The world of medical device design and regulations has a lot of abbreviations. We are going to focus on another of them in this blog – DMR. It stands for Device Master Record, but what is a DMR, why do you need one, what is included, and why is it important?
What is a Device Master Record?
A DMR is a file that contains everything that is needed to manufacture your medical device.
It is a centralised record, so you don’t need a binder with all the documents included. Instead, the relevant documents can be referenced. You don’t need a physical file either, as the information can be stored digitally. As a result, a DMR is typically put together, stored, and updated on an electronic quality management system.
The fact that each piece of information in a DMR can be referenced rather than stored within the same document makes it easier to maintain and update.
It’s also important to note that a DMR is more than just information about the design of a new medical device. Instead, full design information is included in the Design History File (DHF).
A DMR includes some of this design information as there is overlap between a DHF and DMR, but a DMR also includes detail on how the device should be manufactured.
Why Do You Need a DMR?
If you don’t have plans to get FDA approval to enter the US market with your new medical device, you might not need a DMR. This is because a DMR is a specific FDA requirement. That said, all regulators have documentation requirements. The reality is there are minimal differences between the DMR requirements of the FDA and the documentation requirements of other regulators.
If you do want to market your medical device in the US, it will need FDA approval. You will also need to ensure ongoing regulatory compliance. A DMR is essential for these processes, as it will be reviewed by the FDA, including during regulatory audits.
A DMR can also be helpful for the manufacturer of your new medical device product. For example, if the manufacturer starts a new member of staff, everything they will need to know about the production of your device is in the DMR.
What is Included in a DMR?
A DMR needs to include everything that is required to manufacture your medical device from start to finish. It also has to comply with CFR Part 820.181.
The key information you need in a DMR includes:
- Manufacturing instructions for all processes, as well as manufacturing equipment specifications, production environment specifications, etc
- Assembly instructions
- Specification documents, including component specifications and formulations
- Labelling requirements
- Packaging requirements
- Quality assurance processes and procedures, including the quality equipment that is used and the criteria for acceptance
Why is Having a DMR Important?
The main point here is compliance with FDA regulations and to ensure your regulatory audits go as smoothly as possible.
The Importance of Documentation
Whether during the design process, as you update and improve your product, or simply during day-to-day manufacturing, maintaining documentation is an essential part of medical device regulatory compliance. This includes maintaining a DMR.