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F2025L00414, Sch 2 item 1, reg 8AA.2(a) to (b)
Report Class III and Class 4 IVD events
The chief executive officer (however described) of a healthcare facility. The Act definition of reportable medical device is extended to two classes: Class III medical devices and Class 4 IVD medical devices.
Reader note for unit 18: this provision sits in Schedule 2, under Adverse event reporting. The first action it calls for is to build the inventory. The evidence it names first is a class-tagged device inventory. The provision read on this page is Sch 2 item 1, reg 8AA.2(a) to (b). It is unit 18 of 21 in the register.
What the provision requires
The Act definition of reportable medical device is extended to two classes: Class III medical devices and Class 4 IVD medical devices. Other classes stay outside the Stage 1 reporting population until the Stage 2 item commences.
Source pointer: reg 8AA.2(a)-(b).
What it means in practice
Stage 1 starts with the highest-risk device classes. The clause limits the reporting population until Stage 2 expands it.
A facility should build the device list now and tag each device by class. The clause does not require a report for a device outside the list, even where a clinician is concerned; other routes may still apply.
Source pointer: reg 8AA.2; Sch 2 item 2.
Evidence to keep
An auditor or a regulator will ask for the record that shows the duty was met, not a description of the process. Keep these artefacts with the device or facility file.
- A class-tagged device inventory. The duty is defined by device class.
- The reporting decision tree. Shows the class test is applied before a report.
- A log of events considered and not reported, with reasons. Shows the decision was made, not missed.
Source pointer: reg 8AA.2. The artefacts are our suggested evidence, not a form prescribed by the instrument.
Common gaps
- No device inventory by class.
- Reporting only when a clinician asks.
- A list that has not been updated for Stage 2.
Preparation steps
- Build the inventory.
- Brief the wards.
- Test one report.
Dates that matter for this unit
| Date | What happens | Note |
|---|---|---|
| 2026-03-21 | Stage 1 commenced | s 2 table item 3 |
| 2028-04-01 | Stage 2 expands the list | s 2 table item 4 |
Source pointer: s 2 table items 3 and 4.
Where it sits
- Stage 2 expansion, Sch 2 item 2.
- Report content and timing, reg 8AA.3.
Questions this provision raises
Which devices are reportable now?
From 21 March 2026, Class III medical devices and Class 4 IVD medical devices. The list expands on 1 April 2028 to include Class IIa, Class IIb, Class III, Class 3 IVD and Class 4 IVD devices.
Does a near miss count?
The clause defines the reportable device classes. The event test comes from the Act and from regulation 8AA.3. A near miss that does not meet the Act test is not a report under this provision, but it may still belong in the facility's safety system.
Who reports?
The healthcare facility, through its chief executive officer or the officer the Act provides for. The regulation prescribes the device classes and the report content; the Act sets the reporting obligation.
Source pointer for the page
- Citation
- Sch 2 item 1, reg 8AA.2(a) to (b)
- Instrument
- Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 (F2025L00414)
- Official text
- https://www.legislation.gov.au/F2025L00414/latest/text
- Binding party
- reg 8AA.2
- Requirement
- reg 8AA.2(a)-(b)
- Evidence
- reg 8AA.2
- Dates
- s 2 table items 3 and 4
- Silent fields
- Where the instrument does not state a form, a period or a frequency, this page says so rather than filling the gap.
Back to the register. Next: Report within 10 or 45 days, electronically.