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Webinar presentation: Unique Device Identification

8 July 2021


This presentation paper is 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 paper is 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 paper 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: Tracey Duffy
  • Presented at: Online
  • Presentation date: 15 June 2021
  • Presentation summary: An introduction to the Australian Unique Device Identification system, including Q&A

Recording of online webinar presentation


Tracey Duffy

Good morning, good afternoon, good evening to everyone who's joining us here today. We're very excited to be kicking off the first webinar in what will become an ongoing feature on TGA's communication engagement strategy as it relates to the Unique Device Identification project.

I am supported by a team, which you can't see here today, but Michelle, who's the lead for the project, is not able to join me today, so I'm stepping in at the last minute. And hopefully, we'll do the project justice as we go through the webinar today.

As I said, this will be an introductory webinar, there'll be many more to come. And more focused webinars, as we start to focus in on some of the implementation details for UDI here in Australia.

Today, for our first webinar, we've got over 200 registrations, both here in Australia, but also internationally. So, there's quite a bit of interest on this topic, and we hope that the community of interest will grow as we move forward into implementation.

So, I'll go through the slides now and, hopefully, we'll have some time to take some questions at the end. There will possibly be lots of questions, so we'll hold over some of the questions and provide some updates to the question in the coming weeks and months, as well.

So, what we're going to cover today is a background to Unique Device Identification. The status of the Australian implementation and the progress we've made to date. And as I said, an opportunity to ask questions. And if we get to some of the questions, that's going to be great, but I expect we won't get through all of the questions here today.

So, what is Unique Device Identification? Well, as it says, it's pretty self-explanatory, it's a way of identifying medical devices. And the way that we identify the medical devices is to have a unique identification set of numbers and codes so that each device would, logically, have its own separate identification. That we would then store and collect and use for the purpose of identifying that device, both here in Australia, but, obviously, globally is where we want to go.

There are some key drivers for having a Unique Device Identification, not only here, but worldwide. Not only to unambiguously identify a device to ensure that there is tracking and tracing throughout the global supply lines and systems. But for some countries, they have an issue with fraudulent devices. So, the way that we can make sure that what we're talking about and what we're seeing in particular devices anywhere around the world is, in fact, the right device by that manufacturer, and being supplied in the right way.

So, worldwide recognition in the interests of a harmonised UDI model, the International Medical Device Regulators Forum have been working on a harmonised approach for UDI for quite some time. And there's been quite a bit of guidance already published on that on the website.

Other regulators, including the US, have already implemented a UDI, and that's been in place for some years, as are other countries like China and Singapore, and the European Union are also implementing a UDI as part of their EUDAMED and MDR reforms.

In Australia, a number of reviews and global safety issues have identified and made calls on the TGA, healthcare professionals, and our hospital systems to put more effort and focus into improving how devices are managed throughout the supply chain.

Not only from the initial supply but right through an ongoing or the lifecycle of that device. Including when there's a need to do any recalls or product safety advisories to go out. A way of finding out which patients have been implanted by which device is going to be key to the UDI bringing benefits to the healthcare system in the future.

So, what exactly is identification? Well, as I said, it's a unique series of characters that allow the unambiguous identification of a specific model of device on the market. It's globally unique, and it's applied to the model, and then it would be used across the healthcare and supply-chain systems.

Here in Australia, we're really keen for it to be adopted by the healthcare system because it's one benefit from being able to provide the identification information when you first market a device here in Australia.

But the true benefit comes from being able to use that device throughout its lifecycle, including into hospital systems and patient records. So that if something for an implantable device, there is an issue picked up, it can be sorted and searched through hospital systems or healthcare professional systems to identify which patients have been implanted.

Also, if it's not an implantable device, A, you can easily identify that type and model of device to see whether or not you needed to bring it to the attention of the sponsor, or there's some rectification action that's required. But in essence, the identification will have two parts, information about the device, which remains static, and product information, which is more dynamic.

And where would the identification appear? Well, it would appear on all levels of the packaging. And the packaging of a device comes in many different formats and forms. You can have 30 items in a box, such as are identified in the blue box. And you could have that case of 30 boxes within a box. And 50 in a box, which is the green box. All layers of packaging would need device identifiers and need to be linked to a device identification system.

The type of symbologies would be agnostic in terms of symbologies, but it would operate similar to what you see in supermarket and food chain stores, like a barcode. And a two dimensional (2D) barcode, a quick response (QR) code, and also be identifiable by a reader, as well, so by the human eye. And there could be some future technologies involved that we could adopt later on, as well.

