UDI Consultation Paper 3 information and project update

Michelle van Wijk

Thanks, everyone, for joining us this morning, this evening, this afternoon, wherever you are, on our 13th webinar. And today we’re going to focus very much on the third consultation paper, and an update, in terms of where we’re up to with the rest of the project.

Before I begin, though, I’d like to acknowledge the traditional custodians of the land on which we’re meeting today in Canberra, that is the Ngunnawal people. And I’d like to pay my respects to their elders past and present. And I extend that respect to Aboriginal and Torres Strait Islander peoples here today.

So, as I mentioned, we have three items today. So, an update on the Sandpit and some of the feedback we’ve had, where we’re up to. Some information about Consultation Paper 3 to give a bit more of the background and the focus areas. And then, time at the end for questions and answers, which, as Rachel mentioned, will be through our Slido tool. So, please, feel free to put those in as we progress. And now I’d like to hand over to Gary, please.

Gary Pascoe

Thanks, Michelle. Hi, everybody. So, those of you who don't know me, I'm Gary Pascoe. I'm the product owner for the UDI database and have been asked to talk a little bit about where we’re at with Sandpit. Hopefully, everybody’s familiar and has used Sandpit. So, I’ll just give you a little bit of an update on Sandpit, as well as some of the other actions we’ve taken over the last couple of weeks since the last webinar.

So, as you can see in front of you, there, we have 325 registrations; organisations, people, sponsors, manufacturers registered their interest in the Sandpit. So, it’s been a high usage and a high number of people registered. We’re in the process of finalising those, in terms of the access, but as you can see, the bulk of the people, so 316 of those, have been granted access and now using the database.

We probably have a percentage of most of those who have access representing manufacturers and sponsor, so about 75% of the access is coming from manufacturers and sponsors. The other 25% then, really, is a grouping between general public, those who are, probably, representing a manufacturer and sponsor. But also, want to have a look at that and see what’s happening from a general public perspective, as well as some TGA staff and other interested stakeholders from within the healthcare sector.

So, we’ve had really good take-up over the last couple of months. The numbers are slowing down, so if you are interested in using Sandpit, and you haven't had access yet, please, get in touch with us through one of the links that's in the webinar. Or if you haven't seen, it’s on the UDI Hub within the TGA website.

We have a number of records, so different users are testing the Sandpit. And really looking at it from the perspective of ensuring that the validations, the interpretation of the rules within the UDI domain are consistent with their understanding of UDI. But also, just getting a general feel of the process and how the application generally works. So, we’ve had some fantastic feedback coming back to date.

As we’ve mentioned there, there's been 190 calls that we’ve received. We’ve also made a number of calls out, and surveys, with the support team who have been spending a lot of time talking to various users around making sure they get access and online. And then we’ve had about 307 emails. So, we’ve had really active and interesting feedback, so that's fantastic.

Over the last couple of months, we’re actually rolling out, probably, every two to three weeks, updates to the Sandpit version. Those who are using it, we do make those public and announce those at a high level on the banner page. But really, we’ve made four major updates to fix and make some enhancements over the last couple of months.

Largely, they (enhancements) have been around making some useability and refinement. So, there's a couple of small number of errors that have come up, and we’ve made some fixes to those. But largely, it’s around improving the user support for sign up and the account creation. As well as, then, usability of the application.

I know a number of you have had questions about when we first started the run, getting you signed, getting your accounts created, being able to ensure that you had access that you required. So, we did make a few new changes to make that simpler and a bit more intuitive. So, thank you for your feedback in relation to that.

And then that's now flowed through making a number of visibility enhancements around the validation rules for how the application validates between fields. But also, then, ensuring that it’s clearer, in terms of the messaging that's received. So that's been really helpful, and hopefully, people will see some of the refinements and some usability improvements coming through.

We’ve also made a number of changes and refinements to some of the backend activities. So, we’ll talk a little bit more about the connection with the National Product Catalogue (NPC). So, ensuring that we, as part of our testing through that, we can put some validations in place to allow the connection with the National Product Catalogue. And that that flows smoothly for manufacturers and sponsors who use the NPC as a method to have access.

So, there's been a number of things. We will continue to see changes coming through, and I’ll talk a little bit about that in the next moment. So, Michelle, happy to just move on to the next slide.

