SaMD Classification Conflicts and Their Regulatory Impact

Software as a Medical Device (SaMD) is enabling faster innovation, smarter diagnostics, and scalable healthcare solutions. However, as software-driven products move closer to clinical decision-making, regulatory classification has become one of the most critical and misunderstood aspects of market access.

Many SaMD manufacturers invest heavily in development and validation, only to encounter challenges later due to classification assumptions that do not align with regulatory expectations. These challenges are often subtle, but their commercial impact can be significant.

Understanding SaMD Classification Conflicts

A SaMD classification conflict occurs when the manufacturer’s interpretation of risk does not fully align with how a regulatory authority evaluates the software’s clinical role and impact.

This usually happens when:

• The software supports or influences medical decisions more than initially anticipated
• Claims evolve during development or marketing alignment
• The same product is prepared for multiple markets using a single classification logic
• Software updates change functionality without reassessing regulatory positioning

Unlike traditional devices, SaMD classification is influenced less by physical characteristics and more by clinical dependency and consequences of failure.

Why SaMD Classification Is Often Misjudged

SaMD products sit in regulatory grey zones because their risk profile depends on how the output is used, not just what the software does.

Regulators typically evaluate:

• Whether the software informs, supports, or drives clinical decisions
• The seriousness of the medical condition involved
• The level of reliance a healthcare professional places on the output
• The potential harm if the software output is incorrect

As a result, two products with similar technology can fall into different regulatory classes due to differences in intended use wording or clinical context.

Business Impact of Misaligned Classification

For manufacturers, classification is not just a regulatory label it directly affects time, cost, and scalability.

Common downstream impacts include:

• Extended review timelines due to additional justification requests
• Unexpected documentation upgrades, including clinical or performance evidence
• Rework of technical files to match revised risk expectations
• Delays in global expansion, as different markets reassess classification independently

These issues often arise late in the regulatory process, when changes are more expensive and disruptive.

Where SaMD Manufacturers Commonly Underestimate Risk

In regulatory reviews, classification issues often stem from:

• Relying on competitor products without documented rationale
• Over-simplified or marketing-driven intended use statements
• Assuming AI or algorithm updates are “minor changes”
• Treating classification as a one-time decision rather than a lifecycle activity

While none of these are intentional mistakes, they can expose manufacturers to avoidable regulatory friction.

Why a Strategic Classification Approach Matters

A well-defined SaMD classification strategy:

• Aligns claims, risk management, and clinical evidence from the start
• Reduces the likelihood of late-stage regulatory objections
• Supports smoother approvals across multiple regions
• Creates a stable foundation for future software updates and enhancements

Most importantly, it allows manufacturers to plan regulatory investment realistically, rather than reacting to unexpected requirements.

How Regulatory Consultants Support SaMD Manufacturers

An experienced regulatory consultant does not aim to push a product into the lowest possible class. Instead, the focus is on defining a defensible and sustainable classification position that regulators can clearly understand and accept.

This includes:

• Interpreting SaMD guidance in the context of real-world regulatory reviews
• Aligning intended use with clinical dependency
• Anticipating how classification may evolve with product updates
• Supporting consistency across global submissions

This approach helps manufacturers move forward with confidence, rather than uncertainty.

Conclusion:

SaMD classification conflicts are rarely obvious at the start but they can shape the entire regulatory journey of a product. Manufacturers who address classification early and strategically are better positioned to achieve predictable approvals, faster market entry, and long-term compliance.

If you are developing or scaling a SaMD product and want clarity on its regulatory classification, the team at Titans Medical Consulting supports manufacturers with structured, market-specific regulatory strategies.

Sources:

1. IMDRF Software as a Medical Device (SaMD): Key Definitions (IMDRF/SaMD WG/N10)
2. IMDRF SaMD: Possible Framework for Risk Categorisation and Corresponding Considerations (IMDRF/SaMD WG/N12)
3. IMDRF SaMD: Clinical Evaluation Guidance (IMDRF/SaMD WG/N41)
4. EU Medical Device Regulation (EU MDR 2017/745) Annex VIII, Rule 11
5. U.S. FDA Software as a Medical Device (SaMD) Guidance
6. UK MHRA Software and AI as a Medical Device Guidance
7. Health Canada Software as a Medical Device Guidance