May 25th – 29th 2026
Inform Items
-
MDAERS Outage – The TGA has advised that the Medical Device Adverse Event Reporting System may be unavailable from Friday 12 June, 9:00pm to Saturday 14 June, 8:00am AEDT due to a scheduled software update. Plan accordingly, and contact IRIS@health.gov.au if you need urgent assistance during this time.
-
The Complying with the Unique Device Identification timeframes for medical devices document was updated on 22 May 2026. The update included changes to:
- clarify existing devices
- clarify EU MDD to EU MDR and EU IVDD to EU IVDR
- added additional timeline graphics
- added information on consignment stock
- clarified definition of sponsor control
- added compliance date summary
- added information on existing devices in Surgical Loan Kits (SLKs)
Action Items
-
UDI Audit Selection Criteria – The TGA is seeking targeted feedback on proposed additional text for the UDI audit selection guidance, clarifying how UDI requirements will apply to new Class IIb and Class III applications from 1 July. Please comment below the consultation on RegConnect by 8 June to be included in MTAA’s response.
Upcoming MTAA Events
- Medical Device Regulations for Non-Regulatory Professionals Workshop – Next Week! Know someone in your team who keeps asking you to explain TGA requirements from scratch? Forward this one on! MTAA’s Medical Device Regulations for Non-Regulatory Professionals Workshop is this Thursday 4 June, 9am – 2pm at Cliftons Sydney, and it’s built specifically for colleagues in marketing, BD, clinical, supply chain, and beyond. It covers the regulatory basics they need to work better with you, so you can spend less time on the groundwork and more on the actual issues.
