On 1 July 2027 the Schedule 1 material for in-house IVDs becomes the Requirements for the development and use of in-house in vitro diagnostic medical devices (Sixth Edition 2026), replacing the Fifth Edition 2025.
What the provision does
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 rules aimed at laboratories that build or develop in-house IVD software, including embedded or integrated software, software that controls or affects other devices, and standalone software, and software as a medical device, whether or not it uses 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.
Why it matters
This is the only future item in the instrument, and the only one that requires a project rather than a document edit. It reaches software that a laboratory may not think of as an IVD. The 1 July 2027 date is deliberate: the Explanatory Statement says it gives laboratories time to move to the in-house IVD software rules. A laboratory that waits until the date will be doing the inventory, classification and validation work under time pressure.
What changed, and when
Item 11 substitutes table item 20 in clause 1 of Schedule 1 to the 2017 Principles. It commences on 1 July 2027. Until then, the entry continues to name the Fifth Edition 2025. The Explanatory Statement describes the Sixth Edition changes: the companion diagnostics wording moves from a specific medicine to a corresponding medicine, and the edition adds quality standards for in-house IVD software, including embedded and 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.
The Explanatory Statement's Attachment A describes the same item as the "Fifth Edition 2026". That description is wrong on its face: the operative text of item 11, and the body of the Explanatory Statement, both say Sixth Edition 2026. The operative text governs. A compliance record should cite the Sixth Edition and note the discrepancy.
What to do about it
Start with a software inventory, not a policy. List every in-house IVD, every piece of software that drives or influences a device, every standalone tool used to produce a result, and any AI or machine learning component. Classify each under the Therapeutic Goods (Medical Devices) Regulations 2002 and record the basis. Then gap-assess the quality system against the Sixth Edition. The text does not tell you the class of a particular device, so the classification is a judgement to record, not a fact to assume.
What the assessor asks for
| Category | Artefact to have ready |
|---|---|
| Inventory | A register of every in-house IVD and every in-house IVD software item, with the owner and the clinical use |
| Classification | The class 1, 2 or 3 classification for each item, with the regulation and the reasoning recorded |
| Risk | A risk assessment for each item, including data governance and cybersecurity controls |
| Validation | The verification and validation record for each item, including any AI or machine learning behaviour |
| Change control | The change control record that shows how a software change is assessed before release |
| Companion diagnostics | The revised wording and the corresponding medicine identified for each companion diagnostic |
The question that follows. A reviewer may ask which in-house IVDs the laboratory has and how each was classified, and a policy without an inventory cannot answer.
Gaps that lose a file
- Treating software as outside the standard
- No AI or machine learning inventory
- Companion diagnostics still described as a specific medicine
- Waiting until July 2027 to start
- No classification basis for a class 1 to 3 device
Before the date
- Build the inventory now
- Classify each item and record the basis
- Gap-assess against the Sixth Edition
- Plan validation and change control
- Re-date the plan when the edition is applied
Dates
| Date | What happens | Source pointer |
|---|---|---|
| Item 11 commences | s 2 table item 3 |
Cross-references
Schedules · Commencement · The information, communication and reporting standard
Source
Schedule 1 item 11, substituting table item 20 of Schedule 1 to the 2017 Principles. The operative text is F2026L00927 on the Federal Register, with the parent 2017 Principles and the Explanatory Statement. Our statement, not the instrument verbatim.
Not legal advice; does not certify. A reading of the provision and the evidence an assessor commonly samples, not a substitute for the instrument, the standards or your accreditation body's rules.