Learn about the Design Master Record (DMR) and its critical role in medical device development, ensuring proper documentation and regulatory compliance throughout the product lifecycle.
This is the second article in a three-part series. For background, see the introduction to the DHF here.
The device master record (DMR) compiles all instructions, drawings, specifications, and packaging requirements needed to make a medical device from start to finish. While the device history record (DHR) covers specific lots or batches, the DMR defines how to build every individual unit.
FDA requirements for the DMR are found in 21 CFR § 820.181, part of the Quality System regulation’s record-keeping subpart. During an inspection, you must present a DMR that satisfies this section. The rule states:
Each manufacturer shall maintain device master records (DMRs). Each DMR shall be prepared and approved per § 820.40 and shall include, or refer to, the following:
a) Device specifications: drawings, composition, formulation, component and software specifications;
b) Production process specifications: equipment, methods, procedures, and environment;
c) Quality assurance procedures and acceptance criteria;
d) Packaging and labeling specifications; and
e) Installation, maintenance, and servicing procedures.
The DMR’s purpose is to centralize production knowledge separately from design history. A silicone part may appear in the DHF as a design output; the DMR adds the mold number, press settings, and cleaning steps needed to make it.
FDA allows you to reference, rather than duplicate, documents. If your DHF is well-organized, you can simply point to its location in the DMR.
Think “design versus device.” The DHF demonstrates that design controls were followed; the DMR tells production staff exactly how to build, test, package, and service the finished device.
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