Part 2/3 — The Design Master Record

This is the second part of a set of three articles. For more information, check https://medium.com/@kaiyan_medical/part-1-3-the-design-history-file-d681a7945968 with the introduction to DHF.

The device master record (DMR) is the compilation that contains all the information and specifications needed to produce a medical device from scratch to finish. Should include the instructions for all manufacturing processes, drawings, documented specifications, and, packaging requirements. While the device history record makes reference to specific lots, units, or batches of product, the DMR contains specifications for producing an individual device.

The FDA regulations for DMR appear in 21 CFR Part 820.181, under subpart M which handles record-keeping requirements for medical device companies.

When the FDA audits your medical device company, you will be expected to produce a DMR that complies with 21 CFR Part 820.181. Here’s the full text of that part for reference:

Each manufacturer shall maintain device master records (DMR’s). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with 820.40. The DMR for each type of device shall include, or refer to the location of, the following information:

a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;

b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;

c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;

d) Packaging and labeling specifications, including methods and processes used; and

e) Installation, maintenance, and servicing procedures and methods.

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The main purpose of the DMR is to centralize a record of the production process in a way that distinguishes it from the design process. A product engineer might design a silicone part for a medical device and include it in the design outputs portion of the design history file, but the DMR would also include specific instructions for manufacturing the part, including what mold to use, equipment specifications and production methods.

The good news is that the FDA requires you to only reference the mandated items, not duplicate them. If you’ve been organized in creating your DHF, you’ll be able to easily reference that location in your DMR.

Difference between DHF and DMR

The difference between the DHF and the DMR is about design vs device. The design history file is focused on capturing the history of the design and ensuring that it was done according to FDA regulation. The device master record is focused on building the device and ensuring that all necessary items are included to build, test, package, and service it.

References

  1. CFR — Code of Federal Regulations Title 21, Sec. 820.181 Device master record

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