Event Summary
State event ID, awareness date, source, country, complaint link, and concise event description.
4.8
on G2
Free Medical Devices Template
Download a free mdr vigilance report template in Word, PDF, or Markdown. Or turn any video into mdr vigilance report template with Docsie AI — auto-fills every required field.
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] |
Deploy this template immediately when becoming aware of any adverse event, malfunction, or complaint involving your marketed medical device.
This template produces a complete MDR/vigilance report meeting EU MDR Article 87 and FDA MedWatch regulatory submission requirements.
Most vigilance reports fail due to incomplete device traceability, unsupported causality claims, or missed reporting deadlines under MDR timelines.
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.
Already have a walkthrough or training video covering this process? Skip manual drafting. Upload the video and Docsie AI generates mdr vigilance report template with every required field populated — ready for review, signoff, or export.
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 downloading and generating a mdr vigilance report template.
Q: What is a mdr vigilance report template?
A: A mdr vigilance report template is a structured document for regulatory vigilance report assessment for [event_id].
Q: Is the mdr vigilance report template really free?
A: Yes. The mdr vigilance report template is completely free to download in Word (DOCX), PDF, and Markdown formats. No signup or credit card required to download.
Q: How do I turn a video into a mDR Vigilance Report?
A: Upload a process walkthrough, training recording, or screen capture to Docsie. The AI analyzes the video and generates a complete mDR Vigilance Report using this template's structure — every required field auto-filled from the footage.
Q: Can I edit the mdr vigilance report template after downloading?
A: Yes. The DOCX format opens in Microsoft Word or Google Docs. The Markdown format imports into Notion, Confluence, Docsie, or any markdown editor. Customize fields, add your branding, and adapt to your internal workflow.