Serious incidents & near-misses
Regulatory basis - MDR Art. 2(65) and Art. 87 / IVDR Art. 2(67) and Art. 82. The definitions of serious incident and near-miss determine the scope of mandatory vigilance reporting.
Disclaimer - This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.
Anatomy of a serious incident determination
When a device-related event occurs, the manufacturer must work through a structured assessment to determine whether a serious incident report is required. The determination has two elements:
Element 1 — Is there a device malfunction, deterioration, or inadequacy?
| Type | Examples |
|---|---|
| Malfunction or deterioration of characteristics or performance | Device fails to deliver medication, implant fractures, software crashes |
| Inadequacy in manufacturer-supplied information | IFU does not warn of a known risk; contraindication omitted from labelling |
| Use error attributable to ergonomic features | Confusing interface leading to incorrect dose selection |
Element 2 — Did it (or could it) lead to a serious outcome?
| Outcome | Threshold |
|---|---|
| Death | Directly or indirectly caused or contributed |
| Serious deterioration of health | Temporary or permanent; includes life-threatening illness, permanent impairment, foetal distress |
| Serious public health threat | As defined by MDR Art. 2(65)(c) |
Both elements must be present. A device malfunction that poses no plausible pathway to serious harm is not a serious incident.
The "might have led to" standard — practical application
The most challenging aspect of serious incident determination is the counterfactual: events where serious harm did not occur but might have.
Worked examples
Example 1 — Reportable near-miss An infusion pump software error causes the pump to display a "pump occluded" alarm when it is actually delivering medication at double the programmed rate. A nurse catches the error before the patient receives the full double dose. No patient harm occurred.
Assessment: The malfunction might have led to a life-threatening overdose. The double-delivery rate could have been fatal in a critically ill patient. Reportable — serious incident.
Example 2 — Not reportable A blood pressure cuff's velcro fastener degrades and the cuff becomes difficult to apply. A nurse records a blood pressure using a different cuff. No measurement impact.
Assessment: Device deterioration occurred, but there is no plausible pathway to serious harm — the device was simply replaced. Not reportable as a serious incident; managed through complaints/PMS.
Example 3 — Reportable IVD incident An IVD lot is found to have false-negative results for a blood-borne pathogen at low viral loads due to a reagent manufacturing error. Some units have already been used in clinical testing.
Assessment: False-negative results for a serious infectious disease might have led to untreated infection with serious health consequences. Reportable — serious incident; and likely triggers an FSCA for the affected lot.
Near-misses — when to report
A near-miss is an event where:
- A device malfunction or inadequacy occurred, and
- Serious harm would have occurred but for:
- Intervention by a healthcare professional or patient
- Chance (the patient was not connected at that moment)
- Redundant safety systems
Near-misses are reportable under MDR/IVDR if the malfunction "might have led" to death or serious deterioration. The fact that harm was averted does not remove the reporting obligation.
Near-miss reporting is one of the most valuable inputs to the vigilance system — near-misses reveal potential failure modes before they become actual patient harm events. NCAs actively encourage thorough near-miss reporting.
Use errors and ergonomic deficiencies
MDR Art. 2(65) explicitly includes use errors due to ergonomic features within the definition of serious incident. This is a significant expansion from older frameworks:
- If a healthcare professional makes a dosing error because a device's interface is confusing or counterintuitive, and that error leads to or might have led to serious harm, this is a serious incident attributable to the device — not solely a user error
- The manufacturer must assess whether the ergonomic feature is a contributing cause
- This is assessed as part of the risk management process and usability engineering requirements
Investigating a potential serious incident
When a potentially reportable event is identified, the manufacturer must:
- Log and triage: capture the event in the complaints/vigilance management system and assess urgency
- Initiate preliminary assessment: determine within 24 hours whether an immediate safety action or urgent reporting is needed
- Submit initial report: within the applicable timeframe (see Reporting timeframes)
- Conduct full investigation: root cause analysis, device analysis (if device returned), assessment of event sequence
- Submit final report: with investigation conclusions and any corrective actions
- Update PMS and risk management files: incorporate findings
Related pages
Official references
| Reference | Description |
|---|---|
| MDR Art. 2(65) | Serious incident definition |
| IVDR Art. 2(67) | IVDR serious incident definition |
| MDR Art. 87(1) | Reporting obligation |
| MDCG 2023-3 | Serious incident reporting guidance |
| MDCG 2019-14 | Vigilance reporting worked examples |