Electronic Device History Record (eDHR): Digitizing the DHR

An electronic device history record (eDHR) is the digital production record for a medical device or a batch of devices. It shows how each unit was built: the materials and components used, the equipment and operators involved, the inspection and test results, and the approval to release.

Manufacturers digitize the device history record (DHR) by capturing that data at each production step in a manufacturing execution system (MES), in place of paper travelers. Medical device manufacturers have long been required to keep this record. Since February 2, 2026, the requirement sits within the FDA’s Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016.

Eyelit Technologies publishes this guide.

How do manufacturers digitize device history records?

Manufacturers digitize device history records in five steps: they define the record, move data capture to the point of work, enforce the process at each step, sign and review electronically, then release and keep the record.

1. Define what the record must hold. Start from the device’s master record (its specifications, procedures, and acceptance criteria) and from the record requirements in ISO 13485 and 21 CFR Part 820. Then decide which data the eDHR captures at each operation.
2. Capture data where the work happens. Operators enter results, scan components, and record test values in the MES at each workstation. The record builds as the product moves through production.
3. Enforce the process. Configure the MES to check each step before the unit moves on: operator training is current, equipment is qualified, materials are correct, and every required entry is complete.
4. Sign and review electronically. Approvals use electronic signatures controlled under 21 CFR Part 11. Where the system is validated for it, quality teams can focus their review on the exceptions it flags.
5. Release and keep the record. The approved record stays linked to the unit or batch, including its unique device identifier (UDI) where one applies, and remains retrievable for the full retention period. This supports shop-floor traceability under the QMSR.

The move from paper is a change the manufacturer defines, validates for its intended use, and controls under its quality system. One common approach is to start with a single product line, run paper and electronic records side by side during validation, and retire paper for that line before moving to the next. Our guide to MES support for 21 CFR Part 11 covers the validation and electronic signature side in detail.

What is a device history record (DHR)?

A device history record (DHR) is the record that shows a specific medical device or batch was manufactured to its approved specifications.

The former requirement. Until February 2, 2026, the FDA required the DHR under 21 CFR 820.184, which listed its contents:

• dates of manufacture
• the quantity manufactured and the quantity released for distribution
• acceptance records showing the device was made to its master record
• the primary identification label and labeling used
• any unique device identifier (UDI) or universal product code (UPC), and any other identification and control numbers used

The current requirement. The QMSR replaced that section. Part 820 now incorporates ISO 13485:2016, whose clause 7.5.1 requires 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. Part 820 adds US-specific requirements on top: section 820.10(b) requires a documented system for assigning unique device identifiers under 21 CFR Part 830, and section 820.35(c) requires the UDI to be recorded for each medical device or batch. 

The FDA retired the term “device history record” from the regulation. DHR and eDHR remain the industry’s names for this production record, and the record itself is still required.

What changes when the DHR moves from paper to an eDHR?

An eDHR can turn the production record from a document filled in after each step into a system that checks each step as it happens. The table shows what a configured and validated eDHR can enable; each implementation sets which of these it uses.

Scanning paper forms into PDFs gives a digital copy of the paper process. The value of an eDHR comes from enforcement: a configured system can hold a unit at the step where something is missing or out of specification, so the record is complete when production ends.

Which regulations apply to an eDHR?

Two FDA regulations apply to an eDHR: 21 CFR Part 820, which sets what the production record must contain, and 21 CFR Part 11, which sets how electronic records and electronic signatures are controlled.

• 21 CFR Part 820 (QMSR). Incorporates ISO 13485:2016. Clause 7.5.1 sets the record for each device or batch. Sections 820.10(b) and 820.35(c) add the US unique device identification requirements. ISO 13485 clause 4.2.5 requires manufacturers to keep records for at least the lifetime of the device as they define it, and for a minimum of two years from release.
• 21 CFR Part 11. Applies when a manufacturer keeps these required records electronically in place of paper, or keeps both and relies on the electronic version for regulated work. It covers audit trails, electronic signatures, access controls, and system validation.

How does Eyelit MES digitize device history records?

Eyelit MES lets manufacturers digitize device and controlled history records while remaining compliant, removing paper and manual processes.

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.

Eyelit MES holds history records in an immutable record structure, designed so that entries cannot be altered after signature. Eyelit MES supports line-item and whole-record approval by authorized users using secure e-signatures.

Traceability and labeling sit in the same system. Eyelit MES provides multi-level tracking and genealogy across serial, lot, batch, kit, and sub-assembly, traceable forward and backward in a single action. 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.

Eyelit MES integrates with ERP, order entry, and PLM through one point of integration rather than a separate integration per system.

For a side-by-side view of MES platforms, see our comparison of the 10 best MES software platforms for manufacturers.

Sources

1. 21 CFR Part 820, Quality Management System Regulation (eCFR)
2. FDA, Quality Management System Regulation (QMSR)
3. FDA, Medical Devices; Quality System Regulation Amendments, final rule, 89 FR 7496, February 2, 2024
4. 21 CFR Part 11, Electronic Records; Electronic Signatures (eCFR)
5. ISO 13485:2016, Medical devices: Quality management systems, Requirements for regulatory purposes