The Therapeutic Goods Administration (TGA) of the Department of Health, the Australian authority responsible for medical device registration, published a proposed regulatory scheme for personalised medical devices, including those that have been 3-D printed. The document describes the existing situation in detail, surrounding regulations and the particular requirements applicable to the devices of this kind.
Personalised Medical Devices: Scope and Definitions
If a particular patient needs a specific device with characteristics that differ substantially from the standard devices of the appropriate kind already available on the market, healthcare professionals engaged in the treatment of such a patient have two options. They could either create the device needed themselves, or contact a manufacturer to arrange making the devices in accordance with the specifications provided. Since Australia has already started the review of the medical device regulatory framework as a whole, the regulations governing operations with personalised devices would be subject to certain changes and improvements. At this moment in time, the authority considers the possibility to amend existing regulations and assess possible solutions and approaches.
In accordance with the current legislation, personalised devices are regulated as custom-made medical devices and thus, subject to the appropriate exemption. The Therapeutic Goods (Medical Devices) Regulations 2002, core legislative act regulating the sphere of medical devices circulation, provides the definition of the custom-made medical device prescribing that this type of device is one that is:
- Created according to the specifications provided by healthcare professionals in accordance with the particular requirements related to its features and characteristics;
- Created and intended to be used only by a particular patient or particular healthcare professional.
Depending on the personalisation, medical devices could be divided into the following groups:
- Custom-made medical devices made in accordance with the particular needs of one or several recipients to be used by an individual patient or a particular healthcare professional that would be responsible for the device. Such devices are manufactured on-demand providing that there is no device that meets the particular needs already present on the domestic market. Particular specifications are developed by a healthcare professional, who requests a manufacturer make the device needed.
- Patient-matched medical devices that meet the needs of a particular individual (patient) and therefore could only be used by this particular patient. Devices of this type are also manufactured on demand and could be requested either by a healthcare professional or another person, so the manufacturer remains responsible for the device for its whole life cycle. As usual, a device of this type constitutes a standard device adopted by the manufacturer to meet the needs of a particular patient.
- Adaptable medical devices could be adapted to meet the needs of a particular patient after being supplied due to the specific features of design and construction. In this case, the manufacturer predicts expected use scenarios in advance and implements the appropriate elements in the design of the device, which provides healthcare professionals and institutions that use such devices with additional flexibility. The manufacturer provides detailed instructions describing the way the device could be adapted to meet the particular needs and remains responsible for the device during its whole lifecycle.
- Non-adaptable (mass-produced) devices are standard devices designed to meet average requirements and to be used in common situations. They are not specially designed or made to be used by a particular patient or healthcare professional. The manufacturer determines all specifications and remains wholly responsible for such devices.
Current Regulation of Personalised Medical Devices in Australia
Any and all medical devices should be included in the Australian Register of Therapeutic Goods (ARTG) in order to be able to be imported to Australia and placed on the domestic market. To get marketing approval, the device should pass the procedure of conformity assessment aimed at the evaluation of safety, quality and performance of the device for the intended purpose as defined by the manufacturer. In particular, the manufacturer must evaluate the evidence confirming that the device complies with applicable regulations.
To be allowed to include the medical device to the ARTG, the manufacturer shall demonstrate compliance with all requirements established for the particular type of medical device depending mostly on the risk associated with the use of the device in accordance with risk-based classification. At the same time, in the case of custom-made medical devices, the requirements and the regulatory approach could differ substantially. In particular, such differences are mostly connected with the spheres of:
- The conformity assessment procedure;
- Compliance with the essential principles;
- Rules regarding the exemption from entering into the register;
- Adverse events reporting and record keeping.
Requirements to Personalised (Custom-made) Medical Devices
According to the Australian risk-based classification, there are three classes of devices where Class I refers to the devices with the lowest risk and Class III refers to high-risk devices. All medical devices except Class I non-sterile devices without measuring functions are subject to obligatory third-party assessment and state registration. At the same time, custom-made devices are exempt from the aforementioned requirements, so the manufacturer only needs to consult with TGA in the case of certain kinds of devices and also to duly keep records for each particular device and inform the authority about all incidents taking place when using these devices. It is important to mention that the monitoring system existing now with regard to custom-made devices is quite weak since the authority mostly focuses on the devices subject to conformity assessment and registration. This approach is based on the position that custom-made (personalised) devices are associated with low risk.
Essential principles are ones established to set forth basic requirements related to the safety and performance of medical devices. According to the documents, all essential principles could be divided in the following way:
- General essential safety principles that could be applied to any device,
- Principle on information to be provided,
- Principle on clinical evidence requirements,
- Design and construction principles to be applied in certain cases.
Thus, the principles listed above establish the general approach to medical devices regulation while do not establish the requirements regarding the way the manufacturer shall confirm the compliance with such principles. At the same time, it is important to mention that according to the information provided by the authority, custom-made medical devices are not subject to obligatory compliance with all these principles.
The authority emphasizes that under the general rule, custom-made medical devices are exempt from the obligatory inclusion to the ARTG. Thus, no third-party assessment or approval is needed. This approach is based on the specifics of personalised devices due to which some of the general requirements could not be applied to such devices. This also leads to a situation where some of the regulatory mechanisms connected with the ARTG could not be applied to personalised devices, e.g. removal from the market or cancellation of the registration.
As it was already mentioned above, the manufacturer of personalised devices should inform the regulating authority about the devices it manufactures, and also to duly keep records for each device within 5 years.
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