Australia’s Therapeutic Goods Administration (TGA) released an impact statement in December 2019 on a proposed comprehensive reform to how the agency regulates personalized medical devices. Such devices are currently governed by the rules set out in the Therapeutic Goods (Medical Devices) Regulations 2002. The TGA argues that this legislation did not anticipate subsequent technological advances and must be updated in view of the existence of 3D-printed medical devices.
Current regulations governing personalized medical devices
The impact statement explains that in 2002, most customized medical devices were extremely low-risk products such as dentures or eyeglasses that were modified to serve a specific user. It therefore seemed unnecessarily onerous to subject them to requirements such as the conformity assessment procedure or inclusion on the Australian Register of Therapeutic Goods (ARTG). In the rare cases of higher-risk medical devices falling into the personalized category, it was assumed that healthcare professionals would bear responsibility for their safe use. 3D printing has transformed the industry by making it possible to quickly and inexpensively manufacture large quantities of complex, high-risk devices customized for individual users.
Lack of inclusion on the ARTG has major ramifications. Manufacturers of implantable medical devices must report to the TGA annually for their first three years on the TGA, and this requirement does not apply for devices that are custom-made. Removing a conventional medical device from the ARTG effectively makes it illegal, but this is not possible with customized devices. Penalties for regulatory non-compliance are generally based on inclusion on the ARTG, meaning that the current system effectively shields personalized medical devices from most forms of criminal or civil sanctions.
Other shortcomings of personalized device regulations
3D printing is not the only technological innovation that Australia’s regulatory system fails to account for. Devices containing human-origin materials, such as an artificial kidney containing human stem cells, are not regulated as medical devices but rather fall under the Biologicals regulatory framework. One of the proposed changes is to redefine them as medical devices with a biological component.
The TGA also seeks to expand the classification of devices that provide diagnostic imaging. Currently the language of the regulation applies specifically to x-rays, and the agency would like to update the definition to include other imaging techniques, including 3D-printed models.
What reform would look like
Numerous other countries have already updated their regulatory systems to address 3D printing and devices with human-origin materials, and one of the stated objectives of Australia’s change would be to bring its system into line with those of other International Medical Device Regulators Forum (IMDRF) member nations. Australia currently chairs the IMDRF working group on personalized medical devices, established in 2018.
The proposed overhaul would group personalized medical devices into three categories, in line with IMDRF definitions:
- Custom-made medical devices
- Patient-matched medical devices
- Adaptable medical devices
It would require manufacturers of custom-made devices to provide additional information to the TGA and would allow the TGA to inspect manufacturing sites. At the same time, it would give healthcare providers the ability to produce personalized devices without procuring manufacturing certification.
The TGA held public consultations on these proposed comprehensive reforms in 2017 and 2019, along with two formal international consultations in 2018 and 2019 and bilateral consultations with a range of stakeholders. It reports encountering strong support for comprehensive reforms, as opposed to leaving the current regulatory system in place or regulating personalized medical devices under the same rules as conventional devices.