And we're going to take that one on notice. So, it's a really good question, one we haven't had before, so we will go away and come back with a response to that question. But I just wanted to read that one out because I think it's a particularly good one.
And I have one final question for Geraldine, if that is okay with you, Geraldine? And again, it becomes that how do I use this globally, and, also, into Australia? So, if your organisation is using UDI with GS1 in another country, is your GS1 number the same or do we need unique numbers for Australia?
It is the same. As long as you don't fall under the scope of the UDI triggers, where you need to assign the new GTIN, it is the same. The idea of a globally unique identifier and the name, GTIN, start with global, means that you can have an identifier which will work in more than one jurisdiction. So, it is the same.
Michelle van Wijk
Fantastic, thank you very much. And from a post-market surveillance perspective that starts to become really important, in terms of that visibility of the device globally.
So, Rachel is now very kindly showing us some more information and our UDI email address. So, really appreciate any other questions you might want to send through. Any thoughts you might have, please send those through. And we're just a little bit past time. So, once again, I wanted to thank Geraldine very, very much for making the time to come and talk to us today about the GS1 system for UDI labelling.
And to let you know that we'll follow up next month with a discussion with another one of the issuing agencies, to learn about some of the differences between those. But appreciate your time very early, Geraldine. Thank you so much.
Everybody, our next presentation, our next webinar will be the third Tuesday in October, which we'll send out a reminder, which I think is 19th of October. 11:30 to 12:30. So, hopefully, we'll see you again then. Thanks, everybody. See you next time. Bye.
- Committee meetingsACB Meeting #20, 1 September 2023Advisory Committee on Biologicals (ACB) meeting
- Committee meetingsACB Meeting #21, 10 November 2023Advisory Committee on Biologicals (ACB) meeting
- Committee meetingsACMD meeting #73, 8 June 2023Advisory Committee on Medical Devices (ACMD) meeting