So, what we have been doing... And I’ll cover a little bit about the update. So, we do have machine-to-machine functions now up and running. The machine-to-machine access is using a developer portal, which we presented to a number of different stakeholders who are interested in the machine-to-machine and using it as part of the technical working group that was covered last Thursday.

And so, we have had a small number of transactions come through via the machine-to-machine interface. So, if you are interested in testing and trialling the machine-to-machine, please let us know.

Probably, the greater interest to date, and largely, that's because of the process that we have in place with GS1 Australia, is the use of the National Product Catalogue to have data flow through from the National Product Catalogue into the Australian UDI database.

We have implemented or have been working with GS1 Australia to test and put in place a process for providing data through the National Product Catalogue into the UDI database. We’ve had a number of testing cycles with GS1 Australia to have that tested and confirmed. We did make a number of minor changes to make sure data mapping, and everything was occurring. And we’re in the process of actually working with a small set of manufacturers and sponsors, now, to test that through end-to-end.

As we’re talking, we’ve made the machine-to-machine changes. We’re in the process of finalising. We’re starting some work with a number of suppliers with the National Product Catalogue to test manufacturer and sponsor data running through end-to-end from their source system into the National Product Catalogue. And then into the UDI database.

We’ve decided to take a small set of manufacturers and sponsors to test that in the first instance, to make sure that we can validate it end-to-end, and it works within both their business and technical perspective. As well as, obviously, with the TGA’s implementation of UDI. And that's commencing, and we’ve had a good session to kick that off with those manufacturers and sponsors.

In the coming weeks, I know we’ve had a number of organisations also express an interest in using their NPC as the means for exchanging data into the UDI database.

So, we are working very closely with GS1 Australia, and we are coordinating that in the first instance with GS1 Australia to ensure that they're in a place to be able to help that flow through. But it’s looking very positive, and we’ve had really good, interesting outcomes. It will likely cater for a large number of volumes of data coming through, which is pleasing.

The final thing is that we’re looking at the area which we’ve probably had the most feedback, really around the Excel bulk file upload and the functionality that we have implemented in the Sandpit. And we’ve had extensive feedback, both in terms of saying what’s working well, as well as areas that you would like improved.

We’ve taken a lot of that feedback, and those of you who attended the technical working group session last week, we’ve presented some ideas and concepts to how we would like to implement that. Moving to a more streamlined process that would better suit what feedback we received from the manufacturers and sponsors. And particularly, looking at having bulk files or multiple records in a single file, rather than the current approach, which is requesting multiple files for each UDI record.

So that's what we’re working through and we’re looking to, in the coming weeks, make updates. We’ll be sharing those updates with the Sandpit users, as well as then seeking your feedback on that and looking to refine it over the coming weeks.

So, just in final, we are looking to, also, use that information through to the early adopter work. So, those that are sending us data and have agreed to publish it, or looking to publish, then that device information is starting to be considered and looked at by healthcare institutions, organisations, hospitals, registries, etc. To be able to then use that and see how that would then flow through and the implications of UDI from there downstream into the UDI and their systems.

We certainly would like to encourage everybody to keep giving us feedback. We have received a lot to date. However, it is something that Sandpit will be continuing to run right up until the voluntary compliance. So, we are looking to use it as a means to ensure that we get your feedback, which is a nice segue, then, into one of the mechanisms we are using to establish the feedback into our technical working groups.

Those who have participated in webinars before or been involved with the project from a UDI and the TGA’s perspective, for the first half of the year and before Sandpit went live, we had a number of technical working groups that we ran. To elicit and solicit feedback from you around the usability of the application, the end-to-end implementation, and any technical issues that you may have in relation to use of the UDI database.

We have really reinstated those working groups, and the first meeting, or kick-off meeting, was held last Thursday on 15th September, and we’ll be moving into a fortnightly cycle, starting 4th October.

So, there's been a slight variation to the technical working groups. So, rather than meeting weekly, we’ll now work on a fortnightly cycle, which as part of the feedback from the stakeholders was that they would like to have a bit of a longer period of time to consult with various stakeholders within their organisations to give us feedback. So, we’ve moved to a fortnightly cycle, as well as extending the timeframe slightly so that the group can have more time to work through and talk through the specific issues.

