Guidance on Essential Principle 13B for Software-Based Medical Devices

This guidance provides information on interpreting and applying Essential Principle 13B for medical devices in Australia. Essential Principle 13B mandates that manufacturers of software-based medical devices must make the current version and build number accessible and identifiable to users. Manufacturers have the flexibility to choose the style or convention for version and build numbering, which aids in identifying and tracing software throughout its lifecycle.

Manufacturers must determine the most appropriate form and location for displaying the version and build numbers, taking into account various factors. The Unique Device Identification (UDI) regulations will also support the tracking and tracing of medical devices and will be included as part of the Essential Principles. The guidance emphasizes the importance of including version and build numbers for software in medical devices, with specific guidelines differing for devices with fixed software and those with updatable software.

Manufacturers are advised to make version and build number information easily accessible to users, either physically on the device or through electronic means. For devices with multiple embedded software components, each component should have its own version and build numbers. In situations where build numbers are not used, other identification numbers can be utilized for traceability.

The guidance also provides examples of how manufacturers can comply with these requirements across various types of medical device software, including apps, software as a service, electronic devices with simple displays, and implantable devices.

Source: https://www.legislation.gov.au/F2002B00237/latest/downloads##~https://www.legislation.gov.au/F1996B01999/latest/text

Region: Australia