Navigating the Complexities of MDR vs. FDA Cybersecurity Requirements for Medical Devices

Medical device manufacturers face a unique challenge when selling in both the U.S. and EU markets: navigating two vastly different regulatory frameworks. Understanding the differences between the U.S. Food and Drug Administration (FDA) and the European Union Medical Device Regulation (MDR) cybersecurity requirements is vital for ensuring compliance while maintaining efficiency.

At Periculo, we help medical device companies harmonise their cybersecurity strategies to meet both regulatory standards without unnecessary duplication of effort. Here is what you need to know about these two frameworks and how to bridge the gap effectively.

The Two-Market Cybersecurity Challenge

Medical device manufacturers operating in both the U.S. and EU must balance two fundamentally different approaches to cybersecurity compliance:

• FDA (United States): Provides detailed guidance with increasingly prescriptive cybersecurity requirements, including dedicated threat modelling, security documentation, and post-market vulnerability response plans.

• MDR (European Union): Embeds cybersecurity expectations within a broader risk management approach, integrating it into ISO 14971 and post-market surveillance activities.

The result? Many manufacturers create entirely separate documentation sets—doubling their work and increasing the risk of inconsistencies.

Key Documentation Differences

The FDA and MDR frameworks require distinct approaches to documentation:

• FDA: Expects standalone cybersecurity documentation, detailed threat models, and security architecture reports.

• MDR: Requires cybersecurity integration throughout the technical file, embedding security considerations within risk management.

• FDA: Mandates Common Vulnerability Scoring System (CVSS) scoring for vulnerability severity.

• MDR: Focuses on a benefit-risk approach tied to patient safety.

Cybersecurity Risk Management Approaches

While both frameworks prioritise patient safety, they have different methodologies:

FDA Approach

• Dedicated cybersecurity risk assessment

• Threat modelling (e.g., STRIDE methodology)

• CVSS scoring to determine risk severity

• Detailed attack vector analysis

MDR Approach

• Integrated risk management using ISO 14971

• Emphasis on patient safety impact rather than specific security metrics

• Focus on state-of-the-art considerations for continuous risk assessment

Manufacturers that succeed in both markets build a “superset” risk approach, harmonising cybersecurity risk models with appropriate cross-referencing for each framework.

Post-Market Cybersecurity Management: What Happens After a Vulnerability is Found?

Regulators expect a clear plan for addressing cybersecurity threats after a device has been launched. However, the FDA and MDR have different post-market expectations:

• FDA Requires:

  • Specific vulnerability response timelines (7, 30, or 90 days depending on severity)

  • Coordinated disclosure documentation

  • Regular security patches with verification

  • Reporting under 21 CFR Part 806 for certain security issues

• MDR Requires:

  • Integration with the post-market surveillance system

  • Periodic Safety Update Reports (PSUR) including cybersecurity issues

  • Vigilance reporting for serious security incidents

  • Updates to technical documentation for substantial security changes

Without a unified post-market plan, companies risk falling out of compliance in one market while addressing vulnerabilities in another.

The Smart Approach: Harmonising FDA and MDR Compliance

The best strategy is to develop a single, unified cybersecurity approach that aligns with both FDA and MDR requirements. Here are five key harmonisation strategies:

1. Develop a master cybersecurity architecture document that maps to both frameworks.
2. Implement a two-tier risk management approach that integrates cybersecurity with ISO 14971 while maintaining FDA-level documentation detail.
3. Create a unified vulnerability management process with clear triggers for both regulatory bodies.
4. Leverage international cybersecurity standards recognised by both regulators (e.g., IEC 62304, ISO 14971, IEC 80001-1).
5. Prepare market-specific submission packages derived from unified documentation, reducing duplication while maintaining compliance.

Why Periculo?

At Periculo, we specialise in helping digital health companies streamline their cybersecurity compliance efforts. Our approach ensures that you:

• Meet FDA and MDR cybersecurity requirements without redundant documentation. 
• Strengthen risk management strategies that satisfy both regulators.
• Implement a structured, unified post-market cybersecurity plan.
• Reduce compliance workload while accelerating regulatory approvals.

Do not let regulatory complexity slow down your innovation. Download our free MDR vs. FDA Cybersecurity Comparison Chart today to see exactly where the frameworks align—and how you can harmonise your approach effectively.