So, if you haven't received an invite to those technical working groups and you’d like to participate, the UDI mailbox email address is UDI@health.gov.au. Please feel free to send your name, role, and organisation to us, and we’ll make sure that we include you in the invitation list. Anybody who has participated in the technical working groups to date, you should be receiving an invite already. So, if you haven't received that please, also, send an email to UDI@health.gov.au.

So that's, pretty well, my updates. I assume we can take some questions, if you do have any that we can take, at the end of the session as part of the questions and answers session. And I’ll hand over to Michelle to continue with the agenda.

Michelle van Wijk

Thank you so much, Gary. We’re up to now an area that we’re going to talk through, in terms of the Consultation Paper. So, really, in early February 2021, we made the changes to the Therapeutic Goods Act part that were passed by parliament. They are now enforced.

And what that means is that we have approval for the TGA to collect the data and establish the database. And so, what we need to do now is to operationalise all of the requirements in the medical devices’ regulations. So that's the process we’re going through now.

The Australian government will decide on the regulatory changes and make the regulations, so it’s not something the TGA does. But what we do is we’ll seek detailed feedback to inform the government’s decision, and that's the purpose of this third paper. So, we’ve tried to put a proposed regulatory framework in the paper with some questions on particular focus areas. And obviously, it’s open to other responses and feedback, which we’d really appreciate.

So, we’re seeking input across a broad range of stakeholders. So, obviously, manufacturers and sponsors from a perspective of data suppliers and labelling of the devices and supply of the devices into Australia.

But also, then, from the users of the data. So, hospitals, healthcare professionals, clinical quality registries, and so on. Because we want to make sure, as much as we can that the data is usable and that we’ve taken the use of the data into consideration as much as the provision of it. Including the labelling and so on.

So, in parallel, we’re doing our consultation with the Sandpit. So, the ability to give us feedback on the technical aspects and the earlier adopter work, to try and get some early feedback on its use or potential use in hospitals and other systems.

So, really, Consultation Paper 3 follows on from our first two consultations, and the information that we’ve obtained through working groups and other feedback and forums to look at the detailed considerations now for the framework. And that includes feedback on the impact of accepting both European and USA compliant labels.

So, Australia is a small percentage of the market, and we would anticipate that a lot of the devices here are also supplied into Europe and the USA, who have UDI requirements already in place. So, how can we minimise the burden and take those European and USA labels, and what does that mean for users of the labels and the data, as well.

On the second consultation paper, we got feedback around trying to accelerate the full benefits through UDI in Australia, so we’re looking at what that looks like. What does the implementation plan look like, and how do we phase that in line with what other regulators have done?

We’re looking at the scope and exemptions in applying the UDI, so under what circumstances is a UDI mandatory, when is it voluntary, and when are devices exempt, for example.

Providing and maintaining data over the full life of the device. So, we’ve heard how that data might change over the life of the device. There might be a requirement for a new device identifier, as part of a trigger, so if there's a merger or acquisition, for example, and how do we manage that in our database? And then how do users use that data?

What might fees and charges look like for UDI, going forward? Because this is new to the TGA, from 1st July, it will need to be incorporated in our fees and charges. So, what might that look like and what might need to be taken into consideration? And then, challenges around labelling and supporting documentation, so what should we have in place around those?

We’re interested in feedback on potential regulatory burden, which we are really attempting to minimise as much as we can but appreciate feedback in that area. And then some feedback on adoption and use in the broader healthcare setting.

And what we’ve tried to do in the paper is write the intent. So, plain English, purpose, what are we trying to achieve? And then, we haven't put proposed text for future regulations because the regulations will be determined by the government, and we don't yet have those.

I just wanted to come back to this point. So, we’ve really put some underpinning principles together to show the key considerations in Australia. And the first one is patient safety first. So, the purpose of being able to track and trace who has a medical device implanted, where there might be issues with that device, going forward, including in 10- or 20-years’ time.

But the other five underpinning principles are alignment with the International Medical Device Regulators Forum (MDRF), who’s published two papers, the UDI guidance, and an application guide. So, at a high-level in-principle alignment with all of those.

We need to consider the users. So, I mentioned that before. So, how do we accelerate adoption and use in clinical and hospital settings and make it easy for those organisations to use the UDI in their systems.

We’ll make core UDI data accessible to the public, and that will be free of charge. And so that will be available to anybody, and they won't have to log in specifically to access that data or to download it.

