Difference between DHF DMR and DHR

Difference Between DHF, DMR & DHR

When navigating the complexity of medical device documentation, three critical acronyms often emerge: DHF, DMR, and DHR. Each plays a unique role in ensuring compliance with regulatory requirements, fostering quality assurance, and safeguarding the end-user experience. While their names may sound similar, their functions, content, and purposes vary significantly. This article helps in understanding the fundamental differences between DHF, DMR, and DHR.

Design History File (DHF)

DHF means a compilation of records which describes the design history of a finished device. It contains the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.

Device Master Record (DMR)

Device master record (DMR) means a compilation of records containing the procedures and specifications for a finished device. It focuses on assembling the device and ensuring all essential components are available for its construction, testing, packaging, and servicing.

Device History Record (DHR)

DHR is a compilation of records that documents the production history of a medical device. It includes all documentation related to manufacturing and tracking the device, ensuring it was produced in accordance with the specifications outlined in the DMR.

The process begins with the design history (DHF), which outlines the evolution of the design. This progresses to the records detailing how to build and test the device (DMR), ultimately resulting in the complete history of the manufactured device (DHR).

The table below outlines the differences between DHF, DMR & DHR as per their Requirements—

Note: The content may vary based on the type of medical device and processes defined within the QMS.