Personalised Medical Devices Framework

Slide 0

Good morning everyone - welcome to the personalised medical devices webinar. I'd like to start by acknowledging the traditional owners and custodians of the lands on which we're meeting today. For those of us in Canberra that's the Ngunnawal people. I'd like to pay my respects to Elders past, present and emerging. I'd also like to extend that acknowledgment and respect to any Aboriginal and Torres Strait Islander people here today.

Thank you for joining me. My name is Bec Bateson, I am an Assistant Director here at the TGA in the devices emerging technology and diagnostics section. Currently I am the project lead for the introduction of the personalised medical devices framework and today we're going to be providing you with an overview and a bit of a discussion of the framework and the impact of some of the changes.

Slide 3

Today we are predominantly talking about changes to the regulation of custom-made medical devices.

Under the current Regulations, custom-made medical devices are exempt from the requirement to be included in the Australian Register of Therapeutic Goods before they're imported or supplied. Now, I would like to stress that being exempt from inclusion in the Register doesn't mean these devices are exempt from regulation. There are actually a number of existing regulatory requirements for custom-made medical devices that you do need to meet.

Now the main reason these devices were exempt from the requirement to be included in the Register is because in 2002, when the Regulations came into effect, custom-made medical devices were predominantly very low risk. We are talking about products like splints, dentures and aligners, orthotics and prosthetics.

Since 2002 we've seen rapid advances and improvements in technology and the devices that are now being designed and manufactured to suit specific individuals include devices such as orthopaedic implants. That means that if you need a hip replacement we can take a scan of your existing hip and 3D print a patient-matched hip implant in titanium. Under the current regulations, those kinds of devices are exempt from inclusion in the ARTG and can be supplied without an independent oversight.

This is a global issue. Medical device regulators around the world are moving to address the challenge of appropriately regulating these kinds of devices. Here at the TGA is involved with work in the International Medical Devices Regulator's Forum and we've conducted public consultation about this issue over a couple of years. As a result, the Australian Government has agreed to the introduction of a new framework for the regulation of these kinds of medical devices. Collectively those changes are called personalised medical devices framework and it commences on the 25th of February this year.

Slide 4

So this is an overview of the changes with respect to custom-made medical devices. On the left there, you can see the current regulatory situation and the impact of the changes that we're making to custom-made medical devices are on the right. At the bottom you can see adaptable medical devices. The way these devices are regulated is not changing. I will explain a little bit more about those a bit further on and why we've included them.

The primary change is we've taken custom-made medical devices and we've reduced the scope of products that will continue to meet the definition by introducing new concepts, that's patient-matched and medical device using a medical device production system.

Slide 5

Let's start by talking about custom-made medical devices. So, there will still be a definition for custom-made. Devices that meet the definition will continue to be exempt from the requirement to include in the register before they can be imported or supplied. But the devices that meet the new definition of a patient-matched device and devices that meet the definition of an adaptable device, which is a new definition for an existing concept, will no longer be included in the definition of a custom-made medical device.

The impact of this change, as you can see in the graphic at the bottom right there, is that the pool of devices that will continue to meet the definition of custom-made will be dramatically reduced. In practical terms, very few devices are going to meet the new definition of custom-made that has been introduced. For those that do continue to meet the definition, there are new obligations in addition to the existing obligations for those kinds of devices. If you supply a custom-made medical device you will need to supply it with specific information. You will need to keep records about what you supplied and to whom. That's for five years if the device is non-implantable and 15 years if it is implantable.

You will also be required to submit an annual report to the TGA and you will need to allow access to your premises for inspections and review if you are requested.

Slide 6

On this page we have an overview of the time frames for the new requirements. So you have until August this year to register for transition and the 1st of November 2024 to include your device in the Register, if you're supplying a custom-made medical device or a patient-matched device that is transitioning from the 25th of February. Now if you are transitioning, you will need to meet your new regulatory obligations from 25 February. That means you will need to submit an annual report relating to all the devices you manufactured or supplied between 25 February and 30 June this year by the first of October.

Slide 7

Let's talk about where the majority of custom-made medical devices will land under the new framework and that's within the definition of "patient-matched". If you are producing a medical device that is designed and manufactured to fit a specific individual within a design envelope, and you are using production processes that can be validated, verified or reproduced, your device is going to meet the definition of patient-matched. Now those terms I've just used are very familiar to engineers, but I know they're less familiar to some of you. So let me take a moment to explain them in layman's terms.

