The short answer
Most of it is already in force.
Sections 1 to 4 and all of Schedule 1 Part 1 commenced on 13 July 2026. That includes the removal of approvals in principle and the substitution of the information, communication and reporting Sixth Edition 2026. Only Schedule 1 Part 2, item 11, commences on 1 July 2027. It substitutes the in-house IVD Sixth Edition 2026.
| Date | What happens | Source pointer |
|---|---|---|
| 3 July 2026 | Instrument made | Dated 3 July 2026 |
| 6 July 2026 | Registered as F2026L00927 | The Explanatory Statement was registered the same day |
| 13 July 2026 | Sections 1 to 4 and Schedule 1 Part 1 commence | s 2 table items 1 and 2 |
| 13 July 2026 | F2026L00934 (No. 4) commences | Immediately after Part 1; re-enacts item 4 without the comma |
| 1 July 2027 | Schedule 1 Part 2 commences | s 2 table item 3; the in-house IVD Sixth Edition 2026 |
The two dates in a laboratory's plan
Approval machinery and the ICR standard
Use this date for the ICR document register, the messaging conformance evidence, the removal of approvals in principle and the single approval test. Ten item pages and four section pages deal with this date.
The in-house IVD standard
Use this date for the in-house IVD inventory, the class 1 to 3 classification, the software governance framework and the validation plan. One item page deals with this date.
The correction that followed
F2026L00934, the Amendment (Relevant Standards) Principles (No. 4) 2026, commenced immediately after Part 1 on 13 July 2026. It re-enacted Schedule 1 item 4 without the comma in the title. The current compilation therefore reads "information communication and reporting", not "information, communication and reporting". The change is editorial. The substance of item 9 is unaffected.
The discrepancy in the Explanatory Statement
Attachment A item 11 of the Explanatory Statement describes the new in-house IVD standard as the "Fifth Edition 2026". The operative text of item 11 substitutes the "Sixth Edition 2026", and the body of the Explanatory Statement uses the Sixth Edition. The operative text governs. A record that copies Attachment A will cite the wrong edition.
The day count from this record's date, 21 October 2026, to 1 July 2027 is 253 days. The instrument itself gives the date, not a countdown.