Device master record
A Device Master Record (DMR) , often referred to in German as a product master record , is a compilation of reports that contain a precise description of a medical device and all instructions for its production, handling and maintenance. The term coined by the FDA (the American Food and Drug Administration ) is part of the Quality System Regulations (QSR for short, Quality Assurance Regulations) and, together with the Design History File (DHF) and Device History Record (DHR), makes the development as well as the production process of a device can be traced step by step. In this way, the DMR contributes to quality assurance.
With the rapid emergence of new developments in the field of medical technology devices, the regulatory authorities are also facing new challenges. The American Food and Drug Administration (FDA), known both for its strict regulation and the associated reliability, is now assuming an international role model function. The Device Master Record is part of a complex documentation system that aims to regulate the quality assurance of medical devices.
Elements of a device master record
According to document 21 CFR820.181 of the FDA, a device master record should contain the following elements:
- Information on the structure of the device including sketches, compositions, as well as information on components and any software used,
- Provisions for the production process including information on equipment or work devices that are to be used, production procedures and descriptions of the environment in which the production process is to take place,
- Quality assurance measures and provisions for testing the device (already during the production process),
- Packaging and labeling regulations,
- Information on installation and maintenance measures.
The DMR must be checked regularly and, if necessary, revised if, for example, work processes are changed or materials used are replaced. The documentation can also be supplemented and illustrated with aids such as photographs or product samples. Since the creation of the associated documents, such as the device master record, becomes more complicated with the increasing complexity of the newly developed medical devices, there is now a growing number of service providers who have specialized in the creation of the documents required for FDA approval . Outsourcing these tasks enables device manufacturers to concentrate all efforts on the development and production of their devices.
The Device Master Record as part of the Quality System Regulation
The purpose of these quality assurance regulations (QSR) is to create self-regulating systems with the help of which a controlled and predictable production process is possible. Together, "Design History File", "Device Master Record" and "Device History Record" allow the production process of a device to be regulated from the beginning of the design process to the finished product. The "Design History File" (DHF) is to be placed chronologically before the "Device Master Record", as it contains all information about the design process of the device. The DHF is the documentation of the entire development process of a device. The "Device Master Record" accordingly contains the provisions for the subsequent production process. The content of the "Device History Records" (DHR) relates, just like that of the "Device Master Record", to the production phase of a device, in contrast to the DMR, which could be described in a simplified manner as instructions for the production process, is the " Device History Record "a kind of protocol about the production and ensures that this runs according to the specifications recorded in the" Device Master Record ".
Device master record for stand-alone software
If software represents part of a device, it is included in its device master record. However, if it is a separate software for the medical sector, a separate DMR must also be created for this. Transferred to software, the components required in a device master record then correspond to:
- Usage,
- Software requirements,
- if applicable, labels for CD / DVD packaging,
- Instructions for burning the software on CD / DVD, printing the instructions for use and packaging the product,
- for downloadable software: instructions on how to publish it on the Internet,
- Instructions for creating licenses,
- Information on customer care,
- Information on maintenance / revision of the software,
- Installation, uninstallation and configuration instructions,
- Information on training / seminars for working with the software.
The DMR of a software also has to be updated whenever changes are made. Small improvements and changes can be recorded in the existing device master record, while it is even advisable to create a completely new DMR for large modifications.
Quality assurance in Europe
Although many manufacturers of medical technology devices have been following the guidelines of the FDA for years, these are only officially mandatory for devices that are sold on the US market. With the revision of ISO 13485 and the introduction of the Medical Device File, a form of documentation for quality assurance that largely corresponds to the DMR is now also mandatory in Europe.
literature
- Gordon Harnack: Mastering and Managing the FDA Maze . ASQ Quality Press, Milwaukee, Wisconsin 1999, ISBN 978-0873894555
- Bruce Haggar: The Biomedical Quality Auditor Handbook . ASQ Quality Press, Milwaukee, Wisconsin 2013, ISBN 978-0-87389-836-2
- Shreefal S. Mehta: Commercializing Successful Biomedical Technologies: Basic Principles for the Development of Drugs, Diagnostics and Devices . Cambridge University Press, New York 2008, ISBN 978-0-521-87098-6 , p. 204
Individual evidence
- ↑ US Food and Drug Administration: CFR - Code of Federal Regulations Title 21, CITE: 21CFR820.181 Website of the US Food and Drug Administration. Accessed December 31, 2016.
- ↑ Cyrille Michaud: Content of DHF, DMR and DHR for medical device software - Part 2 DMR Accessed on January 31, 2017.
- ↑ Prof. Dr. Christian Johner: Device Master Record DMR: Also for software?!? Accessed December 31, 2016.