Device Master Record and Technical Documentation Procedure

The Device Master Record and Technical Documentation Procedure defines the creation and content of the documentation used for manufacturing a finished medical device.

Purpose

It addresses the Device Master Record and technical documentation summary, helping organize the manufacturing documentation associated with the finished device.

The medical device file terminology in ISO 13485:2016 clause 4.2.3 provides the current QMSR context for this documentation. Device Master Record (DMR) remains a useful organizational term; the former standalone 21 CFR 820.181 requirement is no longer the current citation.

Regulatory framework

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.