Device Master Record (DMR)
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The Device Master Record is the compilation of records containing the procedures and specifications for a finished medical device — device specifications, production process specifications, quality assurance procedures, packaging and labeling specifications, and installation, maintenance, and servicing procedures. It is the manufacturing “recipe” a facility must hold and control for every device it produces.
Where the DHF captures how a device was designed, the DMR captures how it is built. It is compiled once the design is transferred to production and is kept current through the change-control system for as long as the device remains in commercial distribution — a DMR that has drifted from the actual production process is itself a finding.
FDA’s pre-QMSR device quality regulation required each manufacturer to establish and maintain a DMR for each device type. Under the incoming QMSR, which incorporates ISO 13485:2016 by reference, the equivalent construct is the “medical device file” required by ISO 13485 §4.2.3 — the content expectation is materially the same even though the terminology shifts.
A DMR is reviewed alongside the DHR during a device-quality inspection to confirm that production records show conformance to the specifications the DMR defines, and that any deviation went through the manufacturer’s nonconformance and CAPA process rather than being absorbed silently.
- —Captures the manufacturing “recipe”: specs, process, QA procedures, labeling, servicing
- —Compiled at design transfer, then held current through change control
- —FDA pre-QMSR term; ISO 13485 §4.2.3 “medical device file” is the QMSR-era equivalent
- —Reviewed against DHR production records to confirm conformance
21 CFR 820.181 (Device Master Record, pre-QMSR); FDA QMSR (effective February 2026, incorporating ISO 13485:2016 §4.2.3); EU MDR 2017/745 Annex II
Frequently asked questions
What is Device Master Record (DMR)?
The Device Master Record is the compilation of records containing the procedures and specifications for a finished medical device — device specifications, production process specifications, quality assurance procedures, packaging and labeling specifications, and installation, maintenance, and servicing procedures. It is the manufacturing “recipe” a facility must hold and control for every device it produces.
Which regulations cover Device Master Record (DMR)?
21 CFR 820.181 (Device Master Record, pre-QMSR); FDA QMSR (effective February 2026, incorporating ISO 13485:2016 §4.2.3); EU MDR 2017/745 Annex II