In brief

• On 25 February 2021, a new framework for regulating custom-made medical devices (CMMDs) in Australia commenced.
• The framework includes a new definition for CMMDs and many previously exempt CMMDs may now be required to be included in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied in Australia.
• Manufacturers and suppliers of CMMDs should assess their position to ensure they comply with the new regulatory framework.

Background

Prior to the amendments to the therapeutic goods laws in Australia, a CMMD was a device made for a particular individual specifically in accordance with the request of a health professional. The request was required to specify the design characteristics or describe how the device was to be constructed. The definition also encompassed a medical device used by a health professional where the device met the special needs of the health professional’s practice. While the Therapeutic Goods Administration (TGA) was required to be notified of the kinds of CMMDs to be manufactured and sold, CMMDs were exempt from inclusion in the ARTG.

The exemption was intended to only apply to ‘special cases’ in which there was no medical device included in the ARTG that could meet the special needs of a particular patient. However, between 2017 and 2019, the TGA consulted on proposed changes to the medical device regulation framework in Australia and found that the ease and low cost of preparing CMMDs had drastically decreased over the last few years. As a result, the manufacture and supply of CMMDs had grown exponentially. The TGA found that there had been an unexpected reliance on the CMMD exemption in the regulatory framework increasing the risk profile of CMMDs, from low to high, creating a need for more stringent regulatory obligations.

Summary of significant changes

From 25 February 2021, the definition a CMMD has been narrowed in scope, reducing the types of medical devices that fall within the exemption to capture only those devices that are rare, one-off, bespoke devices.

The new definition provides that a CMMD must be intended for the sole use of a particular patient or the sole use of a particular health professional in the course of their practice. It must be manufactured in accordance with a written request of a health professional, and the request must detail particular design characteristics that are intended to address the anatomical and/or physiological features or a pathological condition of the intended recipient (i.e. the patient or health professional).

The requesting health professional must also have determined that there is no other kind of medical device included in the ARTG that addresses the intended recipient’s condition to an appropriate level. The new definition of a CMMD also expressly excludes patient‑matched medical devices, adaptable medical devices or other mass‑produced medical devices (see our discussion below).

In addition, for a CMMD to be exempt from registration, the manufacturer or sponsor must satisfy additional requirements, which include that the manufacturer or sponsor of the device must:

• retain sufficient evidence to substantiate that the conformity assessment procedures specified in the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) were applied to the device
• allow the TGA to enter and inspect the manufacturer’s premises (including those outside of Australia), and
• on request, produce to the TGA the health professional’s request for the device.

Exclusions from the new CMMD definition

As mentioned above, the new definition of a CMMD expressly excludes patient‑matched medical devices, adaptable medical devices or other mass‑produced medical devices.

A patient-matched medical device is a medical device that:

• is manufactured ‘within a specified design envelope’ to match the anatomical or physiological features or pathological condition of a particular individual, and
• is designed by the manufacturer (often in consultation with a health professional) using production processes that are capable of being validated or verified and reproduced.

The term specified design envelope means that the minimum and maximum dimensions, performance limits or other relevant factors that characterise a medical device for production purposes. The specified design envelope may be based on a standard device template.

An adaptable medical device refers to a mass-produced device 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.

A mass-produced medical device means a medical device that is based on standardised dimensions/designs, not designed for a particular individual and typically produced in a continuous production run or homogenous batch.

Where a medical device satisfies the definition of patient‑matched medical devices, adaptable medical devices or other mass‑produced medical devices, will no longer fall within the CMMD exception to inclusion in the ARTG and must now be included in the ARTG before it can be supplied in Australia.

New reporting requirements

For medical devices which fall within the new definition of CMMDs, there will be new regulatory obligations including a new:

• annual reporting obligation setting out details of the devices manufactured or imported in the previous financial year
• 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.

Key takeaways

The new regulatory framework from CMMDs is likely to exclude a large number 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. These medical devices will now fall within the definition of ‘patient-matched medical devices’ and will need to be included in the ARTG.

All medical devices which were previously supplied in Australia under the exception for CMMDs but now do not meet the requirements of a CMMD under the new framework, should have been notified to the TGA before 25 August 2021, to be eligible to comply with the transition arrangements until 1 November 2024.

In all other cases, manufacturers and suppliers will need to apply to the TGA for inclusion of the devices in the ARTG.