The specified design envelope is the limits of design that you are confident and can provide objective evidence for, will result in a medical device that is safe and will meet an individual patient's requirements. That will include factors like physical limits, measurements. It will include raw materials that you're using. It will include the processes that you're using for manufacturing the device. In short, if you know that what you're doing will work, it is likely you're working within a design envelope with production processes that can be validated, verified and reproduced. If you've never done it before, and you're unlikely to do it again, then it's likely that it's still custom-made.

If your devices fall within this definition, you need to notify us by the 25th of August this year that you're going to access the transition arrangements and you will need to submit an application for inclusion in the Register by the 1st of November 2024. The impact of including a patient-matched device in the register is that you will have the same regulatory requirements as any other device.

Slide 8

To give you a visual representation of the timeline, from the 25th of February this year, if you supply a new device to the market that you haven't supplied prior to that date, you will need to include it in the ARTG. Existing devices will need to commence transitioning to inclusion in the register. This process will include acquiring appropriate evidence of conformity assessment, including certification, and submitting an application for inclusion before the 1st of November 2024.

Slide 9

Now we get to a really interesting part of the framework, Medical Device Production Systems. This is a brand new concept, we are the first to introduce it. In short, a Medical Device Production System is an end-to-end system for the manufacture of patient-matched medical devices that is supplied to healthcare facilities so they can produce the devices in house.

Slide 10

The first thing I need to say about this is that this facility is coming soon. The definition will commence in the Regs on the 25th of February, we brought that in as part of the framework but you won't be able to include a system in the ARTG until we sign the legislative instrument to declare them to be a medical device. So, there is still work to be done with the International Medical Device Regulator's Forum to determine how we're going to validate and verify these systems to ensure the devices they produce are safe and fit for their intended purpose. We're going to need to change our internal processes to allow us to appropriately evaluate these systems and we're expecting work will be completed in 18 months to two years, which is well before the date when the transition period ends.

So, with that caveat out of the way, let's have a bit of a discussion about how it will work. First of all, you will need to include the system in the ARTG. Second, it will be classified at the same level as the device it's designed to manufacture. So, if manufacturing a Class I non-sterile non-measuring splint in the dental industry, the medical device production system will be included as a Class I non-sterile non-measuring. If it's used to manufacture a Class III cranio facial implant in a hospital, it's included as a Class III medical device production system in the register.

The critical point here is that when a medical device production system is included in the register, is used by a healthcare professional or another suitable qualified person within a healthcare facility, the devices that are manufactured will be subject to a conditional exemption. What that means is that the person using the system will not need to meet all of the regulatory obligations that a manufacturer would ordinarily meet, providing they use the system to produce devices in accordance with the intended purpose of the system, they do it in accordance with the instructions for use provided by the manufacturer and they do it in accordance with the conditions of the exemption. So, we are still working through conditions. Those conditions are likely to be requirements such as mandatory reporting of adverse events and record keeping. The key aspect here is that the system can be used to manufacture a patient-matched device and the device itself will not need to be included in the ARTG.

This brings me to the final point, the system will need to be supplied in such a manner that the person using it can produce a medical device that is safe and fit for its intended purpose. At a minimum we will need to see comprehensive instructions supplied with the device and with higher risk devices, those measures might include a requirement to complete a dedicated training course with the supplier of the system before it can be used and safety measures such as encryption access that limits the use of the system to the kinds of devices the individual is trained to manufacture. So what we're talking about there, if we have a cranio facial implant system in a hospital and a surgeon has been trained to use the system, the would have encrypted access, they'd be able to use it to produce any kind of cranio facial implant but they wouldn't be able to use it to produce another device like a rib.

Now as I mentioned, these systems will not be a facility available to you for a year or two. For those of you using systems that will meet the definition of a medical device production system that eventually be included in the ARTG, we suggest you register the devices you're currently manufacturing for transition to allow you to continue to legally supply them until the medical device production system facility becomes available. Now, we will be producing more information about this facility as we develop it, so please keep your eye out for that.

Slide 11

Alright, let's talk about adaptable medical devices. I touched on this right back at the start. Adaptable medical device is a new definition for an existing concept. Adaptable medical devices are devices that are intended to be modified at the point of care to suit the individual in question. These devices have always required inclusion in the ARTG and should always have been supplied with instructions for use to allow them to be safely modified at the point of care. The definition has been added to the regulations for the sake of clarity and we have also updated the Essential Principles to explicitly state that they must be supplied with instructions to allow safe modification or assembly at the point of care.

