Several medical devices which were previously supplied in Australia under the exemption for custom-made medical devices will be 'patient matched medical devices' under the new framework, and must be notified to the TGA before 25 August 2021 to be eligible to comply with the transition arrangements until 1 November 2024.

Between 2017 to 2019, the Australian regulator for therapeutic goods (including medical devices), the Therapeutic Goods Administration (TGA), consulted on proposed changes to the medical device regulatory framework in Australia in relation to medical devices which are custom-made or 'personalised' for individual patients, including many 3D printed devices. Previously, all such devices were classified as custom-made medical devices (CMMDs) and were captured under a corresponding exemption.

However, rapid advances in computing technology and materials science have effected exponential change in medical device technology. This has altered the commercial use and corresponding risk profile of medical devices that are 'customised' for individual patients.

The previous exemption was intended to capture 'special cases' where there was no medical device included in the Australian Register of Therapeutic Goods (ARTG) which could meet the requirements of a particular patient. Such medical devices were assessed to have a low risk profile because they would be used only in special cases. However, the relative ease and cost of preparing customised medical devices has markedly reduced in the last decade and, as a result, the manufacture and supply of custom-made and other 'personalised' medical devices under the 'custom-made' exemption has boomed.

The TGA has made it clear that it never intended for there to be such widespread reliance on the custom-made medical device exemption. The corresponding risks of such use warrant more onerous regulatory obligations and scrutiny.

The reforms intend to align and harmonise with the international regulatory approach to CMMDs and other personalised medical devices.

The TGA has summarised the reforms on its website. The Therapeutic Goods (Medical Devices) Regulations 2002 now incorporates the changes that took effect on 25 February 2021, subject to a conditional transitional period until 1 November 2024 (and subject to notice to the TGA before 25 August 2021). The amending legislation is the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019.

Which products are affected by the reforms?

In summary, the following categories of medical devices and related products are likely to be affected by the reforms, among others:

• implantable devices and products;
• mandibular advancement splints (MAS) and sleep apnoea devices;
• dental aligners and retainers;
• prosthetics;
• orthotic devices; and
• systems for 3D printed medical devices.

Further guidance on the products affected by the forms has been published by the TGA. If you are involved in the manufacture, use, supply or advertisement of any of these products you should be familiar with the reforms and obtain further advice where necessary.

Summary of the significant changes

The new framework took effect from 25 February 2021. The key changes include:

• There is a new regulatory classification for 'patient-matched medical devices' which captures all personalised medical devices that are produced within a 'specified design envelope' (meaning, a standardised production process which can be validated and/or verified and reproduced). Importantly, all 'patient-matched medical devices' will have to be entered in the ARTG.
• The previous exemption for CMMDs has been made narrower so that it only captures rare, one-off, bespoke pieces that are designed and manufactured for patients with unique anatomical, physiological or pathological features or needs, for whom any other medical device (including any patient-matched medical device) would not be suitable. It specifically excludes 'adaptable medical devices', 'patient-matched medical devices' and other 'mass-produced medical devices'.

The reforms also anticipate a new regulatory framework for Medical Device Production Systems (MDPS) to allow and facilitate healthcare providers to directly produce personalised devices for treating their patients. Under the new framework, the manufacturer of an MDPS will be considered the legal manufacturer of any devices produced using the system. However, this regulatory framework is not yet complete and further guidance from the TGA is expected to follow.

In addition, the reforms broaden the application of the rules for medical devices that record diagnostic images to a broader range of technology to record patient anatomy for diagnosis and investigation.

Note on definitions – under the new framework:

• 'adaptable medical device' means mass-produced and to be assembled or adapted after it is supplied, according to the manufacturer’s validated instructions, to suit an individual patient’s specific anatomical and/or physiological features or otherwise to perform as intended. For example, a mouthguard intended to be modified by a dentist or orthodontist to fit their patient before use.
• 'mass-produced medical device' means a medical device that is: based on standardized dimensions/designs; not designed for a particular individual; and typically produced in a continuous production run or homogenous batch.

Effect of the regulatory changes for personalised medical devices

The new category for 'patient-matched medical devices' is likely to include the majority of personalised medical devices which were previously supplied as CMMDs, such as dental retainers, mouthguards and fillings which are fabricated in bulk quantities in-house.

Any medical device which:

• has previously been supplied in Australian under the exemption for CMMDs; but
• will be a 'patient matched medical device' under the new framework,

must be notified to the TGA before 25 August 2021 to be eligible to comply with the transition arrangements until 1 November 2024.

Supply of any new patient-matched medical device is now prohibited in Australia (since 25 February 2021) unless it is entered in the ARTG.

For medical devices which continue to be captured by the exemption for CMMDs, there will be new regulatory obligations including a new:

• annual reporting obligation;
• obligation to allow the TGA to inspect the facilities for the production of any CMMD;
• obligation to retain all documentation related to all CMMDs for 5 years or 15 years (for implantable devices); and
• obligation on manufacturers of CMMDs to provide information about each CMMD to the end user.

Further information about the regulatory reforms

This article provides a general overview of regulatory reforms related to custom-made and other personalised medical devices. These form part of a broader reform strategy by the TGA targeting several kinds of medical devices. We previously provided an update on regulatory changes for software based medical devices.

If you are unsure how these reforms impact you or third parties or would like to know more about the regulation of medical devices generally (being custom-made, personalised or otherwise), please contact one of our experts today.