Maps to
QMSR / ISO 13485: §820.181 Device master record.
ISO 13485: §4.2.3 Medical device file
Requirement text
For each medical device type or medical device family, the organization shall establish and maintain one or more files either containing or referencing documents generated to demonstrate conformity to the requirements of ISO 13485 and compliance with applicable regulatory requirements. The file(s) shall include, but are not limited to: (a) general description of the medical device, intended use/purpose, and labelling including any instructions for use; (b) specifications for product; (c) specifications or procedures for manufacturing, packaging, storage, handling, and distribution; (d) procedures for measuring and monitoring; (e) as appropriate, requirements for installation; (f) as appropriate, procedures for servicing.
What changed
Part 820 did not require a Medical Device File as a named, unified structure. Companies were required to maintain a Device Master Record (DMR, at 820.181) — a compilation of records containing the device specifications, production process specifications, quality assurance procedures, packaging and labelling specifications, and installation, maintenance, and servicing procedures. The DMR was production-focused: it described how the device was made and what it had to meet.
ISO 13485 section 4.2.3 introduces the Medical Device File (MDF) as a broader concept. The MDF must demonstrate conformity to ISO 13485 requirements and compliance with applicable regulatory requirements — not just production specifications. This means the MDF must trace design and development outputs (specifications derived from 7.3.4), verification and validation records (7.3.6, 7.3.7), risk management documentation (ISO 14971 risk management file), post-market surveillance outputs, and labelling, in addition to the manufacturing and monitoring content the DMR covered.
The critical structural difference: the DMR was a production artifact that described what to build and how. The MDF is a lifecycle artifact that proves the device was designed, built, and monitored in conformance with the QMS and applicable regulations. Companies that have only a DMR will typically have the manufacturing and specifications content but will be missing the design conformity evidence, risk management integration, and post-market feedback linkages that the MDF requires.
For the QMSR transition, section 820.181 (Device Master Record) remains in place as a QMSR-specific FDA addition alongside the ISO 13485 MDF requirement. Companies must satisfy both — the MDF as the ISO 13485 conformity structure, and the DMR content requirements as an FDA-plus layer. In practice, a well-structured MDF that contains or references all DMR elements satisfies both simultaneously.
Atomic constraints
- •A Medical Device File must be established and maintained for each medical device type or medical device family.
- •The file must contain or reference documents that demonstrate conformity to ISO 13485 requirements and compliance with applicable regulatory requirements.
- •The file must include a general description of the medical device, its intended use/purpose, and labelling including any instructions for use.
- •The file must include product specifications.
- •The file must include specifications or procedures for manufacturing, packaging, storage, handling, and distribution.
- •The file must include procedures for measuring and monitoring.
- •Where applicable, the file must include requirements for installation.
- •Where applicable, the file must include procedures for servicing.
- •The file may contain or reference documents — not all content must be held in a single location, but all referenced documents must be identifiable and retrievable.
- •The file structure must cover the full lifecycle of the device type, not just production — design, post-market, and end-of-life documentation should be traceable through or to the file.
Common gaps
No Unified Medical Device File — DHR and DHF Not Linked
majorThe organization maintains a Device History Record (production batch evidence) and a Design History File (design evidence) as separate, unlinked repositories. Neither document serves as the top-level MDF index that ISO 13485 4.2.3 requires. An auditor asking for the Medical Device File receives a confused response.
MDF Missing Labelling and Instructions for Use
moderateThe organization’s device file contains specifications and manufacturing procedures but does not include or reference labelling and instructions for use. Under ISO 13485 4.2.3(a), the general description, intended use/purpose, and labelling including instructions for use are explicitly required MDF content.
MDF Scope Defined Per Batch, Not Per Device Type
majorThe organization structures its device files around individual production lots (Device History Records) rather than per device type or device family. When asked for the Medical Device File for a product line, no single document or index exists — only batch-specific records.
Installation and Servicing Procedures Absent from MDF
moderateThe device file does not include installation requirements or servicing procedures, which ISO 13485 4.2.3(e) and (f) require “as appropriate.” The organization has installation and servicing content in field service manuals but has not incorporated them into or referenced them from the MDF.
Evidence signals
- •
FILE_EXISTS
(Medical.*Device.*File|MDF|DHF.*Master|Design.*History.*File|Device.*File.*Index)
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CONTENT_MATCH
Does this document serve as an index or compilation of device specifications, labelling, manufacturing procedures, and monitoring procedures for a specific medical device type or family?
Audit defense
Our Medical Device File for [your product] is maintained at [your document ID]. It contains or references all documents required to demonstrate conformity to ISO 13485 and applicable regulatory requirements, including device description, product specifications, manufacturing procedures, monitoring protocols, and labelling. The file is structured to support retrieval of any constituent document within a single working day.