Custom-Made Devices
Definition
A custom-made device is a medical device specifically manufactured in accordance with a written prescription of a duly qualified medical practitioner or any other authorised person which:
- Gives specific design characteristics under the prescriber's responsibility, AND
- Is intended for the exclusive use of a particular patient
Custom-made devices are made to meet the unique needs of a specific, identified individual — they are not manufactured for general commercial supply or in series.
Regulatory Exemption
Custom-made devices are exempt from the device registration requirement under Act 737. This means:
- No Device Registration Number (DRN) is required
- No registration application is submitted to MDA
- No conformity assessment against Essential Principles by a third party is required
However, the exemption is not a complete exemption from regulation — important obligations still apply.
Conditions for Exemption
To qualify as an exempt custom-made device, the device must:
- Be made specifically for one identified patient
- Be made to the specification of a qualified prescriber
- Not be manufactured in series — if substantially similar devices are produced in series (even to a prescriber's template), they may not qualify as custom-made
- Be accompanied by a custom-made device statement (see below)
Custom-Made Device Statement
The manufacturer of a custom-made device must prepare a custom-made device statement for each device. This statement must include:
- Identification of the patient
- Name of the prescribing practitioner
- Device description and specifications
- Statement that the device is custom-made for the identified patient
- Date of manufacture
- Details of the manufacturing site
This statement must be made available to MDA on request.
Obligations That Still Apply
Despite the registration exemption, custom-made device manufacturers must:
| Obligation | Detail |
|---|---|
| Establishment licence | Manufacturers of custom-made devices still need an establishment licence |
| Safety and performance | Devices must meet applicable safety requirements even without formal conformity assessment |
| Quality management | Appropriate QMS controls must be in place |
| Adverse event reporting | Serious adverse events involving custom-made devices must be reported to MDA |
| Record keeping | Manufacturing records and custom-made device statements must be retained |
Common Custom-Made Device Examples
- Dental prostheses (crowns, bridges, dentures) fabricated to patient impressions
- Orthotics and prosthetics (limb prostheses, orthopaedic insoles) fitted to patient measurements
- Hearing aids adjusted/fitted for an individual patient
- Custom surgical implants (e.g. patient-specific bone plates designed from imaging data)
- Ophthalmic lenses ground to patient prescription
Series Production — Not Custom-Made
If a manufacturer produces devices to a standard design with limited personalisation (e.g. adjustable sizes, standard configurations), these are likely not custom-made devices and must be registered in the normal way. The key test is whether each device requires a specific prescription from a qualified practitioner for a named patient.
With the growth of patient-specific 3D-printed implants and devices, the line between custom-made and series-manufactured devices is frequently tested. A 3D-printed device made from a patient's imaging data for a specific patient, under a surgeon's prescription, is likely custom-made. A 3D-printed device produced as a catalogued size range is not. Seek MDA clarification if uncertain.