Elements of Device Master Record (DMR)
23 Jan 2025
The Device Master Record (DMR) is a regulatory requirement established by the Food and Drug Administration (FDA) for medical devices. It mainly contains information on:
- Manufacturing processes
- Documented specifications
- Drawings
- Packaging and labeling requirements
FDA provides its regulations for DMR in 21 CFR 820.181, subpart M. The DMR is part of the Good Manufacturing Practices (GMP) requirements.
FDA’s Requirements to Create a DMR
Whenever the FDA will audit a medical device company, it will expect it to produce a DMR that complies with 21 CFR Part 820.81.
All the manufacturers must have DMRs. The following information about the medical device will be present in each DMR:
- Device specifications, i.e. composition, component specifications, formulation, device drawings, and software specifications.
- Specifications of production processes, including production methods and procedures, specifications of the production environment, and equipment specifications.
- Procedures and specifications for quality assurance. This will also include the acceptance criteria and the quality assurance equipment that will be used.
- Specifications for packaging and labeling, including the methods used for this purpose, packaging materials and procedures.
- Methods for servicing, maintenance, and installation.
We can understand the importance of DMR by considering the example of an engineer who produces a silicone part of a medical device, draws its design, and includes it in the output portions the DHF. However, the DMR of this device will also include any specific instructions to manufacture the particular part, such as
- What mold will be used during silicone casting?
- What will be the equipment specifications?
- What production methods will be employed, etc.
DMR and Its Incorporation in FDA Record-keeping Mandates
For medical device manufacturers, it is essential to know how DMR is incorporated in the record-keeping mandates. The DMR has a relationship with other documents, listed below, which are part of the design control process.
Device Master Record:
DMR will contain data for manufacturing, inspecting and maintaining the medical device, based on the results and specifications defined in the DHF.
Device History File (DHF):
DHF contains a history of the device design from the establishment of its users’ needs and the reports of design review. The device specifications created in the design transfer process are also included in the DHF. It is the documentary basis for the design of the device. It serves as input for the DMR.
Device History Record (DHR):
This record has information regarding specific lots, batches, or units of the product produced by the manufacturer. The purpose of DHR is to enable traceability of the products across their life cycle and help with their root cause analysis (this is done by connecting audit result and customer feedback to specific batches of a product). It documents the application of the DMR.
In the table, there is the comparison between all the documents above:
| Aspect | DHF | DMR | DHR |
| Definition | It documents the phases of the design and the development process | It contains all the instructions for manufacturing and maintaining the device | It records the production history of each batch or unit of the device |
| FDA regulation | 21 CFR 820.30(j) | 21 CFR 820.181 | 21 CFR 820.184 |
| Scope | Demonstrate that the device has been designed following compliant and systematic process | Provide standardized guidance for the production, control and maintenance of the device | Document that each unit or batch produced conforms to the specifications defined in the DMR |
| Content | Design input and output Design verification and validation Project changes Reviews | Technical specifications Manufacturing instruction Test sand criteria for acceptance Labelling and packaging Maintenance and installation | Data and batch number Quantity produced and accepted/rejected Applicable labelling Results of test and inspection Discrepancies or deviations |
| Time focus | Design and development phage | Manufacturing and maintenance phase | During and after the production of each batch/unit |
| Relation between other documents | Input to create the DMR | Define specifications to be followed in the DHR | Verify the conformity of the process described in the DMR |
The Bill of Materials (BOM) is an important part of the DMR. It is a document that describes all the materials, components, and assemblies needed for manufacturing a medical device. The BOM is essential to ensure quality and traceability of the materials used.
The BOM is included in the device specifications section. It is used for:
- Plan and procure materials for production
- Ensure traceability of materials with recalls or post-market investigations
- Facilitate consistency in production.
According to the FDA regulation, the DMR must be updated when there are changes in the production process or specifications.
To can facilitate you in developing a DHR according to FDA’s requirements, TS Q & E can help you with their extensive software built, especially for this purpose. Our QMS support can support the process and help you with BOMs. This, in turn, will ensure that your DHR remains compliant with the FDA 21 CFR 820.
