GLOSSARY

What is Device History Record (DHR)?

Q: What is a DHR in medical devices?

A DHR is the production record proving a specific batch, lot, or unit was manufactured according to its device master record, including manufacture dates, quantities, acceptance records, labeling, and identifiers.

Q: DHR vs DMR vs DHF — what's the difference?

The DHF documents how the device was designed, the DMR is the recipe for building it, and the DHR proves each batch was built to that recipe.

Definition

A device history record (DHR) is the production record for a batch, lot, or unit of a medical device, and is the documented evidence that it was manufactured according to the information in the device master record (DMR). The term comes from FDA’s legacy Quality System Regulation (21 CFR 820.184); under the QMSR, effective February 2, 2026, FDA’s regulation incorporates ISO 13485:2016, and the DHR obligation lives on through ISO 13485’s production record requirements. The industry still widely uses “DHR” day to day. However, you will not find the term in ISO 13485.

Establishing device history records is one of the last steps in the compliance process for medical devices. The DHR was defined in subpart M of the legacy 21 CFR Part 820 (the QSR), which dealt with record-keeping requirements for medical device companies; that content now maps to ISO 13485’s records requirements under the QMSR. Manufacturers are subject to this part whether they keep records on paper, or they use a web-based software QMS to manage documentation. The DHR serves as a production record for medical devices that you manufacture - entries into this document include acceptance records for individual units or batches of product, along with product counts, labels, and any unique product identifiers that have been applied.

FREE DOWNLOAD: Click here to download our Guide to DHF vs. DMR vs. DHR.

DHR vs DMR vs DHF at a glance

Record	What it is	Question it answers
DHF (design history file)	Record of the design process	How was the device designed?
DMR (device master record)	The complete "recipe": specs, procedures, labeling	How do we build it?
DHR (device history record)	Production evidence per batch/lot/unit	Was this batch built to the recipe?

Record

What it is

Question it answers

DHF (design history file)

Record of the design process

How was the device designed?

DMR (device master record)

The complete "recipe": specs, procedures, labeling

How do we build it?

DHR (device history record)

Production evidence per batch/lot/unit

Was this batch built to the recipe?

Note: under the QMSR these three terms were retired in favor of ISO 13485 constructs (e.g., the design and development file and medical device file), but the industry still uses them.

Read the full comparison: Design History File vs. Device Master Record vs. Device History Record.

What should be documented in the DHR?

The legacy QSR (21 CFR 820.184) spelled out what a DHR must contain, and it remains the industry’s de facto checklist:

Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to ensure that DHR's for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:

(a) The dates of manufacture;

(b) The quantity manufactured;

(c) The quantity released for distribution;

(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;

(e) The primary identification label and labeling used for each production unit; and

(f) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used.

Most sections of 21 CFR Part 820 refer to establishing overall quality processes that affect your product design and manufacturing, but the DHR is different in that it is applied to each batch of products that you produce. The DHR mandate requires that new batches of product are tested to ensure that they meet the product specifications established in the device master record.

The mandate also ensures that batches of product are correctly labeled and assigned identification numbers. This creates traceability throughout your supply chain, enabling you to better identify sources of error in case any non-conformance issues arise with your products.

Is the DHR still required under the FDA QMSR?

Short answer: the record-keeping obligation survives; the terminology changed. When the QMSR took effect on February 2, 2026, FDA’s regulation stopped defining the DHR, DMR, and DHF as standalone terms and instead incorporates ISO 13485:2016’s documentation structure (including the medical device file).

Production records that demonstrate each batch, lot, or unit was manufactured according to its specifications are still required, and auditors will still expect the same traceability the DHR always provided: dates and quantities manufactured and released, acceptance records, the labeling used, and UDI or other control numbers.

Practical takeaway: keep your DHR process. Map its contents to the corresponding ISO 13485 clauses in your QMS documentation so the terminology in your procedures matches the regulation your auditors now inspect against.

