UDI consultation paper 3: Detailed considerations for implementing the proposed Australian medical device UDI Regulatory Framework

DTA import from all international regions for distribution into Australia, as well as source locally from local Australian Sponsors and Manufacturers.

As DTA imports devices from both US and EU markets, accepting labels and data from both US and EU will be of great benefit to us and our overseas manufacturers from both a labelling and inventory management perspective becaise it will allow streamlining of processes and data sets without unique Australian processes and support. This would result in faster provision of data and product supply. As the EU and US account for a large amount of the global market it is important to ensure alignment with these regions. If specific AU labelling or data is required that is different to the EU/US this will be additional burden (in terms of costs and processes requiring to be established and maintained to accommodate the additional specific requirements) which is likely to impact product supply to our customers. Too much complexity due to these differences could potentially deter overseas manufacturers from supplying products in the Australian market.

As for Q 1.2 and in addition, accepting US and EU labelling and data allows for common inventory holding and a faster more efficient supply chain without the need for unique labelling to be applied (which would delay provision of product and data to Australian users). Use of the same data set will minimise error and allow faster comparison and identification of the same products

Using the same labels and data sets allows healthcare users to more readily access the same products as the EU and US markets, permitting ease of comparisons and faster identification of products and concerns. Australia is a very small percentage of the international medical device market. Accepting EU and US labels and data enables access and avoids additional burden.

1. The TGA could consider the possibility of connecting/transferring of data by manufacutrers from EUDAMED and GUDID. 2. Less fields being mandatory will also make it easier for manufacturers/sponsors to obtain, input and maintain the data. 3. An ability to 'copy/clone' existing entries and edit the relevant fields for the new entry before publishing rather than entering it all new each time. 4. Ease of visibility and access by manufacturers and sponsors for their own data in the database. 5. Overall creating a flexible, easy to use system will allow for faster implementation and maintenance by sponsors and manufacturers.

For multiple UDIs under same ARTG, the ability to 'copy/clone' existing entries and edit the relevant fields for the new entry before publishing rather than entering it all from scratch. For updates when the ARTG changes, it would affect multiple UDIs and a bulk change would be essential to facilitate this. The GMDN code should also automatically update to match what is on the ARTG. The GMDN Code should not have to be entered independently - it should populate based on the ARTG selected.

We anticipate that supply will be interruped and/or cease for products not able to comply with the Australian UDI requirements. Not all manufacturers are already using UDI and will need to do this specifically to meet the new Australian requirements. In other cases, supply will be delayed if the process requires the UDI to be in the database prior to import/supply. There should be a grace period where products can be supplied in advance of the UDI being entered onto the database. Implementation of UDI onto labels will be an additional step the manufacturers have to implement before shipping the device to Australia which will potentially cause delays - alternative non-UDI labelled stocks will not be able to be substituted if supply issues are experienced (e.g. due to external factors, covid, weather events, transport damages).

There is a large amount of Australian medical device regulatory transitions and reforms (reclassifications, software as a medical device, custom made devices, surgical loan kits, etc.) taking place between 2022 - 2024. This will impact both the Sponsor/Manufacturer and the TGA resources available to implement these alongside the proposed UDI requirements. Devices not meeting up-classification or other new regulatory requirements will be discontinued prior to 1 Nov 2024, so if AusUDID becomes mandatory prior to that date, this will create a lot of work to enter into the AusUDID and then discontinued, with little benefit.

Overseas regulatory changes such as the transition from EU MDD to EU MDR is also taking place throughout 2022-2024, and will impact the availability of manufacturer and sponsor resources as well as reduce the product ranges available. Local updates are required to the ARTG for entries currently supported by expiring MDD Certification. The implementation dates if EUDAMED for UDI will also impact the ability of manufacturers to support an Australian UDI implementation. The Australian UDI implementation should occur after teh EUDAMED -UDI implementation to avoid errors, re-work and unessesary burden on sponsors and manufacturers.