We want to minimise the burden on manufacturers wherever feasible. So, we know that many manufacturers are having to comply with UDI regulations across many countries. And in some cases, those are different, or the underpinning regulatory framework might be different, as well.

The UDI data held by the regulator should be current, correct, easy to access and maintain, and that talks about data validation. Maximised usage and value without having to reword the data. And things like agreed drop-down lists and minimising free text fields.

In terms of international alignment, this has been a focus all the way through, in terms of where Australia needs to align. And so, as I mentioned earlier, we’ll align with the IMDRF framework. And we’re proposing that we accept UDI labelling that complies with either USA or the EU requirements.

And we understand from conversations and feedback that a number of manufacturers are already working towards a universal device label for this purpose, to aid in multiple markets. And we know some of them are also creating a core set of UDI data, and then augmenting that with country-specific requirements to assist in management and providing UDI data to multiple countries.

So, we’re seeing feedback on how that proposal works for data provided and users. And also, with the data elements, should the TGA accept and store USA- and EU-compliant data, in addition to the labels. And that would lend itself to, potentially, different date formats or different metrics. And so, there's some areas around there we need to explore further, and we would really invite feedback on.

It’s worth noting that in Australia we already have a UDI regulatory system, and we need to align with our existing framework. There's no proposal to change how our existing framework works. We’ll need to feed UDI into it.

And so, what we’re proposing, obviously, subject to government decisions, is to amend the medical device regulations to establish the database, require the inclusion of UDIs and related information in the database. And we’re proposing that that's likely to be as part of the Essential Principles. And include related requirements in their Essential Principles, including labelling, for example.

In Australia, the sponsor is principally responsible for ensuring the regulatory requirements are met for devices in Australia. And we know this adds complexity when a labeller might undertake some activities on a sponsor’s behalf, such as attaching a label to a device.

So, we’ve heard that in most cases, the labeller will be the sponsor or the manufacturer. But in some instances, it may be a specialist third party acting on behalf of the sponsor or the manufacturer.

We need to define what the proposed scope of devices is. And so, what we’re proposing in the paper and requesting feedback on is proposing that most kinds of medical devices would be required to comply with the UDI requirements. Unless we identify the Essential Principles for those kinds of devices for which a UDI is not a requirement.

So, we have some Australian areas we are proposing to be in scope, for example, medical devices in the Australian emergency stockpile. Medical devices exempt from inclusion in the ARTG, but that are regulated. And replacement parts where the original part was in scope. Class 1 devices, we know is a challenge more broadly than just Australia. And so, we’d really appreciate some feedback in this area.

Generally, the Class 1 devices are low risk, high volume. And so, there's an administrative overhead in providing the data, for example, for contact lenses, or glass frames, etc. And some of those, we regulate in the same way as other countries and others, we don't. But globally, it’s been recognised there are specific challenges in requiring UDIs for Class 1 devices, which are, generally, those lower risk devices.

We know that the US, for example, has recently released guidance relating to Class 1 devices that in the US are defined as non-life-supporting or non-life-sustaining. They've made some changes to compliance dates and requirements, particularly those consumer health products, which are more of those that are home use and supplied over the counter.

Other considerations for Class 1 devices might be around confusion for consumers if some devices are in the Australian UDI database and others are not. Some Class 1 devices are both consumer health products and used in hospitals, such as specimen containers. And what might the impact be on hospitals if there are some devices that have UDIs and others that don't, in terms of inventory management, auto scanning? Will that be an additional burden on those hospitals?

And then the other consideration is should the TGA consider some kind of grouping mechanism to reduce the number of UDI records that might be required. And that's from the perspective of an administrative overhead, rather than a technical capacity perspective.

In the paper, we’re seeking feedback on some proposed exemptions, and we have a list of those. So, including Class 1, general laboratory, medical devices such as pipets. Medical devices that are surgical loan kits, and that's at the kit level, rather than the individual device level.

Medical devices and IVD medical devices imported into and supplied in Australia under specific schemes, such as the Special Access Scheme, or the Authorised Prescribers Scheme, or any of the other exemption pathways.

Exporter-only medical devices and IVDs because they will be exported to a country that may have different UDI requirements from Australia. Individual single-use disposable devices contained within a system or procedure pack, which are not intended for individual use outside the context of that system or procedure pack.

