On 25 February 2021 the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) (Regulations) were amended to introduce a new regime for the regulation of personalised medical devices. The amendments:
- reduced the scope of the existing definition of a custom-made medical device and introduced three new categories of personalised medical device, including patient-matched medical devices, adaptable medical devices, and medical device production systems; and
- altered the requirements for whether a personalised medical device must be included (registered) in the Australian Register of Therapeutic Goods (ARTG).
The amendments have wide reaching implications for dentists and dental laboratories that manufacture personalised orthodontic appliances, dental implants or other medical devices.
Supplying an unregistered medical device is ordinarily a criminal offence, which can attract a penalty of imprisonment for up to 5 years or a fine of 4,000 penalty units ($888,000), or both. For corporations the fine can reach 50,000 penalty units ($11,100,000). Prior to the amendments, personalised medical devices that met the definition of a custom-made medical device were exempt from the requirement to be registered on the ARTG.
The old definition
Prior to 25 February 2021, a custom-made medical device was a device made for a particular individual specifically in accordance with the request of a health professional. The request had to specify the design characteristics or describe how the device was to be constructed. The definition also encompassed a medical device used by a health professional where the device met the special needs of the health professional’s practice.
The expansive nature of the old definition meant that most devices manufactured by dentists or dental laboratories for individual use by patients were subject to the custom-made medical device exemption. The exemption included most occlusal splints, wax try-ins, surgical guides, aligners, retainers, braces, dentures, implants and other custom made orthodontic appliances.
While dentists and dental laboratories were not required to register the devices they made under the custom-made medical devices exemption they were required to notify the Therapeutic Goods Administration (TGA) of the kinds of custom-made medical devices they manufactured or imported. They were also required to provide the patient with a range of information regarding, instructions, warnings, restrictions, and handling or storage requirements.
The new definition
From 25 February 2021, a custom-made medical device must be intended for the sole use of a particular patient (or a particular health professional in the course of their practice). It must be manufactured in accordance with a written request of a health professional, and the request must detail particular design characteristics that are intended to address the anatomical or physiological features or a pathological condition of the intended recipient (i.e. the patient or health professional).
The requesting health professional must also have determined there is no other kind of medical device included in the ARTG that addresses the intended recipient’s condition to an appropriate level. The new definition of a custom-made medical device also expressly excludes patient‑matched medical devices, adaptable medical devices or other mass‑produced medical devices.
In addition, for a custom-made medical device to be exempt from registration, the manufacturer or sponsor (as applicable) must satisfy additional requirements which include that the manufacturer or sponsor of the device must:
- retain sufficient evidence to substantiate that the conformity assessment procedures were applied to the device;
- allow the TGA to enter and inspect the manufacturer’s premises (including those outside of Australia); and
- on request, produce to the TGA the health professional’s request for the device.
Failure of a sponsor or manufacture to satisfy these additional requirements means that the device is no longer exempt from the offences and penalty provisions of Division 3 of Part 4-11 of the Therapeutic Goods Act 1989 (Cth).
Patient-matched medical devices
A patient-matched medical device is a medical device that:
- is manufactured ‘within a specified design envelope’ to match the anatomical or physiological features or pathological condition of a particular individual; and
- is designed by the manufacturer (often in consultation with a health professional) using production processes that are capable of being validated or verified and reproduced.
The term ‘specified design envelope’ means the minimum and maximum dimensions, performance limits or other relevant factors that characterise a medical device for production purposes. The specified design envelope may be based on a standard device template.
Where a kind of medical device satisfies the definition of a patient-matched medical device, it must be registered on the ARTG before it can be supplied in Australia (subject to the transitional arrangements referred to below).
When registering a patient-matched medical device on the ARTG, the sponsor must determine the correct classification of the device. Medical devices that are not in vitro diagnostic devices are classified as either class I, IIa, IIb, III, or AIMD (active implantable medical device).
The higher the classification of the device, the greater the risk of potential harm it poses, with class I being the lowest risk through to class III or AIMD being the highest risk. Higher classification devices are subject to tighter regulatory controls in relation to both pre-market assessment and post-market authorisation (see the TGA’s overview of medical devices regulation).
The recent amendments introduced a new device classification system relevant to dental devices, which distinguishes between whether devices are non-invasive, invasive (e.g. used in oral cavities) or surgically invasive (e.g. dental implants), and whether they are intended for transient, short-term or long-term use. The new regime also recognises certain diagnostic imaging and anatomical models as medical devices.
The classification rules for medical devices other than IVD medical devices are set out in Schedule 2 of the Regulations. Example classifications of common dental medical devices are set out at Table 1 below.
Adaptable medical device
An adaptable medical device is a mass-produced device. It is intended by the manufacture to be assembled or adapted to address the anatomical and physiological features or pathological condition of a particular individual. Unlike custom-made medical devices or patient-matched medical devices, adaptable medical devices are not manufactured in response to a dentist’s requests but pre-manufactured and then adapted by the dentist to suit the patient. Adaptable medical devices must therefore be registered on the ARTG before they can be supplied.
Devices produced using a medical device production system
The last key definition introduced by the amendments relates to the concept of a medical device production system, which is a system that consists of raw materials and production equipment, that is intended by the manufacturer to be used by a health professional, or suitably qualified person within a healthcare facility, to produce a particular medical device for a patient.
