Postmarket Surveillance, Complaints, Recalls, and Software Labeling
Purpose
Connect post-market processes to software: complaints, vigilance / MDR reporting, recalls and field corrections, cybersecurity coordinated disclosure touchpoints, and labeling / IFU (including on-device strings, UDI display, and versioned patient/clinician instructions) so maintenance (IEC 62304 §6) and QMS CAPA stay coherent.
When to Apply
- Triaging customer complaints that reference software behavior, crashes, or security.
- Deciding reportability (e.g., EU serious incident criteria; US MDR reports).
- FSCA / recall / UDI correction affecting distributed software.
- Updating Instructions for Use, GUI risk messaging, or release notes with safety information.
- Post-market cybersecurity vulnerability handling tied to deployed versions.
Requirements (testable)
- Complaint Intake: Record software version, hardware rev, environment, and symptom for each complaint; link to risk file and known anomalies; route into software maintenance feedback (IEC 62304 6.2.1). Rationale: investigation and trend analysis.
- Investigation: Perform root cause analysis distinguishing software defect, use error, SOUP/CVE, and environmental factors; preserve records per QMS. Rationale: CAPA effectiveness.
- Vigilance / Reporting: Apply EU MDR vigilance rules and FDA MDR reporting for device malfunctions; escalate per timelines when criteria met. Rationale: legal reporting.
- Field Actions: For FSCA / recall, define affected versions, corrective action (patch, config, instructions), customer communication, and effectiveness checks. Rationale: patient safety.
- Software Corrections & Removals: Track 21 CFR Part 806-style distinctions (US) where applicable; document recall strategy including SaaS/OTA distribution. Rationale: regulatory consistency.
- Labeling Control: Maintain master label and IFU under document control; version with software releases; verify UI strings match approved labeling for risks/warnings. Rationale: misbranding prevention.
- UDI & Version Display: Show UDI / version per MDCG 2018-1 (EU) and firm policy; ensure About screen / splash matches released build. Rationale: traceability to field units.
- Postmarket Cybersecurity: Tie CVE handling, SBOM updates, and patch deployment to PMS and risk review (see FDA cybersecurity postmarket expectations). Rationale: sustained security state.
Recommended Practices
- Single field matrix: version × region × config × known issues.
- Automate extraction of displayed version from build metadata into IFU appendices.
Patterns
Complaint record (YAML):
complaint:
id: "CMP-2026-0142"
sw_version: "2.3.1"
text: "App crashed during upload"
investigation: "ROOT-2026-044"
linked_anomaly: "BUG-778"
reportable: false
capa: "CAPA-2026-09"
IFU change note:
## Document history
| Rev | Software | Change |
|-----|----------|--------|
| H | 2.3.1 | Clarified WiFi reconnection warning (HZ-USE-02) |
Anti-Patterns (risks)
- Closing complaints as user error without usability/risk review — risk: missed use-related hazard.
- Silent on-screen text changes for risk warnings — risk: labeling/QMS violation.
- OTA fix without version traceability or customer list — risk: incomplete FSCA scope.
Verification Checklist
Traceability
- IDs:
CMP-*, FSCA-*, LBL-*, IFU-*; link to v*.*.*, BUG-*, HZ-*.
References
- IEC 62304:2006+A1:2015, 6.2 (feedback, problem reports, change communication);
DOC-SW-MAINT, DOC-PROBLEM-RES.
- EU MDR 2017/745 — vigilance (Articles 87–92), PMS (Articles 83–86).
- FDA 21 CFR Part 803 (medical device reporting) — where applicable.
- FDA 21 CFR Part 806 (reports of corrections/removals).
- MDCG 2018-1 v3 — UDI for software (verify revision).
- FDA “Cybersecurity in Medical Devices” — postmarket expectations (current guidance).
Changelog
- 1.0.1 (2026-05-21): Linked complaint intake to IEC 62304 maintenance process (6.2).
- 1.0.0 (2026-03-20): Initial skill for complaints, vigilance, recalls, labeling/IFU, cybersecurity PMS.
