DHF, DMR, DHR…. to the uninitiated they might sound like out-of-town furniture stores or airport codes for exotic destinations but they are, in fact, key acronyms in the world of medical device regulation.
So what do they stand for?
Good question. They are all abbreviations used by the FDA, referring to the required collections of documents that medical device developers must assemble and make available to auditors in order to prove compliance with the regulations, gain FDA approval and go to market with their device in the US.
Can you be more specific?
Of course. The Device Master Record (DMR) can be thought of as the definitive instruction manual for the safe and 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 used that instruction manual in the manufacture of your device.
Design History File (DHF)
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 and 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 that were 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.”
Being able to track 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, it’s been frequently noted that 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 implementation of process is an important part of the FDA’s push for a more proactive approach to quality management.
To this end, the DFH should contain:
- The design and development plan that specified design tasks and deliverables
- Documentation which proves the design was carried out according to the design plan
- Activities of the different phases of the specific design process
- Documentation of design reviews
- Approved design input and output documents
- Validation documentation
- Copies of controlled design documents and change control records
Device Master Record (DMR)
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:
- Device specifications
- Production process specifications
- QA procedures and specifications, including acceptance criteria
- Packaging and labelling specifications
- Details for installation, maintenance, and servicing procedures and methods
Device History File (DHR)
The DHR is the final proof that you have used the ‘instruction manual’ (DMR) and followed the instructions it contains, properly, to manufacture the device.
The FDA specifies that your Device History File must include:
- A date of manufacture for each batch, lot or unit
- The quantity you have manufactured
- Quantity released for distribution
- Labeling used for each production unit
- Any UDI, UPC, or other identification used
The DHF 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.
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 manufacture process.
Backsolving the requirements of the DHF would be pretty much impossible, so adopting a digital document management system (DMS) that can help you contemporaneously index and store all the documentation required to prove the compliance of your process, will clearly lead to a smoother approval and auditing process with the FDA later on.
Using the right DMS will allow you to digitise the production and audit of these three critical review items and save you time, money and stress as you prepare for launch.