Most GSPRs Are Not Clinical—Until Your Clinical Data Proves Them

Written by HATEM RABEH, MD, MSc Ing

Your Clinical Evaluation Expert And Partner

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This confusion reveals a fundamental misunderstanding about how clinical evaluation operates within the MDR framework. Clinical evaluation is not a standalone activity that exists in parallel to technical documentation. It is the mechanism through which you demonstrate that your clinical evidence supports the claims you make about General Safety and Performance Requirements.

And here is what most teams miss: many GSPRs appear purely technical on the surface, but their compliance still requires clinical justification.

What GSPRs Actually Demand

Annex I of MDR 2017/745 contains 23 General Safety and Performance Requirements. Some are clearly clinical in nature—biocompatibility, infection control, performance claims. Others seem entirely technical—software validation, electrical safety, materials selection.

Yet Article 61(1) states that clinical evaluation must confirm compliance with relevant GSPRs. Not some. Not just the obvious ones. Relevant GSPRs. And relevance is broader than most manufacturers assume.

Consider GSPR 17.1 on devices incorporating substances. The requirement addresses chemical safety, toxicology, material compatibility. These feel like bench testing topics. But the clinical evaluation must still demonstrate that the substance, as used in the device, does not produce adverse clinical outcomes in the target population under intended use conditions.

You cannot separate the technical proof from the clinical reality.

The Gap Between Technical Files and Clinical Files

In most technical documentation, GSPR compliance is addressed through design verification, risk analysis, and standards conformity. You show that your device meets IEC 60601-1. You demonstrate software validation per IEC 62304. You prove mechanical integrity through test reports.

This is necessary. But it is not sufficient.

The clinical evaluation must bridge from these technical demonstrations to clinical reality. It must show that the standards you followed, the tests you passed, and the design choices you made actually result in a device that is safe and performs as intended when used on patients.

Here is where the gap opens: manufacturers treat the clinical evaluation as a separate document that addresses only obviously clinical requirements—efficacy, adverse events, benefit-risk. The GSPRs that seem technical get checked off in the technical file and never revisited in the clinical evaluation report.

Then the Notified Body asks: where is the clinical evidence that your electrical safety measures prevent harm in actual use? Where is the clinical data showing that your software validation approach results in clinically acceptable performance? Where is the proof that your materials selection does not cause adverse tissue reactions in your target population?

The manufacturer points to test reports. The Notified Body points to Article 61.

How Reviewers Evaluate GSPR Coverage

When I review a clinical evaluation for GSPR compliance, I look for explicit statements that connect clinical data to each relevant requirement. Not assumptions. Not cross-references to the technical file. Actual clinical evidence or clinical reasoning.

For requirements that are clearly clinical—biocompatibility, sterility, infection risk—I expect direct clinical data. Literature on similar materials in similar applications. Post-market surveillance showing absence of sensitization or inflammatory responses. Clinical study results demonstrating infection rates.

For requirements that appear technical but have clinical implications, I expect clinical reasoning that closes the loop. If you claim compliance with electrical safety standards, the clinical evaluation must address whether your target population includes patients with heightened electrical sensitivity, whether your use environment introduces risks not covered by the standard, whether your instructions for use are sufficient to prevent misuse that could bypass safety features.

The question is always: does the clinical evidence support the assumption that technical compliance equals clinical safety in your specific application?

If your device is used in a highly variable environment—home care, emergency transport, low-resource settings—then standard laboratory compliance may not fully address clinical risk. If your device is used on a vulnerable population—neonates, immunocompromised patients, cognitively impaired users—then additional clinical considerations may apply beyond what the standard requires.

The clinical evaluation is where you address these gaps.

Building the GSPR-Clinical Evidence Matrix

The most effective way to demonstrate GSPR compliance through clinical evaluation is to build an explicit matrix that maps each relevant GSPR to specific clinical evidence or clinical reasoning.

Start by identifying which GSPRs apply to your device. This is not a checklist exercise. You must understand what each requirement actually demands and why it matters for your device type, patient population, and use environment.

For each relevant GSPR, determine whether compliance is demonstrated through:

Direct clinical data: Studies, literature, post-market data that show the requirement is met in clinical use.

Clinical reasoning: Logical explanation connecting technical compliance to clinical outcomes, supported by risk analysis and known failure modes.

Equivalence: Demonstration that an equivalent device meets the requirement and that equivalence extends to this aspect of performance or safety.

Then document this in your clinical evaluation report with clear traceability. Not buried in paragraphs. Not implied. Explicitly stated with references to evidence sources.

When Clinical Reasoning Is Acceptable

Not every GSPR requires new clinical studies. Clinical reasoning is acceptable when it is rigorous, documented, and based on established knowledge.

But clinical reasoning is not the same as assumption.

If you claim that compliance with IEC 60601-1 ensures electrical safety in clinical use, your clinical reasoning must address:

Are there clinical scenarios where the standard’s assumptions do not hold?

Has post-market data confirmed absence of electrical safety incidents?

Do your instructions for use and training materials adequately communicate safety precautions?

Is your target environment within the scope of the standard’s applicability?

If any of these questions raises doubt, clinical reasoning alone is insufficient. You need data.

Clinical reasoning works when you can demonstrate that the technical requirement directly prevents a known clinical hazard, that the standard you followed is appropriate for your application, and that there is no evidence suggesting the technical measure fails to translate to clinical safety.

It fails when you skip the analysis and simply assert that compliance equals safety.

The Role of Post-Market Data in GSPR Compliance

Post-market clinical follow-up is where GSPR compliance moves from prediction to confirmation.

Your initial clinical evaluation may rely heavily on clinical reasoning and literature for certain GSPRs—particularly those with technical dimensions. But your PMCF plan must include mechanisms to verify that these assumptions hold in real-world use.

If you claimed that your materials selection meets biocompatibility requirements based on ISO 10993 testing and literature on similar materials, your PMCF must monitor for sensitization reactions, inflammatory responses, or material degradation over the device lifetime.

If you claimed that your software validation approach ensures clinically acceptable performance, your PMCF must track software-related incidents, usability issues, and any clinical consequences of software behavior in actual use.

The clinical evaluation is not static. It is a living process that continuously confirms GSPR compliance through accumulating real-world evidence.

When Notified Bodies see a clinical evaluation that addresses all relevant GSPRs upfront and a PMCF plan that systematically monitors the assumptions behind each compliance claim, they see a manufacturer that understands the regulatory framework.

When they see GSPRs addressed only in the technical file with no clinical follow-through, they see a gap.

What This Means for Your Next Submission

Before your next submission, audit your clinical evaluation report against Annex I.

For every GSPR that applies to your device, ask: where is the clinical evidence or clinical reasoning that confirms compliance? If the answer is “in the technical file,” you have a gap.

The technical file provides the foundation. The clinical evaluation confirms that the foundation supports the structure.

This does not mean duplicating technical documentation. It means explicitly connecting technical compliance to clinical outcomes. It means showing that you understand the clinical implications of every design choice and every safety measure.

It means treating the clinical evaluation as the regulatory argument that ties everything together—not as a separate document that addresses only the obviously clinical aspects.

Most GSPRs are not clinical in nature. But all relevant GSPRs require clinical justification.

That is the difference between a compliant clinical evaluation and one that leaves the Notified Body asking questions.

When you approach GSPR compliance through clinical evaluation, you are not creating extra work. You are building the regulatory argument that your device is safe and performs as intended. And that argument must be complete.

Peace,
Hatem
Clinical Evaluation Expert for Medical Devices
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