--- title: "Servicing (21 CFR 820.200), Definition | MedTech Terms" description: "Quality system requirements for servicing devices, including service report analysis as potential complaints. Plain-English Quality & Risk definition for MedTec" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/servicing#term", "name": "Servicing (21 CFR 820.200)", "description": "Manufacturers performing service activities must document procedures, maintain records, and treat reports of events meeting MDR criteria as complaints. 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These records should be maintained in accordance with 21 CFR 820.180, General requirements, and 21 CFR 820.200 (b), Servicing records." } }, { "@type": "Question", "name": "How does servicing relate to complaint handling?", "acceptedAnswer": { "@type": "Answer", "text": "Any report of a device malfunction, structural failure, or other issue identified during servicing that meets the definition of a complaint under 21 CFR 820.3(b) must be processed through the manufacturer's complaint handling system. If the event meets MDR criteria, it must be reported to the FDA as per 21 CFR Part 803." } }, { "@type": "Question", "name": "Does 21 CFR 820.200 apply to third-party servicers?", "acceptedAnswer": { "@type": "Answer", "text": "While 21 CFR 820.200 directly applies to manufacturers, manufacturers are responsible for ensuring that any third-party servicing of their devices is performed in a manner that maintains the safety and effectiveness of the device and complies with their quality system requirements. This often necessitates agreements and oversight of third-party activities." } }, { "@type": "Question", "name": "What is the ", "acceptedAnswer": { "@type": "Answer", "text": "The 'right to service' refers to the ability of device owners or independent third parties to obtain necessary parts, tools, and information to repair and maintain medical devices. This is an active area of policy discussion, particularly on balancing intellectual property rights and ensuring consumer access to repairs." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Quality & Risk](/terms?cat=Quality%20%26%20Risk) 6. / 7. Servicing (21 CFR 820.200) [All terms](/terms) Quality & Risk [Quality System](/ecosystems/quality-system) # Servicing (21 CFR 820.200) Quality system requirements for servicing devices, including service report analysis as potential complaints. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Manufacturers performing service activities must document procedures, maintain records, and treat reports of events meeting [MDR](/terms/mdr-reporting) criteria as complaints. FDA has historically scrutinized 'right to service' between OEMs and third-party servicers. What the regulation says Servicing, as per 21 CFR 820.200, requires manufacturers to establish and maintain procedures for performing and verifying servicing activities. These procedures ensure that servicing meets specified requirements and that service reports are evaluated as potential complaints under 21 CFR Part 820, Subpart M, and 21 CFR Part 803 for Medical Device Reporting ( [MDR](/terms/mdr-reporting)) if applicable. The EU MDR (Regulation (EU) 2017/745) also implicitly covers servicing through [post-market surveillance](/terms/post-market-surveillance) requirements, emphasizing manufacturers' responsibility for their devices throughout their lifecycle, including maintenance and repair activities. ## What this means in practice Active area of policy discussion - FDA has held public meetings on third-party servicing and parts availability. ## Examples - A manufacturer performs a scheduled preventative maintenance service on an MRI machine in a hospital, documenting the procedure and findings in the service record. - A field service engineer replaces a faulty component in an infusion pump, and because the failure led to an interruption in therapy, the manufacturer’s complaint handling unit evaluates this as a potential MDR event. - A medical device company provides specialized training and certified replacement parts to a third-party service organization to ensure proper maintenance of its diagnostic imaging equipment. Common pitfalls - • Failing to document servicing procedures and records adequately can lead to non-compliance during FDA inspections. - • Not treating servicing events that meet MDR criteria as complaints can result in underreporting adverse events and potential regulatory enforcement. - • Manufacturers sometimes overlook the need to evaluate third-party servicing activities against their own quality system requirements. - • Assuming that servicing responsibilities end once a device is sold without considering the full product lifecycle can lead to quality system gaps. - • Inadequate training for personnel performing servicing can compromise device safety and effectiveness. ## Frequently asked questions What kind of records must be maintained for servicing activities? Manufacturers must maintain records for each servicing activity, including the type and reason for service, the unique device identifier ( [UDI](/terms/udi)), and the results of the service. These records should be maintained in accordance with 21 CFR 820.180, General requirements, and 21 CFR 820.200 (b), Servicing records. How does servicing relate to complaint handling? Does 21 CFR 820.200 apply to third-party servicers? What is the ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Quality & Risk Complaint Handling Process for receiving, evaluating, and responding to device complaints. ](/terms/complaint-handling) ### More in Quality & Risk · Same category [ Quality & Risk Biocompatibility Ability of a material to perform with an appropriate host response in a specific application. ](/terms/biocompatibility)[ Quality & Risk CAPA Effectiveness Check Verification step confirming a corrective or preventive action actually fixed the problem. ](/terms/capa-effectiveness)[ Quality & Risk Change Control Formal QMS process for evaluating, approving, and implementing changes that could affect product quality or compliance. ](/terms/change-control)[ Quality & Risk Corrective and Preventive Action(CAPA) Systematic process to investigate and resolve quality issues and prevent recurrence. ](/terms/capa) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Quality System](/ecosystems/quality-system) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 eCFR· 1 AAMI· 1 MDIC· 1 1. [1 21 CFR 820.200 Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820) 2. [2 AAMI - Quality Systems Resources Verified AAMI · aami.org ](https://www.aami.org/standards) 3. [3 MDIC Case for Quality Verified MDIC · mdic.org ](https://mdic.org/program/case-for-quality/) 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=servicing) Learn in 60 seconds Card Lesson Quiz Quality system requirements for servicing devices, including service report analysis as potential complaints. - · Active area of policy discussion - FDA has held public meetings on third-party servicing and parts availability. - · FDA has historically scrutinized 'right to service' between OEMs and third-party servicers. Remember this Watch out: Failing to document servicing procedures and records adequately can lead to non-compliance during FDA inspections. Related terms - [Complaint Handling ](/terms/complaint-handling) You may also need Auto-suggested from Quality & Risk and shared keywords. - [Post-Production Information (Risk) ](/terms/post-production-info) - [AAMI SW96 ](/terms/aami-sw96) - [IDE Annual Progress Report ](/terms/ide-annual-report) - [Corrective and Preventive Action(CAPA) ](/terms/capa) - [Quality Management System Regulation(QMSR) ](/terms/qmsr) - [Quality System Regulation(QSR / 21 CFR 820) ](/terms/qsr) [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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