In the medical device industry, DHR, DMR and DHF are three integral cornerstones of the design control process. However, because these terms overlap each other in letters and in contents and requirements, they are commonly confused. If you are still struggling with the keep these three pillars straight, read on.

DHF – Design History File

A Design History File (DHF) documents the design process from the inception to release of a product. The DHF should either contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this device. 

A DHF should contain or reference:

  • User needs, product requirements and other design inputs
  • Design and development plans
  • Risk management plan and report
  • Verification and validation protocols and reports
  • Design outputs
  • Design reviews
  • Design transfer materials
  • Other design and development documentation

The DHF is a living document, so any updates to the medical device should be documented and updated in the DHF.

DMR – Device Master Record

A Device Master Record (DMR) details all the information necessary for the manufacturing of the medical device, the specific material, equipment, and production requirements of a medical device.

Per the FDA the DMR should contain or reference:

  • Design specifications – drawings, composition, formulation, component specs, and software specs
  • Production process specifications – equipment specs, and production methods, processes and environment specs
  • Quality assurance procedures and specifications – acceptance criteria and quality assurance equipment
  • Packaging and labelling specifications – methods and processes used
  • Installation, maintenance, and servicing – procedures and methods

A well-documented DHF helps in maintaining a proper DMR with easy reference to files.

DHR – Device History Record

The Device History Record (DHR) documents all production activities for an individual device.

Per the FDA the DHR should contain or reference:

  • Date(s) of manufacture
  • Quantity manufactured.
  • Quantity released.
  • Acceptance records demonstrating compliance with the DMR.
  • Primary identification label and labelling for each unit.
  • Unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used.

In case of audits, the DHR is essential if the investigator wants to compare it against the DMR for compliance or FDA requirements.

The three D’s are crucial for medical device manufacturers to ensure regulatory compliance. All the files and records are interdependent and a lapse in one document can directly affect the others. For more detailed information on DHF, DMR, DHR or DMF, the team of experts at Prime Path Medtech can help you understand the procedures better as well as support you in the documentation process.