Custom-Made Medical Devices | Changes – February 25, 2021

regulations-custom-made-medical-devices

Custom-Made Medical Devices | Changes – February 25, 2021

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

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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.

TypeDefinitionExample(s)New regulatory framework requirements
Patient-matched medical devicesDevices 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 devicesA 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:

 

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