Devices that are exempted from bearing a UDI carrier, so the UDI information on the relevant level of packaging when included within a system or procedure pack. Custom-made medical devices. And in-house IVDs.

We are proposing a phased implementation, so we’re seeking feedback on the timing for this implementation. And some of the considerations include the US finalising its implementation, but also, the EU dates, in terms of EUDAMED, particularly, and the database being ready for the provision of data.

So, even though some of the EU data compliance dates are in-force around assigning and applying a UDI, and labelling, the provision of data of EUDAMED is not yet in-force because the database isn't publicly available for use for compliance yet.

So, we’ve taken the same approach that other countries have, in terms of a phased implementation, really focusing on high-risk devices first, and then moving through the device categories in a staged way. So, in this case, we’ve looked at two-year periods around the stages. And similarly, for IVD. And we understand that there are direct marking processes needing to be put in place for direct marking of devices that may not have required that before.

So, some of those dates are also a little bit later for mandatory compliance around direct marking to really acknowledge the amount of effort that might have to go into put those UDIs directly on those devices themselves.

So, we’d really appreciate feedback on the compliance dates we’re proposing here and the phasing, whether we can, potentially, go faster, again, to accelerate the full patient safety benefits. But obviously, we need to balance that against the additional requirements, now, and the additional work that manufacturers and sponsors will need to do to be compliant.

The consultation is open on the TGA Consultation Hub, you’ll be able to search and find the UDI consultation paper there. I've shown the screen so if you haven't used it before you just need to search for UDI in there.

We would like feedback through the online survey, if possible, because that makes the consolidation easier. But if that's not possible or feasible, it’s possible to download copies of the paper and provide feedback separately to what’s in the hub.

The consultation was published on 31st August and will be open until 11th October. So, we still have a number of weeks left to provide data. And if you need any assistance, please, let us know through our UDI@health.gov.au email.

And just a final note that the survey is an online survey, so you can use that to then type in answers to questions. And the last question, really, is providing any other feedback. So, if there's anything that we haven't asked, or you think, perhaps, we haven't considered, and should, there is, actually, a general response question at the end that you can provide that feedback to.

So, here you can see we have attached the consultation paper. Previous consultation papers, and a cover sheet, and information around using the hub. So, hopefully, that's covered everything there, but if there's additional questions, please, don't hesitate to let us know.

And just a reminder, the government will decide on the regulatory changes and make the decisions, and the regulations. And so, the feedback is really to inform the government’s decision.

The regulations will need to be in place before voluntary compliance. So, in order to have voluntary compliance, we need the regulations in place, and then the final version of an Australian UDI database, which is now in the Sandpit. So that’s why we’re seeking feedback in parallel.

I’ll take a breath there. So, hopefully, that’s given everyone a background on to the paper, and if you haven't already, then you can go ahead and do the survey and download the paper. So, we’ll stop briefly for the poll questions.

I’ll hand it over to Rachel. And then we will come back in a few minutes, and we’ve got, probably, a good 20 minutes now for questions and answers. So, please, put those in Slido, and we’ll read them from there, and then answer the ones that we can. If there's any we hav to take on notice, then we’ll do that, as well, and make sure we provide an answer at the next webinar.

I'm seeing quite a lot of questions come through, some relating to the consultation, and some relating to the technical side. Some of them are being voted up, so what I might do is start with some of the technical questions, Gary, I’ll hand those to you. And then I’ll answer some of the consultation questions.

So, first question, Gary, if you are okay with that, is, any updates on the machine-to-machine method?

Gary Pascoe

Michelle, so, we have demonstrated the connection to the machine-to-machine. So, anybody who would look to access it via machine-to-machine, we have developed a developer gateway, and developer portal for those, which would provide secret keys, tokens, etc., for anybody looking to access the machine-to-machine updates.

So, if you haven't received any of that, please, let us know. We have demonstrated that with the technical working group last week, and, actually, recorded that session. So, for those who are interested in accessing the developer portal, we’re in the process of just finalising the video from that so that we can get that out to the group. And if anybody’s interested, we’ll just use that to run through the video.

So, there's not any major changes or updates, but it is something that we have had a few people ask us how to access the developer portal. So, we recently recorded that as part of the technical working group, so we’ll get that out to those who have registered for TWGs, as well as those signed up to webinars.

