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:
| Activity | Description | Regulatory treatment |
|---|---|---|
| Servicing | Restoring a device to its original specification (e.g., replacing worn parts, recalibration) | QMSR servicing requirements |
| Remanufacturing | Significantly changing the device's performance, safety specs, or intended use | Treated 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.