Australian Medical Device Essential Principles - Part 2: Proposed alignment with the European Regulation

Closes 13 Nov 2024

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Proposal 13: Amend AUS Essential Principle 13B

We propose to clarify requirements in AUS Essential Principle 13B.

Proposal 13(a). Do you think it necessary to amend AUS Essential Principle 13B to clarify that the current build number be accessible by and identifiable to users of the device, only where the build number is included as an element of the manufacturer’s version control management system?

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The intent of AUS Essential Principle 13B is for users to access sufficient information to identify the version of the software being used and ensure traceability. We recognise that not all device manufacturers use build numbers, so the inclusion of this information would depend on the version control management system used by the manufacturer. As such, we are proposing to clarify the intent of AUS Essential Principle 13B, as for all other principles, that manufacturers are required to comply, where relevant.

Current AUS Essential Principle 13B Software - Version numbers and build numbers

  1. For a medical device that is software, or that incorporates software, the current version number and current build number of the software must be accessible by, and identifiable to, users of the device.
  2. The current version number and current build number of the software:

                      (a)  must be in English; and

                     (b)  may also be in any other language.

Proposal 13(b). If you think other changes are needed for AUS Essential Principle 13B, please explain.