Event Summary
State event ID, awareness date, source, country, complaint link, and concise event description.
4.8
on G2
Free Medical Devices Template
Regulatory vigilance report assessment for [event_id]
Use this template to regulatory vigilance report assessment for [event_id].
| Field | Details |
|---|---|
| Category | Medical Devices |
| Owner | [Team or owner] |
| Version | [Version number] |
| Effective Date | [Date] |
| Review Cycle | [Monthly / Quarterly / Annual / Event-based] |
| Status | [Draft / In Review / Approved] |
State event ID, awareness date, source, country, complaint link, and concise event description.
| Item | Details | Owner | Status |
|---|---|---|---|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]
Identify device name, model, UDI, lot or serial number, software version, and distribution status.
| Item | Details | Owner | Status |
|---|---|---|---|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]
Describe injury, treatment, outcome, exposure, and whether the device was available for evaluation.
| Item | Details | Owner | Status |
|---|---|---|---|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]
Document decision logic for death, serious injury, malfunction, serious public health threat, and regional criteria.
| Item | Details | Owner | Status |
|---|---|---|---|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]
Summarize current findings, DHR review, returned device analysis, and root cause status.
| Item | Details | Owner | Status |
|---|---|---|---|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]
List containment, CAPA, field action, labeling, or risk file updates.
| Item | Details | Owner | Status |
|---|---|---|---|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]
Define report type, authority, due date, submitter, follow-up schedule, and records retained. Use regulatory assessment language and avoid unsupported conclusions.
| Item | Details | Owner | Status |
|---|---|---|---|
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
| [Item or requirement] | [Describe the relevant detail, evidence, or decision] | [Owner] | [Open / Complete] |
[Add context, assumptions, exceptions, evidence links, screenshots, calculations, or reviewer comments.]
Document review conclusions, approvals, unresolved items, and next review date.
| Role | Name | Date | Notes |
|---|---|---|---|
| Preparer | [Name] | [Date] | [Notes] |
| Reviewer | [Name] | [Date] | [Notes] |
| Approver | [Name] | [Date] | [Notes] |
Template Structure
Use this medical devices template as a starting point, then customize each section to match your internal workflow, evidence, and signoff needs.
State event ID, awareness date, source, country, complaint link, and concise event description.
Identify device name, model, UDI, lot or serial number, software version, and distribution status.
Describe injury, treatment, outcome, exposure, and whether the device was available for evaluation.
Document decision logic for death, serious injury, malfunction, serious public health threat, and regional criteria.
Summarize current findings, DHR review, returned device analysis, and root cause status.
List containment, CAPA, field action, labeling, or risk file updates.
Define report type, authority, due date, submitter, follow-up schedule, and records retained. Use regulatory assessment language and avoid unsupported conclusions.
Write a Medical Device MDR/Vigilance Report assessment. Structure with these Markdown sections:
State event ID, awareness date, source, country, complaint link, and concise event description.
Identify device name, model, UDI, lot or serial number, software version, and distribution status.
Describe injury, treatment, outcome, exposure, and whether the device was available for evaluation.
Document decision logic for death, serious injury, malfunction, serious public health threat, and regional criteria.
Summarize current findings, DHR review, returned device analysis, and root cause status.
List containment, CAPA, field action, labeling, or risk file updates.
Define report type, authority, due date, submitter, follow-up schedule, and records retained.
Use regulatory assessment language and avoid unsupported conclusions.
A clinician reported infusion pump IP-700 stopped during therapy in Germany on 2026-04-18.
Model IP-700, serial IP700-22610, software version 4.2.1.
Therapy was restarted on a backup pump with no reported injury.
The malfunction is potentially reportable because recurrence could cause serious injury.
Returned device analysis is pending; DHR review found no production nonconformance.
Firmware review is opened under CAPA-2026-019.
Initial EU vigilance report is due within 10 calendar days of awareness.
Record a walkthrough, training session, or process demonstration. Docsie AI turns it into structured documentation using this template as the starting framework.
Use the template manually, or let Docsie generate the first draft from source footage.
Procedure for receiving and investigating device complaints
DHF summary for [device_name] and design control evidence
Report validating [device_name] meets user needs and intended use
Protocol verifying [device_name] design outputs against design inputs
FSCA plan and notice for [device_issue]
IQ protocol for installing [equipment_or_system] used in device production
Template FAQ
Common questions about using and generating a mDR Vigilance Report.
Q: What is a mDR Vigilance Report?
A: A mDR Vigilance Report is a structured document for regulatory vigilance report assessment for [event_id].
Q: Can I download this mDR Vigilance Report as Word or PDF?
A: Yes. This page includes free downloads in DOCX, PDF, and Markdown formats so you can edit, share, or import the template into your documentation system.
Q: Can Docsie generate this from a video?
A: Yes. Upload a process walkthrough, training recording, or screen capture to Docsie, then use this template structure to generate a first draft automatically.