Having participated in the ongoing sandpit project and working groups, it is DTA opinion that the software system and infrustructure to support the Australian database needs further development, testing and optimisation to meet the complexities and vast diversity observed with medical devices as well as their manufacture and supply chain. The systems need to be robustly designed to accomodate these complexities to ensure the system is a success and fit for purpose. The proposed implementation timelines are too soon to allow the adjustments and testing required. At least an additional 12 month time period is estimated to be required to allow this to be developed prior to voluntary launch of the AusUDI Database (i.e. voluntary implementation from no earlier than 2024). The regulatory details need to be determined before some aspects of the database can be fully designed. At least 12 months is also required post-confirmation of the regulatory changes to allow Manufacturers and Sponsors time to implement internal IT changes to accomodate the new requirements within their systems for machine to machine or other automated population of data sets. Planning, proposal and allocation of budgets will be required for this development. Adequate time is required for this to take place. Phased implementation based on partial data set publication for UDI database should also be considered (e.g. a smaller subset of data could be implemented first, with the remainder of the data set added at a later implementation date)

The AusUDI database system needs to be designed ensuring it can accomodate the volume of data to be input and maintained including changes and corrections along with daily data uploads of significant size. Current and future volumes need to be estimated to allow planning of this. Currently, and at a single point in time Device Technologies estimates it would be utilising over 5 million data points for its product ranges. This does not account for changes. This would be expected to increase. Implementation dates should only apply to the manufacture date of the device, regardless of the Australian import, supply or transit dates.

Class I medical devices are the lowest risk and therefore should be excluded from the requirement of the UDI. Efforts should be focussed on the high risk devices.

Class I medical devices are the lowest risk and therefore should be excluded from the requirement of the UDI. Efforts should be focussed on the high risk IVDs.

Class I medical devices should be out of scope for Australia

Medical devices supplied under Clinical Trials, Special Access Scheme and Authorised Prescribers Schemes should be exempt from UDI requirements as these are unnapproved goods and not in compliance with the Medical Device Essential Principles. Products supplied in Surgical Loan Kits should also be exempt from UDI requirements due to the complexities in this supply method which are currently being reviewed by the TGA.

No - the same requirements should apply for any free of charge medical devices supplied within Australia.

Yes - there should be provision for special requirements for exemptions

It is anticipated that the UDI database entry is created with an ARTG nominated. If there is a second device within the same ARTG which is not required to comply with UDI, then the UDI database entry for that second device would simply not be created, so no complexity is expected in this case. Education may be required for users as to why one is required to be in the UDI database and the other is not.

At this stage it is difficult to provide a definitive Yes/No response to Q4.1 and 4.2 as this depends on many factors including how the UDI database is implemented and the functionality available. It is noted that this topic continues to be discussed with the TGA TWG and should be further explored before a decision is made. Both scenarios present advantages and disadvantages. In either case flexibility is required to accomodate the variety of manufacturing and sponsor business structures, levels of the supply chain as well as changes to these over time, mergeing and divestment of companies or partial-companies and partnerships. The advantage of having one UDI per Sponsor would be that the Sponsor would have direct responsibility for their UDI entry data, however they may have difficulty obtaining accurate data from the manufacturer, leading to more errors and rework. Transfer of Sponsorship also needs the be considered. UDI entries filled in by different sponsors for the same device should be linked or easily identified for user visibility. Confusion will result if the details are different in the different Sponsor UDI entries (e.g. due to errors).

Manufacturer or their nominated party. However this is complex and it is anticipated the TGA would need to introduce legislative powers over the manufacturer in terms of adding, owning and maintaining the data. Many manufacturers are overseas which makes this difficult. At the same time, the manufacturers should be the party directly responsible for this because they have control and access to the infomation required. Sponsors change over time with transfer and cancellation of ARTG entries, however the Manufacturer remains the same. The first authorised Sponsor may not continue to be a Sponsor for the life of the UDI entry and would therefore not always continue to have a relationship with the manufacturer enabling maintenance and updates of any UDI database changes required. The manufacturer would be better placed to be the single source of this information about their products, if the TGA can enforce their responsibility for the data. The manuacturer would need to be able to nominate another party to fullfill the data upload and this party may also change over time. If the manufacturer uploads and maintains the core UDI data, they could nominate multiple local Sponsors to add the Sponsor and ARTG details. This depends on IT system design and capabilities that need futher exploration and testing

Flexibility is important to allow for all real life scenarios, sizes and capabilities of sponsors, manufacturers and other third party entities who might become involved in this activity

The sponsor, manufacturer or their nominated party should have the capability to add or update data they are responsible for. Flexibility is important to allow for all real life scenarios, sizes and capabilities of sponsors, manufacturers and other third party entities who might become involved in this activity.

