The Device Master Record (DMR) of a medical device, as referred to in English, compiles the approved specifications according to which a product is manufactured, tested, packaged, labeled, installed, and maintained. It thus represents the target specifications for serial production: a complete collection of specifications and procedures under document control for a product type or product family. In international standardization, it corresponds to the medical device file according to ISO 13485 Section 4.2.3, which requires one or more files for each product type or product family to demonstrate conformity with the standard and applicable regulatory requirements. Regulation (EU) 2017/745 does not use the term but requires the control of product realization via Article 10, Paragraph 9, Letter g.
Contents of the Medical Device File
ISO 13485 Section 4.2.3 specifies minimum content that extends beyond mere manufacturing specifications: a general description of the product with its intended purpose and use, including labeling and instructions for use, product specifications, specifications or procedures for manufacturing, packaging, storage, handling, and distribution, procedures for measurement and monitoring, and, where applicable, requirements for installation and maintenance or service activities. In operational practice, this includes drawings and bills of materials, material and supplier specifications, software configuration statuses, work and test instructions, acceptance criteria and test equipment specifications, cleaning, packaging, and sterilization parameters, label and language versions, and the assignment of unique product identification. All components are version-controlled and approved; an unapproved specification may not be used in manufacturing.
Function in the Manufacturing and Change Process
The Device Master Record is the anchor of reproducibility. It is built from development results during design transfer according to ISO 13485 Section 7.3.8, by converting verified specifications into manufacturable, tested requirements. Manufacturing and test orders are derived from it, the execution of which is documented in the batch record of a medical device; deviations between specification and execution thus become identifiable. Every change to material, process, supplier, software, or labeling impacts the file via change control and requires an assessment of the effects on risk management, process validation, and technical documentation. For multiple manufacturing sites or contract manufacturers, it must be ensured that all sites operate at the same approved status; the provision of applicable requirements to suppliers is part of the purchasing information according to Section 7.4.2.
Distinction from Technical Documentation, Development File, and Product Specification File
The Device Master Record is not the conformity dossier: The technical documentation according to Annex II of Regulation (EU) 2017/745 is addressed to Notified Bodies and authorities and contains, in addition to information on design and manufacturing, primarily evidence of the basic safety and performance requirements, risk management, and clinical evaluation. Annex II Section 3 merely requires information on design and manufacturing, not the complete manufacturing specification; the level of detail of the file is checked during on-site audits. It differs from the development file of a medical device as a collection of requirements rather than evidence. Finally, it must be clearly distinguished from the pharmaceutical product specification file for investigational medicinal products, which aims at the manufacture and release of investigational medicinal products with the involvement of the qualified person and does not constitute a manufacturing document for medical devices. In the United States, the term has ceased to be a regulatory term since the Quality Management System Regulation became effective on February 2, 2026; the requirements continue to apply via ISO 13485 Section 4.2.3.
Relevance for clinical trials
Investigational products must be manufactured according to defined, approved specifications so that the data collected in clinical trials can be attributed to the product later placed on the market. Annex XV Chapter II of Regulation (EU) 2017/745 requires information on the design and manufacture of the investigational product in the study documentation; the basis for this is the currently valid status of the Device Master Record. If this status is missing or unclear, the representativeness of the study products cannot be proven.
Throughout the study period, every change to the manufacturing, material, or labeling of the investigational product must be evaluated: It can affect the comparability of data, trigger a notification of significant change according to Article 75, and impact the traceability of units distributed to trial sites. Full-service CROs like Mediconomics support manufacturers and sponsors in deriving the description of the investigational product for study documentation from the approved manufacturing specifications, tracking product statuses over the study period, and appropriately evaluating changes from a study perspective.
Frequently Asked Questions (FAQ)
Is the Device Master Record identical to the medical device file according to ISO 13485?
Largely in terms of content. The medical device file according to Section 4.2.3 is the normative term and is somewhat broader, as it explicitly includes the general product description, labeling, and service requirements.
Does it have to be submitted to the Notified Body?
It is not part of the conformity dossier to be submitted, but it is reviewed during audits of the quality management system and the evaluation of product realization and must be consistent with the technical documentation.
Is one file sufficient for an entire product family?
Yes, provided that the products actually form a family with regard to design, materials, and manufacturing process, and the variant- or size-specific specifications are clearly assigned.
Regulatory References
- ISO 13485:2016, Section 4.2.3 – Medical device file
- ISO 13485:2016, Sections 7.3.8, 7.3.9, 7.4.2, and 7.5.1 – Design transfer, changes, purchasing information, production control
- Regulation (EU) 2017/745, Article 10 Paragraphs 8 and 9 – Retention and quality management system
- Regulation (EU) 2017/745, Annex II Section 3 – Information on design and manufacturing
- 21 CFR Part 820 as amended by the Quality Management System Regulation, effective February 2, 2026
