Medical Device Traceability on the Shop Floor: Meeting the QMSR with an MES
Medical device traceability is the ability to show, for any unit or batch, which materials and components went into it, which operations and inspections it passed, who performed them, and where it went after release. On the shop floor, manufacturers build that record as production happens, usually in a manufacturing execution system (MES).
Since February 2, 2026, the US requirements for this record sit in the FDA’s Quality Management System Regulation (QMSR) at 21 CFR Part 820. The QMSR incorporates ISO 13485:2016 by reference, alongside US-specific requirements that include unique device identification (UDI), device tracking where the FDA orders it, and labeling and packaging controls.
Eyelit Technologies publishes this guide.
How do medical device manufacturers maintain compliance traceability on the shop floor?
Medical device manufacturers maintain compliance traceability on the shop floor by identifying every unit or batch, recording each production step against that identity as it happens, and keeping the linked record retrievable for the life of the device.
The regulations set what the record must show, and each manufacturer decides how to put it in place. A common approach uses six shop-floor controls:
- Identify product from the start. Each unit, lot, or batch carries an identifier from the first operation, and its status (in process, on hold, accepted, rejected) is visible at every step.
- Verify materials at the point of use. Operators scan components and material lots before use, and the system checks them against the bill of materials and their release status.
- Record each operation as it happens. The record captures the operation, the equipment used, the operator, the process values, and the inspection or test results.
- Control who and what does the work. Critical tasks go to trained operators, and equipment is calibrated and qualified before use.
- Link labeling and UDI to the record. The label and the UDI applied to each device or batch are recorded against its production history.
- Keep genealogy searchable in both directions. Quality teams can trace a finished device back to its materials, and a material lot forward to every device that contains it.
Take a supplier who reports a problem with one lot of tubing. Forward genealogy lists every device built with that lot, so the quality team can assess the affected devices and decide the right scope for a hold. If a device returns with a complaint, backward genealogy shows the tubing lot, operators, equipment, and test results behind it.
What does the QMSR require for traceability?
The QMSR requires a documented quality management system that complies with ISO 13485:2016, together with applicable US-specific requirements. The table sets out the ones that bear on shop-floor traceability.
| Requirement | Source | What it asks for |
| Quality management system | 21 CFR 820.10(a) | A documented quality management system that complies with the applicable requirements of ISO 13485:2016. |
| Record for each device or batch | ISO 13485:2016, clause 7.5.1 | A record for each medical device or batch of medical devices that provides traceability to the extent specified in clause 7.5.9 and identifies the amount manufactured and the amount approved for distribution. The record is verified and approved. |
| Product identification | ISO 13485:2016, clause 7.5.8 | Identification of product throughout product realization, including its status against monitoring and measurement requirements. |
| Traceability procedures | ISO 13485:2016, clause 7.5.9.1 | Documented procedures for traceability that define its extent and the records to keep. |
| Implantable devices | ISO 13485:2016, clause 7.5.9.2 | For implantable devices, traceability records include the components, materials, and work environment conditions used, where these could affect the device’s specified safety and performance requirements. Distributors keep records of device distribution for traceability, available for inspection, and the name and address of the shipping package consignee are recorded. |
| Life-supporting and life-sustaining devices | 21 CFR 820.10(d) | Manufacturers of devices that support or sustain life, where failure to perform when properly used can reasonably be expected to result in significant injury, also meet the implantable-device traceability requirements in ISO 13485 clause 7.5.9.2. |
| UDI system | 21 CFR 820.10(b)(1) | A documented system for assigning unique device identifiers under 21 CFR Part 830. |
| UDI in the record | 21 CFR 820.35(c) | The UDI recorded for each medical device or batch of medical devices. |
| Traceability for tracked devices | 21 CFR 820.10(b)(2) | Documented traceability procedures under 21 CFR Part 821, where they apply to devices the FDA has ordered to be tracked. |
| Labeling and packaging | 21 CFR 820.45 | Documented procedures for labeling and packaging integrity, inspection, storage, and operations. Labeling and packaging are checked for accuracy before release or storage, where applicable, covering the UDI or other device identification, expiration date, and storage, handling, and processing instructions. Release of labeling is documented, and labeling operations are set up to prevent mixups, with inspection results documented. |
Before February 2, 2026, the FDA set the content of this production record under 21 CFR 820.184, the device history record (DHR) section. The QMSR retired that section and its term, and the record itself is still required. Our guide to the electronic device history record (eDHR) covers that change in detail.
