Medical device reforms: Consumer Working Group meeting statement, Meeting 17, 22 August 2025

Agenda and discussion highlights

The Medical Devices Consumer Working Group (MDCWG) met on 22 August 2025. Members received updates and discussed: 

• Progress and implementation of the Unique Device Identification (UDI) system
• Access to nicotine and medicinal cannabis vaping devices
• TGA website redesign for improved consumer navigation
• Introduction of mandatory reporting of medical device adverse events by hospitals
• Review of the regulatory framework for patient matched medical devices (PMMDs)
• Annual review of the working group

Key updates and outcomes

Unique Device Identification (UDI) system

Members noted that the UDI database is now live with approximately 1,200 UDI records about devices uploaded. The next 12 months will focus on supporting manufacturers and sponsors who supply high risk and implantable medical devices to submit their UDI data.

The TGA will also continue to encourage the healthcare systems to adopt UDI in patient records and registries to improve device traceability and safety.

Nicotine and medicinal cannabis vaping devices

Based on feedback from members, the TGA has updated the medicinal cannabis web pages. These amendments improved clarity and made relevant consumer information more prominent.

The TGA is developing new consumer resources (flow diagrams, FAQs) with input from the working group.

TGA website redesign

Members noted TGA website enhancements are anticipated to be launched in November, based on extensive user testing. Key improvements include a new information architecture, mega menus including one for safety and shortages, and a dedicated consumer guidance section where content will be ordered based on popularity (from analytics) and user needs.

Members provided feedback on resource needs and communication strategies for the new site. 

Mandatory hospital reporting of medical device adverse events

Members discussed the implementation of a new reporting requirement that mandates all public, private, and day hospitals report device-related adverse events to the TGA, starting with high-risk devices and serious incidents in 2026.  Members discussed the need for broader practitioner involvement and raised concerns about the lengthy timelines between implantation and side effects being acknowledged.

The TGA clarified that the Government had carefully considered these matters and in particular, the legal requirements as to who should report, and that health professionals should continue to report voluntarily, and that the system be designed to be scalable and flexible, enabling scope expansion if required.

Patient Matched Medical Devices (PMMDs) regulatory review

The TGA is reviewing the regulatory framework for PMMDs, considering potential options such as licensing, certification, accreditation, notification and extending existing provisions for manufacturing using approved materials.  Members emphasized the importance of direct consumer involvement in governance and consultation to ensure patient safety and access.

Annual review of the working group

The TGA summarized the outcomes of the annual review of the working group.  Around 90% of respondents felt able to contribute meaningfully; challenges included pre-reading volume and the need for more culturally inclusive and accessible communication. There is strong support for integrating cultural safety and focusing on emerging technologies.

Next meeting

The next MDCWG meeting date will be advised soon.