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Update on software as a medical device (SaMD)

TGA presentations: ARCS Scientific Congress Canberra, 10-11 August 2016

18 August 2016


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  • Presented by: Patrick L O'Meley
  • Presented at: ARCS Scientific Congress
  • Presentation date: 10-11 August 2016
  • Presentation summary: This presentation will explore the definition of a medical device and how this applies to software. In addition, the nuances of the kinds of software will be discussed in relation to their likely classification as a medical device.


Update on software as a medical device (SaMD)

The TGA and IMDRF perspectives

Patrick L O'Meley
Biomedical and Software Engineer
Device Vigilance and Monitoring Section, Medical Devices Branch
Medical Devices and Product Quality Division, TGA

ARCS Scientific Congress Canberra, 10-11 August 2016

Slide 1 - Overview

  1. What is a "Medical Device"?
    • Definition and Regulation but not classification
  2. Software as a Medical Device (SaMD)
    • IMDRF working group update (NOT a regulation framework)
  3. Pre and Post-market perspectives
    • Issues and challenges of software Devices
  4. Q and A
    • Time permitting...

Slide 2 - Is it a "device"? Definition

41BD What is a medical device

  1. A medical device is:
    1. any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:
      1. diagnosis, prevention, monitoring, treatment or alleviation of disease;
      2. diagnosis, ________, monitoring, treatment, alleviation of or compensation for an injury or disability;
      3. investigation, replacement or modification of the anatomy or of a physiological process;
      4. control of conception;
    2. and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means (cont...)

Slide 3 - Is it a "device"? Definition

41BD What is a medical device (cont.)

...and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or

    • (aa) any instrument, apparatus, appliance, material or other article specified under subsection (2A); or
    • (ab) any instrument, apparatus, appliance, material or other article that is included in a class of instruments, apparatus, appliances, materials or other articles specified under subsection (2B); or
  1. an accessory to an instrument, apparatus, appliance, material or other article covered by paragraph (a), (aa) or (ab).

Note: Declarations under subsection (3) exclude articles from the scope of this definition. Declarations under section 7 can also have this effect: see subsection 7(4).

Slide 4 - Is it a "device"? What's the Intended Purpose?

41BD 2 Intended Purpose

  • "Intended Purpose" is to be derived from labelling, instructions, advertising material and technical documentation, provided by the Legal Manufacturer
    • (the person under whose name the main equipment).
  • NOTE:
    • The Secretary may declare particular things, devices, classes, types, or articles to be Medical Devices
    • ... or NOT!
    • Such a declaration under this section does not stop articles from being therapeutic goods.
    • Such a declaration takes effect on the day on which the declaration is published - unless specified.

Slide 5 - Is it a "device"? Software becomes a device...

...when it meets the definition of what is a medical device.

That is, when the legal manufacturer intends* for the software to be used in:

  • diagnosis,
  • prevention,
  • monitoring,
  • treatment, or
  • alleviation, of disease

* The intention is ascertained from statements made by the Manufacturer in labelling, instructions, advertising material or any other documentation provided with or about the software.

Slide 6 - Is all "medical software" regulated by TGA?

  • NO (please see previous discussion)
  • EXCLUSIONS may include:
    • Software that is limited to managing and presenting information (HIS, dosage calculator)
    • Software that are simply sources of information (like a textbook) or advice to health professionals or consumers
      • (except if it relates to the advertising of therapeutic goods, labelling, and instructions for use)
  • INCLUDED likely includes
    • Software that has a role in diagnosing or managing illness
    • Software that analyses clinical data, such as the results of blood tests or ECGs
  • The TGA already regulates medical device software used for therapeutic purposes under the medical devices regulatory framework. Mobile apps would be considered within this framework.

Slide 7 - Is it regulated? Software regulated by TGA

  • Software Used in Manufacturing
  • Software for maintaining QMS
  • Software systems and toolsets
  • Software with a therapeutic purpose
    • Firmware/embedded Software in
      • Monitors, Defibrillators, Pumps
      • In vitro diagnostic devices
      • Implantable (Pacemakers etc)
    • Traditional Applications
      • Central Station on a PC
    • Standalone Software (on a disk only)
    • Apps (from app store)

Generally NOT Regulated:

  • No therapeutic purpose
    • (not itself, nor part of, a device)
  • HIS, LIMS, PACS...
    • Info storage and retrieval only with no "device" functions/features

Possible room for doubt:

  • Configuration/Setup Software
  • Service Tools
  • "Measurement" displays (graphs etc)

Slide 8 - How is software regulated by TGA?

  • The TGA regulates medical device software used for therapeutic purposes under the medical devices regulatory framework (if they meet the definition).
    • Mobile apps would be considered within this framework
    • Standalone Software would also be considered within this framework
  • Regulation is risk based, and depends on the intended purpose
  • Manufacturers of medical device software products (other than Class 1 - lowest risk) to obtain Conformity Assessment certification,
  • All medical devices are expected to meet the Essential Principles for safety and performance.
  • For further information, please refer to Section 13 in Part 2 of the Australian Regulatory Guidelines for Medical Devices (ARGMD).

