The substance: a master compilation of device specifications and procedures, and batch-level production evidence — now reached through ISO 13485 clauses 4.2.3 and 7.5.1 via QMSR 820.10; the former §§820.181/820.184 are Reserved.
The DMR/DHR names are gone — FDA eliminated the record types (preamble Comment 31); the Medical Device File (4.2.3) is the successor structure, and QMSR 820.35(c) adds UDI recording for each device or batch.
Batch-record completeness and review before release, and UDI inclusion — organizations without a controlled specification index or a batch-record review gate before distribution are routinely cited.
Maps to
Pre-QMSR Part 820: §820.181 Device master record., §820.184 Device history record.
ISO 13485: §4.2.3 Medical device file
FDA QMSR (2026): §820.35 Control of records., §820.10 (incorporates ISO 13485 § 4.2.3 Medical device file)
Requirement text
A master record compilation must be maintained for each device type, containing device specifications, production process specifications, quality assurance procedures, and packaging/labeling specifications (the former DMR concept, now carried by the ISO 13485 medical device file, clause 4.2.3). A production record must be maintained for each batch, lot, or device, demonstrating manufacture in accordance with those specifications and identifying the amount manufactured and approved for distribution (the former DHR concept, now carried by the ISO 13485 clause 7.5.1 batch record, with UDI recorded per QMSR 820.35(c)).
Why this clause exists
The DMR and DHR pair embeds a fundamental quality architecture into the QMSR: the DMR establishes what conforming production looks like (the master specification and process baseline), and the DHR documents what actually happened for each lot (the production execution record). Without the DMR, there is no authoritative standard against which production can be compared. Without the DHR, there is no traceability of what was actually done, who did it, what equipment was used, and whether acceptance criteria were met. The DMR-to-DHR relationship is what allows an investigator — whether internal quality personnel or an FDA inspector — to examine a specific lot and determine whether it was manufactured in accordance with current approved specifications. The QMSR reaches both records through ISO 13485 — the master compilation as the Medical Device File (REQ-ISO13485-4.2.3-MDF), the batch record through clause 7.5.1 — with QMSR 820.35(c) adding UDI recording; a well-structured MDF that contains or references the full former-DMR content carries the transition cleanly. The requirement that the DHR include the actual label used for each lot is the linkage between the labeling control procedure and the lot-level production record — it prevents after-the-fact uncertainty about which label version was applied to a distributed lot. DHR review and approval before lot release is the formal quality gate that ensures production records are complete and acceptable before devices leave the facility.
What changed
"Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with § 820.40. The DMR for each type of device shall include, or refer to the location of, the following information: Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications; Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications; Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used; Packaging and labeling specifications, including methods and processes used; and Installation, maintenance, and servicing procedures and methods. 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: The dates of manufacture; The quantity manufactured; The quantity released for distribution; The acceptance records which demonstrate the device is manufactured in accordance with the DMR; The primary identification label and labeling used for each production unit; and Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used."
"For each medical device type or medical device family, the organization shall establish and maintain one or more files either containing or referencing documents generated to demonstrate conformity to the requirement of this International Standard and compliance with applicable regulatory requirements. The content of the file(s) shall include, but is not limited to: a) general description of the medical device, intended use/purpose, and labelling, including any instructions for use; b) specifications for product; c) specifications or procedures for manufacturing, packaging, storage, handling and distribution; d) procedures for measuring and monitoring; e) as appropriate, requirements for installation; f) as appropriate, procedures for servicing."
Δ The DMR and DHR are consolidated into the single Medical Device File concept, which adds intended use, instructions for use, and measuring/monitoring procedures while dropping the detailed batch-level production history requirements of the DHR.
Common gaps (what we see in audits)
- No Defined DMR Index or Compilation — Companies 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 — Batch 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 — The 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 — Product 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' — The QMS still uses 'DMR' terminology but lacks a formal 'Medical Device File' that complies with ISO 13485 §4.2.3.
Related clauses
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