Regulatory References:
| Regulation / Standard | Description |
|---|---|
| EU Regulation 2017/745 (MDR) | Articles 87 and 89 (Incident analysis, vigilance, field safety corrective actions) |
| ISO 13485:2016 | Section 8.2.3 |
| German Medical Devices Law (MPDG) | Chapter 5, Articles 71–83 |
| German Medical Device EU Adjustment Ordinance (MPEUAnpV) | All |
| MDCG 2023-3 | All |
| MEDDEV 2.12/1 rev. 8 | All |
Related Documents:
– SOP Vigilance
Purpose
This form evaluates whether an event with potential adverse effects on health constitutes a serious, reportable incident.
Incident Overview
| Field | Details |
|---|---|
| Event Description | \ |
| Report Date & Time | |
| Affected Device | \ |
| Incident Classification | ( ) Reportable Incident ( ) Non-Reportable Incident |
| Proposed Action | \ |
Incident Assessment Criteria
Based on guidance from MEDDEV 2.12/1 rev. 8 and MDCG 2023-03, events that satisfy all three criteria below qualify as serious incidents and must be reported. Non-reportable incidents should still be documented and reviewed as part of quality processes like CAPA or post-market surveillance.
Note: This form can also be used to justify why an event is not deemed a reportable incident.
Criterion 1: Event Description
Definition: An event has occurred that aligns with the definition of an incident under Article 2(64) MDR.
An “incident” refers to any malfunction, performance deterioration, use-error (due to ergonomic issues), insufficient information provided by the manufacturer, or undesirable side-effect.
| Field | Response |
|---|---|
| Applicable? | ( ) Yes ( ) No |
| Explanation: | \ |
| Event Category: |
Examples of incidents:
– Technical failures resulting in device malfunctions.
– Unclear or insufficient instructions for use.
– Ergonomic issues causing user errors.
– Undesirable side effects (refer to MDCG 2023-3, para. 8).
Criterion 2: Device-Event Relationship
Definition: A causal relationship between the device and the event is confirmed, reasonably likely, or suspected.
| Field | Response |
|---|---|
| Applicable? | ( ) Yes ( ) No |
| Explanation: | \ |
Considerations:
– Expert opinions (e.g., physicians).
– Prior incidents with similar characteristics.
– PRRC (Person Responsible for Regulatory Compliance) assessment.
Criterion 3: Event Outcomes
Definition: The event caused, might cause, or could potentially cause:
| Outcome | Applicable? |
|---|---|
| Death of a patient, user, or another person | ( ) Yes ( ) No |
| Serious deterioration in health | ( ) Yes ( ) No |
| Serious public health threat | ( ) Yes ( ) No |
Serious deterioration in health includes:
– Life-threatening illness or injury.
– Permanent impairment of body structure or function.
– Prolonged hospitalization.
– Need for medical or surgical intervention.
– Chronic disease.
– Indirect harm due to diagnostic errors.
| Field | Response |
|---|---|
| Applicable? | ( ) Yes ( ) No |
| Explanation: | \ |
Key References for Decision-Making
| Reference | Explanation |
|---|---|
| Intended Use | Defined use according to the manufacturer’s labeling, instructions, or promotional material (MEDDEV 2.12/1, Section 4.6). |
| Incident Definition | Malfunctions, performance deterioration, or inadequate labeling/instructions that could lead to death or health risks (MEDDEV 2.12/1, Annex I). |
| Direct/Indirect Harm | Harm resulting directly or indirectly from the device, including delayed treatment or incorrect diagnostic results. |
| FSCA (Field Safety Corrective Actions) | Manufacturer actions to address risks associated with device use, including modifications, recalls, or updates (MEDDEV 2.12/1). |