Regulatory Requirements for SaMD: and IEC 62304 Compliance

For founders in the MedTech space, the development of Software as a Medical Device (SaMD) comes with a unique set of regulatory challenges. Unlike traditional medical devices, where software is merely an embedded component, SaMD operates independently to provide critical medical functions. As a result, regulatory bodies worldwide impose strict compliance requirements to ensure patient safety and device effectiveness. Among these, IEC 62304 stands out as the internationally recognized standard for the lifecycle processes of medical device software.

Understanding and navigating these regulatory requirements is crucial for any founder aiming to bring an SaMD product to market successfully. Failing to comply not only increases the risk of rejection by regulatory bodies such as the FDA or MDR but can also delay product launch and escalate development costs.

Why IEC 62304 Matters for SaMD

IEC 62304 defines requirements for the entire lifecycle of medical device software, from development to maintenance and risk management. Compliance demonstrates safety and effectiveness to regulatory bodies.

For instance, an AI-powered diagnostic tool analyzing MRI scans must adhere to IEC 62304 to mitigate risks of misdiagnosis. A European startup seeking CE marking faced delays due to poor documentation and incorrect risk classification, requiring months of rework. Early integration of IEC 62304 principles could have streamlined their approval process.

Regulatory Requirements: A Global Perspective

Different regulatory bodies impose varying requirements for SaMD, but IEC 62304 remains a core benchmark. Here’s how it aligns with key regulatory frameworks:

• FDA (U.S.): The FDA recognizes IEC 62304 as part of its guidance on medical device software. To gain 510(k) clearance or De Novo classification, SaMD developers must demonstrate adherence to software lifecycle management, validation, and cybersecurity measures.
• European Union (MDR): IEC 62304 compliance is essential for obtaining CE marking under the EU Medical Device Regulation (MDR). The standard supports adherence to the General Safety and Performance Requirements (GSPR) outlined in MDR.
• Health Canada: Canada’s regulatory requirements align closely with the FDA and EU MDR, making IEC 62304 a crucial compliance tool for market entry.

Key Challenges and Practical Approaches

1. Software Risk Classification
   • IEC 62304 categorizes software into three safety classes (A, B, C) based on the severity of harm that a software failure could cause.
   • Misclassifying software risk can lead to inadequate testing or excessive regulatory scrutiny.
   • Practical Example: A startup misclassified their glucose monitoring app, leading to additional verification and delayed market entry.
2. Documentation and Traceability
   • Compliance requires detailed traceability between software requirements, risk management activities, and verification testing.
   • Insufficient documentation is a common reason for regulatory rejection.
   • Practical Example: A U.S.-based SaMD company faced an FDA recall due to gaps in software update traceability.
3. Software Maintenance and Cybersecurity
   • Regulatory bodies expect robust post-market surveillance and cybersecurity measures.
   • IEC 62304 emphasizes software updates, vulnerability management, and security protocols.
   • Practical Example: An AI dermatology tool suffered a security breach, leading to an urgent patch and compliance audit.

Conclusion: A Strategic Approach to Compliance

For founders, IEC 62304 compliance should not be seen as a regulatory burden but as a strategic advantage. Early adoption of its principles streamlines regulatory approvals, enhances software reliability, and reduces long-term development costs.

Building a regulatory-compliant SaMD requires foresight, meticulous documentation, and proactive risk management. By integrating IEC 62304 from the start, MedTech founders can accelerate time-to-market while ensuring their software meets global safety and performance standards.

Investing in compliance today paves the way for sustainable growth and market success tomorrow.

ITR VN - A trusted tech hub in MedTech and Digital Health

‍