How do UDI, traceability, and device tracking differ?
UDI, traceability, and device tracking are three separate requirements, and each one answers a different question about a device.
Unique device identification (UDI) labels the device. Under 21 CFR 801.3, a UDI is made up of a device identifier and, when applicable, a production identifier. The device identifier is the fixed part that identifies the labeler and the specific version or model. The production identifier is the conditional, variable part. When it appears on the label, it identifies one or more of the lot or batch, the serial number, the expiration date, and the date of manufacture.
Traceability connects that identifier to production history. It is the manufacturer’s own record of what each device or batch was made from and how it was made, built on the shop floor and kept under ISO 13485 clause 7.5.9.
Device tracking follows certain devices after they leave the factory. Under 21 CFR Part 821, the FDA can issue an order requiring a manufacturer to track a Class II or Class III device that meets one of three criteria: its failure would be reasonably likely to have serious adverse health consequences, it is intended to be implanted in the human body for more than one year, or it is a life-sustaining or life-supporting device used outside a device user facility. Tracking lets those devices be located promptly if a notice or recall is needed. For a tracked device, the manufacturer keeps a written tracking procedure and a quality assurance program with audits, and tracks the device for its useful life.
The UDI gives each device an identification reference that connects these records. Traceability records hold the production genealogy, and Part 821 tracking applies to the devices the FDA has ordered tracked. Recording the UDI against the production record lets a manufacturer start from a device in the field and reach its production history.
What should a shop-floor traceability record capture?
A shop-floor traceability record captures the identity of the product and every input and check applied to it, at the point in production where each one happens.
| Point in production | What the record captures |
| Material receipt and release | Supplier lot, quality status, and expiration date for each material and component. |
| Kitting and consumption | Which material lots were issued to which work order, unit, or batch. |
| Each operation | The operation performed, the date and time, the operator, and the equipment used. |
| Process values | The parameters recorded during the operation, against their approved limits. |
| Inspection and test | Results against acceptance criteria, with the person or system that recorded them. |
| Rework and nonconformance | Any deviation, its disposition, and the steps repeated. |
| Labeling | The label applied, its UDI, and label reconciliation. |
| Release | The quantity manufactured, the quantity approved for distribution, and the approval to release. |
Paper travelers can hold much of this data. Linking it by hand across a full production run is the slow part, and it is where gaps appear, which is why many manufacturers move to shop floor traceability software. An MES records each entry against the product identity at the time it happens.
How does Eyelit MES support shop-floor traceability?
Eyelit MES lets manufacturers digitize device and controlled history records while remaining compliant, removing paper and manual processes.
Eyelit MES provides multi-level tracking and genealogy across serial, lot, batch, kit, and sub-assembly, traceable forward and backward in a single action.
Operator and equipment controls sit in the same system. Eyelit MES Asset Management tracks equipment availability and preventive maintenance within the MES, covering durables, tooling, spare parts, and calibration instruments, and Operator Certification restricts critical tasks to trained resources.
Eyelit MES models workflows and routings with re-entry for rework, re-inspection, test, and repair cycles, through web-based drag-and-drop process modeling with unfreeze, checkout, freeze, and version control, representing actual shop-floor processes without customization.
Labeling follows the same pattern. Eyelit MES provides controlled label management: graphical layout, data, and validation approved in one system with e-signatures, version control on every change, and label reconciliation records retained for audit.
For electronic records and signatures, see our guide to MES support for 21 CFR Part 11. For a side-by-side view of platforms, see our comparison of the 10 best MES software platforms for manufacturers.
Sources
- 21 CFR Part 820, Quality Management System Regulation (eCFR)
- FDA, Quality Management System Regulation (QMSR)
- 21 CFR 801.3, Definitions: unique device identifier, device identifier, production identifier
- 21 CFR Part 821, Medical Device Tracking Requirements (eCFR)
- FDA, Medical Device Tracking
- 21 CFR Part 830, Unique Device Identification (eCFR)
- ISO 13485:2016, Medical devices: Quality management systems, Requirements for regulatory purposes
