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When do UDI rules start for each medical device class?

The earliest general start day is 1 July 2026, for some Class IIb and Class III devices. Class IIa starts on 1 July 2027. Class I sterile, Class 3 IVD and Class 4 IVD start on 1 July 2028. Class 1 and Class 2 IVD start on 1 July 2029. A certificate under Directive 93/42/EEC or 98/79/EC can move a date later; an MDR 2017/745 certificate does not meet the defined term.

The short answer above is the direct answer. The detail below carries the clause and the date.

Key date: 1 April 2028. Schedule 2 Part 2 commences and widens adverse event reporting. The UDI amendments commenced on 25 March 2025 and apply from each device general start day. All dates.

What is the general start day?

It is the day from which the UDI supply, import and export rules apply to a device. The dictionary sets it by class and, for several classes, by whether an EU certificate was in force on a named cut-off and whether stock had been made and labelled, and had not reached the Australian market, before a named date. It is not the ARTG inclusion date.

Which classes start first?

Class IIb and Class III devices can start on 1 July 2026 where no EU certificate was in force on 30 June 2026 and the stock condition is not met. A certificate, or stock made and labelled before the relevant date, can move the start to 1 January 2028 or 1 July 2029. The device class alone does not give the date.

When does direct marking start?

Direct marking has its own table. Class III starts on 1 January 2028. Class IIa and Class IIb start on 1 January 2029. Class I sterile, Class 3 IVD and Class 4 IVD start on 1 July 2029. Class 1 CT944 or CT943 and Class 2 IVD start on 1 July 2030. Implantable devices are exempt.

Why does the register show a possible repeal in 2028?

The Federal Register title record lists a possible future repeal on 2 April 2028 under section 48A of the Legislation Act 2003. That is a register entry, not a statement that the instrument will be repealed. A continuation would change it. Check the register before relying on a long-term date.

How should a sponsor record the date?

Record the class, the EU certificate status at the cut-off, the stock condition and the first supply date. Then calculate the general start day and the 30th day for the database entry. Keep the calculation with the device file so another person can repeat it.

Questions

Is the key date 1 April 2028 the UDI start date?

No. 1 April 2028 is the commencement of Schedule 2 Part 2, which widens adverse event reporting. The UDI amendments commenced on 25 March 2025 and apply from each device general start day.

Can a later certificate move the date?

For some classes, yes, if the certificate is one under Directive 93/42/EEC or Directive 98/79/EC and was in force on the named cut-off, such as 30 June 2027 for Class IIa. An MDR 2017/745 certificate does not meet the defined term and does not move the date.

Do all devices in a class share one date?

No. The stock condition and the certificate branch can produce different dates within the same class. Calculate the date per model, not per class average.

The unit pages behind this answer

Know which transaction triggers the duty, Sch 1 item 8, reg 11.85(1) to (2).
Enter identifiers within 30 days, Sch 1 item 6, reg 13C.2(1) to (5).
Directly mark reusable devices, Sch 1 item 6, reg 13C.5(1) to (2); Sch 1 item 7 direct marking start day.

Check your own device

The free check returns the start day, the 30th day and the privacy step for a class and certificate branch. It does not decide whether a device is in scope. How the record is built.

Not legal advice; does not certify. Source: F2025L00414, Federal Register of Legislation, retrieved 2026-10-20.