Adverse Event Reporting — Timelines
Reporting timeframes
The HP(MD) Regulations 2010 set out specific timeframes for reporting adverse events to HSA. The timeframe depends on the severity of the event:
| Event type | Reporting timeframe |
|---|---|
| Death or serious deterioration in health — where a causal relationship with the device is not unlikely | 10 calendar days from becoming aware of the event |
| Death or serious deterioration in health — where the causal relationship is unlikely but cannot be excluded | 30 calendar days from becoming aware of the event |
| Malfunction or deterioration that could lead to death or serious deterioration if it recurs | 30 calendar days from becoming aware of the malfunction |
When does the clock start?
The reporting timeline begins when the dealer or registrant becomes aware of the event — not when the event occurred. Companies should therefore have internal processes to ensure adverse event information received by any part of the organisation (sales, customer service, technical support) is flagged to the responsible regulatory person promptly.
Initial vs follow-up reports
Where all information is not available at the time of the initial report, an initial (preliminary) report should be submitted within the applicable timeframe with the information available. A follow-up report with additional details should then be submitted as further information becomes available.