Why Your GSPR Analysis Fails Clinical Review

Written by HATEM RABEH, MD, MSc Ing

Your Clinical Evaluation Expert And Partner

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The General Safety and Performance Requirements are not administrative boxes. They are clinical statements that must be substantiated with objective evidence. Each requirement you declare applicable becomes a clinical claim that must survive scrutiny.

When I review a technical file, the gap between the GSPR declaration and the clinical evidence is often the first red flag. The manufacturer states conformity in Annex I, but the CER contains no corresponding data. No analysis. No justification. Just silence.

That silence is what triggers the major objection letter.

The GSPR Is Not Just Design Input

Most teams approach Annex I during design and development. They map each requirement to design specifications, verification tests, and risk controls. That work is necessary. But it is not sufficient for clinical evaluation.

The GSPR establishes what the device must achieve in clinical use. Chapter I covers general requirements: benefit-risk ratio, design and manufacturing characteristics, performance and safety. Chapter II addresses information supplied by the manufacturer. Chapter III is device-specific.

Each of these requirements translates into a clinical question. Does the device perform as intended in the target population? Are the risks acceptable relative to the benefits? Is the information provided adequate for safe use?

These are not engineering questions. They are clinical questions. They require clinical evidence.

Where the Disconnect Happens

The problem starts when manufacturers treat the GSPR analysis as a compliance document separate from the clinical evaluation. The quality team closes Annex I during design review. The clinical team starts the CER months later using a standard template. The two documents never talk to each other.

I have reviewed files where the GSPR declares full conformity to all applicable requirements, while the CER explicitly states that certain clinical data are missing and will be collected post-market. That is not alignment. That is contradiction.

The Notified Body sees this immediately. If you declare conformity to a performance requirement, but your clinical data show only surrogate endpoints or partial evidence, the declaration is unsupported. If you claim acceptable risk, but your appraisal identifies residual concerns that require PMCF, the claim is premature.

This is not about being conservative or overly cautious. It is about internal consistency. The technical file must tell one coherent story.

The Reviewer’s Perspective

When a Notified Body reviews your file, they do not start with the CER. They start with the technical documentation overview. They read your intended purpose, your claims, your GSPR analysis. That sets the expectation.

Then they open the CER. And they check whether the clinical data support what you declared.

If the GSPR says the device meets the benefit-risk requirement under Section 1, the reviewer expects to find a benefit-risk determination in the CER that references quantitative data. If the GSPR references performance under Section 3, the reviewer looks for performance endpoints in the appraisal.

When those elements are missing or generic, the reviewer does not assume good intent. They assume the clinical evaluation is incomplete.