Michelle van Wijk

Great. Thank you. And the next question, also, a technical one to you, Gary, is when will the new Excel template for bulk upload be available for testing?

Gary Pascoe

It’s a very good question. So, we’re actually working through that at the moment. We are looking to have a version of that out to groups, just to have a look at from the Excel spreadsheet perspective. So, we’ve made a number of usability improvements, as changing the paradigm, or changing the approach in how the spreadsheet works.

So, our aim is within the next couple of weeks to have that out. If it doesn't happen within that period of time, we will be pretty disappointed. So, we’re just making sure and testing that, and making sure it’s right, we want to get it as close to a good state as possible in the next couple of weeks, and then we’ll issue that out through the Sandpit version.

Once we’ve done that, then we’ll seek feedback and any comments and make ongoing refinements.

Michelle van Wijk

Fantastic, thank you. And another technical one for you. Has the TGA developed a list of country-specific attribute fields for Australia, i.e., regional-specific dataset not captured by the EU or US?

Gary Pascoe

That's a good question. It’s probably technical, as well as regulatory. So, we have, identified what the Australian-specific data elements are. We are looking to, have received feedback through the consultation paper, in terms of other elements.

We’ll refine that list once that's happened, and obviously, with the recommendations from government. Michelle talked a bit about this, we don't have anything that publishes where the differences are within the Australian context.

But it is, certainly, something that we’re looking to have a revision to the data dictionary to reflect that. So, our current data dictionary does highlight those fields, but it is something that needs ongoing development until after the regulations are finalised.

Michelle van Wijk

Thanks, Gary. And I think that's good feedback to know. One of the things we’re looking at doing is developing all of the supporting documentation. So, we understand some of the regulators have done this particularly well, so we’re looking at what we need to publish. Perhaps that's something we can consider when we put information together, a specific Australian list, in addition to the data dictionary that you mentioned.

I might take some of the regulatory questions now. We’ve had a couple relating to the timeframe, what is the timeframe in Australia? and when will the government decision be made?

So, really, we are working towards a voluntary compliance date of 1st January 2023. And our first mandatory compliance date on 1st July 2021. And so, the government regulations will need to be in place for the voluntary compliance. So that's the date we’re working towards, both from a regulatory perspective and then, from a technical perspective.

And we understand there's time, once those regulations are finalised, for, particularly manufacturers and sponsors, to prepare for the new regulations. And that's why the first mandatory compliance date is 1st July 2024, to give sufficient time to prepare.

So that's in 18 months from the regs to 1st July. And obviously, there might be some manufacturers or sponsors who might be already ahead of that because they’re already supplying into the EU, or the US, or both. And therefore, it’s not a significant impact, in terms of the work they need to undertake. And so that's why we’ve got this early voluntary compliance. Again, to try and accelerate the patient safety benefit, the full benefits.

I've got a question on the software, which has got the most votes. So, regarding the proposed software UDI requirement, that the UDI would be searchable on the manufacturer’s website. Just trying to understand the purpose of this. So, what’s the intent behind the requirement?

We’ll take that one on notice, to provide the detail behind it. But the intent around the software that is proposed in the paper is really to align with what the US already has in place. And so, if we need to then decompress that and look at individual areas in that, please provide that feedback back in the paper. But really, we are proposing that we are aligned more closely with the US on that.

I think when the IMDRF did some of the work, that a lot of these areas were emerging. And so, therefore, they might not be covered at the same level of detail by the IMDRF. But as the US has been running for a number of years, that's why we’ve proposed, in this case, that it might be appropriate to align with the US.

I have another question with seven votes. Can you kindly elaborate further on the first question in the consultation. We do not understand what TGA means by saying should we accept both US- and EU-compliant labels? Are you referring specifically to units of measure, etc.?

So, yes, what we’re proposing there, US- and EU-compliant labels with the UDI data. So, if there are differences between the US and the EU, in terms of the UDI requirements, in terms of the labelling. So, there might be some differences where a whole UDI doesn't fit on a particular label, for example, around which part, whether it’s the human readable part or the machine readable, the scannable, part that needs to be on there.

So, what we’re saying is those are different across the US and the EU, we are proposing that we accept both of those. And the issue there, or the challenge there, and the reason we’re seeking feedback on that is because we want to understand if that has an impact on the users.

