Item 11 repeals table item 20 in clause 1 of Schedule 1 to the 2017 Principles and substitutes a new item. The new item names the Requirements for the development and use of in-house in vitro diagnostic medical devices (Sixth Edition 2026), publication year 2026. The item commences on 1 July 2027. The Explanatory Statement explains the change: the companion diagnostics wording moves from a specific medicine to a corresponding medicine, and the edition introduces quality standards for pathology laboratories that manufacture or develop in-house IVD software, including embedded or integrated software, software that drives or influences other devices, and standalone software or software as a medical device, with or without machine learning or artificial intelligence. It describes a risk-based governance framework and a link to the Therapeutic Goods (Medical Devices) Regulations 2002, under which manufacturers of class 1 to 3 in-house IVDs must be accredited to the standard.
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