Complaint Handling

Complaint Handling is a critical quality management system process that ensures medical device manufacturers systematically receive, document, investigate, and respond to customer complaints. It serves as a primary source of post-market surveillance data and often triggers corrective actions, regulatory reporting, and product improvements.

Definition and regulatory basis:
Complaint handling is required by multiple regulatory frameworks including FDA 21 CFR 820.198, ISO 13485 Clause 8.2.2, and EU MDR Article 83. A complaint is defined as any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after release.

FDA 21 CFR 820.198 requirements:
The FDA Quality System Regulation mandates that manufacturers:
- Establish and maintain complaint handling procedures
- Review and evaluate all complaints to determine if investigation is required
- Maintain complaint files containing caller/complainant information, device details, nature of the complaint, dates received and investigation results
- Document investigation findings and any corrective actions
- Maintain complaint files for the longer of two years or the expected lifetime of the device
- Submit Medical Device Reports (MDRs) when required

ISO 13485:2016 requirements:
ISO 13485 requires organizations to establish procedures for timely complaint handling including:
- Receipt and recording of complaints
- Initial evaluation to determine if the complaint requires investigation
- Investigation of complaints when appropriate
- Determination of corrective action needs
- Verification of effectiveness of any corrective action
- Reporting to regulatory authorities as required
- Input to management review and risk management processes

Complaint handling process steps:

1. Receipt and Documentation
- Log all complaints in a centralized system with unique identifiers
- Record complete information: complainant details, device information, date received, method received, nature of complaint
- Acknowledge receipt to complainant within defined timeframe

2. Initial Review and Triage
- Screen complaint to determine validity and completeness
- Assess severity and potential impact to patient safety
- Determine if regulatory reporting (MDR, vigilance) required immediately
- Assign priority level for investigation

3. Investigation
- Conduct thorough root cause analysis when appropriate
- Review device history record (DHR), design history file (DHF), and relevant quality records
- Examine returned product if available
- Interview personnel involved in manufacturing/testing
- Document findings comprehensively

4. Evaluation and Action
- Determine if CAPA required based on investigation findings
- Assess if complaint represents a trend or isolated incident
- Update risk management file if new hazards identified
- Consider field safety corrective action or recall if warranted
- Document rationale for actions taken or not taken

5. Response and Closure
- Communicate findings and resolution to complainant when appropriate
- Ensure all required documentation complete
- Close complaint with appropriate approvals
- Track closure timelines against internal targets

Regulatory reporting obligations:
Complaints may trigger mandatory reporting to regulatory authorities:
- FDA MDR (21 CFR Part 803) - Death, serious injury, or malfunction likely to cause death/serious injury
- EU MDR Vigilance (Article 87) - Serious incidents and field safety corrective actions
- Canada Mandatory Problem Reports - Deaths, serious deterioration in health, incidents requiring intervention
- Japan PMDA adverse event reporting - Deaths, serious health hazards, device defects

Metrics and trending:
Effective complaint handling systems monitor:
- Total complaints received per period
- Complaint rate per units distributed
- Average time to investigate and close complaints
- Complaints by product line, type, and root cause
- Trend analysis to identify systemic issues
- Complaints requiring MDR/vigilance reporting
- Customer satisfaction with complaint resolution

Integration with other QMS processes:
Complaint handling interfaces with:
- CAPA system - Complaints frequently trigger corrective/preventive actions
- Risk management - New hazards identified through complaints update ISO 14971 files
- Post-market surveillance - Complaint data feeds PMS plans and reports
- Management review - Complaint trends reviewed regularly by top management
- Internal audit - Complaint handling procedures audited for effectiveness
- Regulatory reporting - MDRs, vigilance reports, field safety notices

Common complaint sources:
- Healthcare professionals (physicians, nurses)
- Patients and caregivers
- Distributors and sales representatives
- Service personnel and field engineers
- Internal quality monitoring (production, testing)
- Regulatory authorities
- Social media and online platforms

Documentation requirements:
Complete complaint files must contain:
- Original complaint information (written, transcribed from verbal)
- Device identification (model, lot/serial number, manufacturing date)
- Complainant information (name, facility, contact details)
- Dates (complaint received, investigation initiated/completed)
- Investigation findings and supporting data
- Root cause determination (when investigated)
- CAPA linkage if corrective action initiated
- Regulatory reporting determination and MDR number if applicable
- Closure approval and date

Best practices:
- Establish clear definitions of what constitutes a complaint vs. inquiry or service request
- Train customer-facing personnel to recognize and properly document complaints
- Use complaint management software for tracking and trending
- Implement automated alerts for high-severity complaints requiring immediate action
- Conduct periodic complaint handling audits to ensure procedure compliance
- Share complaint insights across organization to drive continuous improvement
- Maintain transparency with customers about investigation status and resolution

A robust complaint handling system demonstrates regulatory compliance, protects patient safety, identifies product improvement opportunities, and builds customer trust through responsive and thorough problem resolution.