--- title: "Complaint Handling, Definition | MedTech Terms" description: "Process for receiving, evaluating, and responding to device complaints. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Quality & Risk](/terms?cat=Quality%20%26%20Risk) 6. / 7. Complaint Handling [All terms](/terms) Quality & Risk [Quality System](/ecosystems/quality-system) # Complaint Handling Process for receiving, evaluating, and responding to device complaints. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Per 21 CFR 820.198, manufacturers must maintain procedures for receiving, reviewing, and evaluating complaints, with timely investigation and - when reportable - submission to FDA under 21 CFR Part 803. What the regulation says Complaint handling is a critical [post-market surveillance](/terms/post-market-surveillance) activity mandated by various regulatory bodies. For instance, the FDA, under 21 CFR 820.198, requires medical device manufacturers to establish and maintain procedures for receiving, reviewing, and evaluating complaints. Similarly, the [EU Medical Device Regulation](/terms/mdr) (EU [MDR](/terms/mdr-reporting)) Annex I, Section 3, emphasizes the importance of a quality management system that includes post-market surveillance activities, explicitly covering the handling of complaints. Furthermore, [ISO 13485](/terms/iso-13485):2016, clause 8.2.2, details requirements for complaint handling processes as part of the overall quality management system. ## What this means in practice Complaint handling is the entry point for the post-market feedback loop, feeding [CAPA](/terms/capa), vigilance, and risk management updates. ## Examples - A medical device manufacturer receives a report from a hospital indicating that a surgical instrument malfunctioned during a procedure, requiring a procedure to be restarted. - A patient contacts a MedTech company via their website to report an unexpected side effect experienced after using a new diagnostic device. - An internal quality control team identifies a trend of similar issues across multiple devices during routine complaint review, prompting a broader investigation. Common pitfalls - • Failure to define clear criteria for what constitutes a complaint can lead to underreporting or misclassification. - • Inadequate investigation of complaints can result in recurring issues and potential harm to patients. - • Delay in reporting reportable events to regulatory authorities can lead to severe non-compliance penalties. - • Treating complaints solely as customer service issues rather than critical quality data can prevent effective corrective actions. - • Insufficient documentation of complaint investigations and resolutions can lead to audit findings and regulatory scrutiny. ## Frequently asked questions What is the primary purpose of a complaint handling system? The primary purpose is to systematically receive, evaluate, and investigate feedback about potential issues with a medical device, ensuring product safety and quality. How does complaint handling relate to corrective and preventive actions (CAPA)? Are all complaints reportable to regulatory authorities? ## Cross-references ### Precedes Comes before in a typical workflow or lifecycle. - [ Corrective and Preventive Action(CAPA) ](/terms/capa) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Quality & Risk Corrective and Preventive Action(CAPA) Systematic process to investigate and resolve quality issues and prevent recurrence. ](/terms/capa)[ Post-Market Medical Device Reporting (FDA)(MDR) FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions. ](/terms/mdr-reporting)[ Post-Market Medical Device Vigilance Reporting and management of serious incidents and field safety corrective actions. ](/terms/vigilance) ### QMS Foundations · From this learning path [ Quality & Risk FDA Form 483 Notice of inspectional observations issued at the conclusion of an FDA inspection. Adjacent lesson ](/terms/form-483?from=qms-foundations)[ Quality & Risk Design Controls Structured process governing the design of medical devices. ](/terms/design-controls?from=qms-foundations)[ Quality & Risk Design History File(DHF) Compilation of records describing the design history of a finished device. ](/terms/design-history-file?from=qms-foundations)[ Quality & Risk Quality Management System Regulation(QMSR) FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference. ](/terms/qmsr?from=qms-foundations) ### Post-Market Mastery · From this learning path [ Post-Market Field Safety Corrective Action(FSCA) Action taken to reduce a risk of serious deterioration in health associated with a device. ](/terms/fsca?from=post-market-mastery)[ Post-Market Medical Device Recall Removal or correction of a marketed device that violates FDA law. ](/terms/recall?from=post-market-mastery)[ Post-Market Periodic Safety Update Report(PSUR) Periodic EU MDR/IVDR report summarizing post-market surveillance findings. ](/terms/psur?from=post-market-mastery)[ Post-Market Post-Market Surveillance(PMS) Activities to monitor device safety and performance after market release. ](/terms/post-market-surveillance?from=post-market-mastery) Cited by Where this term appears across MedTech Terms. Learning paths (2) - [QMS Foundations](/paths/qms-foundations)Lesson 8 of 10 - [Post-Market Mastery](/paths/post-market-mastery)Lesson 7 of 9 Ecosystems (1) - [Quality System](/ecosystems/quality-system) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 eCFR· 1 MDIC· 1 FDA· 1 1. [1 21 CFR 820.198 Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820) 2. [2 MDIC Case for Quality Verified MDIC · mdic.org ](https://mdic.org/program/case-for-quality/) 3. [3 FDA - Quality Systems Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Tying cybersecurity into your QMS? We help align cybersecurity activities with ISO 13485 design controls and ISO 14971 risk management. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Quality & Risk Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=complaint-handling) Learn in 60 seconds Card Lesson Quiz Process for receiving, evaluating, and responding to device complaints. - · Complaint handling is the entry point for the post-market feedback loop, feeding CAPA, vigilance, and risk management updates. Remember this Watch out: Failure to define clear criteria for what constitutes a complaint can lead to underreporting or misclassification. Related terms - [Corrective and Preventive Action(CAPA) ](/terms/capa) - [Medical Device Reporting (FDA)(MDR) ](/terms/mdr-reporting) - [Medical Device Vigilance ](/terms/vigilance) You may also need Auto-suggested from Quality & Risk and shared keywords. - [Servicing (21 CFR 820.200) ](/terms/servicing) - [Post-Production Information (Risk) ](/terms/post-production-info) - [Post-Market Performance Follow-up(PMPF) ](/terms/pmpf) - [Coordinated Vulnerability Disclosure(CVD) ](/terms/cvd) - [IDE Annual Progress Report ](/terms/ide-annual-report) - [Design Controls ](/terms/design-controls) [All Quality & Risk terms](/terms?cat=Quality%20%26%20Risk) From the Blue Goat network Related resources and services on this topic. - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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