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Good question. They are all abbreviations used by the FDA in their medical device quality regulation. DHF stands for Design History File, DMR stands for Device Master Record, and DHR stands for Device History Record.
They are the required collections of documents that medical device developers must assemble and make available to auditors to prove compliance, gain FDA approval, and market their devices in the US.
The Device Master Record (DMR) can be thought of as the definitive instruction manual for the compliant manufacture of your medical device, while the Design History File (DHF) is the complete record of the way that instruction manual was designed and compiled in the first place. The Device History Record (DHR), on the other hand, is the demonstrable proof that you have followed that instruction manual as you have manufactured your device.
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DMR (Device Master Record) |
DHF (Design History File) |
DHR (Device History Record) |
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An ‘instruction manual’ for manufacturing your medical device |
Proof the ‘instruction manual’ was compiled correctly |
Evidence you have followed those instructions correctly |
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Includes:
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Includes:
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Includes
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The Design History File is a repository for all the records that demonstrate your medical device was designed and developed in accordance with an approved design plan.
The DHF can be either a collection of the actual paper documents generated throughout a product design and development process or a central index of documents and their storage location within a digital DMS (document management system).
As the name suggests, the DHF is focused on the history of the design, ensuring it was carried out according to the FDA regulations. The requirement is found in (21 CFR Part 820.30)
“Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plans and the requirements of this part.”
ISO 13485:2016 refers to this requirement as well, making explicit reference to ‘a design and development file’ that must be created for each medical device.
Importantly, ISO notes that the DHF should record details of all the changes made to the design during the planning and development process.
“The organization shall maintain a design and development file for each medical device type or medical device family. This file shall include or reference records generated to demonstrate conformity to the requirements for design and development and records for design and development changes.”
Tracking the history of change requests as well as the details of their approval, implementation, and review is one of the key objectives of regulation in this sector. After all, most faults with a manufactured device can be traced back to a failure of the change control process in its conception and design. The self-policing of these standards through better documentation and process implementation is an essential part of the FDA’s push for a more proactive approach to quality management.
To this end, the DHF should contain:
If the DHR shows in detail how the final ‘instruction manual’ for the device was compiled, then the Device Master Record is the instruction manual itself.
In other words, it contains all the information needed to produce the device safely, in accordance with the design and the regulation that covers it.
Section 820.181 of the FDA QSR is quite specific about what the device master record should contain. It includes:
The DHR is the final proof that you have used the ‘instruction manual’ (DMR) and followed the instructions it contains to manufacture the device correctly.
The FDA specifies that your Device History Record must include:
The DHR must also include your acceptance records, which show that you have followed and implemented all of the processes outlined in the DMR in a compliant way.
‘Backsolving’ many of these document requirements can be difficult or even impossible for developers. Retrospectively pulling together the right files and grouping them in different digital locations for review can take a long time, ultimately leading to confusion and dangerous duplication.
This is a particular problem when the files themselves change as you evolve your processes and implement corrective actions. The FDA need the DHF and the DMR to show the latest, approved versions of all the documents you use to design, build and product manage your device, plus the history of all your decision making all in one place.
To meet these demands choose an eDMS (electronic document management system) that lets the same files exist and be updated simultaneously in different parts of the system.
Each of the three Ds of medical device development has a different function within the regulatory scheme of the FDA. They are outputs that, taken together, prove complete compliance in each phase of the development and manufacturing process
Using the right DMS will allow you to digitise the production and audit of these three critical review items. It will save you time, money and stress as you design, manufacture, and manage your device in the future.