Quick Reference Cards
Printable one-pagers for essential MDR/IVDR procedures
Quick Reference: Medical Device Incident Reporting
Keep visible in clinical areas
⚠️ REPORT IF:
- • Death or serious injury occurred
- • Device malfunction could have caused harm
- • Near miss prevented by user intervention
- • Patient condition worsened unexpectedly
- • Medical/surgical intervention was required
✅ IMMEDIATE ACTIONS:
- Ensure patient safety first
- DO NOT discard or clean the device
- Isolate device with packaging/accessories
- Document: date, time, what happened
- Record device ID (UDI, serial, lot)
- Contact Medical Device Lead
Internal Contact
Ext: _______
Medical Device Lead
_____________
After Hours
_____________
Quick Reference: MDR Device Classification
Classification overview for procurement decisions
Class I
Lowest Risk
Bandages, wheelchairs, stethoscopes
Class IIa
Low-Medium Risk
Hearing aids, catheters, diagnostic ultrasound
Class IIb
Medium-High Risk
Ventilators, infusion pumps, X-ray machines
Class III
Highest Risk
Pacemakers, hip implants, heart valves
Software as Medical Device (SaMD) - Rule 11
Class III
Decision could cause death/irreversible harm
Class IIb
Decision could cause serious harm
Class IIa
All other diagnosis/treatment software
Quick Reference: FSCA Response Checklist
When you receive a Field Safety Notice
Acknowledge Receipt
Confirm receipt to manufacturer within specified timeframe
Check Inventory
Search for affected lot/serial numbers in all locations
Alert Clinical Staff
Notify all affected departments of required actions
Implement Actions
Quarantine, recall, modify, or monitor as directed
Patient Review (if implants)
Identify affected patients, schedule clinical reviews
Confirm Completion
Submit completion confirmation to manufacturer
Quick Reference: Vigilance Reporting Timelines
MDR Article 87 - Manufacturer deadlines
| Incident Type | Deadline | Notes |
|---|---|---|
| Serious public health threat | 2 days | From awareness of threat |
| Death | 10 days | From awareness |
| Unanticipated serious deterioration | 10 days | From awareness |
| Other serious incidents | 15 days | From awareness |
| FSCA implementation | Before start | Report before implementing action |
| Trend increase | Immediate | Upon detection of trend |
Quick Reference: UDI System
Understanding Unique Device Identification
UDI Components
UDI-DI (Device Identifier)
Fixed - identifies the device model
Example: (01)00857674002010
UDI-PI (Production Identifier)
Variable - lot, serial, expiry, manufacturing date
Example: (17)250130(10)A123
Why Record UDI?
- • Required for FSCA tracking
- • Essential for incident reporting
- • Enables supply chain traceability
- • Patient safety in recalls
- • Implant traceability requirement