While many aspects of FDA and ISO 13485 quality system requirements can be found in other industries, Device Master Records (DMR) are something that is unique to medical devices. This can lead to confusion about what a DMR is, what is required, and how a DMR can best be integrated into a medical device quality management system.
Along with design controls, a lack of a proper DMR can lead to audit findings and even FDA warning letters in cases where the entire device information is not obtainable.
In this article, we will cover the ins and outs of Device Master Records, looking at both the ISO 13485 and 21 CFR part 820 requirements. One thing to note is that ISO 13485 uses the term Medical Device File instead, which we will cover in that section of the article.
Table of Contents
What is a Device Master Record?
A Device Master Record is a collection of every document needed to manufacture, package, and possibly service a medical device. Going by the FDA’s definition a DMR is: “a compilation of records containing the procedures and specifications for a finished device”.
While this seems daunting, in practice, a DMR typically functions as a table of contents. It gives a brief overview of the order in which the medical device is produced and tells the reader where to find each piece of information.
Something to keep in mind is that a Device Master Record is a general document for a device, and is not intended to reference any specific batches or lots. That information is kept in the Device History Record (DHR), which is much more specific to each batch of a medical device that is produced.
What are the FDA requirements for a DMR (21 CFR Part 820.181)?
If a medical device company is subject to an FDA inspection, a DMR is something that has a high possibility of being reviewed. As we will see, this is because a DMR is a jumping-off point for every process related to manufacturing a medical device. For this reason, it is important to understand all of the requirements for creating a medical device DMR.
The general FDA requirements for a DMR are that:
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.
One very important piece of the requirements is that the FDA allows a medical device company to “refer to the location” of all of the required information. Looking at the required information, it’s easy to see why this is so important. Many of the documents inside of an MDR change consistently, and may have dozens of different revisions.
If you are going to include all of the information directly in the DMR, you will have to update each document as part of change control (or document control). This is very tedious and difficult to keep track of, which is why it is almost always better to reference each piece of information.
Some other things to keep in mind are that:
- It is also a good idea to have access to all of the validation information related to both the device and the processes.
- All of the prints and material compositions should be included for not just the device, but also every component that is used in the device.
- Production processes include items like which equipment will be used, the specifications for the equipment when manufacturing the device, and environmental specifications, such as if the device will be manufactured in a cleanroom.
- Acceptance criteria can include the dimensions that are inspected on a part, as well as the sampling plan that will be used for the components and devices.
- Packaging is a major element of medical devices, especially the labels which will be used for the devices. This means the DMR should reference the type of packaging used and the most current revision of any labels used with the device.
What are the ISO 13485 requirements for a Medical Device File (4.2.3)?
That was all of the FDA requirements for a DMR. So what are the ISO 13485 requirements for a DMR?
First off, ISO 13485 does not specifically reference a Device Master Record. Instead, it includes a requirement for a Medical Device File (MDF). The DMR and MDF are very similar, however, a Medical Device File is a bit broader and usually includes both the Device Master Record and Design History File (DHF).
We’ll review the other differences between the FDA and ISO 13485 requirements in the next section, but for now, let’s look at the ISO 13485 requirements for an MDF.
The first thing to note is that ISO 13485 also lets a company reference the documents needed for an MDF, which is in line with FDA requirements.
So what does ISO 13485 say is required in an MDF?
- General description of the medical device, intended use/purpose, and labeling, including any instructions for use;
- specifications for product;
- specifications or procedures for manufacturing, packaging, storage, handling and distribution;
- procedures for measuring and monitoring;
- as appropriate, requirements for installation;
- as appropriate, procedures for servicing.
As we can see, the requirements for a Medical Device File are very similar to the requirements for a Device Master Record.
One important note for both the FDA and ISO 13485 requirements is that “installation” refers to any installation that must be performed at the end user’s facility for a medical device. It is not referring to implanting a medical device in a patient.
Differences between FDA and ISO 13485 requirements
Now, what are the differences between the FDA and ISO 13845 requirements?
The first is that the FDA language states that a DMR should be for “each type of device”, while ISO 13485 specifically says that an MDF is for a “medical device family”. This is not a major difference but is something to consider when setting up a medical device DMR.
There are certain aspects of a Device Master Record (or MDF) that can apply to a product family such as the process, equipment, inspection, etc. information. While there are also certain aspects that need to be included for each individual device, such as part drawings.
The next difference is that ISO 13485 specifically requires that the intended use and instructions for use be included in the MDF. This information is still required by the FDA, however, it can be found in other locations of the regulations.
The final difference is that the FDA requirements include the maintenance of a medical device in a Device Master Record, while that requirement is not found in ISO 13485.
Overall, it is best to look at both the FDA and ISO 13485 requirements when you are creating a Device Master Record or Medical Device File, in order to be totally compliant.
Documenting a DMR for ISO 13485
Now that we know what information should be in a DMR, let’s look at how to document that information. In many cases, this is the most difficult part of setting up a Device Master Record for a medical device company.
The first way to document the information would be through a single record. A company could create one massive document that contains every piece of information required for the DMR.
As you can imagine, this would be an extremely difficult task. Not only would the file be large to the point of being unmanageable, but the company would also need to update the DMR every single time any file within the DMR is updated.
Therefore, it is doubtful that a company would want to take this approach. As mentioned, the FDA and ISO 13485 allow the required documents to be referenced in the DMR/MDF, so companies should make use of this allowance if possible.
There are a couple of different ways that a company could go about referencing the required documents for their Device Master Record.
A company could choose to have the DMR set up as a file that houses each individual document that is needed. While this would be more useful than having all of the information within one document, it would pose the same problems related to changing documents.
The next approach would be to set up a DMR as a table of contents. Create a document that contains a reference to all of the required documents, including the document names, numbers, and locations. This would allow an easy reference to everything needed for the Device Master Record.
It would be even better if all of the required information could be hyperlinked from the DMR. Hyperlinking would allow instant access to the most relevant versions of each document.
While those are a couple of examples, there are many different ways that a medical device company could construct its DMR. Setting up a Device Master Record would be a powerful use case for an eQMS or similar software, and save a company a lot of time and energy.
Wrapping up
That was an overview of the FDA requirements for a Device Master Record and ISO 13485 requirements for a Medical Device File. As we have shown, the two requirements are very similar, however, there are a few important differences that a company may want to keep in mind during an audit. Hopefully, you are able to feel more confident in creating a Device History Record for a medical device.
If you have any questions or ideas, feel free to leave them in the comments below.
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