So, what are some of the fundamental concepts of a globally harmonised UDI System. Now, these are taken from the IMDRF document, the final document that was issued back in 2013. So, Australia has looked at this document and will be adopting these concepts of the globally harmonised UDI System.

And there's nothing too difficult in this, other than the harmonisation part because there may be some difficult implementation requirements required in different countries. So, where possible, we will need to be very mindful of these.

But in terms of a unified and harmonised system, the core elements is that the UDI and UDI carrier are to be based on standards. And we all know that standards bring about a level of harmonisation and a way of being able to ensure that we're talking about the same thing.

It should be applied to a device anywhere in the world and be able to use globally. There could be national or local identification numbers in place, but that should not be a substitute for the UDI. Regulatory authorities should not specify the procedure for modifying these UDI standards. And the UDI core element should not be modified either because that brings inconsistency and some confusion into the system.

There's also some concepts around the labelling and types of interface for data submissions. And every medical device should be identified by UDI unless it is exempt. And we might talk a little bit about that later on. In terms of the database, this is an example of the US FDA's GUDID database. And in relation to the database, there are a few things that we've adopted here in Australia as concepts. And that as a regulator, we would store static information, and not necessarily include dynamic production information. And definitely no patient information.

Other healthcare systems, such as in supply chains, hospitals, or registries will collect more information, potentially, about the device, including some of that dynamic production information. And that's the way we see it happening here in Australia, as well. What data are we proposing to store? So, here again, looking at what's been implemented in the US, in particular, and taking on board the information that's in the IMDRF guidance, this is a list of the type of information that you would typically see on a UDI and on a label so that you'll be able to find out the information. And we would store this information in a database that would allow easy tracking and tracing.

There's, roughly, data broken down into two areas. There's the device information, and then there's device characteristics, such as sterility, storage, and handling, and so on. And so, we've put together this conceptual diagram as to how we might see it working here in Australia. So, conceptually, the UDIs would be issued by an issuing agency. And at the moment, we have identification, here in Australia, that we would support the issuing agencies, three issuing agencies, to issue UDI labelling to a medical device.

And they are the three agencies that are in the top left-hand corner. And issuing agencies that are also recognised by the US FDA at the moment. And they would issue the UDI to the manufacturer, who would then place it on their labelling. And you can see that down in the bottom left-hand corner. Now, the labelling and the information contained in the UDI would have to be submitted to the Australian sponsor. So, here in Australia, as you know, we have an Australian sponsor who's the legal representative who is responsible for the device here in Australia. And the information that's provided to the sponsor could be uploaded into the UDI repository. Or, we are working on whether or not it makes sense for the manufacturer to upload some of the information into the UDI repository.

And that's part of the consultation that we'll be having in the coming few months, as to the roles and responsibilities between the Australian sponsor and the manufacturer and the submission of the UDI data into the Australian UDI database. The other concept that we're exploring is to whether or not we will be able to, and hopefully, we'll be able to, accept bulk uploads into the UDI repository here in Australia. To decrease the regulatory burden in having to type out information into a number of databases around the world. Looking at options that we can utilise the input once, and then used many times for the purposes of Australia. Given that Australia is such a small market when it comes to medical devices.

Now, obviously, when the data goes into the UDI database, we are also offering a publicly accessible version of the database, which can be used and downloaded by universities, hospitals, healthcare professionals. Anyone who might want to access the UDI data for the purposes of identifying a medical device. The UDI label would, also, when the supply of the device would physically reach Australia, be part of all the packaging and being delivered to the hospital. Hospitals would then, if they have the IT systems and the capability to record the UDI information. And in those cases where there's a registry involved, the ability for a registry, such as the Joint Registry or the Breast Implant Registry, would also be encouraged to adopt the UDI as part of their database, going forward, as well.

And that's the subject of quite a lot of discussions and negotiations over the next few months, as we assist all the relevant stakeholders to understand the value and the benefits of adopting the UDI in the healthcare system here in Australia. So, what have we learned so far? In the past 12 months, the team here at the TGA have been doing a lot of engagement and communication with those who have already been involved in implementing a UDI system in other countries. So, we've talked with regulators, we've talked with sponsors and manufacturers, and we've also talked to issuing agencies. And what we've learned is there are some key factors that would bring significant value to our thinking about how we implement here in Australia. And then, obviously, there's some challenges, based on what we've learnt to date, but the challenge of having a different legislative framework here in Australia.

