Home / Dates
Every date in F2025L00414, with the provision behind it
The key date is 1 April 2028, when Schedule 2 Part 2 commences. The UDI dates start earlier and depend on device class, EU certificate status and, for some classes, stock already made. This page keeps the two sets apart.
Key date, stated precisely. 1 April 2028 is the commencement of Schedule 2 Part 2, which widens mandatory adverse event reporting. It is not the start of the UDI amendments. Schedule 1 commenced on 25 March 2025. The register also lists a possible future repeal on 2 April 2028 under s 48A of the Legislation Act 2003. A continuation would change that entry.
The commencement table
| Item | Provisions | Commencement | Date |
|---|---|---|---|
| 1 | Sections 1 to 4 and anything not elsewhere covered | The day after registration | 2025-03-25 |
| 2 | Schedule 1 | The day after registration | 2025-03-25 |
| 3 | Schedule 2 Part 1 | 21 March 2026 | 2026-03-21 |
| 4 | Schedule 2 Part 2 | 1 April 2028 | 2028-04-01 |
| 5 | Schedule 3 | The day after registration | 2025-03-25 |
Source: F2025L00414 s 2. Column 3 of the table is not part of the instrument, as the table itself notes.
General start day and direct marking start day
The general start day governs the UDI supply, import and export rules. The direct marking start day governs the duty to mark a reusable device itself. They are separate tables and can fall in different years.
| Device | General start day | Direct marking start day | Source |
|---|---|---|---|
| Class I medical device supplied sterile | 1 July 2028, or 1 January 2029 if an EU certificate was in force on 30 June 2028 | 1 July 2029 | dictionary, general start day (a); direct marking start day (a) |
| Class IIa medical device | 1 July 2027, or 1 January 2029 if an EU certificate was in force on 30 June 2027 | 1 January 2029 | dictionary, general start day (b); direct marking start day (b) |
| Class IIb medical device, implantable | 1 July 2026, 1 January 2028 or 1 July 2029 depending on the EU certificate and the stock condition | 1 January 2029 | dictionary, general start day (c); direct marking start day (c) |
| Class IIb medical device, not implantable | 1 July 2026, 1 January 2029 or 1 July 2029 depending on the EU certificate and the stock condition | 1 January 2029 | dictionary, general start day (d); direct marking start day (c) |
| Class III medical device | 1 July 2026, 1 January 2028 or 1 July 2029 depending on the EU certificate and the stock condition | 1 January 2028 | dictionary, general start day (e); direct marking start day (d) |
| Class 1 IVD with GMDS code CT944 or CT943 | 1 July 2029, or 1 January 2030 if an EU certificate was in force on 30 June 2029 | 1 July 2030 | dictionary, general start day (f); direct marking start day (e) |
| Class 2 IVD medical device | 1 July 2029, or 1 January 2030 if an EU certificate was in force on 30 June 2029 | 1 July 2030 | dictionary, general start day (g); direct marking start day (f) |
| Class 3 IVD medical device | 1 July 2028, or 1 January 2029 if an EU certificate was in force on 30 June 2028 | 1 July 2029 | dictionary, general start day (h); direct marking start day (g) |
| Class 4 IVD medical device | 1 July 2028 | 1 July 2029 | dictionary, general start day (i); direct marking start day (h) |
Source: Schedule 1 item 7, dictionary. The certificate branches use the date the certificate was in force, not the date the device was made.
What counts as an EU certificate. The dictionary defines it as a conformity assessment document issued under Council Directive 93/42/EEC or Directive 98/79/EC. A Regulation (EU) 2017/745 (MDR) certificate does not meet that definition and does not move a start day. Check the directive named on the certificate before you answer the check.
All dated events in the record
| Date | Event | Note | Source |
|---|---|---|---|
| 2025-03-20 | Instrument made | signature page | F2025L00414, signature block |
| 2025-03-24 | Instrument registered | Federal Register title record, asMadeRegisteredAt | api.prod.legislation.gov.au/v1/titles/F2025L00414 |
| 2025-03-25 | Sections 1 to 4, Schedule 1 and Schedule 3 commence | the day after registration | s 2 table items 1, 2 and 5 |
| 2026-03-21 | Schedule 2 Part 1 commences | Stage 1 adverse event reporting | s 2 table item 3 |
| 2026-07-01 | Earliest general start day | Class IIb and Class III branches without an EU certificate | dictionary, general start day (c), (d) and (e) |
| 2027-07-01 | Class IIa general start day | where no EU certificate was in force on 30 June 2027 | dictionary, general start day (b)(ii) |
| 2028-01-01 | Class III and some Class IIb start days; Class III direct marking start day | certificate branches | dictionary |
| 2028-04-01 | Schedule 2 Part 2 commences: the key date | reportable devices expand to Class IIa, Class IIb, Class III, Class 3 IVD and Class 4 IVD | s 2 table item 4; Sch 2 item 2 |
| 2028-04-02 | Possible future repeal on the register | statusPossibleFuture under s 48A of the Legislation Act 2003; a continuation would change this | Federal Register title record F2025L00414 |
| 2028-07-01 | Class I sterile and Class 3 and 4 IVD general start days | where the certificate branch does not apply | dictionary, general start day (a), (h) and (i) |
| 2029-01-01 | Extended start days for Class I sterile, IIa, IIb and III; IIa and IIb direct marking | certificate and stock branches | dictionary |
| 2029-07-01 | Extended start days for Class IIb and III; direct marking for Class I sterile and Class 3 and 4 IVD | certificate and stock branches | dictionary |
| 2030-01-01 | Class 1 CT944 or CT943 and Class 2 IVD start days with an EU certificate | certificate branch | dictionary |
| 2030-07-01 | Class 1 CT944 or CT943 and Class 2 IVD start days without an EU certificate; their direct marking start day | the last dates in the tables | dictionary |
How to read a date for one device
- Take the class from the ARTG entry, not from the product family name.
- Check the EU certificate on the named cut-off for that class. A certificate on a different date does not move the start day.
- For Class IIb and III, check the stock condition: made and labelled before the cut-off, and not supplied in Australia before it.
- Record the first supply on or after the general start day. The 30-day database window begins on that day.
- If the device is reprocessed between patients, read the direct marking start day separately. Implantable devices are exempt.
The free check does this arithmetic from the record. Run it on one device. Not legal advice; does not certify.