The device master record is a design document specifically requested by the FDA Quality System Regulation, as per 21 CFR 820.181. If we follow the definition reported in the regulation:
Device master record (DMR) means a compilation of records containing the procedures and specifications for a finished device.
If we move further in the regulation, there is a detailed lists of items that the DMR shall contain:
The DMR can be considered as the collection of all the information needed to manufacture the devices. As per FDA regulation, it is acceptable that DMR provides reference to all the documentation covering those specific requirements, rather than physically collecting all the documentation in one place.
Device Master Record (DMR) and Design History Record (DHR)
The design history record (DHR) is rather different from the device master record (DMR). The DHR is the set of documents that demonstrates that the design process of a medical device has been performed according to the design plan and as per applicable regulations. The DHR typically contains, for example, design plan, design review, verification & validation test plan and test reports, design transfer, etc.
DMR for Software
The device master record shall contain specifications of the device. When the medical device is a software, this means that the DMR shall reference the software requirement specifications as per ISO 62304.
As mentioned before, the DMR shall also contain production process specifications. In case of SAMD, production process is very limited but, for example, it can contain instructions to publish the software on the web or SOP related to location of the binaries and configuration files of the version.
Moreover, if the software is delivered in a physical media, the DMR shall contain the labelling information of the specific media.
SOP related to maintenance and support process shall be mentioned in the DMR. Typically this includes the problem resolution process and issue escalation process.
Moreover, since the device master record shall include documentation related to installation and servicing, all the documentation related to software delivery shall be mentioned in the DMR. This can include, for example, installation instructions, training, support instructions etc.
Device Master Record (DMR) and Medical Device File
The Medical Device File is a new requirement which has been introduced in the ISO 13485:2016. There is quite a big overlap between the two documents, but basically we can say that the medical device file requested by the ISO 13485 corresponds to the DMR (a typical requirement from FDA) plus all the design documentation of the medical device (thus the Design History Record).
Production and Service Provision
The device master record is a key document related to the manufacturing operations of the medical device industry. Regarding manufacturing operations, 4EasyReg has prepared a specific procedure for Production and Service Provision ready fo be download from our 4EasyReg Shop.
Conclusions
In conclusion, we have been talking about the Device Master Record, what should be clearly mentioned inside this document and the specific difference with a similar document named Medical Device File, specifically requested by ISO 13485:2016. The DMR may change depending if we are talking about a standard manufacturing process or a stand alone medical device software.
Subscribe to 4EasyReg Newsletter
4EasyReg is an online platform dedicated to Regulatory matters within the medical device, information security and AI-Based business.
We offer a wide range of documentation kits to support your compliance efforts towards a wide range of standards and regulations, such as ISO 13485, EU MDR, ISO 27001, ISO 42001 and much more. . Specifically, in our webshop you will find:
- ISO 13485 Documentation / Compliance Kit
- EU MDR Documentation Kit
- MDSAP Documentation Kit
- ISO 27001 Documentation / Compliance Kit
- ISO 42001 Documentation / Compliance Kit
- FDA Cybersecurity Documentation
Within our sister platform QualityMedDev Academy, a wide range of online & self-paced training courses is available, such as for example:
- Complaint Handling and Vigilance Reporting
- Artificial Intelligence in Medical Device. Regulatory Requirements
- Unique Device Identification (UDI) Requirements according to EU MDR
- Clinical Evaluation Process According to EU MDR
- Medical Device SW Verification & Validation
- Risk Management for Medical Devices
- Usability Evaluation for Medical Devices
As one of the leading online platforms in the medical device sector, 4EasyReg offers extensive support for regulatory compliance. Our services cover a wide range of topics, from EU MDR & IVDR to ISO 13485, encompassing risk management, biocompatibility, usability, software verification and validation, and assistance in preparing technical documentation for MDR compliance.
Do not hesitate to subscribe to our Newsletter!
