Software as a Medical Device – Upcoming Changes to the Australian Regulations
With advancements in software and medical device technology extending beyond the current scope of the Therapeutic Goods Regulations, new legislation is due to take effect in August 2020.
Since the Australian Regulatory Framework for medical devices was adopted in 2002, the use and accessibility of software in medical applications has advanced beyond expectation. At the time of introduction, software was largely controlled by, and integrated into, physical medical devices. Software that was standalone and which could analyse data, inform, or even replace, clinical decision making and clinical diagnoses, was almost science fiction.
And in an age where just about everyone is consumed by access to ‘smart’ devices, from phones and tablets to watches, the lines between consumer products, medical devices and Software as a Medical Device (SaMD) are inherently blurred, and as a result, the TGA has introduced specific guidance around what exactly constitutes a SaMD product and defined new requirements for their regulation.
In February 2019, the TGA released a proposal for the regulation of software, including SaMD, and outlined some of the very real limitations regarding the current state of SaMD regulation in Australia.
The limitations identified included:
- The classification rules do not adequately consider the potential for SaMD to cause harm to patients.
- The ability for SaMD to be directly accessed and downloaded by users/patients without physician prescription/management or regulatory oversight on post-market actions.
- A lack of clarity in the regulatory requirements for demonstrating SaMD safety, quality, and performance.
The proposal was open for consultation for six weeks, receiving extensive industry feedback, and culminated in the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019.
So, just how is Software as a Medical Device (SaMD) regulated under the existing legislation?
The current regulations do not include provisions for software and SaMD separately to physical medical devices. Where this poses particular issue, is that the classification rules that exist for medical devices currently only consider the possible harm caused by a physical interaction of a medical device with a human. As SaMD does not have this physical interaction, the risks associated with these types of products relate more to analysis and calculation errors, and inaccuracy in diagnoses and clinical/treatment recommendations.
It is for this reason, the current classification rules result in the classification of SaMD products that do not necessarily align with the level of risk posed to the patient.
What does this mean for SaMD manufacturers and sponsors?
Limitations with the current regulations mean that many SaMD products are classified as low risk even though the potential risk for users may be much higher. As Class I medical devices do not require third-party oversight for entry onto the ARTG, this has meant a streamlined and time-efficient ARTG registration process and Australian market entry for manufacturers and sponsors of SaMD products.
What changes will be introduced for SaMD under the new regulations?
Following the implementation of the new legislation, practical changes will be seen in the SaMD regulatory environment in Australia, including:
- New classification rules, largely aligned with the EU MDR.
- Amendment to Essential Principle 12.1 relating to cybersecurity, privacy and data security, and lifecycle controls.
- Amendment to Essential Principle 13.2(3) to allow electronic provision of Instructions for Use.
- New Essential Principle 13B to state that the version number of the software must be identifiable.
How will this affect manufacturers and sponsors?
Introduction of classification rules directly relevant to SaMD, and the unique scope of risks they pose to patients, means that many SaMD products currently classed as low risk (Class I) will increase in classification to Class IIa, Class IIb and Class III medical devices and would, therefore, require manufacturers to obtain Conformity Assessment certification to allow inclusion on the ARTG.
When do the changes come into effect?
The legislation is due to come into effect on 25 August 2020.
For manufacturers and sponsors with existing SaMD ARTG entries, or who have filed ARTG applications prior to 25 August 2020, there will be a transition period to comply with the new regulations once they come into effect. Sponsors will have up until 1 November 2024 to reapply for inclusion of their SaMD products on the ARTG under the new classification rules.
For new applications, manufacturers will be required to conform to the revised regulations from the implementation date. In many cases, this will result in higher risk classification, thereby requiring the SaMD product to undergo Conformity Assessment prior to entry on the ARTG.
The changes to SaMD products are not the only thing covered by the new legislation due for implementation on 25 August. We will also see the introduction of regulatory changes for personalised medical devices, and further reclassifications in some specialist device areas.
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