Electronic device history records (eDHR)

An electronic device history record (eDHR) is a digital version of the DHR, assembled automatically from your production, acceptance, and labeling records instead of compiled by hand from paper travelers. eDHRs cut review time, reduce transcription errors, and make batch-release and audit evidence searchable. Learn more in our guide to eDHRs, or see how Greenlight Guru's QMS keeps production records connected to your device documentation.

What role does DHR play in the QMS?

The DHR plays an important role in the quality system at your medical device company. Here are a few ways that companies are leveraging the DHR to improve their processes, get better results, and stay compliant with the latest standards and regulations:

Using DHR to facilitate CAPA investigations - if a non-conformance issue or customer complaint is presented to your CAPA team, the team can determine the UDI, UPC, or other product identifier associated with the complaint. This allows your team to identify potentially problematic batches or production runs of devices and find the root cause of the issue. This allows your quality manager to determine whether non-conformance issues were confined to a specific batch of product, or if the issue is affecting products in all batches.
Using DHR to facilitate process improvement - imagine that a batch of product passes your acceptance criteria, but is later found to contain a greater-than-acceptable proportion of non-conforming product. The ability to trace non-conformance issues back to a specific batch can help you understand the problem and redesign your acceptance criteria to prevent future occurrences of the defect.
Using DHR to limit liability and save money - The device history record allows manufacturers to demonstrate that batches of product were tested for acceptance with the DMR before being released for distribution (More on decoding the difference between DHR and DMR here). It also allows targeted recalls if only a certain batch is found to be defective. Imagine you release 100 batches of product for distribution and receive 3 non-conformance complaints from the same batch. Referencing your DHR, you'll realize that it's just a single batch that has defects, and you can issue a targeted recall of that batch instead of recalling all 100.

Is a DHR still required under the QMSR?

Yes in substance, no in name. When the QMSR took effect on February 2, 2026, FDA removed §820.184 and the defined term "device history record." The requirement to keep records demonstrating each batch, lot, or unit was manufactured to specification did not go away. It now flows from ISO 13485:2016 (incorporated by reference in Part 820), including the medical device file (clause 4.2.3), production and traceability records (clause 7.5), and product acceptance records (clause 8.2.6). If your quality system already maintains compliant DHRs, you are largely covered, but your procedures and terminology should be updated to reference the ISO 13485 clauses. Full breakdown: QMSR & the End of DMR, DHR, DHF

Make managing your DHR easy with Greenlight Guru's QMS solution

DHR is a living document - it should be updated each time you manufacture a new batch of product with unique device identifiers and conduct tests against your acceptance criteria for the new batch of product. Greenlight Guru's QMS uses built-in document controls to ensure that your important records never get lost or deleted, and you can easily update your DHR with each new batch of medical devices that you release for distribution.

The DHR mandate also allows for linking between documents, so you'll be able to include links to the full results of acceptance testing within your DHR. Having all of your information in one place makes the audit process go smoothly and will save you time and money when applying for ISO certification or dealing with an FDA audit.

Frequently Asked Questions

What does DHR stand for in medical devices?

In medical device manufacturing, DHR stands for device history record — the production record proving a batch, lot, or unit was manufactured to specification. (Not to be confused with other uses of "DHR," such as hospital systems or stock tickers.)

Is the DHR still required after the QMSR?

The name was retired, the substance was not: equivalent production-record requirements apply under ISO 13485:2016, incorporated into 21 CFR Part 820 as of February 2, 2026.

How long must device history records be kept?

Under ISO 13485, records must be retained at least the lifetime of the device and no less than two years from release.

What is the difference between a DHR and a DMR?

The DMR is the recipe: specifications and procedures for building the device. The DHR is the proof: the record that a specific batch followed that recipe.

What is a DHR in medical devices?

The production record proving a specific batch, lot, or unit was manufactured according to its device master record, including dates, quantities, acceptance records, labeling, and identifiers.

DHR vs DMR vs DHF — what’s the difference?

The DHF documents how the device was designed; the DMR is the recipe for building it; the DHR proves each batch was built to that recipe. See our full DHF vs DMR vs DHR comparison.