The TGA should continue to engage with sponsors and manufacturers to design and test the various approaches to determine which option/s are fit for purpose. It may be a combination of both approaches are possible.

Any sponsor may start or cease supply of products included in their ARTG entry at any time without advising the TGA, therefore this is not monitored by regulatory teams and would increase burden if it were required to be monitored. A device may be supplied initially, then not for a long time, and then again supply may recomence due to many reasons. There is no restriction as long as the ARTG is current. Entering a commercial end date should be optional, as long as the ARTG is current. Once the ARTG is cancelled the commercial end date can match the cancellation date for that Sponsor/ARTG.

Misalignment in triggers with EU or US would impact the ability to implement the UDI in Australia. Referring to Q1, manufacturers and sponsors will have increasing difficulties maintaining labels and data for the Australian market if the triggers are not aligned. This will add resource burden and inventory supply risk.

In the current sandpit and proposed Data Dictionary there is mis-alignment and confusion around the rules being proposed and implemented. For example, in mandatory fields required, especially some of those with Yes/No answers. Further refinement of these to align with the EU and US rules are required. Other examples: 1. DEHP is a required field in Sandpit whereas, it is not a field in GUDID, and the proposed Data Dictionary has 'No' for mandatory. We agree it should not be mandatory. 2. Manufacturer's address is neither mandatory nor a trigger point in Sandpit. It is however mentioned as mandatory in UDI Dictionary. It is also not in alignment with the GUDID database. The manufacturers address should not be mandatory. 3. Prescription Use and OTC do not apply to medical devices. These should be removed from the data elements. 4. Brand name, model or version number should not be mandatory if it is possible to enter 'N/A'. 5. Software information should be optional and not mandatory. 6. The GMDN code should not be mandatory, rather it should populate from the ARTG linked.

Yes. We expect any products which are not able to comply with UDI will need to have their ARTG cancelled prior to the applicable mandatory implementation date

This will depend on the IT systems implemented and any overlapping/duplication in data which is required to be uploaded independently.

The GMDN code should be only in the ARTG. Introducing an 'up to date' different GMDN to what is on the ARTG entry will cause confusion and additional complexity. The Sponsor and Manufacturer will not be able to maintain an 'up to date' GMDN code in addition to the ARTG GMDN code. There is already confusion and different approaches amongst various parties about how the GMDN system is applied in Australia so further complicating this will cause more issue without a measurable benefit. The GMDN associated with the ARTG is able to be used for all parties' post-market monitoring purposes.

Flexibility is required as catalogue and model number is used differently by different manufacturers based on the types of devices. Either model number or catalogue number should be trigger and not both. Only one of them should be mandatory to fill and not both.

This will disincentivise companies to keep the data current. This is likely to impact the variety of new product available in Australia. It is possible in some cases that only older product matching the UDI entry would be imported to keep costs reduced.

This will disincentivise companies to make new products available in Australia. It is possible in some cases that only older product matching exisiting UDI entries would be imported to keep costs reduced.

Alignment with EU and US data sets, as well as no limitations on the number of changes and no fees for updating the records will make it easier for labellers/sponsors/manufacturers to keep data up to date.

There should be no specific fees for companies using machine to machine, NPC or bulk transactions.

Any required fees should be covered under the annual ARTG fee structure.

1. The UDI implementation for devices contained in surgical loan kits is complex and requires further exploration before implementation dates and details are put in place. We agree that the SLK itself should be excluded from the UDI requirements.

Alignment with the EU requirement is necessary to avoid issues in Australia.

