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Complaint Log

Complaint handling template

Complaint Log for medical device complaint and vigilance management

Use this editable Complaint Log to capture, evaluate, investigate and close complaints with traceable decisions and clear reporting routes.

Capture complaints consistentlyRecord awareness dates, device traceability and evaluation rationale.
Link to vigilanceIdentify reportable events and feed trend analysis.
Close the CAPA loopConnect complaint findings to corrective and preventive actions.

  • Best for: complaint handling, vigilance reporting, PMS data capture and trend analysis.
  • Includes: editable sections for complaint intake, evaluation, investigation, closure and reporting.
  • Format: editable template available through the standard WooCommerce download flow.
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Lexqara supports manufacturers in turning complaint data into actionable PMS insights while meeting MDR vigilance obligations. Explore the Resource Center or review our Post-Market Surveillance Services.

Description:
This Complaint Log (LOG-VIG-001) helps us track each complaint from receipt to closure, ensuring traceability, timely escalation, and consistent vigilance decisions.

  • Assign and record the unique complaint ID COMYYYY-XXX.

  • Capture the complaint Date and maintain the log up to date until closure.

  • Link the log entry to the Complaint form (FORM-VIG-001) record.

  • Support escalation to MDR vigilance using SOP-VIG-001 when needed.

  • Enable trend monitoring for non-reportable events.

Your needs:

  • Complaint log template

  • Complaint log template for ISO 13485 and MDR compliance.

  • Reduce missed follow-ups, improve traceability, and strengthen audit readiness.

Use this log whenever we open, update, or close a complaint to keep one controlled overview of status, owners, and escalations.

It supports consistent oversight. CHU is the team responsible for complaint handling; it matters because it centralizes ownership. Trend monitoring is ongoing review of non-reportable events; it matters because patterns can change benefit-risk.

  • Register every complaint and keep the log current until closure.

  • Maintain unique complaint identification COMYYYY-XXX.

  • Ensure complaint receipt details are captured and updated when new information arrives.

  • Escalate reportability evaluation using SOP-VIG-001 when applicable.

  • Record decision outcomes to support CAPA linkage and closure review.

At Lexqara, we help you connect complaint logging, vigilance decision records, PMS trend inputs, and CAPA traceability into an inspection-ready workflow. Resource Center [https://lexqara.com/resource-center] and Post-Market Surveillance support [https://lexqara.com/services/post-market-surveillance]. EU MDR (Regulation (EU) 2017/745) [https://eur-lex.europa.eu/eli/reg/2017/745/oj]. Request a short gap assessment.

Template preview

Template preview: Complaint Log

Review the key sections included in the Complaint Log template before downloading it. This preview shows the structure and content you will receive in the editable file.

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Sheet: LOG-VIG-001

Complaint Log LOG-VIG-001
Complaint # Devices involved Complaint Short Description Awareness Date Complaint Initiation Date Date of Evaluation Closure Date of Investigation Closure Date of Corrections Reporting to Authorities? Country and Date of initial reporting Country and Date of follow-up Country and Date of final report HHE? CAPA? Date of Closure
COM2024-00X [Device Name] [Short Description] DD/MM/YYYY DD/MM/YYYY DD/MM/YYYY DD/MM/YYYY DD/MM/YYYY Yes/No [Country]: DD/MM/YYYY
[Country]: DD/MM/YYYY		 [Country]: DD/MM/YYYY
[Country]: DD/MM/YYYY		 [Country]: DD/MM/YYYY
[Country]: DD/MM/YYYY		 HHEYYYY-XXX CAPAYYYY-XXX DD/MM/YYYY

The complete template content is displayed above. The editable file is available after adding the product to cart.

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Need expert support? Explore Post-Market Surveillance (PMS) & PMCF Services for Medical Devices | Lexqara.

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