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Each page answers in its first sentence, states what the provision does, names the date, lists the evidence a NATA assessor samples, the gaps that lose a file and the preparation step. The status column carries the only two states that matter: In force 13 July 2026 and Starts 1 July 2027.
The instrument is short. Ten of the eleven items commenced on 13 July 2026. The future item is the in-house IVD standard, and it only matters to a laboratory that develops or uses an in-house IVD.
Sections 1 to 4
The name, the commencement table, the authority and the machinery that gives the Schedule effect.
| Provision | Page title | Status |
|---|---|---|
s1-name | Name of the instrument | In force 13 July 2026 |
s2-commencement | Commencement | In force 13 July 2026 |
s3-authority | Authority | In force 13 July 2026 |
s4-schedules | Schedules | In force 13 July 2026 |
Schedule 1 Part 1, items 1 to 10
The approval machinery: the removal of approvals in principle across eight parent provisions, the ICR Sixth Edition 2026, and the free-access note.
| Provision | Page title | Status |
|---|---|---|
part1-objects | Purpose and objects: the approval list | In force 13 July 2026 |
part1-high-confidence-object | The high-confidence object | In force 13 July 2026 |
part1-approval-test | The approval test | In force 13 July 2026 |
part1-six-month-bar | The six-month bar | In force 13 July 2026 |
part1-assessment-report | The assessment report condition | In force 13 July 2026 |
part1-amended-application | The amended application | In force 13 July 2026 |
part1-interim-trigger | Interim approval: the trigger | In force 13 July 2026 |
part1-interim-conditions | Interim approval: the conditions | In force 13 July 2026 |
part1-icr-standard | The information, communication and reporting standard | In force 13 July 2026 |
part1-standards-note | The free-access note | In force 13 July 2026 |
Schedule 1 Part 2, item 11
The in-house IVD Sixth Edition 2026, which commences on 1 July 2027.
| Provision | Page title | Status |
|---|---|---|
part2-in-house-ivd | The in-house IVD standard | Starts 1 July 2027 |