eDHRElectronic Device History Record

An electronic device history record (eDHR) is the production evidence for a medical device kept in electronic form: what was built, from which materials, to which approved revision, by whom, with which inspection results, which labels, and what the release decision was. "DHR" is the name the former Quality System Regulation (QSR) used. Since 2 February 2026, FDA's Quality Management System Regulation (QMSR) incorporates ISO 13485:2016 by reference, and the matching ISO concept is the record of production for each device or batch of devices. Many manufacturers still call that record a DHR or eDHR.

The record can be kept per unit, per lot or per batch. Which level is right depends on the product, how it is identified, and the traceability that applies to it. Current 21 CFR 820.35(c) requires the UDI to be recorded for each medical device or batch of medical devices, and implantable or life-supporting devices carry additional traceability expectations. Serialised devices are usually recorded per unit; many lower-risk devices are recorded per lot or batch.

Under the former QSR, §820.184 required a device history record for each batch, lot or unit, showing the device was made according to the device master record. It listed the content expected: dates of manufacture, quantity made, quantity released for distribution, acceptance records, the primary identification label and labeling for each production unit, any UDI or UPC, and any other device identification and control numbers. That section no longer exists in current Part 820.

The QMSR amended Part 820 rather than removing it. Current Part 820 requires a quality management system that meets ISO 13485:2016, plus FDA-specific additions. For records, current §820.35 adds required content for complaint records, servicing records and UDI recording; it does not restate the old §820.184 list. The ISO 13485 production-record expectations (paraphrased: a record for each device or batch that gives traceability to the extent required, identifies the amount made and the amount approved for distribution, and is verified and approved) now carry that role, alongside the standard's control-of-records requirements.

The QSR named three records. The terms remain common in industry, but the current framework uses ISO 13485's structure, and FDA's QMSR FAQ explains how the former records relate to it.

Whatever the names, the relationship still matters: the production record should show which approved revision of each specification, instruction and label applied when the product was made. A record that only links to the latest revision makes that hard to prove, so many systems store the revision used with the record.

Neither the QMSR nor ISO 13485 requires production records to be electronic. Paper travelers remain a legitimate choice, particularly in low-volume production. Manufacturers move to electronic records for practical reasons: fewer transcription errors, entries captured when the work is done, faster retrieval, and easier trending across many records.

Common weaknesses of paper records

• Transcription errors when readings are copied from an instrument display.
• Entries completed later from memory rather than at the time of the work.
• Missing or illegible pages that delay review and release.
• Slow retrieval when records are archived off site.

What electronic records can improve, if configured and validated

• Readings taken from connected instruments where a supported connection is set up.
• System time stamps and an audit trail showing who entered or changed what, and when.
• Steps, reviews and signatures enforced in the order your procedures require.
• Retrieval of a device's, lot's or batch's history by identifier.

Electronic records also bring obligations. Where FDA-required records are kept electronically, or electronic signatures are used for them, 21 CFR Part 11 applies within its scope, and the system must be validated for its intended use.

The exact content comes from your procedures, the incorporated standard, current Part 820 and any other requirements that apply to your device. Most defensible record sets cover the following.

1. Identity

Product and model, the unit, lot or batch identifier, the UDI where Part 830 requires one, the work order, the dates of manufacture, and the approved revisions of the specifications and instructions used.

2. Materials and components

Component and material lots or serial numbers consumed, linked to their receipt and supplier records, so you can trace from a component lot to every finished unit or batch that used it to the extent your traceability requires.

3. Process steps

Each step performed, who did it and when, the equipment used and its calibration or maintenance status where relevant, the measured values against their acceptance criteria, and any deviation.

4. Labels and identification

The labels and labeling used, including the UDI content printed where applicable, and any label checks your procedures require.

5. Inspection, acceptance and quantities

In-process and final acceptance results, the quantity made and the quantity approved for distribution, and who verified and approved the record.

6. Nonconformance and rework

Any nonconformance, its evaluation and disposition by authorised people, rework instructions used, and re-inspection results.

7. Signatures and audit trail

Where electronic signatures are used for FDA-required records, Part 11 expects the signer's printed name, the date and time, and the meaning of the signature, linked to the record. Part 11 also expects secure, computer-generated, time-stamped audit trails for those electronic records.

21 CFR Part 830 requires most devices to carry a UDI on their label and packages, with exceptions and alternatives set out in the rule. A UDI has a device identifier (DI) and, where the label carries them, production identifiers (PI) such as lot or batch, serial number, expiration date or manufacture date. Which production identifiers appear depends on what the label carries for that device.

Current §820.35(c) requires the UDI to be recorded for each medical device or batch of medical devices. In practice, store the UDI content actually printed with the production record, and include any print or scan verification your procedures require.

Submitting device identifier data to FDA's GUDID, or to EUDAMED for devices placed on the EU market, is a separate obligation with its own process. Production records support that work but don't replace it.

ISO 13485 (clause 8.3, paraphrased) expects nonconforming product to be identified and controlled so it is not used or delivered unintentionally, with evaluation, disposition by authorised people, and records kept. Rework must follow documented instructions and the reworked product must be re-verified.

In an electronic record, the original failed result should stay visible. The record should show the nonconformance, its disposition, the rework instruction used, the re-inspection and the person who approved the outcome. A failed value that is simply overwritten removes the evidence a reviewer needs.

ISO 13485 expects software used in the quality management system and in production to be validated for its intended use, with the effort proportionate to risk. Part 11 also requires validation of systems used for FDA-required electronic records. Typical evidence includes:

• User requirements for how the record system will be used.
• A risk assessment of the functions that affect product quality or record integrity.
• Installation and operational qualification evidence for the configured system.
• Performance or user-acceptance evidence for your intended use, products and procedures.
• A traceability matrix linking requirements, tests and results.
• Change control and periodic review to keep the system in its validated state.

The manufacturer owns its intended-use validation and its approvals. A supplier can provide documentation and support; it cannot validate your use for you.

1. Live links to specifications without the revision in force when the product was made.
2. Audit trail disabled, filtered or never reviewed.
3. Shared logins, so entries and signatures cannot be attributed to a person.
4. Printed or exported records that no longer match the system record after later changes.
5. Rework recorded without a nonconformance, disposition or re-inspection.
6. Equipment used without its identity or calibration status recorded where it matters.
7. Label content recorded without the identifiers actually printed.
8. Retention periods not defined for each record type.

Retention has no single fixed number. Set it from the incorporated standard (which ties the minimum to the device lifetime you define, with a floor), any applicable FDA and other regulatory requirements, product-specific and contractual requirements, and the type of record. Under the former QSR, §820.180(b) set the period at the device's design and expected life and no less than two years from release; that is historical context, not today's rule. Keep the audit trail for as long as the record it supports.

Production records also feed complaint investigation, medical device reporting under 21 CFR Part 803, corrections and removals under Part 806, and, for EU devices, post-market surveillance. Structured fields for components, lots and configurations make it far easier to identify affected units or batches when a problem is found.

V5 Ultimate supports electronic device production records through its manufacturing, quality and controlled-records modules. What you get depends on your plan, configuration and permissions, and your procedures decide the workflow.

• Work orders and production instructions, with steps performed and reviewed in V5.
• Lots and traceability, GS1-128 labels and label design and print.
• Regulated reports including eDHR, BMR, MMR and CoA.
• 21 CFR Part 11 electronic signatures, audit history and controlled-document workflows.
• Deviations, corrective actions and quality review alongside production.
• Equipment and maintenance records; automated device measurements need supported, configured connections.