So, we’re proposing it because we think it will be easier on manufacturers and sponsors and reduce the burden. But we want to hear, particularly, from the users and anyone who actually needs to look at those labels and the UDI component of those labels, to really see whether it’s going to make it more difficult for them. Or where there might be some things we need to consider as part of that work.

So, hopefully, I've answered that question. We’ve got one, which is how comparable are the Australian UDI requirements to EUDAMED, the EU IVDR for alignment and adoption?

So, right now, we don't have a document that defines the differences and the similarities across Australia and the EU. We know that we already have some regulatory differences for IVDs in Australia, and so we’re not proposing we move away from our existing regulatory framework. So, the UDI will be in addition to our regulatory framework, which is already in place.

Can the recording for this webinar be released to the public earlier? We’d like to share the advice with overseas manufacturers prior to the consultation closing. So, we will do our absolute best to have this webinar up and quickly available to enable that to occur. So, the answer is we’ll do our best and, hopefully, we’ll be able to do that.

I've got a question around procedure packs, which contain a medicine and a device. So, those combinations where the primary mode of action is the medicine. And the question is, will this be exempt from UDI requirements as is in the case in the US and the EU?

In these market, co-packaged drug and device combination product packaging does not need to contain UDI information. So, I'm not sure we’ve covered that exact example in the proposal, but the proposal would be yes, they would be excluded because they are then regulated as a medicine, not as a device. But we will have a look at that and see if we need to provide some more clarity or any further questions around that one. So, we’ll add that to our list of things to cover.

Is there a character limit on the UDI response portal for each question? That is a really good question. And the answer is, there is a total maximum limit. I'm actually not quite sure what that is, so apologies. But I think it’s around 500 characters.

And so, if you see some of the responses have a single line, where we’ve thought they're likely to be shorter. Some have multiple lines and larger space. Effectively, they are the same. You can have the same maximum characters.

But if you're finding that is too difficult in your response, can you, please, let us know. Because we can make some adjustments in the consultation portal to accommodate that if particular answers, for example, are proving to be a little bit difficult for one line because then you have to keep scrolling through the line. So, thank you for that question on the paper.

Another one that we’ve received, can you explain further on question one of the paper? So, if the ARTG has approved the labels, should the database accept them? So, I'm not quite sure what that means. But really, the ARTG is our Australian Register of Therapeutic Goods, which has a listing of all approved or authorised devices that can be supplied to the Australian market.

And so, what we are doing is, mandatory compliance, when it comes into effect, will mean that every model of device on the ARTG will be required to have a mandatory UDI label and meet the mandatory requirements. Unless it’s one of the devices, which are exempt from the UDI requirements. So, hopefully, I understood that question correctly. If not, please, write in again.

I might take some technical questions now, Gary, and I will hand those over to you, they're now being voted to the top of the list. What level of data transfer is being tested from the National Product Catalogue database? So, if you're overseas, the Australian National Product Catalogue is the equivalent of the Global Data Synchronization Network and other data pools. But it’s a very Australian-specific one.

So, the question is what level of data transfer is being tested from the NPC, all the fields, or only mandatory fields? That is, how will the ARTG be linked if we opt for the NPC data upload? So, Gary, that one’s over to you.

Gary Pascoe

Sure, Michelle. So, two parts. The first part of the question was what level of data transfer is being tested. So, we are testing all fields. Obviously, the NPC will have a range of other data attributes and data elements that aren't relevant to UDI. We don't transfer those over, but anything that's coming from the NPC that relates to the Australian UDI record, both mandatory and optional, we are testing, and have tested, and mapped all those into the UDI database.

There will be different levels of validation. So, if you don't send us a mandatory field, we’ll, send back a message saying we can't process the record because mandatory fields are missing. So, there's elements of different levels of validation, with mandatory and optional fields. And so, hopefully, that answers the question.

Including in one of those data elements, the NPC does cater for the provision of the ARTG ID as part of that data transfer. And so, those of you, or those organisations that do use the NPC, that does have the ARTG ID associated with the UDI record coming from the NPC, then we will load that into the UDI record and associate that with the ARTG entry. Essentially, that will happen as it’s still a part of the process.

Those organisations, or those sponsors and manufacturers who don’t have their ARTG ID, we’re still working through, in terms of what that process would be and how that could be.

We have a range of options from using the online portal, as well as having a bulk spreadsheet that you can provide that linkage yourself and upload if you have a large number of records. And online record-by-record entry is just too difficult. So, we’re working through that, but certainly, the NPC data transfer allows for ARTG to come through. Hopefully, that's covered everything.

Michelle van Wijk

Thanks, Gary. Another technical question for you. Will there be an export function in the final AusUDID?

Gary Pascoe

Yes, so we have an export functioning in the Sandpit now. So, it’ll export into a JSON or a machine-readable file. We’re, effectively, mirroring standard practice within the medical device industry and in line with other regulators. So, you can export a full download of the database. You can search certain record, and filter out, and export those record.

Alternatively, we have, also, a daily, monthly, weekly update, so any records that were changed in the last week, we’ll be able to have that capability to download those, as well. At the moment in Sandpit, we just have full download, and we’re in the process of just finalising the weekly, monthly, daily process. But that will definitely happen once voluntary compliance goes live.

Michelle van Wijk

Thank you so much, Gary. We’ve got some more technical questions. What I might do is hold some of those on notice. So, we’ve got one, which is why do Class 2A and 2B devices have a combined implementation date when the profile is very different? So, appreciate any feedback you have in the paper around that, noting that risk profile is important.

We’ve also had one, which I will read out, and then we might take on notice. So, for reclassification products, where they won't be up classified, and the manufacturer will stop production by 2024, November, will these also need to comply with UDI implementation by July 2024?

So that will, essentially, mean devices that enter Australia between July and November 2024. So, it will be a requirement if they meet the first mandatory compliance date. But we’ll look into that further, as well, because that's one of the complexities between the other work that's going on around reclassification of devices and EU alignment, and the UDI work. So, we’ll take that one on notice and have a look at that, as well.

We have a question on how is TGA managing to align the local IVD GMDN collective terms with the Global IVD GMDN codes? So, it’s a good question, and it’s something we will seek feedback on in the consultation.

So, we’re proposing some more changes around how we use the Global Medical Device nomenclature, going forward, in relation to UDI because it will be at the model of device level and, also, model of device level for IVDs. And so, we’re looking at some changes around that, in terms of how we align those in both keeping the code current, potentially. And also, how we have IVDs, and how they use the collective terms. So, appreciate your feedback on those as part of the consultation.

We just have a few minutes left, so for anyone, if you haven't already asked a question or we haven't answered anything, we will take the rest of these on notice. So, I will answer one more, which we can do in the timeframe and then we’ll make a note of the rest. But if you've got others that we haven't answered or that occur to you after the webinar, please, feel free to send them through to us at UDI@health.gov.au.

So, two, I think, quick ones that we can answer. Will implementation dates shift if EUDAMED dates shift? And so that's a really, really good question, and appreciate your feedback in the consultation as to whether they should. So, if the EU dates move, should the TGA move its proposed dates or its actual dates, depending on the timeframe to align with the EU dates. So, appreciate feedback on that.

The other one we’ve got, which there's a bit of a question around is, can the EU UDI database be used in mass upload to the AusUDI database. And that's something we can look at. Obviously, then we’ll be highly dependent on the EU dates around the provision of data if we use that as a source.

But definitely, if there are things that we could consider around either the US GUDID or the EU system, in terms of loading data that is, somehow, then approved or modified as needed. Appreciate that feedback as part of the consultation. Or as part of the technical working group if there's some technical considerations there.

So, I see we’re right on time. I’d really like to thank everyone. They're really great questions, we’ll look through the rest of them. And reach out to us, please, if you need anything else between now and the October close date for the consultation paper.

I think, before I wrap up, we really want to thank everyone for the tremendous input, support, feedback and for everyone who’s logged into the Sandpit. For everyone who’s joined one of our groups or provided feedback through other forums. It’s really important that we get this feedback, and we really appreciate the openness and your ability to share that with us. It helps inform the government decisions and our design of the technical database, as well.

So, I just wanted to say thank you, particularly because for some of us in Australia, that's really easy to manage, but I know a number are dialling in from overseas at crazy hours, or in scrubs from hospitals. We do really appreciate the support and the input.

So, thanks, everyone, for joining. We’ll get this up on the website as quickly as we possibly can. Noting the close date and the ability to share it. We’ll try and provide some other answers, as well. So, thank you so much. We’ll see you third Tuesday in October. Thank you.