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Submissions received: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices

2 December 2019

The TGA thanks respondents who provided a submission in response to the public consultation paper: Personalised medical devices, including 3D-printed devices.

The consultation related to a proposal to update the regulatory framework to better regulate personalised medical devices, including those made using 3D printers. The purpose of this consultation, which followed on from earlier public consultation and forums in 2017 and 2018, was to understand the potential effect that the proposed changes may have on the medical devices industry, health care professionals, patients and healthcare system more broadly.

Six questions were included in the consultation paper seeking feedback on the level of support for the proposals; any perceived advantages, disadvantages, or unintended consequences; comments and suggestions; anticipated financial implications; and estimated time periods that might be required to effectively implement the proposed new arrangements, if agreed by the Government.

A total of twenty (25) submissions were received.

TGA summary

Advancing technology has significantly shaped the 'personalised medical device' sector, enabling device manufacturers to easily and rapidly produce individualised medical devices, including 3D-printed devices, to meet the needs of individual patients and health care professionals. In the Therapeutic Goods Act 1989, these types of devices typically fall within the current definition of 'custom-made medical device'. In Australia, through an exemption pathway, custom-made devices are exempt from regulatory review and certification prior to supply.

There are no limits in the current Australian framework to the types of devices that can be supplied under the custom-made medical device exemption pathway. This means that simple non-invasive devices and (usually) higher-risk implantable devices can be supplied without regulatory oversight. The exemption pathway, implemented over twenty years ago, was intended to be used only by manufacturers of low-risk devices.

The TGA in its consultation paper, proposed that the existing regulatory requirements for personalised medical devices are no longer fit-for-purpose and sought feedback on proposals to amend the regulations to incorporate appropriate regulatory safeguards, commensurate with expectations from the public, to reflect the technological advancements now available in the field of personalised medical devices manufacture.

This consultation focussed on proposed regulatory reforms that included introducing new definitions for personalised medical devices under three categories (custom made, patient matched, and adaptable), together with associated regulatory controls applied commensurate with the risks represented in each of the categories. A new type of medical device system was also proposed to be introduced, the medical device production system (MDPS), to enable healthcare professionals to safely produce personalised medical devices, often at point of care, using a certified turnkey system. Use of a certified system would mean that healthcare professionals producing these types of medical devices would not then be required to obtain manufacturer certification.

The consultation paper also proposed an update to the classification rules relating to anatomical models used for the investigation of the anatomy and for the planning of surgeries; changes relating to the way medical devices with human-origin components would be regulated, to ensure alignment with international norms; and a clarification for when a person would be held responsible for being a (new) manufacturer of a medical device following adaptation or modification of an already-supplied medical device made by another manufacturer.

The TGA received 25 submissions in response to the consultation paper. The highest stakeholder group amongst respondents was manufacturers (8 responses) followed by industry representative bodies (6 responses) and healthcare representative bodies (4 responses). Other stakeholders comprised the remainder of submissions.

The overall level of support for the proposed changes was positive. There were high levels of support for the new definitions and for clarifications that modifications must be intended by the original manufacturer. Changing the requirements for supplying custom-made devices, regulating devices with a human-origin component, and updating the classification rule for devices that record diagnostic images received varied levels support. There was less obvious support for the proposed new medical device production system (though it was supported overall), 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, for instance, that Medical Device Production Systems are intended to be turnkey solutions for producing particular medical devices—not open manufacturing systems for hospital use, that their use would not be compulsory, and that their respective manufacturers would be responsible for validating their use by end users; the consultation paper was, perhaps, not sufficiently clear on these points.

Consumer peak bodies were supportive of all proposed changes based on improved health outcomes and increased safety for patients. Numerous submissions from other stakeholders recognised improvements to patient safety and reduced risk as being a direct advantage of the proposed changes. There was support for alignment with global best practice. Manufacturers recognised the need to revise the current regulations to account for current and future evolution in the medical device manufacturing space and the growth of personalised medicine and implant customisation. Some respondents disagreed with certain definitions included in the proposal and provided suggested amendments.

Issues raised against some of the proposed changes came from a range of stakeholders, such as the scope of the proposed definitions, the regulatory burden associated with the new definitions, concerns about particular aspects of the exemption framework for custom-made devices, and the introduction of the Medical Device Production System for the reasons mentioned previously.

Post consultation and next steps

Since the publication of the consultation, the TGA has attended a number of conferences and given presentations at numerous fora. In October 2019, the TGA hosted the International Medical Device Regulators Forum (IMDRF) Personalized Medical Devices (PMD) Working Group in Canberra. The PMD Working Group met face-to-face to discuss the public consultation submissions received on the group's draft Personalized Medical Devices - Regulatory Pathways document, and to incorporate the public feedback into a final document. This version will be submitted to the IMDRF Management Committee for formal approval and publishing in 2020.

The TGA has considered the feedback received from the 2017 and 2019 consultations, the work undertaken by the IMDRF Working Group on Personalized Medical Devices, and feedback from targeted stakeholder engagements; and has undertaken to ensure that policy options presented to Government for consideration reflect this input.

Areas requiring further clarity and the development of specific additional guidance have been identified from the submissions both to the TGA's consultation as well as those made to the IMDRF work group's consultation on regulatory pathways. The TGA will undertake further and broader stakeholder engagement, develop detailed guidance material in support of the regulation of personalised medical devices. Based on the feedback from consultations, significant education and information materials and workshops will be required, publishing of online decision trees and use of medical device production systems by multiple health practitioners.

In addition, the TGA will continue its international collaboration and harmonisation work in this area via its contributions to the IMDRF PMD Working Group.

Submissions received

All submissions that were not marked as confidential are now available in PDF format.

3 A B C G H J M N O PS

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  • Consultation submission: Smith & Nephew Pty Ltd