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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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Option 1 - Status quo

The benefits of maintaining the status quo are limited. It will save the costs associated with changes where medical devices shift from mainstream (requiring ARTG inclusion) to custom-made (which are exempt). Option 1 also does not address any of the limitations of the current regulatory approach:

  • Current custom-made medical device definition allows for a large (and growing) proportion of the types/categories of medical devices that are eligible for custom-made exemption - far beyond the original intent
  • insufficient mechanisms for the Australian Government to have effective oversight and visibility of the personalised medical device sector, which is predicted to become more significant over time as the market moves further towards personalised medicine
  • insufficient mechanisms for investigation following adverse events relating to or involving personalised (custom-made) medical devices, as a result of limited record-keeping requirements (particularly around record-retention timeframes)
  • insufficient compliance and enforcement mechanisms for dealing with unsafe devices or manufacturers
  • misalignment with international norms for human-origin material - medical device combination products, which results in unnecessary regulatory burden for industry

Option 2 - Comprehensive package of regulatory reforms

Under Option 2, the proposed regulatory changes are intended to address the three dimensions of the stated problem, and additionally align with the objectives for regulating medical devices in general, which are:

  • minimising public health and safety risks
  • maintaining consumer confidence in the safety and performance of medical devices
  • aligning, as far as possible, with international best practice
  • minimising unnecessary regulatory burden

The proposed changes are expected to provide benefits to patients being treated with personalised medical devices and to healthcare providers who use personalised medical devices in their practices, primarily improved clinical outcomes for patients. The strengthening of regulation for personalised medical devices would ensure that an appropriate and consistent level of third-party oversight is in place, which would minimise the risk of harm to patients. This would also give healthcare providers more assurance that the medical devices will perform as intended.

Additionally, the proposed changes are expected to provide benefits to the regulated industry sector. Some devices currently covered under the Australian custom-made exemption would require third-party assessment to make them eligible for inclusion in the ARTG. This facilitates reimbursement processes for some devices and also provides a degree of public confidence in the products. The changes would also level the playing field for manufacturers by making the device categories and requirements clearer and more consistent. Manufacturers, particularly of patient-matched devices, who are already ensuring their devices comply with the essential principles for safety and performance, would not be unfairly competing against manufacturers who are not subject to the same degree of regulatory oversight.

Most of these proposed changes would move the regulation of personalised medical devices in the direction of international alignment. For example, regulatory oversight or approval of patient-matched medical devices is already required in multiple jurisdictions including the USA and Canada. Australian manufacturers who are currently using the custom-made exemption for their patient-matched medical devices may find that complying with the new arrangements opens up additional international markets for their products.

Finally, changing the Australian regulatory pathway for medical devices with human-origin material, such as 3D-bioprinted devices, would better align with other jurisdictions. This is expected to benefit manufacturers because it would reduce confusion about and the regulatory burden of complying with the requirements of multiple jurisdictions.

One of the key benefits for custom-made devices is the ability to custom-make a device to meet the specific needs of an individual patient, and the ability to provide a device where a mass-produced device is not available or would provide a less than optimal solution. The ability to create anatomically-correct models of a patient prior to surgery enables diagnosis, and also allows the surgical team to train and plan for surgeries, which may potentially reduce the risk of errors, reduce surgery time, make surgery possible at all, and reduce post-operative complications.

Option 2 offers potential benefits patients, health professionals, health care systems and the medical devices industry.[32]

Benefits for patients

  • Solution for an otherwise un-solvable problem (for example, patients of uncommon size or shape, or with a unique anatomical condition)
  • Precise implant shapes
  • Reduced surgery and recovery times (generally speaking the shorter the surgery duration to lower the risk to the patient (from infection and anaesthesia)
  • Better aesthetic results
  • Reduced post-operative complications.

Benefits for healthcare systems and health professionals

Healthcare systems include various facilities such as hospitals and dental surgeries, and the health care professionals who work within them.

  • Visualisation and planning of procedures using anatomically correct models which may have the following benefits:
    • Better selection of devices and other surgical tools
    • Decreased surgical risk and increased accuracy (of incisions for example) and potentially resulting in less surgical errors and faster postoperative recovery
    • Better anticipation of difficulties that can potentially arise during surgery/procedures
  • Other benefits potentially include:
    • Reduced postoperative complications
    • Decreased risk of soft tissue trauma
    • Decreased duration of surgical procedure time (less anaesthetic) due to reduced need, for example, to reshape a massproduced implant
    • Less misplacements and errors during the procedure
    • Decreased radiological exposure during the procedure.


  • Increased demand should continue to drive innovation and growth in the industry
  • The ability to meet the medical needs associated with the increasing geriatric population and an increasingly sedentary lifestyle will increase demand for certain orthopaedic and dental devices which will continue to drive the market

Option 3 - Regulate custom-made medical devices in line with other medical devices

Regulating custom-made medical devices in line with other medical devices has the benefit of increasing visibility and oversight of these medical devices. It shifts these medical devices into an established and proactively managed regulatory framework with clearly outlined responsibilities and accountabilities for manufacturers and sponsors, and provides a range of compliance and enforcement mechanisms for the regulator not currently applicable to custom-made medical devices.

However, the significant limitations of this option, including forcing most personalised medical devices from forecast supply into the Australian market, mean this option is not realistically viable. The impact on patients, healthcare systems, health professionals and the medical devices industry could not be supported, and this option also does not address numerous aspects of the problems associated with the development and growth of personalised medical device technologies.


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