This should be voluntary. Sponsors and manufacturers should have flexibility in methods of provision, at the same time simplicity for patients. If link or PDF needs to be changed for PIL in the UDI database, we will need a fast, easy way to do this for a large number of UDI at the same time. URLs and company structures, IT systems or methods of provision of PILs may change and this constantly need updates. The manufacturer/sponsor may choose another more suitable method internationally to provide the PIL which is not related to the AusUDID. Having PILs available on multiple locations and in different versions could be confusing and difficult to maintain.

Ease of PIL access, along with how changes and updates are made, recorded and viewed need to be considered from the Manufacturer, Sponsor and User perspective.

Changes and mapping would mostly be the complexities. There would need to be an ability to have multiple PIL for each ARTG.

A purpose-built repository may be better - as CMI/PI are managed for medicines.

The GMDN should only be sourced from the ARTG entry, there should not be a different GMDN for the AusUDID. Multiple GMDN may apply to the one UDI entry because each ARTG may have a different GMDN code associated with it according to that Sponsor's ARTG application and declaration of conformity.

The GMDN code should be only in the ARTG. Introducing an 'up to date' different GMDN to what is on the ARTG entry will cause confusion and additional complexity. The Sponsor and Manufacturer will not be able to maintain an 'up to date' GMDN code in addition to the ARTG GMDN code. There is already confusion and different approaches amongst various parties about how the GMDN system is applied in Australia so further complicating this will cause more issue without a measurable benefit. The GMDN associated with the ARTG is able to be used for all parties' post-market monitoring purposes. The GMDN is part of the kind of medical device - which may or may not match the current code in the GMDN Agency.

Every manufacturer implements the GMDN into their technical file slightly differently to meet various international requirements. When each country also implements the system differently it adds significant complexity, as well as burden and cost of maintaining these GMDN codes and technical files. One change in one country affects all documentation internationally, and in Australia, the flow on effect already existing is a requirement for a TGA submission to change the GMDN code on teh ARTG entry, or otherwise a new ARTG submission.

In all cases, there will be increased burden for the Australian UDI implementation. In addition to this there are a significant number of local Australian and New Zealand companies manufacturing only for the local Healthcare market. They are not already applying UDI for EU, US, or other regions. Therefore this will require significant additional burden, including costs and resource to implement. Additional activities for all sponsors/manufacturers regardless of regions include: entering data, validating data, creating UDI, labelling physically UDI, monitoring and maintaining changes to physical and electronic UDI records. It is essential this burden is minimised by alignment with overseas requirements as well as only implementing elements of the UDI where there are measured benefits to be gained.

The burden to apply UDI requirements to some products will not be possible for some manufacturers/sponsors. The costs or other resources needed many be prohibitive in many cases, resulting in reduction in partial or whole product ranges made available in Australia.

The TGA should ensure ease of searchability for all fields, with good user interface visibility of results, by users and other stakeholders to reduce confusion and queries to sponsors/manufacturers/TGA, etc. Education and user support will avoid wasted time to answer queries. Data Users should be able to download single UDI data in a single pdf or single clean spreadsheet format. For multiple UDI records, users should be able to download single spreadsheet.

1. Alignment as much as possible with EU and US implementation and timelines is essential to a smooth and least burdensome Australian UDI implementation. Australian specific requirements need to be avoided as this will always add cost and resource required to implement and maintain.

2. Further work is required on the structure of the AusUDID (e.g. single UDI entry or multiple per sponsor) as well as complexities around GMDN coding, SLKs, software, direct marking, implementation staging and dates, mandatory fields, unique trigger requirements, etc. before implementation commences.

3. The transfer of ARTGs between sponsors, merging, divestment, and partnerships between manufacturers, sponsors and other parties in the supply chain such as distributors who are neither need to be accounted for in the AusUDID system.

4. The entities responsible for data need to be determined and tested.

5. The AusUDID is understood to currently be intended to be accessed through the TGA TBS system, which currently mainly Sponsors or Agents access. Security of data needs to be considered, and additional parties will require access depending on the final methods of data provision, maintenance and user access.

6. Significant training, education and support to users and providers in terms of IT systems as well as usability and requirements will be needed.

7. Flexibility is critical in methods used to populate and maintain data in the AusUDID, for example, the ability to upload and edit data using any method, regardless of the original method used, as well as ability to correct errors at any time without penalty.