Sections 1 to 4 and Schedule 1 Part 1 commenced on 13 July 2026. Schedule 1 Part 2, the in-house IVD item, commences on 1 July 2027. Ten of the eleven amending items are already in force, so only the in-house IVD standard is still ahead.
The commencement table in section 2 has three rows. Sections 1 to 4 commence on 13 July 2026. Schedule 1 Part 1 commences on 13 July 2026. Schedule 1 Part 2 commences on 1 July 2027. The practical effect is that the approval machinery and the ICR standard have been in force since the middle of 2026, and only the in-house IVD standard waits. A laboratory that plans against a single 2027 date will miss the ICR change by more than a year. A laboratory that treats the whole instrument as already in force will apply the in-house IVD standard before it commences. The two dates are the first thing to get right.
Why does the Explanatory Statement mention both dates?
Because the instrument has two commencements. Attachment A repeats the section 2 table and describes the items in each Part.
Is 1 July 2027 a deadline for every laboratory?
No. It applies to item 11 and to a laboratory that develops or uses in-house IVDs. A laboratory with no in-house IVDs has no work under that item.
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.