DHF, DMR, DHR with DDF, MDF & MDR TD — A Practical Crosswalk

Same quarter: a design review, a pilot build, and an NB conversation. Use this playbook to align FDA, ISO 13485, and MDR documentation once—then reuse it everywhere.

What You Need to Know (Fast)

DHF (Design History File), DMR (Device Master Record), and DHR (Device History Record) originate in FDA’s legacy device quality regulation (21 CFR 820). ISO 13485 uses a lifecycle view with a DDF (Design & Development File, clause 7.3.10) and an MDF (Medical Device File, clause 4.2.3) (ISO 13485). In the EU, MDR uses Technical Documentation (Annex II & III) (MDR). FDA’s QMSR final rule (announced Jan 31, 2024; published Feb 2, 2024) incorporates ISO 13485 and becomes effective February 2, 2026. Plan your transition now.

How to Do This Right — Core Principles

• Map artifacts to the lifecycle. User needs, risk, and usability live in the DHF/DDF (the Usability Engineering File per IEC 62366‑1 sits here); manufacturing specs, labeling, and software build instructions belong in the MDF; unit/lot evidence goes into production/DHR records; PMS closes the loop through CAPA and risk. ISO 14971 Risk Management File is a core DDF element and a living document updated by PMS.
• Control sources, not copies. Inside the MDF, reference the canonical drawing, SOP/WI, labeling spec, or software configuration in PLM/eQMS. Avoid pasted duplicates that drift out of sync.
• Maintain traceability. Keep a simple matrix: needs → inputs → outputs → V&V → MDF specs → production/DHR evidence; link PMS trending to risk updates.

Visual Crosswalk — lifecycle flowchart

Expert Deep Dive

QMSR terminology shift. Under QMSR, FDA incorporates ISO 13485. The Medical Device File (MDF) becomes the central production file, and FDA no longer uses DHF/DMR/DHR terms in regulation; keep internal crosswalks so legacy evidence maps cleanly to DDF/MDF and production records (ISO 13485 clauses 4.2.3 and 7.3.10). This requires a documented gap analysis to show how legacy records fulfill each relevant ISO 13485 clause.

FDA lens (historical). For devices released before Feb 2, 2026, DHF/DMR/DHR references in legacy 21 CFR 820 remain a useful shorthand (DHF, DMR, DHR), but post‑effective‑date inspections evaluate against QMSR/ISO structures. Production records under ISO 13485 (§7.5) include evidence like process parameters, equipment used, and personnel—broader than the legacy U.S. DHR scope.

For SaMD & Connected Devices — practical IEC 62304 mapping

• Integrate IEC 62304. Treat your software development file as DHF/DDF content and map CI/CD artifacts to software configuration items (IEC 62304).
• Record deployments as production/DHR events. Capture: build/commit, approvals, environment snapshot, automated/clinical acceptance, rollback plan.
• Capture SBOM & environment. Store SBOMs, container digests, OS/DB versions, and IaC/module versions with the MDF.
• Automate traceability. Link epics → inputs → outputs → verification; export immutable snapshots into DDF/MDF at release.
• AI/ML components. Document dataset versions and governance, model validation, bias testing, drift monitoring, retraining criteria, and versioned model cards.

QMSR compliance checklist — final rule (Feb 2024), effective (Feb 2, 2026)

Target full QMSR conformity by February 2, 2026. Inspections after the effective date will review current conformity; legacy records may be used if your documented gap analysis shows equivalence to ISO 13485.

• Run a gap analysis. Compare procedures to ISO 13485 clauses 4.2.3 (MDF), 7.3.10 (DDF), 7.5 (production), and 8.x (PMS/CAPA). Add a glossary/crosswalk.
• Update procedures & training. Revise design control, document control, software lifecycle, and production records; train teams on the new references.
• Pilot an end‑to‑end trace. One device family: needs → DDF → MDF → production records → PMS; measure evidence pull time.
• Prepare for inspection. Keep a QMSR binder: glossary, crosswalk, sample MDF, trace matrix, PMS summary, CAPA status.

Data Table Examples

Design Traceability Matrix (DHF/DDF)

This table demonstrates the crucial links between user needs, design requirements, design outputs, verification evidence, and associated risk controls. It proves that design inputs are realized and tested throughout development.

