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Complaint Handling & MDR Interface

What is a complaint?​

Under 21 CFR § 820.3(b), a complaint is any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.

Key points:

  • All complaints must be documented — oral complaints must be transcribed
  • A complaint is not the same as an MDR reportable event — all MDR events generate complaints, but not all complaints are MDR-reportable
  • Internal quality issues identified before distribution are not complaints — they are nonconformances

Complaint handling requirements — § 820.198​

§ 820.198(a) — Written procedures​

Manufacturers must establish and maintain written procedures for receiving, reviewing, evaluating, and investigating complaints.

§ 820.198(b) — Complaints involving MDR events​

Each complaint must be evaluated to determine whether it represents an event that must be reported under 21 CFR Part 803 (MDR). This MDR evaluation decision must be documented in the complaint file — including the reason for non-reporting when the decision is not to report.

§ 820.198(c) — Complaint investigation​

All complaints involving the possible failure of a device to meet specifications must be reviewed, evaluated, and investigated. For each complaint investigated, the file must contain:

  • Device name, lot/serial number, date of failure
  • Name and address of complainant (if known)
  • Nature and details of the complaint
  • Date the complaint was received
  • Decision as to whether an investigation is necessary — with justification if no investigation
  • Investigation results
  • Corrective action taken
  • Reply to complainant (if applicable)

§ 820.198(d) — Formal complaint files​

Formal complaint files must be maintained at the manufacturing establishment. If complaints are evaluated at another site (e.g., customer service centre), records must be reasonably accessible to the manufacturing establishment.

MDR evaluation workflow​

Customer complaint received
        ↓
Document complaint in complaint management system
        ↓
Assign complaint handler; gather device/event details
        ↓
Evaluate: Does this meet MDR reportability criteria?
        ├── Death or serious injury → 30-day MDR (or 5-day if urgent)
        ├── Malfunction likely to recur and cause death/SI → 30-day MDR
        └── Not reportable → Document rationale in complaint file
        ↓
Investigate complaint (if required)
        ↓
Determine corrective action (CAPA if systemic)
        ↓
Close complaint file; retain records

QMSR requires that complaint data be used as a data source for CAPA (§ 820.100). Manufacturers should:

  • Trend complaints by device type, failure mode, and complaint category
  • Identify complaint rate thresholds that trigger CAPA investigations
  • Include complaint trend analysis in management review

Official resources​

Complaint Timeframe Requirements

While 21 CFR § 820.198 does not specify fixed deadlines for complaint investigation completion, FDA expects:

Rapid evaluation of MDR reportability — within a reasonable timeframe (typically 1–3 business days to enable timely submission within the 30-day window) to enable timely MDR submission if required

Complaint investigation — should be conducted expeditiously; unreasonable delays may be cited as QMSR deficiencies

MDR-reportable complaints — must be submitted within 30 days of discovery (or 5 days if death or serious injury and urgent public health notification is needed), which drives faster evaluation timelines

Complaint Record Retention

Complaint files must be retained for the lifetime of the device plus additional time as specified in your device master record, or as required by applicable regulations (e.g., implantable devices typically 5–10 years post-market). If your company distributes devices through multiple channels (direct sales, distributors, customer service centers), you must have a system to track and retrieve all complaint records—complaints evaluated at remote sites must be reasonably accessible to the manufacturing establishment within a defined timeframe (typically 1–2 business days for inspection purposes).