Software now plays a crucial role in most industries and sectors across the developed world. Digital platforms are critical to the performance, productivity and reach of most businesses. The healthcare industry is no exception. Software is changing how clinicians practice medicine, how individuals manage their own health, and how patients interact with their healthcare providers.
Regulatory changes targeted at software based medical devices, including software which can be classified as a medical device in its own right ('SaMD'), will take effect on 25 February 2021. The regulatory changes follow an extensive consultation and revision process, which was delayed by the COVID-19 pandemic.
This article provides a brief summary of what you need to know about the incoming changes:
- What is software as a medical device?
- Why are regulatory changes being made?
- What are the changes and which software is affected?
- How long do you have to comply?
What is software as a medical device ('SaMD')?
A medical device is defined in section 41BD of the Therapeutic Goods Act 1989 (Cth) to include most products which:
- are used in or for humans;
- are intended to be used to diagnose, prevent, monitor, treat or alleviate a disease or injury, or modify or monitor anatomy or physiological functions of the body; and
- achieve their intended purpose by a physical, mechanical or chemical action.
All therapeutic goods, including medical devices, are regulated in Australia by the Therapeutic Goods Administration ('TGA').
Software which falls within the definition of a medical device may include:
- software-based medical devices, for example, software which controls or configures another medical device; and
- software that satisfies the definition of a medical device in its own right, for example, software which analyses X-Ray or MRI images and provides diagnostic recommendations or information.
Why are regulatory changes for SaMD being made?
Challenges associated with the regulation of software as a medical device were considered by the International Medical Device Regulators Forum Working Group as far back as 2013. The Group published a series of technical guidance documents which were intended to address some of the regulatory issues encountered across several international jurisdictions.
In Australia, a number of inquiries have revealed concerns about medical devices and patient safety more broadly (not limited to SaMD). These include the National Department of Health's Expert Review of Medicines and Medical Devices Regulation and the Senate Community Affairs References Committee inquiry into transvaginal mesh implants and related matters.
In response to those concerns, the TGA announced a three-part strategy to strengthen Australia's regulatory system for medical devices on 4 April 2019. The overall purpose is to improve, on the one hand, the safety, quality and performance of devices supplied in and from Australia and, on the other hand, transparency and in turn, public confidence in the regulator. The reform strategy involves:
Strategy 1: Improving how new devices get on the market;
Strategy 2: Strengthening monitoring and follow-up of devices already in use; and
Strategy 3: Providing more information to patients about the devices they use.
The changes to the regulation of SaMD will take effect on 25 February 2021 and are part of Strategy 1.
What are the changes and which software is affected?
The key regulatory changes which will take effect on 25 February 2021 include amended essential principles to clarify the regulatory requirements for SaMD products and new classification rules for SaMD products.
The changes to the Essential Principles can be summarised below.
- Essential Principle 12.1 has been amended to clarify the technical expectations of SaMD products, including with regards to cyber security; the management of data and information; and requirements relating to development, production, and maintenance.
- Essential Principle 13.2(3) has been amended to allow information, where applicable, to be provided electronically for SaMD products, rather than in hard copy.
- A new Essential Principle 13B, introduces a requirement that all SaMD products clearly identify the current version and build number.
The new classification rules for SaMD products reflect a similar regulatory approach to that taken in the European Union Medical Devices Regulations 2017 (although there are some important differences between the two).
In summary, the new rules provide that all SaMD products will be classified according to:
a) the intended purpose of the product, namely whether it is intended to be used for:
- diagnosing and/or recommending treatment or intervention for a disease or condition;
- screening and/or specifying treatment or intervention for a disease or condition;
- monitoring the state/progression of a disease or condition; or
- providing therapy through provision of information; and
b) the level of risk posed by the product to individuals and/or public health, especially in the event that the product malfunctions or provides incorrect information to the user.
For every SaMD product, the higher the level of risk, the higher the classification and therefore, the more stringent the regulatory requirements will be.
Importantly, a number of SaMD products are specifically excluded from the regulatory requirements. These include:
- consumer health products including software intended to be used for self-management of an existing condition that is not serious (without providing specific treatment or treatment suggestions). For example: wearable fitness tracking devices and software 'apps' which promote behavioural changes to improve general health parameters (eg diet, exercise and UV exposure);
- enabling technology intended to support telehealth, remote diagnosis, healthcare or dispensing. For example, video-conferencing software, medical imaging storage and review software and health facility management software;
- digitisation of paper-based or other published clinical rules or data. For example, simple dose calculators, electronic patient records, patient surveys;
- population based analytics that do not drive outcomes for individuals; and
- laboratory information management systems including software that facilitates the electronic transfer of data between medical devices (but does not control any medical device or analyse any data).
In addition, some clinical decision support software is exempt from some of the regulatory requirements if it does not directly process or analyse medical information from another medical device, and is intended to provide or support a recommendation to a health professional but not replace the clinical judgement of such a professional.
The TGA has published a series of draft flow charts to assist sponsors and manufacturers determine how their product may be classified.
How long do you have to comply?
The new classification rules will apply to all new applications for inclusion in the Australian Register of Therapeutic Goods (ARTG) made on or after 25 February 2021.
Transitional arrangements will apply to devices which are currently included in the ARTG, or which are the subject of an application lodged before 25 February 2021, and would receive a higher classification under the new rules. Such products may continue to be supplied during the transition period under their existing classification as long as the TGA is notified by 25 August 2021. The transition period will end on 1 November 2024.
If you need assistance with navigating these changes, whether it's an application for approval of a new medical device, the possible reclassification of an existing medical device, or engaging with the TGA regarding the draft guidance document, feel free to contact us.
Note: The national reform strategy being implemented by the TGA is not limited to the regulatory changes described in this article. Other reforms relate to the conformity assessment certification requirements for some medical devices and the procedures for expedited ('priority') regulatory assessments. Other aspects of the reforms specifically affect systems and procedure packs, personalised medical devices, IVD companion diagnostic devices, disinfectants and tampons and menstrual cups.
If you have any questions about anything in this article or require assistance in relation to regulation of medical devices (whether SaMD or otherwise), please don't hesitate to contact a member of our expert team.
