So much can change over a nearly 20 year period. 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 Australian Therapeutic Goods Administration (TGA) has introduced specific guidance around what exactly constitutes an SaMD product, and defined new requirements for their regulation.

In February 2019, 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 by the Australian regulator 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.

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 current classification rules for medical devices 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. For this reason, the current classification rules result in 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 Under new regulations, current products classified as low risk Class I may be upclassified which will introduce increased scrutiny for manufacturers and sponsors.

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 life cycle 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 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 was due to come into effect on 25 August 2020. TGA has however, now proposed a new transition date of 25 February 2021. Transitional provisions are also in place for legacy devices.

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 with the revised regulations from the implementation date. In many cases, this will result in a higher risk classification, thereby requiring the SaMD product to undergo Conformity Assessment either by a Notified Body, or the Australian regulator directly, 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.

About Brandwood CKC

Brandwood CKC offers deep support for navigating international regulatory processes. Whether it’s a TGA application, a strategy for MDR transition, a US pre-submission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. Brandwood CKC understands you need a commercial approach which delivers viable options.

Contact Brandwood CKC to discuss your needs and how they can help. You can drop them an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)