top of page

Medical Device Acronyms - DHF, DMR, DHR

There are a LOT of acronyms within the medical device world. Three of the most connected and confused are DHF, DHR, and DMR. Let’s unpack them together:

DHF – Design History File FDA 21 CFR Part 820.30 says “the design history file shall contain, or reference, the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements for this part.”

These are the paper and electronic records collected as part of the design and development process, that prove the resulting device is compliant, such as:

  • User needs and design inputs you defined at the start of the project

  • Design outputs that you generated to build the device

  • Design verification and validation protocols and reports 

  • Design reviews associated with user needs, design inputs and outputs, and design verification and validation protocols

  • All materials relevant to transfer the design into manufacturing

DMR – Device Master Record

FDA 21CFR Part 820.40 says the DMR for each type of device should “include or reference the location” for several pieces of information:

  • Device specs (drawings, composition, formulation, component and software specs)

  • Production specs (equipment, methods, procedures, environment specs)

  • Quality assurance procedures and specs (acceptance criteria, equipment used)

  • Packaging and labeling specs, methods, and processes

  • Installation, maintenance, and servicing procedures and methods

DHR – Device History Record The DHR provides the traceability for each specific device. The FDA says the DHR should “include or refer to the location of” these items:

  • Dates of manufacture

  • Quantity manufactured

  • Quantity released for distribution (which implies you track any rejects)

  • Acceptance records (test and validation) who show the device meets the DMR specs

  • The primary identification label and labeling used for each production unit

  • Unique Device Identifier (UDI or serial #), Universal Product Code (UPC), or any other device identification or control numbers(s) used

Notice the difference in focus:

- The DHR is the records collected during design, development, & regulatory approvals

- The DMR is the recipe to manufacture and test the device

- The DHR provides the history for each final device to show it meets the requirements in DHR and DMR. You should have a DHR for each batch, or lot – even if it’s a single unit.

Final thought: It may help to think of them sequentially DHF – DMR – DHR. Or if you’re getting the “D’s” confused: The design goes in a file, the device has a record. To verify that your records are complete in each category, auditors often have a checklist. Consider doing the same, and then auditing your files for completeness.


Featured Posts
Recent Posts
Search By Tags
Follow Us
  • Facebook Basic Square
  • Twitter Basic Square
  • Google+ Basic Square
bottom of page