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Incident Assessment Form

Use this Incident Assessment Form template to systematically evaluate whether a device-related event qualifies as a serious and reportable incident under medical device vigilance requirements. This form is essential for documenting the assessment, supporting compliance with EU MDR Article 87 and ISO 13485:2016, and should be completed whenever an adverse event or potential safety issue involving a medical device occurs. Completing this form ensures proper investigation, recordkeeping, and reporting to competent authorities when required, helping you maintain regulatory compliance and patient safety.
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Incident Assessment Form

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1. Scope

This form assesses whether an event with a potentially negative impact on the state of health constitutes a serious and reportable incident. Reporting of incidents is performed according to SOP Vigilance (consectetur adipiscing).

2. Definitions

3. Qualification for Reportable Event

Not all events are required to be reported. The requirements for reporting are outlined in SOP Vigilance, MDCG 2023-3, and Article 87 and 88 of MDR 2017/745.

Any incident which meets all three basic reporting criteria A – C listed below is considered a serious incident and must be reported to the relevant competent authority:
A. an incident (Article 2(64) MDR) has occurred, and
B. the incident directly or indirectly led, might have led or might lead to any of the outcomes of a serious incident (Article 2(65) MDR), and
C. a causal relationship between the serious incident and the manufacturer's device has been established, is reasonably possible or suspected.

When determining whether an event is reportable, the form in Section 3.1 can be filled out. If it is determined that the event is a non-reportable event, the form is completed and can be saved for record if desired. If it is determined that the event is reportable, then the rest of the form shall be filled out and the event should be investigated and reported according to SOP Vigilance and the instructions within this form.

3.1 Qualification Criteria

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4. Incident Assessment Report

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Mapping of Requirements

Medical Device Certification Made Easy.