Where a health professional uses a medical device production system that is registered on the ARTG to produce a medical device, the health professional will not be required to register the finished product (medical device) provided that they followed the instructions for use of the medical device production system.
Notification and reporting requirements for custom-made medical devices
Within 2 months after first manufacturing a custom-made medical device in Australia, the manufacturer (dentist or dental laboratory) must give the following information about the device to the TGA:
- the manufacturer’s name and business address; and
- a description of the kinds of medical devices being custom made by the manufacturer, including the device nomenclature system code for any such devices (e.g. the GMDN code).
If a dentist uses an overseas dental laboratory to manufacture a custom-made medical device and the dentist imports the device, the dentist will be considered the sponsor. Within 2 months after first importing a custom-made medical device into Australia, the sponsor must give the following information about the device to the TGA:
- the sponsor’s name and address; and
- the manufacturer’s name and business address.
The initial notification form can be accessed via: https://www.tga.gov.au/custom-made-medical-devices
The manufacturer or sponsor of a custom-made medical device must, prior to 1 October each year, provide the TGA with a written report in the approved form setting out details of the devices manufactured or imported that financial year.
In addition to the TGA notification requirements, manufacturers or sponsors are required to give information to patients regarding the medical devices they supply. The general information that must be provided with all medical devices is set out at in Schedule 1 of the Regulations. Further specific information that must be provided to patients with custom-made medical devices is set out at Schedule 3 of the Regulations.
Patient-matched medical devices, adaptable medical devices, mass‑produced medical devices or other devices that require registration on the ARTG are subject to the reporting requirements relating to registered medical devices, which includes notifying the TGA about adverse events or problems associated with the device.
Transitional arrangements for patient-matched medical devices
The amendments included transitional arrangements for patient-matched medical devices that are manufactured on or after 25 February 2021 and before 1 November 2024.
A sponsor or manufacturer of a patient-matched medical device is exempt from having to register the device provided it notifies the TGA in writing before 25 August 2021 of each kind of patient-matched medical device it intends to supply in Australia on or after 1 November 2024.
The sponsor must also notify the TGA of the following:
- the name and address of the sponsor;
- the name and address of the manufacturer of that kind of medical device;
- the device nomenclature system code (GMDN code) of that kind of medical device;
- the medical device classification of that kind of medical device; and
- the unique product identifier given to each medical device of that kind.
Where the sponsor notifies the TGA of the above, it will be able to supply patient-matched medical devices until 1 November 2024 without having to first register the device on the ARTG.
This article was written by Karen Keogh, Partner and David Wallace, Associate.
Table 1: Example classifications of common dental medical devices
|Medical Device||Intended Use||Classification||Rationale|
|Occlusal splint||To reduce tooth wear from bruxism or relieve temporomandibular joint pain or facial muscle pain||Class I||Likely a class I device in accordance with Classification Rule* 3.1(2)(b)(ii).|
|Bleaching tray||To whiten teeth||Excluded||Likely excluded as dental bleaches and dental whiteners are excluded (see item 3 of Schedule 1 of the Determination†).|
|Mouth guard||To prevent sports induced trauma||Excluded||Excluded (see item 2A of Schedule 1 of the Regulations‡)|
|Wax-up||To show patient cosmetic transformation||Excluded||Likely excluded as does not meet the definition of a medical device under section 41BD of the TG Act¥.|
|Special trays||Preparation steps for dentures||Excluded||Conditionally excluded under item 11 of Schedule 2 of the Determination.|
|Occlusal rims and wax try-ins||Preparation steps for dentures||Class IIa||Where the device is used in the 'investigation of the anatomy or of a physiological process' it will be considered an 'anatomical model', which is a class IIa device, in accordance with Classification Rule 5.4.|
|Radiographic guide||To take Cone Beam Computed Tomography scans||Class IIa||Likely a class IIa medical device in accordance with Classification Rule 5.4(1).|
|Surgical guide||To prepare for surgical implant||Class IIa||Likely a class IIa medical device depending on application of classification rule 5.4(2).|
|Removable orthodontic device||To treat orthodontic conditions without a surgically invasive device||Class I||If the device is intended for transient or short term use (up to 30 days continuously) in the oral cavity it will likely be classified as class I in accordance with Classification Rule 3.1(2).|
|Non-removable orthodontic device||To treat orthodontic conditions without a surgically invasive device||Class IIa||Likely a class IIa device if used for long term (i.e. more than 30 days continuously). See Classification Rule 3.1(2)(c)(ii)|
|Removable passive retainer||For retention post-orthodontic prescription||Class I||If not used continuously for more than 30 days, then likely to be a class I.|
|Removable dentures (partial or complete)||To restore function & aesthetic||Class I||If not used continuously for more than 30 days, then likely to be a class I.|
|Locator implants for overdentures||To support overdentures||Class IIb||Locator implants are likely to be a class IIb device. See classification rule 3.4(2).|
* The Classification Rules are set out in Schedule 2 of the Regulations.
† The Determination: Therapeutic Goods Excluded Goods Determination 2018 (Cth)
‡ The Regulations: Therapeutic Goods (Medical Devices) Regulations 2002 (Cth)
¥ The TG Act: Therapeutic Goods Act 1989 (Cth)