Description:
This Complaint Handling Procedure defines how we receive, document, investigate, report, and close complaints to protect patients and maintain compliant vigilance processes.

• Establish a Complaint Handling Unit (CHU) with defined Quality/Regulatory roles and PRRC oversight.

• Capture minimum intake data (complaint details, contact method, awareness date) and device traceability including UDI where available.

• Assign unique complaint ID COMYYYY-XXX and register in LOG-VIG-001 Complaint log using FORM-VIG-001 Complaint form.

• Evaluate complaint criteria with “Yes/No” decisions and documented justification.

• Determine regulatory reporting using a two-stage process and country-specific SOP-VIG-XXX timelines.

• Investigate complaints (DHF/DHR/DMR/QMS/supplier data, testing) and document outcomes, limitations, and root cause.

• Trigger HHE and potential FSCA when broader patient/user impact is suspected.

• Link risk estimation, CAPA decisions, corrections, and Quality Manager closure approval with controlled archiving.

Your needs:

• Complaint handling procedure

• Complaint handling procedure for MDR decision-making

• Reduce rework, improve vigilance consistency, and strengthen audit readiness.

This procedure is used whenever any device-related problem is reported, from initial receipt through investigation, regulatory communication, corrective action, and closure under EU vigilance expectations.

It includes decision rules and evidence expectations. HHE assesses potential health impact to support FSCA decisions; it matters because it drives timely containment. FSCA is an action to reduce risk in the field; it matters because it protects patients and compliance.

• Document intake, device traceability, and complaint history updates.

• Assign complaint ID and maintain the complaint log until closure.

• Perform documented complaint evaluation with justification.

• Assess reportability and timelines per country and SOP-VIG-XXX.

• Record regulatory communications and attach supporting evidence.

• Perform investigation, confirmability rationale, and root cause.

• Evaluate risk vs the risk management file and initiate/justify CAPA.

• Document corrections and obtain Quality Manager closure approval.

At Lexqara, we streamline complaint handling, vigilance readiness, PMS trend integration, CAPA linkage, and audit/inspection support through practical templates and training. 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.