EU MDR/IVDR Technical File vs FDA Device Master Record: What Manufacturers Need to Know

Medical device manufacturers expanding into both the European Union and the United States often face a familiar question:

Are the EU MDR/IVDR Technical File and the FDA Device Master Record (DMR) the same thing?

At first glance, both sets of documentation describe how a device is designed, manufactured, and verified for safety and performance. Yet beneath the surface, they reflect two very different regulatory philosophies.

Understanding those differences and structuring your documentation accordingly is essential to achieving global market access efficiently and avoiding rework, delays, or audit findings.

The EU Technical File Explained

Under the EU Medical Device Regulation (EU MDR 2017/745) and EU in vitro diagnostic medical devices Regulation (EU IVDR  2017/746), every medical device (excluding custom-made or investigational products) must have a Technical File.

The Technical File demonstrates that the device meets the MDR’s General Safety and Performance Requirements (GSPRs), and it forms the foundation of your conformity assessment by a Notified Body or Competent Authority.

In simple terms, the Technical File is the complete narrative of your device’s safety and performance, containing evidence such as:

• Device description, intended purpose, and design specifications.
  
• Risk management and usability data.
  
• Biological and chemical safety evaluations.
  
• Clinical evidence and post-market surveillance planning.
  
• Labelling, IFU, and conformity declarations.
  

Think of it as the regulatory dossier for Europe, structured to prove compliance with every applicable clause of the MDR/IVDR.

The FDA Device Master Record (DMR)

Across the Atlantic, the U.S. Food and Drug Administration (FDA) takes a different approach.

Under 21 CFR Part 820 of the FDA’s Quality System Regulation (QSR), manufacturers must maintain a Device Master Record (DMR).

The DMR compiles all instructions, drawings, specifications, and procedures required to manufacture a device consistently and correctly. Typical components include:

• Manufacturing and assembly procedures.
  
• Equipment and process specifications.
  
• Quality assurance checks and inspection criteria.
  
• Packaging and labelling instructions.
  

The DMR sits alongside two other essential FDA records:

• Design History File (DHF) – documenting design and development activities.
  
• Device History Record (DHR) – recording the production history for each device or batch.
  

In short, the DMR is not a public regulatory submission but a manufacturing blueprint the operational core that ensures every device is built and controlled exactly as approved.

Shared Principles Between the Two Systems

Despite their different emphases, the EU Technical File and the FDA DMR share several common principles:

• Traceability: Both demand clear linkage between design, manufacturing, and verification evidence.
  
• Controlled documentation: Each requires change control, document versioning, and secure record retention.
  
• Demonstrable safety and quality: Both must show that the product is designed and produced under a compliant quality system.
  
• Audit readiness: Each serves as evidence of conformity—whether for an EU Notified Body audit or an FDA inspection.
  

Both systems ultimately aim for the same outcome: a safe, effective, and consistently manufactured medical device.

Key Differences Between the Technical File and DMR

Aspect	EU MDR/IVDR Technical File	FDA Device Master Record (DMR)
Purpose	Demonstrates compliance with MDR and supports conformity assessment.	Defines how the device is manufactured to meet design specifications.
Regulation	EU MDR 2017/745, Annex II & III, EU IVDR  2017/746.	21 CFR Part 820 (Quality System Regulation).
Focus	Regulatory and clinical performance.	Operational and manufacturing control.
Audience	Notified Bodies and Competent Authorities.	FDA investigators and internal manufacturing teams.
Content	Design evidence, clinical data, performance evaluation for IVDs, GSPRs, labelling, and PMS plans.	Manufacturing processes, specifications, inspection criteria, equipment calibration.
Associated Records	Clinical Evaluation Report (CER), Risk Management File.	Design History File (DHF), Device History Record (DHR).
Change Control	Updates reviewed by Notified Body depending on risk class.	Changes documented and verified under FDA design control.

Practical Tips for Manufacturers Targeting Both Markets

For organisations marketing in both the EU and the U.S., duplication can easily arise. A harmonised approach saves time and ensures consistency.

1. Build a single Quality Management System (QMS)

Implement ISO 13485 as your central framework; it bridges EU and FDA requirements and simplifies documentation alignment.

2. Create a regulatory mapping matrix

Link MDR Annex II/III elements, Annex I GSPRs, 21 CFR 820 clauses, and ISO 13485 requirements to clarify overlap and avoid duplication.

3. Harmonise evidence

Assemble a master clinical and pre-clinical dossier that can be tailored for EU Clinical Evaluation/Performance Evaluation Requirements under EU MDR/IVDR and FDA submissions (510(k) or PMA).

4. Cross-reference shared documents

Use the same reports (e.g. biocompatibility, software validation, sterilisation data) in both files, ensuring version control and audit trails are maintained.

5. Maintain synchronised change control

Any modification to design or manufacturing should be reflected simultaneously in both the Technical File and DMR.

6. Plan your regulatory strategy early

Define whether your product will require Notified Body review (EU) or PMA-level evidence (U.S.) before compiling either dossier.

This proactive planning avoids last-minute document restructuring during audits or FDA inspections.

Are They the Same? Not Quite.

The EU MDR Technical File and the FDA Device Master Record serve complementary but distinct functions.

• The Technical File tells the regulatory story, proving safety, performance, and conformity.
  
• The DMR tells the manufacturing story, showing how that design is consistently realised.
  

For manufacturers operating in both regions, success lies in creating a unified documentation ecosystem: one set of verified data, tailored for each regulator’s expectations.

LFH helps MedTech manufacturers build, align, and maintain compliant documentation for multiple markets. From Technical File creation and DMR structuring to QMS integration and regulatory gap analysis, our consultants ensure your device records are globally consistent, audit-ready, and strategically aligned.

FAQs – EU MDR/IVDR Technical File vs FDA Device Master Record