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Device History Record (DHR) Template for Medical Device Batches

A device history record proves that a specific lot or serial number was built and released according to its device master record. This template gives you a clean structure you can fill in and export, then attach to the lot paperwork.

Fill in

Manufacturer

Device name and model

Lot or serial number

Work order / production order

Device master record / device file reference

Quantity manufactured

Quantity released for distribution

Production start date

Production end date

Labeling and UDI used

Acceptance activities summary

Nonconformances during this lot

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Device History Record (DHR) Template

Device History Record

Manufacturer: Meridian Orthopedics Inc. Device: Cannulated bone screw 4.0 mm x 36 mm, model CS-4036 Lot / serial: L2610-0417 Work order: WO-118204 Device master record: DMR-CS-4036 Rev F

Quantities and dates

Quantity manufactured: 500 Quantity released for distribution: 492 Production start: 2026-10-05 Production end: 2026-10-12

Manufacturing steps

Step	Operation / instruction ref	Date	Operator	Result
10	Material receipt and verification
20	Machining / forming
30	Cleaning and passivation
40	Final inspection
50	Packaging and sterilization

Acceptance records

Incoming material cert verified (Ti-6Al-4V ELI, heat 7731). In-process dimensional checks per sampling plan. Final inspection per INS-CS-4036. Passivation and cleaning validated process PV-014.

Labeling and identification

Label LBL-CS-4036 Rev C, UDI-DI (01)00812345000417, lot (10) and expiry (17) printed

Nonconformances and deviations

NCR-2291: 8 pieces scrapped for thread gauge fail. No other deviations.

Release

Production supervisor / Date

Quality assurance reviewer / Date

Authorized releaser / Date

This is a starting point built from the typical content of a device history record, not legal advice. Your device master record, procedures and the regulation that applies to you (21 CFR Part 820 as amended, EU MDR, or other) define what your DHR must contain. Keep the completed record with the lot and retain it for the period your procedure requires.

Automate DHR assembly from your ERP

Optional: a short review of how lot, inspection and NCR data in your ERP could populate device history records.

Optional. The tool and every export work without this. No spam.

How to use this template

Enter the manufacturer, device, lot or serial number, work order and the device master record revision, then add quantities, dates, labeling, acceptance results and any nonconformances. Export to PDF or Word and complete the step table and signatures by hand or in your document system. One record covers one lot or serial number, so make a new one for every production order.

Always reference the revision of the device master record used
Record quantity made and quantity released separately
Cite NCR and deviation numbers instead of describing them again
Keep the label and UDI printed on the lot with the record

What the record has to show

Under the old FDA Quality System Regulation the DHR was defined in 21 CFR 820.184: dates of manufacture, quantity manufactured, quantity released, acceptance records, the primary identification label and any device identification and control numbers. ISO 13485 clause 7.5.1 asks for a record for each medical device or batch that provides traceability and identifies the amount manufactured and approved for distribution. Check which version of the rule applies to your market, because FDA moved to the Quality Management System Regulation that incorporates ISO 13485.

Worked example

A orthopedic screw lot of 500 pieces is built under work order WO-118204. Eight pieces fail a thread gauge check and are scrapped under an NCR, so 492 pieces are released. The DHR shows 500 made, 492 released, the NCR reference, the passivation process validation, the label revision and the three signatures. An auditor can pick the lot number and trace every claim back to a source record in minutes.

Common mistakes

The usual failures are a blank release signature, a quantity released that does not match the shipment, a missing reference to the DMR revision, and records that say pass without the measured value. Paper DHRs also grow slowly because people attach loose inspection sheets; list every attachment by document number so nothing gets orphaned. In an ERP, the work order, lot and inspection results often already exist and can feed the record automatically.

Frequently Asked Questions

What is a device history record?

It is the record of how one batch, lot or unit of a medical device was manufactured and accepted. It shows dates, quantities, what was released, acceptance results and labeling, and proves the device was built to its device master record.

Is a DHR the same as a batch record?

In practice the terms overlap. Batch record is common in pharma and general manufacturing. DHR is the medical device term, and it carries device-specific content such as UDI, labeling and release for distribution.

How long must a DHR be retained?

Retention is set by regulation and your procedure. A common rule is the expected life of the device but not less than two years from release, and EU MDR sets its own periods. Confirm with your regulatory affairs lead for each market.

Can a DHR be electronic?

Yes. Electronic records are accepted if the system is validated, access controlled and audit trailed. For FDA this means meeting 21 CFR Part 11 expectations where they apply. Many manufacturers build the DHR from MES and ERP data.

If your lot, inspection and nonconformance data already sit in SAP, Infor, Epicor or NetSuite, Netray can help assemble the DHR from that data on your own infrastructure, with a human approving release.

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