How does servicing relate to complaint handling?

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.

Does 21 CFR 820.200 apply to third-party servicers?

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.

What is the right to service debate about?

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.

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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 CyberLast reviewed September 19, 2026

Definition

Manufacturers performing service activities must document procedures, maintain records, and treat reports of events meeting MDR criteria as complaints. FDA has historically scrutinized 'right to service' between OEMs and third-party servicers. Under the QMSR, servicing requirements now follow ISO 13485 clause 7.5.4, with FDA keeping specific rules for service record content. Service reports should be analyzed for trends and fed into complaint handling and CAPA where appropriate. FDA's 2024 guidance on remanufacturing clarifies when work by third parties on a device goes beyond servicing and becomes remanufacturing, making them a manufacturer.

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) if applicable. The EU MDR (Regulation (EU) 2017/745) also implicitly covers servicing through 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

Manufacturers must maintain records for each servicing activity, including the type and reason for service, the unique device identifier (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.

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Updated: 9/19/2026

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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.
·Under the QMSR, servicing requirements now follow ISO 13485 clause 7.5.4, with FDA keeping specific rules for service record content.

Remember this

Watch out: Failing to document servicing procedures and records adequately can lead to non-compliance during FDA inspections.

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