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January 21, 2026
Approximately 5 minutes
Medical Device Incident Reporting and Investigation Scheme (IRIS) Overview
Medical Device Incident Reporting and Investigation Scheme (IRIS) Overview
1. Purpose of the IRIS System
The Medical Device Incident Reporting and Investigation Scheme (IRIS) is the TGA's online portal for receiving and managing reports of adverse events and incidents involving medical devices. It replaced the previous paper-based and email reporting methods to improve efficiency, data quality, and timeliness of reporting. Source: https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/how-we-manage-your-medical-device-adverse-event-report/medical-device-incident-reporting-and-investigation-scheme-iris
IRIS supports mandatory reporting requirements under the Therapeutic Goods Act 1989 and helps the TGA fulfill its role in monitoring post-market safety and performance of medical devices.
2. Who Must Report and When
Mandatory reporting applies to:
- Sponsors of medical devices included in the ARTG
- Manufacturers (when aware of incidents)
- Importers and exporters in certain cases
Reports must be submitted as soon as possible after becoming aware of an incident, particularly for serious events or those indicating potential systemic issues. Voluntary reports from healthcare professionals, patients, and the public are also accepted and encouraged. Source: https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/how-we-manage-your-medical-device-adverse-event-report/medical-device-incident-reporting-and-investigation-scheme-iris
3. How to Submit a Report via IRIS
Users access IRIS through the TGA eBusiness Services portal after registering an account. The system guides reporters through mandatory and optional fields, including:
- Device details (ARTG number, model, manufacturer)
- Incident description
- Patient outcome (if applicable)
- Reporter and sponsor contact information
After submission, a unique Device Incident Report (DIR) number is generated for tracking. Source: https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/how-we-manage-your-medical-device-adverse-event-report/medical-device-incident-reporting-and-investigation-scheme-iris
4. TGA Processing and Investigation
Upon receipt, reports undergo initial triage based on risk level. High-priority incidents (e.g., death, serious injury) are fast-tracked. Investigators may:
- Request additional information via questionnaire
- Assess causality and severity
- Conduct trend analysis across similar reports
- Coordinate with sponsors for root cause investigation Source: https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/how-we-manage-your-medical-device-adverse-event-report/medical-device-incident-reporting-and-investigation-scheme-iris
The TGA uses IRIS data to identify emerging safety signals and inform regulatory actions.
5. Outcomes and Communication
Possible outcomes include:
- No further action required (low risk, isolated event)
- Request for sponsor to implement corrective actions
- Field safety notices, recalls, or hazard alerts
- Updates to the ARTG entry or conditions of inclusion
De-identified information from reports contributes to the public Database of Adverse Event Notifications (DAEN - medical devices). Source: https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/how-we-manage-your-medical-device-adverse-event-report/medical-device-incident-reporting-and-investigation-scheme-iris
6. Benefits of IRIS
- Improved data quality through structured fields and validation
- Faster processing and response times
- Better trend detection and signal management
- Enhanced transparency via DAEN publication
- Secure, confidential handling of sensitive information
The TGA continuously improves IRIS based on user feedback and evolving needs.
7. Support and Resources
Guidance documents, FAQs, and training materials are available on the TGA website. For technical issues or questions about reporting, contact the IRIS support team via email or phone. Source: https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/how-we-manage-your-medical-device-adverse-event-report/medical-device-incident-reporting-and-investigation-scheme-iris
Effective use of IRIS by all stakeholders strengthens Australia's medical device post-market surveillance system and contributes to ongoing patient safety.
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