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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 May 5, 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.
    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.
    Grouped by theme

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    eCFR·1AAMI·1MDIC·1
    1. 1
      21 CFR 820.200
      Verified
      eCFRecfr.gov
    2. 2
      AAMI - Quality Systems Resources
      Verified
      AAMIaami.org
    3. 3
      MDIC Case for Quality
      Verified
      MDICmdic.org

    Inline markers like [1] jump to the matching reference above.