Exemptions from Reporting
Overview
There are specific circumstances where an adverse event or near adverse event does not need to be reported to the TGA, even if it meets the general definition. These exemptions are aligned with international frameworks — particularly the EU Medical Device Regulation — and reflect situations where reporting would not add regulatory value. However, the exemptions are narrowly defined and have important limitations. When in doubt, sponsors should report rather than rely on an exemption.
Circumstances Where Reporting May Not Be Required
Reporting may not be required where the event relates to:
1. Deficiency found before use A deficiency in a new device discovered by the user before it was used on a patient, where the deficiency would have led to an adverse event if the device had been used.
2. Expected and documented side effects An expected side effect or outcome that is clearly and specifically described in the device's instructions for use or labelling, provided it was anticipated in the clinical evaluation and is within the device's known risk profile.
3. Events not caused by the device An event where the cause has been definitively determined to not involve the medical device — for example, where the adverse outcome is solely attributable to the underlying patient condition and no device malfunction or deficiency contributed.
4. Single patient events with no replication risk In very limited circumstances, events involving a single patient where the cause is definitively identified and there is no risk of recurrence or impact on other patients — though this exemption is applied very cautiously.
Critical Limitations on Exemptions
Exemptions do not apply when:
- The TGA has specifically identified a device, event, or issue as one requiring close monitoring — affected sponsors will be notified by the TGA when this is the case
- The exemption would otherwise apply but the event involves a death
- There is any reasonable uncertainty about whether the exemption criteria are met
Overseas remedial actions always require reporting: Even if a specific adverse event occurring overseas does not need to be reported to IRIS, any recall, field safety corrective action, or other remedial action taken overseas for devices supplied in Australia must be notified to the TGA Recalls team under PRAC. This obligation is not subject to the adverse event reporting exemptions.
The Default Position: Report if in Doubt
The TGA consistently encourages sponsors to report adverse events even when they are uncertain whether reporting is required. Key reasons:
- Individual reports contribute to pattern detection that may not be visible from a single event perspective
- Failure to report when required is a breach of ARTG conditions and can attract significant penalties
- The exemptions are interpreted narrowly by the TGA
- Reporting is not an admission of liability