Legacy File Crosswalk (QMSR Transition)

A "Rosetta Stone" mapping historical FDA 21 CFR 820 documents (DHF, DMR, DHR) to ISO 13485 terminology (DDF, MDF, Production Records) for QMSR. Use the pointers to locate equivalent documentation.

Detailed Production Record (DHR Excerpt)

Example Device History Record showing manufacturing parameters, equipment, personnel, and acceptance results for a lot/unit. Links back to approved manufacturing instructions (MDF) to demonstrate compliance.

Copy‑Ready Templates (CSV)

Tip: copy into your PLM/eQMS or spreadsheet; keep IDs immutable.

artifact_id,artifact_type,source_id,verification_evidence,release_id,status,risk_control_ids,requirement_version,spec_version
USR-001,User Need,,TC-045;TR-012,REL-2025.10,approved,RC-12;,v1.0,
REQ-010,Design Input,USR-001,TC-045,REL-2025.10,approved,RC-12;RC-19,v1.2,
DES-210,Design Output,REQ-010,VR-033,REL-2025.10,approved,RC-19,v1.1,v2.0
LBL-015,Labeling Spec,DES-210,IR-009,REL-2025.10,approved,,v1.0,v3.1

legacy_record,iso_13485_target,clause,location_pointer,version,risk_link
DHF Plan,DDF plan,7.3.10,PLM://project/123/dhf-plan,v1.3,RMF://project/123#USR-001
Design Outputs,MDF: product specifications,4.2.3,PLM://project/123/specs,v2.0,RMF://project/123#REQ-010
DMR Work Instructions,MDF: production procedures,4.2.3,PLM://mfg/wi,v5.4,RMF://project/123#PROC-04
DHR Lot Record,Production record,7.5,PLM://mfg/lots/2025-10,v1.0,RMF://project/123#LOT-2025-10

record_id,lot_or_unit,process_params,equipment_id,operator_id,acceptance_results,trace_to_mdf,release_id,timestamp
PR-2025-10-001,LOT-2025-10,temp=75C;speed=120rpm,EQ-014,EMP-442,pass,MDF://revB,REL-2025.10,2025-10-14T10:22Z

Quick Comparison

Impact for Manufacturers, RA/QA Leads, Founders & NB‑Facing Teams

• Faster audits. Clean separation with links typically cuts evidence retrieval time.
• Lower change risk. Single‑source references reduce misbuilds and labeling errors.
• Global reuse. One lifecycle map supports U.S., EU, and other markets without rebuilding files.

Global Terminology Tips

Use market‑specific terms in procedures, but keep an internal legend so teams recognize that DHF/DMR/DHR ≈ DDF/MDF/production records. Teach the chain “DHF/DDF → MDF → production records → PMS.”

FAQ

• Do variants need separate DHFs under QMSR?
  Keep a master DDF with variant addenda; ensure traceability to variant requirements and V&V. Older DHF content maps to DDF sections.
• Can PLM be our MDF?
  Yes—if it enforces document control, approvals, and immutable references. The MDF should reference canonical PLM records, not copies.
• How will FDA treat pre‑2026 records?
  After Feb 2, 2026 inspections will evaluate QMSR conformity. Legacy QS records can be used if they demonstrate equivalence to ISO 13485 requirements and the gap analysis is documented.
• How do we capture SaMD/AI releases?
  Treat deployments as production/DHR‑equivalent events: build/commit, approvals, environment snapshot, acceptance evidence, rollback plan, SBOM, dataset versioning, and model validation artifacts.

Regulatory References

• ISO 13485:2016: DDF (§7.3.10), MDF (§4.2.3) — ISO catalogue.
• EU MDR 2017/745: Annex II (design/production), Annex III (PMS) — EUR‑Lex.
• FDA QMSR Final Rule: announced 2024‑01‑31; published 2024‑02‑02 — Federal Register; FDA QMSR.
• Legacy 21 CFR 820 (historical terms DHF/DMR/DHR) — eCFR.
• IEC 62304 (software lifecycle) — IEC Webstore.
• IEC 62366‑1 (usability engineering) — IEC Webstore.
• ISO 14971 (risk management) — ISO Catalogue.

Disclaimer: Regulatory information evolves quickly. This page was last updated on 2025‑10‑14. Confirm current QMSR guidance and any FDA enforcement discretion before audits.