How do Medical Device Manufacturers Maintain Traceability on the Shop Floor?

Under the FDA’s Quality Management System Regulation (QMSR), in force since Feb. 2, 2026, a medical device manufacturer must be able to show, for each device or batch, what was built, to which revision, from which materials and with what result. The QMSR amends 21 CFR Part 820 and incorporates ISO 13485:2016 by reference.

ISO 13485 clause 7.5.1 requires a record for each medical device or batch that provides traceability to the extent set out in clause 7.5.9, and identifies the amount manufactured and the amount approved for distribution. 21 CFR 820.35 adds the FDA’s own records requirements, including recording the UDI for each medical device or batch.

The QMSR no longer defines the device history record (DHR) as a separate record type, and the former 21 CFR 820.184 has been removed. Many of the requirements once tied to the DHR are covered by ISO 13485 clause 7.5.1, which requires a record for each medical device or batch. Plants still commonly call it the DHR, or the eDHR when it is electronic.

On the shop floor, that record is built at the point of work: the operator and their training status, the equipment used, the material lots consumed, the revision built to and each inspection result. The manufacturer remains responsible for compliance; software holds and links the records.

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One example: Eyelit MES provides multi-level tracking and genealogy across serial, lot, batch, kit and sub-assembly, traceable forward and backward in a single action. For more on how that record is kept in practice, see this guide to medical device traceability on the shop floor.

For design engineers, traceability starts with the design. When a change is approved, the shop floor needs to work from the right revision and the production record needs to show it.

How an Engineering Change Reaches the Production Record, and Where it Slows Down

ISO 13485 clause 7.3.9 requires design and development changes to be identified, reviewed, verified, validated where appropriate and approved before they are put into use. The change also has to be assessed for its effect on parts already made, product in use and regulatory requirements.

An engineering change order (ECO) usually moves through four handoffs:

1. Release in PLM. The ECO releases revised drawings, the bill of materials and specifications.
2. Manufacturing engineering. The team updates routings, work instructions and inspection plans.
3. Shop floor system. The MES or equivalent receives the new revision and the point where it takes effect.
4. Production record. Each unit or batch is recorded against the revision it was built to.

Changes slow down at the handoffs: revisions re-keyed by hand, an unclear point where the change takes effect and work in progress that spans the changeover, leaving units or batches built to different revisions unless the point of effect, routing, instructions and inspection criteria are controlled.

Two items in the ECO make each handoff faster:

• Stating the point of effect by serial number, lot or date.
• Identifying the production records and documents the change affects, such as routings, work instructions, labels and inspection plans.

What Electronic Records and E-signatures Need Under 21 CFR Part 11

Under 21 CFR 11.1, Part 11 covers electronic records kept or transmitted under FDA records requirements, electronic records submitted to the FD and electronic signatures used in place of handwritten ones. FDA's guidance Part 11, Electronic Records; Electronic Signatures — Scope and Application reads this narrowly. In practice it applies to:

• required records kept electronically in place of paper or relied on electronically for regulated activities
• records submitted to the FDA electronically
• electronic signatures intended to replace handwritten signatures, initials or other required signings

Manufacturers should assess which of their records and signatures fall within that scope.

Section 11.10 sets controls for closed systems, including validation, audit trails and authority checks. The same guidance describes enforcement discretion for specified Part 11 requirements, including certain validation and audit trail provisions. The underlying recordkeeping requirements remain in force, as do the other Part 11 controls, such as authority checks and the electronic-signature requirements. ISO 13485 clause 4.1.6 separately requires validation of software used in the quality management system.

Section 11.50 requires each signed record to show the signer’s printed name, the date and time and the meaning of the signature, such as review or approval. Section 11.70 requires signatures to be linked to their records so they cannot be excised, copied or otherwise transferred.

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As an example, Eyelit MES supports Electronic Device History Records (eDHR) for medical device manufacturers under 21 CFR Part 11: electronic records, e-signature requirements, validation documentation and audit trails.

Where ECO approvals and production-record approvals use electronic records or signatures within Part 11’s scope, define the signature meanings and roles in the change procedure, so the record shows who approved what and in what role.

Building Serial and Lot Tracking into the Design Early

Traceability is cheapest to design in. Under 21 CFR 801.20, device labels and packages generally must bear a unique device identifier (UDI), subject to the exceptions in the regulation. Under 21 CFR 801.40, the UDI includes a device identifier and, where the label carries them, a production identifier conveying the lot or batch number, serial number, manufacturing date or expiration date.

ISO 13485 clause 7.5.9.2 adds requirements for implantable devices: records of the components, materials and work environment conditions that could cause the device to fall short of its safety and performance requirements.

These are design decisions:

• Tracking level. Decide which components are serialized and which are lot-tracked and record it as a bill-of-materials attribute.
• Marking. Decide where the serial number is marked and leave space for it.
• Scan points. Decide where each part is scanned during assembly.

A sub-assembly tracked at the right level lets one query run forward from a supplier lot to every finished device or backward from a device to every component inside it.

Classifying Changes as Major or Minor

ISO 13485 clause 7.3.9 requires changes to be reviewed, verified and validated as appropriate and approved before they are put into use, with their significance assessed against function, performance, usability, safety and regulatory requirements. For devices cleared through 510(k), the manufacturer must separately decide whether a change needs a new submission, using the FDA guidance Deciding When to Submit a 510(k) for a Change to an Existing Device.

Many manufacturers use major and minor categories in their own change procedure. That works when the criteria are written down and the category supports the technical and regulatory assessment rather than replacing it.

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Record the assessment and its reasoning against each change. An auditor reading the production record can then see which criteria applied, and why. One example: Eyelit MES version control distinguishes major from minor changes, tracked against individual build products, approved by authorized personnel via e-signature with full change traceability recorded.

Running Trial Builds of a New Revision Alongside Production

New revisions often need trial builds while the current revision is still in production. Three controls keep the two apart in the record:

1. A separate routing version for the trial revision, released through the same change process.
2. Clear identification and status. ISO 13485 clause 7.5.8 requires product to be identified and its status known throughout production. Mark trial units by revision and keep them out of distribution until the change is approved.
3. Lot or serial splits to set aside control units for comparison against the current revision.

For example, Eyelit MES Experiment Management alters production flows without disrupting flow revisions or current WIP, uses lot and serial splits to identify control lots, and is also used for NPI and equipment testing.

Where a process output cannot be fully checked by inspection, for example sealing or sterilization, ISO 13485 clause 7.5.6 requires the process to be validated. Trial builds often supply that evidence, so plan them as part of the change, with the records defined before the first unit is built.

Key Takeaways for Design Engineers

• The record follows the change. Each ECO identifies its point of effect and the records it affects.
• Check which records and approvals fall under Part 11 and define signature meanings in the change procedure.
• Traceability starts with the bill of materials, with tracking level, marking and scan points decided at design time.
• Assess each change against written criteria and record the reasoning.
• Keep trial builds identified and separate.

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