The TGA published an updated version of the Essential Principles Checklist applicable to medical devices and In-vitro diagnostic devices (IVDs). The change involved the addition of requirements in relation to programmed or programmable medical devices or software that is a medical device.
The changes have been incorporated in 12. Medical devices connected to or equipped with an energy source.
The new requirements address the design, manufacture and maintenance of programmed or programmable medical devices or software in terms of the:
- Safety, performance, reliability, accuracy, precision, usability, security and repeatability for its intended use and acknowledged state of the art;
- Risks, fault conditions and disruptions to performance and the corresponding elimination or reduction measures applied;
- Privacy, integrity and quality of the data or information;
- Use of a computing platform;
- Data that influences or is used by the device;
- Correct operation of the device and provision of instructions to do so; and
- Provision of cybersecurity.
It should also be noted that 13B – Software – version numbers and build numbers specifies that the current version and build number of the software must be identifiable and accessible by users and must be presented in English.