Identification of Returned Medical Device

[ISO 13485 Cl 7.5.8] 

The purpose of this clause is to ensure that returned medical devices are clearly identified and segregated to prevent accidental mix-up, re-use, or re-shipment until they are evaluated and dispositioned properly. Returned devices may come back due to:

• Customer complaints or defects,

• Field safety corrective actions,

• Recalls, or

• Routine servicing.

Key Requirements

Returned Product Must Be Identified Clearly: All returned devices must be labeled, tagged, or logged immediately upon receipt. Identification must include details like:

• Device name, model, lot or serial number,
• Customer or return authorization number, and
• Reason for return (e.g., defect, recall, or damage in transit).

Prevent Unintended Use or Mix-up: Returned devices must be segregated from conforming inventory.

• For example, using a “Returned Material Area” or “Hold” tag. This avoids accidental reuse, rework, or resale before proper evaluation.

Evaluation and Investigation: Each returned device must undergo:

• Visual inspection and functional testing (if required).
• Root cause analysis if related to complaints or nonconformance.
• Decision on disposition repair, rework, scrap, or return to customer.

Recordkeeping: Maintain records of all returned devices including:

• Identification of the device (model, lot/serial number),
• Return reason and source,
• Investigation summary,
• Final disposition and approval signatureThese records support complaint handling (8.2.2) and corrective action (8.5.2) processes.

Reuse or Rework Control: If the returned device is repaired, refurbished, or reworked, the activity must follow documented, approved procedures.

• Device must meet original specifications before being released again.

• Record the rework history and maintain traceability to the original device lot or serial number.