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January 22, 2026
Approximately 5 minutes
Medical Device Incident Reporting (MDIR) Guide – TGA Overview
Medical Device Incident Reporting (MDIR) Guide – TGA Overview
1. Purpose of the MDIR Guide
The Medical Device Incident Reporting (MDIR) guide provides detailed instructions for sponsors, manufacturers, importers, and other responsible entities to correctly complete and submit incident reports via the IRIS online system. It aims to ensure reports contain sufficient information for the TGA to assess risks, identify trends, and take appropriate regulatory action to protect public health. Source: https://www.tga.gov.au/resources/resources/user-guide/medical-device-incident-reporting-mdir-guide
Accurate and timely reporting is a legal requirement under the Therapeutic Goods Act 1989 and supports continuous monitoring of device safety and performance post-market.
2. Who Must Report and Reportable Incidents
Mandatory reporting applies to sponsors of devices included in the ARTG when they become aware of:
- Death or serious injury/death associated with the device
- Deterioration in the health of a patient/user
- Potential for death or serious injury
- Malfunction or performance issue that could lead to harm if it recurs
Voluntary reports from healthcare professionals, patients, and the public are also accepted. Source: https://www.tga.gov.au/resources/resources/user-guide/medical-device-incident-reporting-mdir-guide
3. Key Sections and Mandatory Fields in IRIS
The IRIS form requires completion of several critical sections:
- Device Details: ARTG number (mandatory), brand/trade name, model/catalogue/serial/lot numbers, manufacturer/sponsor details
- Incident Description: Clear, factual description of what happened (avoid opinions or disclaimers here)
- Clinical Event: Patient outcome/impact (death, serious injury, no harm, etc.)
- Similar Events: Number and rates of similar incidents in Australia and worldwide
- Root Cause Analysis: If known, suspected cause and corrective actions taken or planned Source: https://www.tga.gov.au/resources/resources/user-guide/medical-device-incident-reporting-mdir-guide
Incomplete or inaccurate mandatory fields may result in the report being rejected or returned for correction.
4. Common Pitfalls and Best Practices
Common issues include:
- Entering multiple ARTG numbers in one field (submit separate reports)
- Using abbreviations or capital letters in descriptions (avoid for DAEN readability)
- Omitting similar event data or providing only qualitative information (provide quantitative rates)
- Including patient outcome or analysis in the wrong section
Best practices:
- Review the report carefully before submission
- Use the "Other devices involved" field for additional devices
- Attach supporting documents (photos, test reports, etc.) when relevant
- Keep sponsor contact details updated to receive follow-up requests Source: https://www.tga.gov.au/resources/resources/user-guide/medical-device-incident-reporting-mdir-guide
5. Submission and Follow-up Process
After submission, a unique DIR number is issued. Do not resubmit if no number is received—contact iris@health.gov.au instead. The TGA performs initial triage and may send questionnaires for clarification or additional information, particularly for serious events or when causality is unclear. Source: https://www.tga.gov.au/resources/resources/user-guide/medical-device-incident-reporting-mdir-guide
Respond promptly to questionnaires to avoid delays in risk assessment.
6. Post-Reporting Responsibilities
Sponsors must:
- Monitor for similar incidents and update the TGA if trends emerge
- Implement corrective actions when root causes are identified
- Notify the TGA of field safety corrective actions or recalls
- Provide updates on resolution of supply or performance issues linked to the incident Source: https://www.tga.gov.au/resources/resources/user-guide/medical-device-incident-reporting-mdir-guide
De-identified report information contributes to the public DAEN database.
7. Additional Resources and Support
The MDIR guide includes examples, screenshots of IRIS fields, and links to related TGA resources. For assistance, contact the IRIS support team via email (iris@health.gov.au) or phone. Regular review of the guide and TGA safety alerts is recommended to stay compliant with reporting obligations. Source: https://www.tga.gov.au/resources/resources/user-guide/medical-device-incident-reporting-mdir-guide
Accurate MDIR submission through IRIS strengthens Australia's medical device post-market surveillance and contributes to ongoing patient safety.
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