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

EU definition:

The ability of two or more devices, including software, from the same manufacturer or from different manufacturers, to:

1. exchange information and use the information that has been exchanged for the correct execution of a specified function without changing the content of the data, and/or
2. communicate with each other, and/or
3. work together as intended.

EU definition:

The analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer.

EU definition:

‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical discipline.

Current AUS definition:

lay person, for the use of an IVD medical device for self‑testing, means an individual who does not have formal training in a medical field or discipline to which the self‑testing relates.

Proposed change:

Amend the AUS definition of lay person in the AUS Regulations to more broadly apply to all devices.