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Servicing

Regulatory basis — § 820.200​

21 CFR § 820.200 (QMSR) requires manufacturers to establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements, when servicing is a specified requirement.

Servicing requirements apply when:

  • The device label, IFU, or contract specifies that the manufacturer provides servicing
  • Servicing is part of the manufacturer's business model (e.g., preventive maintenance contracts)

Service records — § 820.200(b)​

Each servicing event must be documented in a service record containing:

  • Device name and identification (serial number, model, UDI)
  • Date of service
  • Individual(s) performing the service
  • Service performed (maintenance, repair, adjustment)
  • Test and inspection data (post-service acceptance data)
  • Customer complaint number (if the service was initiated by a complaint)

Service reports and MDR interface​

If servicing reveals information about device performance that could constitute an MDR-reportable event, the service report must be evaluated for MDR reportability and a complaint file must be opened. Service technicians must be trained to recognise and report potential adverse events.

Servicing vs remanufacturing​

Remanufacturing is distinct from servicing:

ActivityDescriptionRegulatory treatment
ServicingRestoring a device to its original specification (e.g., replacing worn parts, recalibration)QMSR servicing requirements
RemanufacturingSignificantly changing the device's performance, safety specs, or intended useTreated as manufacturing — requires all manufacturer obligations including potentially a new 510(k)

A third-party service company that only restores devices to original specifications is not a remanufacturer. A company that modifies a device beyond its original specifications, changes its intended use, or relabels it is considered a remanufacturer and must comply with all manufacturer regulatory requirements.

Official resources​

Third-party service companies performing servicing on behalf of the manufacturer (e.g., under contract) must comply with QMSR servicing requirements. The manufacturer remains responsible for ensuring service records are documented and evaluated for MDR reportability. A service agreement should clearly define roles and responsibilities for compliance.