Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019 (Cth)
This article applies to organisations that manufacture medical devices.
Schedule 2 and 3 of the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019 (Cth) (the Amending Regulations) commenced on 25 February 2021, amending the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) (the Regulations).
Programmed or programmable medical device or software that is a medical device
Meaning of medical device
We note that the Amending Regulations are part of a suite of changes introduced to modernise the regulation of medical devices in Australia. In particular, these changes commenced alongside the Therapeutic Goods (Excluded Goods) Amendment (Software-based Products) Determination 2021 (Cth) (the Determination). Given its relevance to the Amending Regulations we have briefly discussed the effects of the Determination below.
The Determination clarifies when software as a medical device (SaMD) will not be regulated by the Therapeutic Goods Administration (the TGA). Under the Determination several categories of SaMDs are excluded, including SaMDs for:
- consumer health life-cycle prevention, management and follow up devices;
- enabling technology for telehealth, health care facility management;
- digitisation of paper based data;
- population based analytics.
We note that each of the above categories is expanded upon in the Determination and must meet certain conditions to be excluded. For example, typically a medical device will not be excluded if it is intended to be used or the purpose of diagnosis, screening, prevention, monitoring, prediction, prognosis, alleviation, treatment, or making a recommendation or decision about the treatment, of a disease, condition, ailment or defect.
The Amending Regulations have inserted new risk-based classifications in relation to programmed or programmable medical devices, or software that is a medical device (devices), into the classification rules for medical devices other than IVD medical devices, located in Schedule 2 of the Regulations. The new classifications cover the following uses for devices:
- use in relation to diagnosing or screening for a disease or condition;
- use for monitoring the state or progression of a disease or condition;
- use in specifying or recommending treatment or intervention;
- providing therapy to a person through the provision of information.
The new classification rules for SaMDs and programmable medical devices classify the device according to its potential to cause harm.
The Amending Regulations have also amended the essential principles contained in the Regulations to address SaMD’s more specifically. The essential principles set out the design and manufacturing requirements for all medical devices. Manufacturers that design and produce devices are required to ensure their safety, reliability and performance, and manage risk as required prior to the amendments, however manufacturers must now also design and produce devices ensuring the following:
- the resilience of the device in relation to interactions;
- suitable warnings provided by the device where required (for example where a disruption to the device could cause harm to a patient);
- user’s ability to verify correct operation of the device;
- maintenance of the integrity and quality of any data or information, including privacy.
In addition, devices must be developed, produced and maintained in line with current advancements in technology, instructions for use are to be provided and cybersecurity issues must be taken into account. Devices that are software or incorporate software must also have a version number and build number available to users of the device.
The TGA has released guidance that covers all of the regulatory changes for software based medical devices. This guidance can be accessed here.
Personalised medical devices
Custom-made medical devices are exempt and are not required to be included in the Australian Register of Therapeutic Goods (the ARTG). The Amending Regulations have significantly reduced the scope of medical devices captured under the custom-medical device exemption. This means that many medical devices will no longer be exempt. We anticipate that this will have a significant impact for any organisation currently relying on the custom-made medical device exemption.
The Amending Regulations have also amended the definition of a custom-made medical device exemption which is now intended to cover rare one-off bespoke pieces for patients who cannot utilise other medical devices.
The definition of a custom-made medical device now excludes ‘patient-matched medical devices’, ‘adaptable medical devices’ or other mass-produced medical devices. Organisations that will still rely on the custom-made medical device exemption should be aware that the Amending Regulations have inserted new conditions which they will have to comply with.
The conditions require manufacturers to:
- provide annual reports for custom-made medical devices that were supplied in the previous year;
- allow the TGA to conduct inspections;
- hold records about the device for 5 years (for non-implantable) or 15 years (for implantable devices).
Patient-matched medical devices
Most significant, is the introduction of the ‘patient-matched medical devices’ which previously were exempt under the custom-made exemption, but now must be included in the ARTG.
A patient-matched medical device means a medical device that:
- is manufactured and designed within a specific design envelope to match:
- either or both of the anatomical and physiological features of a particular individual; or
- a pathological condition of a particular individual; and
- is designed by the manufacturer (even if the design is developed in consultation with a health professional); and
- is manufactured using production processes that are capable of being either or both validated and verified and reproduced.
The TGA provided examples of retainers or orthopaedic implants that may be considered a patient-matched medical device, provided the above definition is satisfied. Notably, the TGA has advised that most devices made under the custom-made medical device exemption would now be considered patient-matched medical devices.
Medical devices that were supplied in Australia before 25 February 2021 under the custom-made medical device exemption will be eligible for a transition period that will extend the deadline from 25 February 2021 to 1 November 2024.
To receive the extended deadline manufacturers must submit a notification of transition before 25 August 2021. The notification can be made here. If a notification is not made, the device must cease being supplied from 25 August 2021, unless it is registered on the ARTG.
New patient-matched medical devices that were not supplied in Australia before 25 February 2021 will not be eligible for the transition period and will need to comply with the new requirements from 25 February 2021.
Adaptable medical devices
Adaptable medical devices are also excluded from the definition of a custom-made medical device. Adaptable medical devices are medical devices that are intended by the manufacturer to be assembled or adapted after it has been supplied, in accordance with to manufacturer’s instructions to address certain features of a particular individual. Generally, the health practitioner adapting these devices is not considered a manufacturer, providing they follow the instructions given by the manufacturer.
Medical device production systems
The Amending Regulations have also introduced the concept of medical device production systems (MDPS).
An MDPS means a system that consists of raw materials and main production equipment (whether or not the system also consists of software), where the system is intended by the manufacturer to be used (whether or not with ancillary inputs or equipment) by a health professional, or suitably qualified person within a healthcare facility, to produce a particular medical device for use in relation to a patient of the health professional or healthcare facility.
A unique feature of the MDPS is that it will, rather than a health practitioner, generally be the manufacturer of a medical device.
Specifically, the Amending Regulations also prescribe health professionals, or suitably qualified persons within a healthcare facility, who produce a medical device (the final device), as not being manufacturers of medical devices, where the following criteria are satisfied:
- a medical device production system is used to produce the final device;
- the medical device production system is included in the Register as a kind of medical device.
We recommend that organisations review the guidance published by the TGA for a detailed summary of the regulatory changes to personalised medical devices. This guidance can be accessed here.
Organisations that currently utilise the custom-made medical devices exemption must reassess their medical devices and consider whether they are still exempt. If not, these organisations must notify the TGA if they intend to benefit from the transition period. Organisations who intend to manufacture new ‘patient-matched medical devices’ must ensure they comply with the new requirements. Manufacturers of SaMDs or programmable medical devices should review the new exclusions and ensure their design and manufacturing processes are updated to comply with the changes to the essential principles.
For further information please contact the Law Compliance team:
Phone: 1300 862 667