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.
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: