Personalised medical devices cover a range of products. Custom-made medical devices are medical devices designed and made as specified by a health professional to be used by a specific individual. They are not to be confused with mass-produced off-the-shelf devices that are customised, adapted or modified after supply, also known as adaptable medical devices.
Custom-made medical devices are generally not required to be included in the Australian Register of Therapeutic Goods (ARTG). However, on February 25, 2021, the definition of “custom-made medical devices” was changed. A majority of the devices that have been supplied under the custom-made medical device exemption will soon be required to be included in the ARTG. There is a transition period until 01st November 2024, which will allow the continued supply of devices provided they are eligible.
The devices that will be excluded in the new definition of custom-made medical devices include patient-matched medical devices and devices produced using a Medical Device Production System (MDPS). The manufacturers and sponsors of these devices are required to:
- Ensure implementation of the appropriate conformity assessment procedures and documenting evidence demonstrating the devices meet the Essential Principles
- Include the kind of medical device in the ARTG to enable legal supply within, or export from, Australia
The new definition of Custom-Made Medical Devices specifies that these devices are manufactured:
- for the sole use of a particular patient or particular health professional in the course of the health professional’s practice
- in accordance with a written request of a health professional with specific design characteristics to address either or both the anatomical and physiological features, or a pathological condition of the intended recipient
- because there are no alternative devices available on the ARTG to address the intended recipient’s needs and they do not match the definition of patient-matched medical device or adaptable medical device.
The following table summarises the definitions, examples and new framework requirements for the non-custom made medical devices.
|Type||Definition||Example(s)||New regulatory framework requirements|
|Patient-matched medical devices||Devices manufactured:|
• within a specified design envelope to match the anatomical features of a particular individual; and • using processes able to be validated and verified and reproduced.
|Dental retainers moulded to match a particular patient’s teeth|
Mass-produced orthopaedic implant that is personalised to a specific person’s age, height and weight, provided these factors fall within the design envelope that has been validated
|Devices to be included in ARTG before supply.|
Only one inclusion is required if a “kind” of devices have the same sponsor, manufacturer, classification, Global Medical Device Nomenclature (GMDN) code and Unique Product Identifier (UPI).
|Medical Device Production System (MDPS)||A system consisting of raw materials and main production equipment that is intended to be used as a complete system by a health professional / healthcare facility to produce a particular medical device for use in relation to a patient of the health professional / healthcare facility.||A system used to produce patient-matched dental crowns for adult patients incorporating:|
• ceramic blocks • ceramic filling machine • post-machining finishing equipment • CAD/CAM proprietary software
|The appropriate conformity assessment procedures to be applied to the MDPS relevant to its classification, demonstrating it meets all relevant Essential Principles.|
The MDPS to be included in the ARTG with the same classification as the highest class of device it produces.
|Adaptable medical devices||A mass-produced medical device intended by the manufacturer to be assembled or adapted after it has been supplied, in accordance with the manufacturer’s instructions, to:|
(a) address either or both the anatomical and physiological features of a particular individual; or (b) address a pathological condition of a particular individual; or (c) otherwise perform as intended by the manufacturer.
|Mass-produced polymer surgical implant for cranial reconstruction that is:|
• supplied in a sterile state; and • intended to be thermoformed during the cranial reconstruction procedure to suit the individual patient’s anatomical features
|No changes to regulatory requirements, except ensuring the information supplied with the device conforms to the updated essential principles.|
The following decision tree from the TGA will allow manufacturers and sponsors of medical devices understand whether their devices will be considered custom-made medical devices under the new regulatory framework: