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Regulation impact statement: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices
Version 1.0, December 2019 - OBPR reference: 24680
Formal engagement for reforms to the personalised medical devices regulatory framework began in August 2017 at a targeted workshop for fifty invited participants including representatives from the medical device industry (both large and small organisations), hospitals, surgeons, researchers, patients, and government. There was consensus at the workshop on the need to reform the medical device regulatory frameworks for custom-made devices, especially high-risk (permanently implantable) devices, enabled by 3D-printing.
In November 2017, the TGA released a consultation paper - Proposed regulatory changes related to personalised and 3D printed medical devices. The consultation was available through the TGA website for a six-week period and closed on 22 December 2017.
The paper included proposed ways to address the increasing trend for personalised medical devices. While the regulatory changes were not limited to 3D-printed medical devices, 3D-printing was one of the main themes, as this technology enables personalisation of medical devices in a fast and potentially up-scalable manner.
Results of 2017 consultation
The responses to the consultation paper showed broad stakeholder support for the proposed reforms and a strong awareness of the need for improvements to the regulation of personalised medical devices. Twenty-four submissions were received, from industry and industry representatives, healthcare practitioners and organisations, government, universities and consumer representatives.
The submissions indicated that there was still need for greater clarity, in particular, regarding the proposed definitions. The need for clarification was especially evident regarding the boundary between the proposed ‘custom-made’ and the proposed ‘patient-specific’ definitions and there were multiple requests for explanatory examples. There were also several submissions indicating uncertainty, and requesting further explanation of what exactly would be seen as a medical device production system.
In order to obtain additional feedback from affected stakeholders, the TGA publicly released another consultation paper on 11 February 2019, seeking submissions until 31 March 2019. The document included an invitation to comment on the proposed options, specifically, seeking feedback on the suitability and potential impact that any proposed changes to the regulations might have.
The 2019 consultation included a proposal to align the new definitions for personalised medical devices in Australia with the IMDRF definitions that were published in November 2018. These definitions provided additional clarity when compared with those consulted on in Australia in 2017. The IMDRF definitions paper included examples for each of the different categories.
Twenty-four submissions were received. Overall, there was a strong consensus across all stakeholder groups, with a majority of respondents supporting the proposed changes to the regulatory framework for personalised medical devices. A number of submissions were complementary of the leading role that Australia was playing as Chair of the International Medical Device Regulators Forum personalised medical devices working group.
Submissions also focussed on ensuring a level playing field for manufacturers and hospitals that are manufacturing more than custom-made medical devices, international alignment, cost of compliance, and the need for clear guidance and education from the TGA. Some specific issues were identified through the consultation:
- A number of submissions were concerned about the proposed new medical device production system (MDPS), but it was clear that much of the feedback stemmed from a misunderstanding of how the regulations would apply both to these devices and to other types of manufacturing systems. Clarification on this misunderstanding was provided in the outcomes summary for the consultation.
- There were a number of responses from members of the low-risk assistive technologies sector who were concerned about increased regulatory burden. They mistakenly believe that their Class I products would require third-party certification if the proposals are implemented. They also believe that each and every device that is supplied would need an ARTG entry. In reality, there would not be any additional regulatory requirements in this sector. Many of the products in this sector are not medical devices and a current consultation on options to exclude f certain products used for and by people with disabilities from regulation should alleviate these concerns.
- Some smaller Australian manufacturers who have been engaged in custom-made implantable medical devices also appear to have limited understanding of the medical devices regulatory framework. Stakeholder education for this cohort will be a priority for the TGA.
- Hospital respondents want the freedom to manufacture more than custom-made medical devices but have concerns about meeting the cost of regulatory compliance.
Stakeholders responding to the consultation were:
- Manufacturers (8), Industry Associations / Organisations (6), Healthcare Representative Bodies (3), Healthcare Providers (3), Consumer Organisations (2), Not for Profit (1), University (1)
No respondents strongly opposed the proposed reforms. The small number of submissions that opposed one or some of the proposals also supported others and there was a misunderstanding of current regulatory requirements as noted above.
Some respondents opposed some parts of the proposals for application to all categories of devices, most notably there were several submissions that suggested potentially increased reporting requirements for custom-made medical devices should be limited to higher-risk devices.
International (IMDRF) consultations
In addition to the consultation conducted in Australia, the IMDRF personalised medical devices working group has conducted two formal international consultations. The first was to establish definitions for personalised medical devices, which were published in 2018  (see Appendix 1), and the second was undertaken in 2019 to establish regulatory pathways for each category of personalised medical device. These international consultations received broad support and the proposed changes for Australia are aligned with the IMDRF approach.
Consultations with selected stakeholders
In additional to the consultation processes outlined above, bilateral consultations have been undertaken on particular aspects of the proposed changes with a range of stakeholders, including member of key consultative forums (the RegTech Forum and the Advisory Committee on Medical Devices), and discussions with a number of respondents to the TGA consultations on personalised medical devices and members of the healthcare sector, including public and private hospital peak bodies.
|||2017 consultation paper available on TGA website: Consultation: Proposed regulatory changes related to personalised and 3D printed medical devices|
|||A summary and copies of responses to the 2017 consultation are available on the TGA website at: Submissions received: Proposed regulatory changes related to personalised and 3D printed medical devices|
|||2019 consultation paper available on TGA website: Consultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices|
|||2018 consultation paper available on the IMDRF website at Definitions for Personalized Medical Devices|
|||2019 consultation paper available on the IMDRF website at: Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews|