The in-house IVD Sixth Edition 2026 replaces the Fifth Edition 2025 on 1 July 2027. It adds quality standards for in-house IVD software, including embedded and standalone software and software as a medical device, and changes the companion diagnostics wording from a specific medicine to a corresponding medicine.
Item 11 substitutes table item 20 in Schedule 1. The new entry names the Requirements for the development and use of in-house in vitro diagnostic medical devices (Sixth Edition 2026). The Explanatory Statement says the edition introduces quality standards for 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. The 1 July 2027 date is intended to give laboratories time to transition.
Does the standard apply to software only?
No. It applies to in-house IVDs, and the Sixth Edition adds quality standards for laboratories that manufacture or develop in-house IVD software.
Can we wait until 1 July 2027?
The date is fixed, but the inventory and classification work can start now. Waiting compresses the assessment into the period after the item commences.
Where this comes from
The register states each provision in our own words and cites the section or item. The dates page separates the two commencements. The official text is F2026L00927 on the Federal Register.
Not legal advice; does not certify. The standards themselves are separate documents and are not reproduced here.