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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

21 February 2020

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Need for government action

There are three key reasons that government action is required on this issue:

  • the rapid emergence of new technologies and rapid uptake of personalised medical devices
  • the continued need for international alignment
  • no other suitable mechanisms to manage issues with personalised medical devices

Emerging technology

The rapid development in the technological complexity of personalised medical devices, expansion well beyond the manufacturing techniques envisaged by the authors of the existing custom-made regulatory framework, and expected massive growth in the number of such personalised medical devices over the coming years, mean that changes are required in the way these devices are regulated to provide sufficient oversight to safeguard patient safety.

The world is seeing a shift towards more personalised medicine. Personalised medicine has the potential to deliver improved health outcomes for patients, and to lower consequential burden on the healthcare sector. Use of autologous (the individual’s own) cells and tissues can result in improved outcomes for patients, and reduced adverse events, complications, or difficulties that stem from rejection of foreign material.

However, as outlined above, the shift towards the use of personalised medical devices brings with it significant challenges, including in how to best to regulate these new types of devices and associated technologies.

International alignment

The Australian medical device market is only a small fraction (around two percent) of the global market[21] (4.3 billion US$ out of approximately 400 billion US$ globally) and the vast majority of medical devices supplied in Australia, even many custom-made devices, are increasingly manufactured by overseas entities and imported here. The regulatory framework for medical devices in Australia is necessarily aligned with the frameworks of other larger jurisdictions to ensure ease of importation, which allows access to the greatest number of safe medical devices for Australian patients. Regulatory marketing approvals gained in the EU, the USA, Canada and Japan can be used to support market authorisation in Australia.

Due to their unique nature, it can be difficult for manufacturers of personalised medical devices to validate their design, perform sufficient testing, and maintain the quality of manufactured parts. IMDRF member regulators have recognised the problems relating to the design and manufacture of personalised medical devices and are in agreement that action is needed.

Internationally aligned regulation of medical devices also facilitates access to medical devices, especially in Australia. Harmonisation of regulatory frameworks minimises duplication of regulatory oversight (such as reassessing the same device in multiple jurisdictions), while still assessing the safety, quality, and performance of medical devices. This can also apply for personalised medical devices.

In 2017, Australia proposed a new work item to address the specific challenges with personalised medical devices, resulting in the formation of the IMDRF Personalized Medical Devices working group. The working group consulted internationally and then published definitions for personalised medical devices in 2018[22]. It has recently consulted internationally on a draft document that proposes regulatory pathways for each category of personalised medical device[23] .

International regulators, through the IMDRF, have recognised the problems relating to the design and manufacture of personalised medical devices and have agreed that action is needed.

There is now an opportunity for Australia to implement regulatory reforms that are commensurate with the foreseen risks while ensuring minimal regulatory burden but also timely availability of personalised medical devices to individuals who need them. As the regulation of medical devices for supply into or out of Australia is undertaken at the federal level, changes to the medical device regulatory framework necessarily lies with the Australian Government[24].


Footnotes

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