Ah, acronyms.
The medical device industry is full of them, almost as much as business English (oops). When they’re also similar to each other, it’s easy to get confused.
DHF, DMR, DHR stand for Design History File, Device Master Record, and Device History Record. They respectively concern the design, production planning, and production recording of a medical device.
In the context of European regulation, there is no trace of these terms. The Medical Device Regulation (MDR) 2017/745 doesn’t mention them at all. Imported from the United States, they can be traced back to the FDA’s 21 CFR 820.
Design History File (DHF)
The DHF is the archive of everything done for the design of the medical device.
FDA specifies that the DHF must contain or reference the records necessary to demonstrate that the design and development were carried out in accordance with the design plan and applicable requirements.
Therefore, all documentation developed during the design of the medical device makes up the Design History File. In detail, it must contain:
- Input elements (functional, performance, regulatory, safety, and usability requirements. Along with all necessary information, including those derived from previous projects).
- Output elements (product, production, and testing specifications).
- Plans and records of the design implementation, review, verification, and validation phases.
- Material related to the transfer of design to production.
For European regulation, the DHF is part of the technical file of the product. Therefore, it is subject to evaluation by the notified body during the certification of the medical device and during periodic surveillance audits.
It captures the latest state of the medical device and for this reason must be kept up to date by the manufacturer.
Device Master Record (DMR)
The DMR is the collection of product manufacturing instructions.
Everything necessary to produce and test the product is part of the DMR. It’s not wrong to think that the DMR consists of documents generated during the design and therefore part of the DHF.
In fact, the DMR must contain:
- Product specifications (drawings, components, materials, and software specifications).
- Production and testing instructions (procedures, equipment, measuring instruments, methods, work environment requirements, and acceptance criteria).
- Packaging and labeling instructions.
- Installation, maintenance, and service procedures.
Having collected the phases and chronology of design (DHF), gathered the design outputs that explain how to produce and test (DMR), all that remains is to manufacture the product.
Device History Record (DHR)
Just as the DHF is the archive of everything done for product design, the DHR is the archive of everything done for product manufacturing.
The DHR therefore must include:
- Date of manufacture and quantity.
- Production and testing records (demonstrating compliance with the DMR).
- Labeling.
- UDI and other product identification codes (REF, serial number, lot).
It’s usually good practice to develop checklists for production and testing to be filled out with the required information during production with reference to the DMR.
The manufacturer must maintain a DHR for each batch or unit produced.
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