Device Master Record Legacy term

A record the Quality System Regulation required for each device type. The record compiled the device specifications and the production procedures. The record also held the quality assurance, packaging, labeling, and servicing procedures. The medical device file now serves this purpose.

Replaced by

Medical device file, ISO 13485:2016 clause 4.2.3

Where the replacement is written

ISO 13485:2016 clause 4.2.3; 89 FR 7496, response to comment 31

Old rule

21 CFR 820.181, in Part 820 before February 2, 2026

Also called

DMR

Related terms