Slide 12

The final aspect of the new framework is the reclassification of some medical devices including diagnostic images and anatomical models. Any devices that meet this description will be reclassified to Class IIa. That is, unless they are already classified at a higher level. So if a device that meets this definition is already included in the ARTG as Class IIb, it will continue to be a Class IIb.

First up are devices used to record patient images for diagnosis or monitoring of a disease, injury or disability or the investigation of a physiological process and there are two key components there. One, they must meet the definition of a medical device and two, the images must be acquired through a method that relies on energy outside the visible spectrum.

Second are anatomical models. Again, I need to stress that they must meet the definition of a medical device in order for these rules to apply. Educational models that are used in a GP's surgery to show someone what their reproductive system looks like are not used to diagnose and/or monitor a disease, injury or disability or investigate a physiological process. However, if a surgeon 3D printed an anatomical model using CT data from a patient's spine to aid with diagnosis and pre-surgical planning, that would meet the definition of a medical device.

Finally, we have software-based devices that are used to generate a virtual anatomical model. As above, these products need to meet the definition of a medical device before they can be impacted by the classification rule. Now, a frequent question we are getting about these products is, if the software-based device is included in the ARTG, must you also include the virtual model it produces? And the answer is no, providing the software manufacturer intended for you to use their software for this purpose. If you are using ARTG included software to produce a virtual model in accordance with the instructions that you got from the manufacturer, the model itself does not also need to be included in the ARTG.

Slide 13

All right. That concludes our overview of the new framework. Before we commence the questions, I would like to point out some important dates and some things that you need to do. First of all, please read the guidance. I know it's an extensive document but we've worked hard with members of industry in various sectors to give you a good overview and some practical examples of how the new framework will apply. We will also be updating the guidance with new versions as we refine the information and we will be producing more resources to support you. Other educational material including fact sheets will be produced to support you and particularly if you are transitioning a device to inclusion in the ARTG.

Second, if you haven't already, please take the stakeholder survey to tell us what industry you're from and which areas of the framework you need more information about. We will use your contact information to make sure that we get you the information that you need as it becomes available.

If you need to include your patient-matched in the ARTG or you need to reclassify your devices at a higher level, please register for transition before the 25th of August this year. If you don't register for transition, you will need to cease supply until you have an inclusion that's in the register after this date.

If you are supplying a custom-made medical device or transitioning one to patient-matched, you need to submit your first annual report by the 1st of October this year. We are in the process of designing an online form to make this an easy process for you and if you have submitted a custom-made medical device or transition notification we will send you information about how to submit your report in June.

Finally, please submit your application for inclusion in the register or reclassification by the 1st of November 2024. With higher risk devices, the application may not be complete by that date but the application does need to be in place before then.

Slide 14

Okay folks, as mentioned we will be producing more information and guidance to help you over the coming months. My team and I have taken the liberty of taking contact details that are available online. We are also cold calling in person those businesses and those healthcare providers that we cannot find email addresses for, please don't hang up on us, we are not scammers. We will also be working with a number of industry groups to produce dedicated content for each sector including webinars that will focus on specific questions relating to your sector. So we have some coming up with ADIA, ADA and AOPA.

If you do need more help, you can find it through SME Assist. SME Assist is a dedicated service that the TGA offers to help small to medium enterprises, start-ups and researchers who are developing new medicines and medical devices understand their regulatory and legislative obligations.

The SME team runs workshops in major cities around Australia which cover the basics of regulation, market authorisation, manufacturing, advertising and post-market monitoring. They do live stream and record their workshops, and they also have pre-recordings of workshop topics available. You can find all of these on the SME Assist hub of the TGA website.

Those resources are going to be particularly useful for those of you transitioning to an inclusion in the register, if you've never included a device in the register before and I really encourage you to make use of them. We also encourage you to subscribe to our SME Assist email list to stay up to date with the latest SME information including upcoming workshops, new guidance and webinars.

You can also contact the SME Assist team via the details shown on this slide.

So I'd like to thank you for bearing me with through that overview. I am going to hand you over to Rachel and then we are going to come back after we've had a chance to look at some of the questions that you've sent through and if you are still sending those through, we'll collate them and try to get a bit of a narrative happening to address them.

Note that we have not provided a transcript of the Q and A session. Please advise SME Assist on 1800020653 or email sme.assist@tga.gov.au if you experience any accessibility issues.