DMR to MDF Transition: Complete Documentation Migration Guide

Reading time: 11 minutes | Last updated: December 2025

One of the most visible changes in QMSR is terminology:
Device Master Record → Medical Device File
Design History File → Design and Development File
Device History Record → Medical Device Record or Batch Record

But here’s what most articles still don’t tell you: you don’t have to rename a single document.
The transition is almost entirely conceptual — make sure your content satisfies ISO 13485:2016, regardless of what you call it.

With FDA’s October 2025 draft guidance on QMS information for premarket submissions now public and the December 16 QMSR webinar looming, the clock is ticking — but you can prepare without panic.

In this article

• The real differences between DMR and MDF
• DHF → Design and Development File transition explained
• DHR → Batch Record requirements
• Three practical approaches to documentation migration
• Exactly what FDA investigators will (and won’t) care about in 2026

Understanding the Terminology Change

QSR used FDA-specific terms that exist nowhere else: DMR, DHF, DHR.
ISO 13485 uses Medical Device File (MDF), Design and Development File, and distributed production/traceability records.
QMSR incorporates ISO 13485:2016 by reference, so starting February 2, 2026, investigators will cite ISO clause numbers and terminology.

Your existing documentation structure is almost certainly acceptable. The content requirements are substantially similar — FDA is not asking you to rebuild your QMS, only to demonstrate conformity to ISO 13485.

Device Master Record → Medical Device File

What QSR Required
§820.3(j) – A compilation of records containing the procedures and specifications for a finished device (device specs, production specs, QA procedures, packaging/labeling, installation/maintenance/servicing).

What ISO 13485 Requires
ISO 13485:2016 Clause 4.2.3 (exact 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 this International Standard and compliance with applicable regulatory requirements.”

Typical MDF contents or references: description & intended use, labeling, design specs, production specs, risk management, clinical evaluation (if applicable), regulatory submissions, post-market procedures.

The Actual Difference
MDF is broader and explicitly lifecycle-oriented. If your DMR already references design outputs, risk files, and regulatory submissions, you are probably already compliant.

Action Required → Quick self-assessment (answer yes/no):

• Does your DMR reference design outputs?
• Does it reference risk management files?
• Does it reference regulatory submissions or UDI data?
• Can you demonstrate regulatory conformity from its contents/references?

All “yes” → keep calling it a DMR forever if you want.
Any “no” → add cross-references or expand scope.

Design History File → Design and Development File

What QSR Required
§820.30(j) – Records demonstrating design was developed per the approved plan and 21 CFR Part 820.

What ISO 13485 Requires
Clause 7.3.10 – Maintain a design and development file for each device type/family containing records of conformity and all design changes.

The Actual Difference
Purpose is nearly identical, but ISO 13485 places stronger emphasis on risk management woven throughout the entire design process and traceability of every change.

Action Required → Same quick check:

• Does your DHF contain all design control records?
• Is risk management visibly integrated or clearly referenced at each stage?
• Are design changes documented with rationale, risk review, and verification?

All “yes” → no action needed beyond optional terminology update.

Device History Record → Batch Record / Medical Device Record

What QSR Required
§820.3(i) – Production history of a finished device (dates, quantities, acceptance records, labels, device IDs, etc.).

What ISO 13485 Requires
No single “DHR” term. Requirements are distributed:

• Clause 7.5.1 → records of amount manufactured, amount approved, identification
• Clause 7.5.9 → traceability records (extent determined by risk & regulatory requirements)
• Clause 8.2.6 → evidence of conformity and release authorization

The Actual Difference
Purely structural. Your current DHR almost certainly already contains everything ISO requires — just organized differently.

Action Required → Same quick check as above. If traceability gaps exist, fix them based on product risk (e.g., implantables need more than bandages).

Three Practical Approaches to Documentation Migration

Approach 1 – Minimal Change (Recommended for 90 % of companies)

• Keep all existing names and folder structures
• Add one paragraph to your Quality Manual with equivalence mapping
• Train staff on the mapping → Zero re-issuing of documents, zero disruption

Approach 2 – Parallel Documentation

• New products use ISO terminology
• Legacy products stay on old terminology until next major change → Clean long-term outcome with manageable short-term overhead

Approach 3 – Full Restructuring

• Rename and reorganize everything → Almost never justified unless you are doing a complete QMS overhaul anyway

What FDA Investigators Will Actually Look For in 2026

They WILL care about

• Content & completeness
• Accessibility (can you find it in <10 min?)
• Currency & control
• Traceability and risk integration

They will NOT write you up for

• Calling your MDF a “DMR”
• Keeping your old folder structure
• Having “DHF” in document titles

Practical Transition Guidance

1. Update your Quality Manual (one paragraph is enough)
“This Quality Management System uses terminology consistent with the historical FDA Quality System Regulation. For QMSR and ISO 13485:2016 alignment, the following equivalences apply:

• Device Master Record (DMR) = Medical Device File (MDF) – Clause 4.2.3
• Design History File (DHF) = Design and Development File – Clause 7.3.10
• Device History Record (DHR) = Production & Traceability Records – Clauses 7.5 & 8.2.6”

2. Train on the changes that actually affect daily work

• Top management accountability
• Risk-based thinking everywhere
• Internal audit now follows ISO clause structure
• CAPA vs. nonconformity process separation

3. Use dual references during 2026 if it helps
“Medical Device File (formerly DMR)” is perfectly acceptable.

Download: QMSR Documentation Transition Checklist (2026-ready)

One-page PDF with all assessment questions above + Quality Manual template paragraph.
👉 Download here (free, no email required)

Related Resources

• Complete QMSR Compliance Guide 2025-2026
• QMSR vs QSR: 15 Critical Differences
• How to Run a QMSR Gap Analysis (Free Template)
• FDA October 2025 Draft Guidance – QMS Information for Premarket Submissions
• QMSR Terminology Glossary

Questions about your specific documentation?

We review DMRs/DHFs against the final QMSR in <48 hours — without forcing you to rename anything.

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QMS.Coach LLC | neel@qms.coach |