But these aren't insurmountable, and hopefully, over the next few months, as we have more focused webinars on some of these challenges, we will be able to work through some of the details and come up with our position on many of these things. Our ability to pilot what we'd like to see in Australia would also be a way of working through some of these matters to find a resolution and a way of landing on a position.

We're grateful for those who have already embarked on the journey, particularly those who have been issuing and been supplying the UDI information to the US market for quite some time now. So, it's important we leverage the learnings from these implementations so that we can learn from that and either not make the same mistakes, but also improve the way we implement here from the get-go. Rather than having to step backwards and work forwards after we've learnt along the way. So, we do appreciate that.

The key things about adding value is the clarity and the clear guidance. That's a real big thing that came through in all of our conversations. Being really clear about how you could use the UDI, the benefits and a shared understanding about the roles and responsibilities for UDI. Particularly in the downstream use of the UDI.

So, whilst the UDI will be a requirement under regulatory arrangements, the use of the UDI

is not mandated throughout the healthcare system. So, it's about selling those benefits and being able to share those benefit throughout the healthcare system that will truly see the benefits realised.

And there needs to be sufficient time to prepare. That came out as a very strong point when we spoke to manufactures and sponsors. The ability to prepare and make sure that what's required in Australia is going to be practical and you have sufficient time to put in place the arrangements. Because it does take time to change processes and procedures at the manufacturing sites to accommodate new labelling requirements. And we do understand that.

So, many of these things, we'll be working through in more detail over the coming months. So, what's the status of what we've done so far? And I'll be going through a little bit of these things in more detail in the next few slides. So, the first things we've done is, obviously, establish the project. And there are eight streams to our work here in Australia. There's probably many more, but these are the first eight that we focused on.

Number one is really trying to understand what the regulators are putting in place, and what's been the experience by the manufacturers and the organisations who have been involved in that implementation. And as I mentioned before, learning from that experience.

The second stream of work is around communication, engagement, and a changed management. Communication and engagement is going to be critical to the success of UDI here in Australia. So that there's a common understanding of what we're trying to achieve and the benefits that could be delivered not only from a healthcare perspective but, ultimately, the patient. So, from a patient's perspective, being able to identify what type of device you have is one thing. But having information about the model and the type of device is so much more rich information that will give them peace of mind when they're provided or know that they have access to that information.

And we've seen a number of recent examples of where this has created some difficulty and challenges, particularly when we've had to either recall or provide some information or advice to patients about the implants that they may have received. And we've seen a recent example of this in Victoria, where they had a media campaign about breast implants. Now, obviously, a media campaign is not the ideal way of communicating information about a particular type, or types, of devices that we might have some concerns about. It will be much easier and better and more streamlined and targeted if we knew and were able to identify precisely what model and what patient has been implanted with a particular medical device.

So, thinking about how we communicate that, and the benefits is critical to this project. There's, obviously, the technical database and interoperability considerations. These are going to be critical to not only accept the data but look at how we reduce the regulatory burden of manufacturers having to input the same data into a number of different databases. And also, here in Australia, we have the Australian Register of Therapeutic Goods (ARTG). So, the linkage between the UDI information and the UDI database and the ARTG is a very key component to our thinking about our design and database interoperability.

The legal and legislative framework has recently been put into place, and I'll go through that in a little bit more detail. But that was one of the first steps that we did. Putting in place and making sure that the Australian government and the parliament had an opportunity to provide input into what the legal and legislative framework would be for the UDI. And so, preparing documentation for the consideration of government occurred last year.

The fifth stream of work is around the issuing agency framework. And I mentioned earlier that there are three issuing agencies that we've recognised. Putting in place some guidance and some other information to provide some clarity around who's responsible for receiving the labelling and submitting the labelling information will be further clarified in our guidance.

And that goes to the operational side. So, the operational aspects of it. The planning for a phasing or a transition approach. And, more importantly, the governance around the whole project, going forward. And you can see on the right-hand side, there are different sub-projects that relate to each of the streams. So, for example, we have a sub-project, which we started on the Global Medical Device Nomenclature, so the GMDN.

The GMDN will form part of the UDI. But what we've identified is that there are some updates required in the ARTG to align the most up to date GMDN codes in the ARTG, with what will come through in the UDI. So that we don't have a mismatch between different device information in two different datasets.

And we've also started a project on looking at how we could publicly make the data accessible. And being able to identify the differences between what's going to be required in Europe, through the EUDAMED, and TGA, and US FDA, to have a look at the harmonisation, and identify where there's no harmonisation, where the issues actually are.

So, many of you will know that this has been a little while in coming. So, we've done a number of consultations, and we're always going back to the consultations and what they told us.

We undertook our first consultation in early 2019, and that was about the original proposal of introducing into Australia the UDI concept, based on the IMDRF principles. We received 49 submissions from that process from a broad range of interested stakeholders. There was strong consensus to introduce the UDI here in Australia. And there was also a strong preference for the TGA to establish and manage that data. So, that's what we've got forward with, in a proposal to government, which has been accepted by the government, and that's why we're progressing to the next stages.

There's also a strong requirement and need and understanding that there needed to be a link with the data that the TGA already holds in the ARTG. So, those levels of linkages to all the information we currently have was seen to be a really powerful way of supplementing the information we have about devices here in Australia. So, I want to thank those folks who did provide a submission to that first consultation with that feedback, which we've used to move forward.

The second consultation we did in late-2020, going into early-2021. And here again, we got a strong response. We received over 90 responses to this consultation. And this consultation went to the next step and looking at what some of the benefits could be throughout the healthcare system for a UDI.

We've published all of the feedback that we received from this consultation recently, so if you're interested, there'll all available now on our website.

And it's really important to note that the information coming out of that second consultation paper is going to be driving some of the early work that we do, in relation to setting up a phased approach. Including the question of whether or not we could have a pilot. So, many of the things that came through in that second consultation are being the focus of our work in the coming months. In terms of the highlighted thing that came through in the second consultation, there are a few things that I just wanted to focus on. The first strong emphasis came from making sure that the rollout here in Australia was going to be practical. And making sure that it was phased to allow lead time, and also to allow people to prepare for implementation, moving forward.

And so that's a really strong message that we received, and one that we are going to implement in the rollout here in Australia.

The second point which stakeholders made, which isn't surprising, is a system that will... They talked about mirroring the US FDA or EU schemes but, obviously, we would have to be mindful of the two schemes, both in the US and the EU, may differ somewhat. We don't have all the details of the EU scheme. There are some guidances available, but how it actually works in a practical sense, there are still some details to be found out.

So, whilst we understand and recognise the alignment factor is critical here in Australia because we are such a small global market, we do have to take account of what's happening in those larger markets. And make it simpler and make it less regulatory burdensome for those sponsors who are bringing products to market here in Australia, to be able to comply with our regulations here around UDI.

So, some of the things that came through that stakeholders told us is the benefits that could be found by leveraging data available from other sources. Such as the GUDID in the US, so could we, in fact, just pull data off the already accessible public website? Or could we pull data from the National Product Catalogue, to try and work out whether that would be a good way of using the data, rather than rekeying data from a sponsor's perspective? So, they're some of the things that we will explore as part of the first phase.

The next areas that proved to be quite influential in the feedback that came back from the second consultation was around the provision of data. Mainly around who. Who should provide the data, and I mentioned that earlier. But also, how. How the data should be available. And I briefly mentioned earlier about the opportunity to use bulk uploads and downloads. The arrangements and rules around changes, whether there'd be structured, or unstructured data required or acceptable. And how to correct data, and what the triggers would be for when a new UDI or new data upload would be required.

So, all of these things, I think, came from some of the implementation learnings in the US.

And they make sense for us to have a lot of clarity on here in Australia before we go to full implementation.

One of the fundamental questions that came through in our second consultation was around this concept of a Basic UDI-DI, which is in the European system. And there were strong views both for and against this concept being here in Australia. And I guess from our perspective, the Basic UDI-DI is a way of packaging or making a family or a grouping of similar or kind of devices.

And as you know, here in Australia, for those who are in Australia, we already have the ability to create kind-of device in our ARTG, which groups those things together already.

So, in some way, the concept of Basic UDI-DI is already here in Australia, it's how we actually apply the concept in a UDI sense that we do need to do a bit more work on fleshing that out.

And then, obviously, there was a lot of feedback on the benefits, and we received benefit information and ideas from across all parts of the health system, including suggestions how these might be measured. And that's going to be really important for us to be able to measure the benefits because from regulatory point of view, we can measure the benefits, in terms of regulations being complied with.