1---2name: postmarket-labeling-ifu3description: Postmarket Surveillance, Complaints, Recalls, and Software Labeling4---56# Postmarket Surveillance, Complaints, Recalls, and Software Labeling78## Purpose9Connect **post-market** processes to software: **complaints**, **vigilance / MDR reporting**, **recalls and field corrections**, **cybersecurity coordinated disclosure** touchpoints, and **labeling / IFU** (including on-device strings, UDI display, and versioned patient/clinician instructions) so maintenance (IEC 62304 §6) and QMS **CAPA** stay coherent.1011## When to Apply12- Triaging **customer complaints** that reference software behavior, crashes, or security.13- Deciding **reportability** (e.g., EU serious incident criteria; US MDR reports).14- **FSCA** / recall / UDI correction affecting distributed software.15- Updating **Instructions for Use**, GUI risk messaging, or **release notes** with safety information.16- Post-market **cybersecurity** vulnerability handling tied to deployed versions.1718## Requirements (testable)191. Complaint Intake: Record **software version**, **hardware rev**, **environment**, and **symptom** for each complaint; link to risk file and known anomalies; route into software maintenance feedback (IEC 62304 6.2.1). Rationale: investigation and trend analysis.202. Investigation: Perform **root cause** analysis distinguishing **software defect**, **use error**, **SOUP/CVE**, and **environmental** factors; preserve records per QMS. Rationale: CAPA effectiveness.213. Vigilance / Reporting: Apply **EU MDR** vigilance rules and **FDA MDR** reporting for device malfunctions; escalate per timelines when criteria met. Rationale: legal reporting.224. Field Actions: For **FSCA** / recall, define **affected versions**, **corrective action** (patch, config, instructions), **customer communication**, and **effectiveness checks**. Rationale: patient safety.235. Software Corrections & Removals: Track **21 CFR Part 806**-style distinctions (US) where applicable; document **recall strategy** including SaaS/OTA distribution. Rationale: regulatory consistency.246. Labeling Control: Maintain **master label** and **IFU** under document control; **version** with software releases; verify UI strings match approved labeling for risks/warnings. Rationale: misbranding prevention.257. UDI & Version Display: Show **UDI** / **version** per **MDCG 2018-1** (EU) and firm policy; ensure **About** screen / splash matches released build. Rationale: traceability to field units.268. Postmarket Cybersecurity: Tie **CVE** handling, **SBOM** updates, and **patch deployment** to PMS and risk review (see FDA cybersecurity postmarket expectations). Rationale: sustained security state.2728## Recommended Practices29- Single **field matrix**: version × region × config × known issues.30- Automate extraction of **displayed version** from build metadata into IFU appendices.3132## Patterns33Complaint record (YAML):34```yaml35complaint:36 id: "CMP-2026-0142"37 sw_version: "2.3.1"38 text: "App crashed during upload"39 investigation: "ROOT-2026-044"40 linked_anomaly: "BUG-778"41 reportable: false42 capa: "CAPA-2026-09"43```4445IFU change note:46```markdown47## Document history48| Rev | Software | Change |49|-----|----------|--------|50| H | 2.3.1 | Clarified WiFi reconnection warning (HZ-USE-02) |51```5253## Anti-Patterns (risks)54- Closing complaints as **user error** without usability/risk review — risk: missed use-related hazard.55- **Silent** on-screen text changes for risk warnings — risk: labeling/QMS violation.56- OTA fix without **version traceability** or **customer list** — risk: incomplete FSCA scope.5758## Verification Checklist59- [ ] Complaint records include software version and investigation outcome.60- [ ] Reportability assessed per jurisdiction; submissions logged if required.61- [ ] Field actions documented with affected versions and communications.62- [ ] IFU/label revision matches released software; UI spot-checked.63- [ ] UDI/version display verified on device for the release build.64- [ ] Cybersecurity patches tied to risk review and customer notification policy.6566## Traceability67- IDs: `CMP-*`, `FSCA-*`, `LBL-*`, `IFU-*`; link to `v*.*.*`, `BUG-*`, `HZ-*`.6869## References70- IEC 62304:2006+A1:2015, 6.2 (feedback, problem reports, change communication); `DOC-SW-MAINT`, `DOC-PROBLEM-RES`.71- EU MDR 2017/745 — vigilance (Articles 87–92), PMS (Articles 83–86).72- FDA 21 CFR Part 803 (medical device reporting) — where applicable.73- FDA 21 CFR Part 806 (reports of corrections/removals).74- MDCG 2018-1 v3 — UDI for software (verify revision).75- FDA “Cybersecurity in Medical Devices” — postmarket expectations (current guidance).7677## Changelog78- 1.0.1 (2026-05-21): Linked complaint intake to IEC 62304 maintenance process (6.2).79- 1.0.0 (2026-03-20): Initial skill for complaints, vigilance, recalls, labeling/IFU, cybersecurity PMS.
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