Australia’s Department of Health has published the first set of amendments to the Therapeutic Goods (Medical Devices) Regulations in the course of amending the medical device framework. This framework was developed on the basis of information collected through public consultations held at the end of 2018 and the beginning of 2019. The authority notifies that additional amendments will take place in the future, so the Therapeutic Goods Administration (TGA), a state agency responsible for medical device regulation, will continue to cooperate with the parties involved to develop an efficient framework.
Software-Based Medical Devices
Despite the fact that medical device regulation based on the risk associated with the use of the device would remain immutable, some substantial changes are set to take place shortly. The most important changes are related to innovative devices utilizing software, namely:
– The agency implements new classification rules based on the risk of causing harm to patients by providing data and information that could be potentially wrong or erroneous. These rules are based on the principles introduced by the EU Medical Devices Regulation 745/2017 (MDR) for the purpose of harmonization with EU regulation. It is important to mention that due to the new changes certain medical devices would be assigned to lower classes while devices intended for monitoring and diagnostic purposes would mostly remain in the same classes. At the same time, therapeutic medical devices should be assigned to higher classes. The TGA also notifies that these changes would not cover the classification of in vitro diagnostic medical devices.
– Additional requirements for the development, production and maintenance would be implemented to cover issues related to cybersecurity and protection of information.
– Medical devices based on the utilization of software would be subject to another application procedure allowing manufacturers to submit all information in electronic form rather than in paper form.
– Under the new requirements, the information on the type of software should be made accessible to users of the appropriate medical devices.
These changes will enter into force on August 25, 2020.
Custom-Made and Companion Diagnostics Medical Devices
The new changes also include amendments to the regulations on personalized (custom-made) medical devices. In accordance with the new changes, the definition of the custom-made medical device would be more strict while additional definitions of personalized medical devices would be introduced. Exemptions on custom-made medical devices would also be subject to changes, such as:
– It would be required to provide an annual report for devices provided within the previous year,
– The agency would be entitled to perform on-site inspections of production facilities,
– All information on supplied devices should be stored for 5 and 15 years for non-implantable and implantable devices respectively.
The amendments also implement a Medical Device Production System (MDPS) and a special regulation under which healthcare facilities would be able to produce personalized medical devices without the obligatory certification as long as these devices would be used only internally by the facility itself. Due to changes to the classification rules, certain imaging devices would be assigned to a higher class.
With software-based medical devices, the new regulations would become effective on August 25, 2020. Some types of custom-made medical devices would also be regulated under transitional provisions. The amendments also introduced the concept of “IVD companion diagnostic medical devices” to harmonize the Australian regulation with the US and EU regulatory practice. According to the definition, devices of this type would be used to select patients when it is necessary due to the nature of therapy and other operations. Companion diagnostic medical devices are IVDs providing information necessary for safe use of the appropriate medicines. All devices of this type would be subject to the regulations applicable to Class 3 IVDs under which a compulsory audit should be held.
To be defined as IVD companion diagnostics, a device should meet the following criteria:
– It should be either IVD or in-house IVD produced by the healthcare facility or laboratory,
– Its main purpose should be to decide whether the benfit or risk of the use of the medicinal product is greater, or to monitor the way the patient’s organism responses on the particular medicinal product,
– The information provided by the manufacturer with the device should explicitly indicate that it is necessary to use the device to ensure safety when using particular medicine,
– It should not be intended for the purpose of assessing biological compatibility.
It is important to mention that the described criteria are the same as used for IVD comparison diagnostic medical devices under the regulatory framework established by the US Foods and Drugs Administration (FDA) and in the European Union. The new rules on IVD companion diagnostics would enter into force on February 1, 2020, while some of the devices would be subject to regulation under the transitional framework. The agency also requires making all applications regarding the devices of such type prior to June 30, 2022.
According to the amendments, the changes to classification rules are more substantial than new classification rules for software-based devices described above. Due to these changes, certain devices would be subject to reclassification. For example:
– Spinal implantable devices used to restrict motions for patients with serious injuries currently defined as Class IIb medical devices would be partially subject to classification under Class III (in particular, the devices contacting the spinal column). As any and all implantable medical devices, they would also be subject to obligatory audits.
– Active medical devices would also be defined as Class III medical devices instead of Class IIa and Class IIb used previously if such devices have diagnostic functions and could be used for patient management. In general, all active implantable medical devices and accessories thereto should be defined as Class III.
– Medical devices used to introduce a substance into the human body or administer medicines should be reclassified into a higher class. This group includes all devices used for inhalation purposes or to deal with severe cases and life-threatening conditions, and also the devices containing medicinal substances that should be introduced into the patient’s organism.
– Medical devices contacting the most important organs and systems of the human organism, including the heart, central circulatory system or central nervous system are also subject to reclassification. Under the new rules, such devices should be classified as Class III devices instead of Class IIa as provided by the rules existing before.
New classification rules introduced by the present amendment would take effect on August 25, 2020.
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