Slide 9 - Measuring functions - a point of contention

1.4 Medical devices with a measuring function

  1. For these Regulations, a medical device has a measuring function if the device is intended by the manufacturer to measure:
    1. quantitatively a physiological or anatomical parameter; or
    2. a quantity, or a qualifiable characteristic, of energy or substances delivered to or removed from the human body.
  2. The measurements given by a medical device that has a measuring function:
    1. must:
      1. be displayed in Australian legal units of measurement or other units of measurement approved by the Secretary for the particular device; or
      2. be compared to at least one point of reference indicated in Australian legal units of measurement or other units of measurement approved by the Secretary for the particular device; and
    2. must be accurate to enable the device to achieve its intended purpose.

Slide 10 - IMDRF International Medical Device Regulators Forum


IMDRF - SaMD Quality Management Principles: A grouping of QMS activities from a software perspective

  • A governance structure provides leadership, accountability and an organization with adequate resources that assures the safety, effectiveness and performance of SAMD;
  • SaMD lifecycle processes - A scalable set of quality processes that apply commonly across lifecyle activities;
  • A set of key lifecycle activities that is scalable for the type of SaMD, the size of the organization takes into account important elements required for assuring the safety, effectiveness and performance of SaMD.
  • Leadership and organizational support provides a foundation for SaMD lifecycle processes
  • SaMD lifecycle processes support and apply across the saMD lifecycle activities.

Diagram of concentric rings displaying the following from the outside in: Leadership and Organizational Support, Managing SaMD lifecycle Processes, and SaMD Lifecycle activities.

Slide 11 - IMDRF - SaMD: several key achievements

  • Definitions paper - what is SaMD
  • Risks paper - framework for classifying risk
  • Quality Management Systems (QMS) - translating QMS into SaMD development
  • Clinical Evidence - WIP

Slide 12 - IMDRF SaMD - Clinical


The diagram shows the relationship between SaMD Functionality (x axis) and Impact (y axis) for the classes of SaMD defined by IMDRF. Type 1 devices have low impact and low functionality - and they generally inform clinical decisions for non-serious conditions. By contrast Type 4 devices treat or diagnose critical conditions and are shown to have both high functionality and high impact. The limits of the SaMD are also shown - software that only optimises processes or passes information is not an SaMD (shown below Type 1) and software that is embedded is not an SaMD (shown above Type 4)

Slide 13 - Pre-market - Some general issues

  • Evidence - having Adequate/appropriate evidence regarding
    • Performance
    • Algorithms
    • Design and Quality documentation
    • Instructions
  • Classification - accessory or device?
    • Classification rules for devices

Slide 14 - Post-market - some general issues

  • Feature Creep - crossing the definitional line, one feature at a time
  • E.g. a blood sugar level (BSL) tracking app
    • Record BSL (rev 1.0)
    • Graph BSL (rev 1.3)
    • Trend BSL (rev 2.3)
    • Alert BSL (rev 2.7)
  • Blind to the Regs - not being aware of building a regulated Medical Device
    • Home tinkerers
    • An "obvious" extension of an existing product - remote view
  • Feature obfuscation - deliberate "de-emphasising" of features to down-classify a device - practiced in USA
  • Media and Public Interest - matching the promise to reality
    • Health market to reach $26 billion by 2017 (was just $700 million in 2011!)

Slide 15 - Post-market incidents and complaints

  • Learning to recognise reportable incidents is a big challenge - users may think...
    • Software issues are managed by a "reboot" - so no report is needed... wrong.
    • Software issues are misidentified as "user issues" - no report needed... wrong.
  • Software issues most evident immediately after an update/upgrade
  • Upward trends (relating to quality) are reportable
  • Capturing and tracking incidents and complaints - a big challenge
  • Linking incidents to risk management - closing the feedback loop
  • TGA's Recognise, Retain, and Report campaign

Slide 16 - Post-market regulatory actions


  • Safety related updates under URPTG - not widely known in Software industry
  • Software expected to follow IEC 62304 - recognised as state-of-the-art - linked to Essential Principles
  • Proliferation of "manufacturers" - with limited or no medical domain knowledge
  • Software recalls - fixed by the time its reported


  • Software recalls - fixed "overnight" - everywhere, globally...
  • Feedback in stores for possible complaint records
  • Some ecosystems (e.g. Apple) can "force" updates or disabling of features and apps

Slide 17 - Summary

  • What is a "Medical Device"?
    • Something that meets the definition in the Act
  • Software as a Medical Device (SaMD)
    • If it looks like a duck...
    • IMDRF paper open for comment
  • Post-market Perspectives
    • Tracking and reporting incidents
    • Updates aligned to correct regulatory pathway
  • Q and A (Time permitting...)

Slide 18 - Questions?

Patrick L O'Meley
Biomedical and Software Engineer
Devices Post-market Review Coordinator

1800 141 144

Slide 19 - Advice on software/apps regulation

The TGA web statement - worth a read:

Some highlights follow...

Other useful sources:

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