Personalised and Patient-Matched Devices
Overview
Personalised and patient-matched devices include a wide range of products where dimensions, geometry, or design are tailored to an individual patient — from orthopaedic implants sized to a specific patient's anatomy, to 3D-printed surgical guides, to patient-specific implants designed from medical imaging data. The regulatory treatment depends critically on whether the device qualifies as a custom-made device (exempt from ARTG) or is a manufactured device (requires ARTG inclusion).
The Key Distinction
Custom-made devices (ARTG-exempt): Must be made specifically for a named patient, based on a written prescription, and cannot use a mass production process. Truly bespoke, one-off fabrication for a specific patient based on a health professional's prescription may qualify.
Patient-matched / personalised devices (require ARTG inclusion): Devices that are manufactured to patient-specific dimensions using a standard manufacturing process — even if each device is dimensionally unique — are generally not custom-made and require ARTG inclusion. This includes most 3D-printed devices, which use a standard (if patient-specific) CAD-to-print process.
3D-Printed Medical Devices
3D printing is transforming personalised device manufacturing, but regulatory status depends on the process, not the technology:
- 3D-printed devices manufactured using a validated, repeatable process with patient-specific geometry inputs are generally not custom-made — they require ARTG inclusion
- Truly one-off devices fabricated for a named patient by a health professional as part of their clinical practice occupy a more complex position — specific TGA guidance should be consulted
The TGA has published guidance on 3D-printed devices:
👉 3D-printed medical devices — TGA
Regulatory Obligations for Patient-Matched Manufacturers
Manufacturers of patient-matched devices that are not custom-made must:
- Classify each device type (noting that patient-matched implants are often Class IIb or III)
- Hold an ARTG entry for the device type
- Comply with Essential Principles, including demonstrating safety and performance for each patient-specific variant
- Report adverse events