But what's the downstream benefits to the patient? That's the key area that we're really interested in, as well.

And it was really pleasing that those members of the healthcare system and health professionals who responded to our consultation paper were equally in agreement with us of being able to measure those benefits.

And what we also heard was the TGA support needed to be quite strong and intensive. We heard from the experience of other regulators and other manufacturers that this was a make-or-break key element of the design of the system. Making sure we had a helpdesk, our data dictionary, ongoing communications. Having a sandpit or test environment similar to the US model were all critical to ensuring we support those who needed to submit the UDI data have that availability of help and support when they needed it.

And the last comment I'll make from the consultation process is on the Global Medical Device Nomenclature. And then this one, in particular, we'll need to do a bit more work on, also given the fact that the European Union is developing the European Medical Device Nomenclature (EMDN). Which would need to, in some way, shape, or form be either matched or recognised by GMDN here because in Australia, we require GMDN.

But there's a question mark about how and what the European system will look like if you've got a device that's been manufactured and complying with European regulations and is also being supplied to Australia.

So, I'm going to move on to progress to date because there has been much more progress to date since the consultation papers. We were very excited that in the last budget, we received the approval of the Australian government to spend some $7 million to establish the UDI database here.

And also, on 19th February this year, the Therapeutic Goods Act changes were approved by the parliament and received Royal Ascent. So, it means we now have the Head of Power and the legislative basis upon which we can move forward with. And we've, as I said, had regular meetings with other regulators, including the US, the EU, UK, Singapore, Canada. And regular meetings with the Australia Digital Health Agency.

And for those who are familiar with TGA, the TGA Transformation project, which is an IT modernisation project, we've also been dealing with them and connecting with them about the data and analytics stream of how to go forward with UDI.

We've engaged a delivery partner. We went out to market to find a suitable organisation who has the skills and abilities to partner with the TGA, in terms of the technical side of the UDI database. And we commenced work with them last month.

And we've created a model of identifiers that could be used across the healthcare system. And now we're in the process of validating those identifiers. And when we looked across the healthcare system and asked different people about how they were identifying medical devices in their different systems, there was a multitude of different ways this was occurring.

So, one of the challenges we have is I guess, in that communication and engagement strategy, is if we have all these different identifiers, will the UDI take the place of those? Is the UDI just an additional identifier? And working through what makes sense so that it's just not an overburdensome process of having to add another lot of identifiers to different IT systems and databases that are currently established throughout the healthcare system. Including registries or electronic medical records or hospital systems.

We've also started work to test the level of match between device that are on the US GUDID public data platform and the ARTG, to see if there's a good match of certain devices that we could potentially use as part of a first phase or a pilot approach. So that ongoing work and that work behind the scenes has been quite comprehensive over the last few months.

And we've got an internal governance model agreed so that, going forward, there's good strong governance and project management approaches and timeframes and milestones being tracked and monitored within the Health Department here.

There are a number of delivery approaches emerging. What we've found that as we've progressed and through our discussions and consultations, there's four themes that have been coming through quite strongly.

And these are the level of alignment, which is going to be critical for Australian sponsors to understand and for the TGA to have, I guess, an appreciation of what sponsors are going to have to be required to do globally, as well as here in Australia. The delivery method is also a delivery approach we need to be mindful of. So, starting small with continuing validation implementation, versus a large full-scale big-bang approach. So, we've really looked at starting small. Our consultation identified that, and it's certainly something that's a bit more measured and can be managed a lot better if we start small and then continually upscale as we go along.

The level of industry and depth of industry involvement cannot be underestimated. And depending on how large an organisation is, whether it's a multinational, what other requirements are imposed upon you from other regulators, as well.

So, thinking through, making sure we engage and collaborate and codesign where possible to understand the differing requirements that you might be receiving from different regulators around the world.

And also, the codesign will require deep participation to understand uploads, downloads, and interaction of data, and how data is collected for different systems globally, as opposed to what we're going to require here in Australia. It shouldn't be bespoke and different, we should be using similar approaches where we can, to allow that easy data transfer and uploading and downloading functionality.

And strategic alignment. Here again, strategically, when we think about the TGA, we think about not only national but international strategic alignment, and other agencies and organisations within Australia. But also outside of Australia, to ensure that information that we receive through UDI is going to be useful for others strategically.

So, this is a just a quick snapshot of where we've landed. We've landed in the in between of a quick-and-focused and a progress-and-pivot. So, we're taking a bit of a foot in each camp, in terms of we're going to be quick in some small sectors before we start to ramp up and pivot going along the way.

And I think it's a good, measured approach, where we've learnt from others, adopted where it makes sense, and then we have the ability to move more quickly as we progress and engage in consultations to work out the details as we go forward.

So, what does this mean, in terms of practical implementation? It means around 60- to 90-day time period of defined milestones and pivot points. And so, this is a bit of a snapshot of how we're thinking about implementing. So, producing a tangible asset, testing a hypothesis, reaching a decision, and then starting some end-to-end exposure in trial sites or a pilot site. And then, thinking through what does that mean for the longer term.

Also, creating a sandpit where we can test out some of those things, and creating a UDI blueprint that will give the early adopters, but those who aren't early adopters, an idea of where we're heading to so that preparation work can start. And there's going to be some decisions along the way. For example, a decision on Class 1 devices and the timing of when Class 1 devices should be included in the UDI is, obviously, a decision point that will need to be made.

There's some key questions and decision points, as I said. And the questions and decision points, we're just collating a whole big, long list of these, and they will continue. Some of these things I've already talked about, the linkage of the ARTG to the UDI data, what do we do about legacy devices.

Now, legacy devices in Australia may or may not mean the same thing in how other regulators have managed the question of legacy devices. And there are other issues that when we've spoken to our colleagues in other countries, they have still yet to resolve some things. So, there's quite a lot of ongoing work that needs to be done.

The biggest thing for us is our position where the US FDA and the EU regulations are not aligned, what do we do here in Australia, and what we've seen with a number of our other reforms that we've done here in Australia. We've put the question out to the stakeholders involved and asked them for their feedback about what makes sense. And it might be it's not one or the other, it might actually be both. We don't know, but it's something that we have to keep very mindful watch on as we go forward.

And the ability to leverage existing data sources. For example, is there a way that we can leverage existing data sources to upload information to ours? Excuse me. Grouping mechanisms, we've spoken about, and aligning data.

So, the approach we're going to take is we're going to prioritise all of the key questions and decisions, decide which approach to resolve, through a consultation, resolve them, and then work our way through on to the next one.

So, we're going to prioritise, decide, and resolve. And that's the way we'll go through each of the issues that come about that have either been identified by the TGA or, indeed, identified by external stakeholders.

The engagement is going to be quite broad. Here is a slide with a lot of information about who we think needs to be engaged. If you're listening today and can't see your name up in that slide and you'd like to be involved and engaged, please let us know. Send us an email or put something in the chatbox. Because, obviously, we don't want to leave anyone out.

And then, how will we engage? Monthly webinars. We are planning to have monthly webinars that will be based on particular topics to help us through resolving some of the priority issues.

We're also thinking of having a number of workshops to be designed and created, depending on the type of things we need to nut through. A number of working groups will also be providing detailed technical input into some of the questions we need to resolve. And there may be the need for consultation papers.

This just gives an overview of some of the working group framework we think we'll have up and running in the next little while. And so, you can see here that there'll be different categories of topics, and then we will call in and engage those who wish to be involved in some of these conversations on a needs' basis. So, any input or interest that you'd like to identify to us early on, we'll collect information and have you on our database.

So, some of the challenges that we'll go through in working through with the working groups are on the slide here. And it'll be important that if any of these issues are of particular interest to you, that you put your hand up and notify us that you'd like to be involved in some of these. There's an ongoing, I guess, focus on some of these, which may or may not be resolved in our pilot sites, but, going forward, they will have to be identified and resolved. And our guidance be very clear on how to deal with these matters.

So, the next steps, a communication strategy, and an engagement strategy. Better understanding how we can utilise the US data. The analysis will continue between the alignment between the EU and the US requirements and rules. The delivery partner is up and running, so their first deliverable is a sandpit, and that will form the foundation of our Australian UDID. And enable our earlier adopter work to progress.

And defining and establishing our helpdesk functionality. That will be really important to get up running fairly soon, particularly in supporting our early adopter projects. Early adopter projects, we have recently had conversations with... And I'm pleased to report that we'll be having an early adopter project in Queensland with the Queensland Health Department. And that will be done in consultation, also, with the Safety and Quality Commission here in Australia.

So that real safety focus and the ability to track and trace our medical devices through the healthcare system in Queensland will be an early adopter project. And one of our webinars, going forward, will provide some further information on that. But we're hoping that early adopter project will test out the UDI uptake in both public and private hospitals. And also, how it can be used in patient records and discharge summaries and things like that. And really focusing on those benefits that can be delivered.

We'll stop here now, and I'll have a look at the questions and answers. And there's a live poll that we'll be focused on in the next few minutes. Okay, so we've got quite a few questions in the chatbox. I appreciate this would happen, we won't be able to go through them all today. And we did receive quite a few questions prior to the webinar today, as well.

So, one of the first things that I can see from the questions is there's some really good suggestions in here, particularly around the experience in EUDAMED and, also, the experience in the US. So, absolutely, we take on all of those suggestions on board. And hopefully, we'll get more and more of those coming through as we go through our workshops and so forth.

There's a question here about the box being too small to have a barcode. They'll all be identified as to what to do in that case because some devices and boxes and labelling are quite small. So, we'll have to have that very clearly spelt out in our guidance. I'm assuming that we're not the first ones to deal with this, so we'll be looking at what the US has done in this case, as well as what the Europeans have said they'll accept, in terms of the final box issue.

There's a question here around are there any limitations on public access to the UDI by any stakeholder around the world. Our option of providing a public-facing website for the UDI data would mean that it would be public-facing. So that would mean that it would be available anywhere around the world where you have access to the internet. And so, we think that, like any other website, it would be available. It just depends on what we make available on the website.

It's not working. This is not working. One of the next questions is around the exceptions that both the EU and the US FDA have offered as part of their regulations. I do agree that we to look at what exceptions have been put in place and the rationale for those exceptions in those other countries. There's usually a rationale. We'll also have to look at the work that IMDRF have done in their guidance around exceptions, if there is some guidance in there around harmonisation of exceptions.

It might be that in Australia we have exceptions based on the timeframes that are required to implement in Australia. As well as some difficulties in sorting out how we apply the UDI to a ‘kind of device' here in Australia.

So, there may be some differences in approach, based on the fact that we have some differences in our legislative framework around device regulation here in Australia, as opposed to the US and EU. But absolutely agree, we should be looking at those exceptions that are currently in place.

I'm just looking through the other details. There's one in here around the use of UDI in tracking and tracing. And the question is how the UDI would be used to make it easier to track if a device ever needs to be recalled? Or if there needs to be some advice given to a patient who may have received an implant that has some safety issue? And whilst, as I said, here at the TGA, we would regulate the requirement for every device to have a UDI available when the device is supplied. But it is up to the healthcare professional or the hospital to also use that UDI in their own systems and records.

Now, obviously, we can't control what healthcare professionals or hospitals do with any data, but, certainly, that's why we're trying to have this very broad engagement strategy to encourage the adoption of the UDI in their systems. But at the end of the day, it is up to whoever is supplied with the device what they wish to do with the UDI. And we'll be strongly encouraging people to adopt the UDI into their systems.

And that's part of the reason why in the Queensland pilot, which I mentioned, we're working closely with state government to see how it could be adopted in the state government system. But also working with the Safety and Quality Commission to work through what safety aspect could potentially be included in safety and quality requirements.

There's a number of other... So, there's a question around the overall schedule of the implementation. When the government provided us with the approval to use the funding in the budget announcement last year, they set a timeframe of four years to get the database up and running. So, four years is our implementation timeframe, and that'll bring us up to 2024.

Obviously, the database will have to be up and running then, but which devices are required to submit data to the database may or may not include all classes of devices. We will have to work that through and make sure that it's practical. But in terms of the schedule of implementation, we will start with high-risk implantable devices, similar to other regulators, and then work backwards to have a realistic timeframe.

Now, unfortunately, I've been provided with a big timeclock saying we've reached the end of time, and so I would like to thank you for joining in to this webinar. Jumping in at the last minute has been a challenge, but that's what we're going to be doing. Meeting lots of challenges with this project along the way, and we do hope that those how have engaged with us today will continue to engage.

If you're interested in joining the workshops and future webinars, there'll be information on our website. We're creating a specific website for UDI so you can keep in touch and keep up to date with all the information. We will take all the remaining questions and package those up into some information that we'll also include as part of our ongoing work.

So, I'd like to thank you all for your participation and look forward to the next catch-up we have via webinar. Thank you.