🧭 Navigating EU MDR and FDA Guidelines: A Software Validation Roadmap

July 28, 2025

As the healthcare industry undergoes a digital transformation, software as a medical device (SaMD) and embedded software in medical devices face increasing regulatory scrutiny. The EU Medical Device Regulation (EU MDR) and the FDA’s 21 CFR Part 820 and Part 11 provide the foundational frameworks for software validation. However, navigating these two sets of regulations can be daunting for manufacturers, especially those bringing products to both European and U.S. markets.

This blog provides a comprehensive roadmap for software validation that ensures regulatory compliance, product quality, and patient safety across both jurisdictions.

📌 Understanding Software Validation: Why It Matters

Software validation is not just a box-ticking exercise — it ensures the software performs consistently, meets user needs, and does not compromise clinical outcomes or patient safety. For regulatory bodies like the FDA and EU MDR, validation is mandatory and closely tied to the product’s risk classification, intended use, and software life cycle.

🇪🇺 EU MDR: Key Validation Requirements

Under the EU MDR 2017/745, software is considered a medical device if it is intended for diagnosis, prevention, monitoring, treatment, or alleviation of disease. The regulation introduces stricter rules for software validation, including:

Risk Classification: Most software now falls under Class IIa or higher, requiring rigorous validation.
Clinical Evaluation & Performance Evidence: Real-world data or simulations may be required.
Software Life Cycle Processes: Manufacturers must adopt IEC 62304, ensuring traceability from design to retirement.
General Safety and Performance Requirements (GSPRs): Equivalent to FDA's design controls, they outline expectations for software design, development, usability, cybersecurity, and post-market surveillance.

🇺🇸 FDA Software Validation Guidelines

The FDA’s guidance on software validation stems from:

21 CFR Part 820 (Quality System Regulation)
21 CFR Part 11 (Electronic Records and Signatures)
FDA Guidance on Premarket Submissions for Software Contained in Medical Devices
FDA Guidance on SaMD and AI/ML-Based Software

FDA emphasizes a risk-based approach, including:

Establishing intended use and user needs
Creating a Software Requirements Specification (SRS)
Validation and verification plans
Documented testing of all functionalities, including edge cases
Maintaining a Design History File (DHF)

🔍 Key Differences Between EU MDR & FDA

Criteria	EU MDR	FDA
Risk Classification	Often higher for software	More flexible risk assessment
Software Standards	Mandatory use of IEC 62304, ISO 14971	Recommended but not mandatory
Post-market surveillance	Strong emphasis with PMS & PMCF	Focus on complaint handling & CAPA
Regulatory Updates	More recent and stringent (post-2021)	Stable, but evolving with AI/ML framework

🛤️ The Roadmap to Global Software Validation

To meet both EU and US regulatory demands, manufacturers can follow this unified roadmap:

1. Define Intended Use and Risk Class

Start with clear definition of what the software does, who it serves, and its risk level.

2. Adopt Global Standards

Use IEC 62304 (software life cycle), ISO 14971 (risk management), and IEC 82304 (health software safety) to cover both EU MDR and FDA expectations.

3. Implement a Robust QMS

A Quality Management System (ISO 13485 or FDA QSR) ensures consistency and quality in development, maintenance, and post-market activities.

4. Create a Traceable Validation Package

Include the following:

User Requirements
Design Inputs/Outputs
Test Plans and Protocols
Verification and Validation Reports
Risk Analysis and Mitigation
Cybersecurity and Data Privacy Assessment
Maintenance and Change Control Documentation

5. Conduct Independent Validation

Third-party testing or validation teams help maintain objectivity and traceability.

6. Document, Document, Document

Ensure that all design controls, testing outcomes, and regulatory evidence are meticulously documented in:

Design History File (FDA)
Technical Documentation (EU MDR)

7. Prepare for Audit and Submissions

Whether it’s an FDA 510(k)/De Novo submission or a CE marking application, your documentation should be audit-ready.

⚠️ Common Pitfalls to Avoid

Ignoring interoperability requirements
Underestimating cybersecurity impacts
Treating validation as a one-time event instead of a lifecycle process
Failing to implement usability testing or human factors engineering
Missing updates on evolving regulations, especially for AI/ML software

🚀 Future-Proofing Validation: AI, SaMD, and Agile Methods

With AI/ML-based SaMD on the rise, both FDA and EU MDR are working toward adaptive regulatory frameworks. Validation strategies must accommodate:

Algorithm updates post-launch
Continuous learning models
Real-time performance monitoring

Agile development, CI/CD, and real-world evidence will play a growing role, but must still align with static validation principles like traceability and risk control.

✅ Conclusion

Navigating the EU MDR and FDA software validation landscape is complex but achievable with a structured, standards-aligned approach. By integrating validation into every phase of the software life cycle, organizations can not only meet compliance but also accelerate their time-to-market with confidence.

Validation is not just a regulatory requirement — it’s a competitive differentiator in the digital health age.

Visit : Akra (Akra AI) | Software As a Medical Device (SaMD)

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