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Short answers to the questions the rule raises
Each answer starts with a 40 to 60 word response, then the detail with the clause. These pages are for the reader who has one question and does not want the whole register.
Does the Australian UDI database hold personal information?
Yes, but only in three narrow cases. The database may hold the name of the registered person, an authorised representative of the manufacturer, or an authorised representative of a registered person. The two representative categories need written consent before entry, and representative information must not be published.
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.
What must a healthcare facility report from 1 April 2028?
From 1 April 2028 the chief executive officer of a healthcare facility must report adverse events involving Class IIa, Class IIb, Class III, Class 3 IVD and Class 4 IVD devices to the Secretary. A death or serious deterioration is reported within 10 days. An intervention or treatment case is reported within 45 days. The report goes in an electronic form.
What written consent is needed for an authorised representative?
An authorised representative of the manufacturer, or of a registered person, must consent in writing before their information is included in the Australian UDI Database. The consent should record the notice the representative saw, the scope of the information, the date and the withdrawal route.
What happens to the UDI record when a device is cancelled?
Cancelling a device does not automatically delete its Australian UDI Database record. The information must not be removed unless the Secretary is satisfied that removal is appropriate in all the circumstances. A representative can still ask for their own information to be removed in writing.
Go deeper
- The full obligation register, one page per unit.
- The free scope and date check, for one device at a time.
- The privacy path, for representative information.
- All dates, including the key date and the possible repeal.