Maps to
QMSR / ISO 13485: §820.181 / 820.184
ISO 13485: §4.2.3
Requirement text
A Device Master Record (DMR) must be maintained for each device type, containing device specifications, production process specifications, quality assurance procedures, and packaging/labeling specifications. A Device History Record (DHR) must be maintained for each production batch or lot, demonstrating that devices were manufactured in accordance with the DMR.
What changed
Part 820 sections 820.181 and 820.184 defined two foundational device record concepts unique to FDA regulation. The Device Master Record (DMR, 820.181) required a compilation of records containing the procedures and specifications for a finished device, including device specifications, production process specifications, quality assurance procedures and specifications, packaging and labeling specifications, and installation and servicing procedures. The Device History Record (DHR, 820.184) required records demonstrating that each finished device was manufactured in accordance with the DMR, including dates of manufacture, quantity manufactured, quantity released for distribution, acceptance records, the primary identification label and labeling used, and any device identification including UDI.
ISO 13485:2016 does not have equivalent concepts to DMR and DHR. The standard addresses document control (4.2.4) and record control (4.2.5) generally, and the medical device file (4.2.3) which is a compilation of documents defining a medical device. However, the ISO 13485 medical device file is focused on regulatory submissions (technical documentation), not on the manufacturing record compilation that the DMR represents. Similarly, ISO 13485 requires production records but does not prescribe the specific DHR content structure that Part 820 defined.
This is one of the most significant QMSR-specific retentions. The FDA retained both the DMR (now under QMSR 820.35) and DHR requirements because they are fundamental to FDA's inspection approach. FDA investigators use the DMR as the reference standard and the DHR to verify each batch was manufactured in accordance with that standard. The QMSR preamble emphasized that these records are essential for FDA's ability to verify manufacturing compliance and that ISO 13485's general record requirements are insufficient for this purpose. Companies must maintain both the DMR compilation and batch-specific DHRs with all required content elements, including UDI.
Atomic constraints
- •A Device Master Record (DMR) must be established and maintained for each device type.
- •The DMR must include device specifications (design outputs), production process specifications, quality assurance procedures, and packaging/labeling specifications.
- •A Device History Record (DHR) must be maintained for each production batch, lot, or unit.
- •The DHR must include manufacture dates, quantity manufactured, quantity released for distribution, acceptance records, and device identification including UDI.
- •The DHR must demonstrate the device was manufactured in accordance with the DMR.
- •DMR and DHR must be available for FDA inspection.
- •The DMR must include or reference installation, maintenance, and servicing procedures and methods where applicable per QMSR 820.181.
- •The DHR must include the primary identification label and any labeling used for each production lot, demonstrating labeling control per QMSR 820.184.
- •The DMR must be updated whenever design changes, process changes, or specification revisions are implemented, maintaining alignment between the DMR and the actual current manufacturing requirements.
- •Each DHR must be reviewed and approved by a designated individual before finished devices are released for distribution.
- •The DMR must include or reference procedures for environmental controls, cleaning, and maintenance of production equipment where those procedures are needed for device conformity.
- •The DHR must identify the person(s) who performed each significant manufacturing step or inspection activity, enabling traceability of each production decision.
Common gaps
No Defined DMR Index or Compilation
majorCompanies have individual documents (specifications, procedures, work instructions) but no DMR index that compiles or references all documents constituting the complete DMR for each device type. Without a DMR index, there is no single point of reference to verify that all required manufacturing documentation exists and is current.
DHR Does Not Contain All Required Elements
majorBatch records or production records lack one or more of the required DHR elements: dates of manufacture, quantity manufactured, quantity released, acceptance records, primary identification label, labeling used, or UDI. Incomplete DHRs cannot demonstrate that the device was manufactured in accordance with the DMR.
DMR Not Maintained Current with Design Changes
moderateThe DMR index or compilation is not updated when design changes are implemented. New or revised specifications, procedures, or work instructions are controlled individually but the DMR compilation falls out of date, creating a disconnect between the DMR and actual current manufacturing requirements.
DHR Review Not Required Before Product Release
moderateProduct is released for distribution without formal review and approval of the completed DHR. The DHR should be reviewed to verify all required data is complete and all acceptance criteria were met before finished devices are released.
Missing 'MDF Index'
minorThe QMS still uses 'DMR' terminology but lacks a formal 'Medical Device File' that complies with ISO 13485 §4.2.3.
Evidence signals
- •
FILE_EXISTS
(Device.*Master.*Record|DMR|Device.*History.*Record|DHR|Batch.*Record|Manufacturing.*Record)
- •
CONTENT_MATCH
Does this document describe the device master record, device specifications compilation, batch record requirements, or device history record content and maintenance?
Audit defense
The Device Master Record for [your product] ([your document ID]) compiles all device specifications, manufacturing procedures, and quality procedures defining a conforming device. Device History Records are completed for each production batch demonstrating manufacture in accordance with the DMR, with UDI included per QMSR 820.181 and 820.184.