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July 2024
“Interpretation and application of Essential Principle 13B for medical devices.
This guidance provides information on how to interpret Essential Principle 13B and how it applies to medical devices in Australia.
It provides following information:
Essential Principle 13B requires manufacturers of software-based medical devices to make the current version and build number accessible and identifiable to users
Manufacturers have flexibility in choosing the style or convention for version and build numbering
The version and build numbers help in identifying and tracing software throughout its lifecycle
Manufacturers must determine the most appropriate form and location for displaying the version and build numbers based on various factors
The Unique Device Identification (UDI) regulations will support tracking and tracing of medical devices and will be part of the Essential Principles
Discusses the importance of including version and build numbers for software in medical devices, with different guidelines for devices with fixed software and updatable software
Manufacturers are advised to make this information easily accessible to users, either physically on the device or through electronic mechanisms
For devices with multiple embedded software components, manufacturers should provide version and build numbers for each component
In cases where build numbers are not used, manufacturers can use other identification numbers for traceability
Also provides examples of how manufacturers can meet the requirements for different types of medical device software, such as apps, software as a service, electronic devices with simple displays, and implantable devices”
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