Both patient-matched and custom-made medical devices are personalised before they are manufactured. Dental aligners, for example, are a patient-matched medical device that are designed in a software suite to suit a specific person before they are manufactured.
Adaptable medical devices are personalised after they are manufactured. A limb prosthesis, for example, is assembled using pre-manufactured components to meet the needs of a specific person.
It is important to understand what these definitions mean.
Please refer to Personalised medical devices (including 3D-printed devices) for more information.
Personalised medical devices
Personalised medical devices are medical devices that are devices that are specifically designed and manufactured, or adapted/modified, to meet the needs of an individual. The TGA uses three (3) specific terms to describe personalised medical devices:
- Patient-matched medical devices;
- Adaptable medical devices; and
- Custom-made medical devices
Custom-made medical devices
A custom-made medical device is defined in the Therapeutic Goods (Medical Devices) Regulations 2002- external site (the Regulations) as a medical device that:
- (a) is intended by the manufacturer to be for:
- (i) the sole use of a particular patient (the intended recipient); or
- (ii) the sole use of a particular health professional (the intended recipient) in the course of the health professional’s practice; and
- (b) is manufactured by the manufacturer in accordance with a written request of a health professional (the requesting health professional) and with particular design characteristics specified by that health professional in the request (even if the design is developed in consultation with the manufacturer), where those design characteristics are intended to address:
- (i) either or both of the anatomical and physiological features of the intended recipient; or
- (ii) a pathological condition of the intended recipient; and
- (c) the requesting health professional has determined is necessary to address the matters covered by paragraph (b) because there is no kind of medical device included in the Register to address those matters or to address those matters to an appropriate level.
However, a custom-made medical device does not include a patient matched medical device, an adaptable medical device or other mass produced medical device.
- PageMedical devices reforms: Personalised medical devicesGuidance on progress of regulatory refinements to personalised medical devices.
- GuidanceCustom-made medical devicesInformation for manufactures, sponsors and health professionals on the definition of a custom-made medical device and how they are regulated by the TGA.