Your SSCP is not a summary—it is a clinical argument

Written by HATEM RABEH, MD, MSc Ing

Your Clinical Evaluation Expert And Partner

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The Summary of Safety and Clinical Performance is not a technical requirement you tick off at the end of your clinical evaluation. It is a clinical communication tool aimed at two audiences who do not read technical files: patients and clinicians.

Yet most SSCPs I review read like condensed versions of the CER. They assume the reader understands medical device terminology, regulatory classifications, and risk-benefit trade-offs. They do not.

The SSCP must answer a question that neither the IFU nor the CER answers: Why should this device be used in real clinical practice, and what does that mean for the patient?

The regulatory expectation behind the SSCP

MDR Article 32 and Annex XIV Part A require the SSCP to be made publicly available via Eudamed. This is not an accident. The regulation intends for this document to be accessible to the public—not just professionals.

MDCG 2019-9 provides the template and clarifies the scope. The SSCP must allow a clinician to understand the device’s intended purpose, patient population, clinical benefits, residual risks, and alternatives. It must allow a patient to understand what the device does, what it does not do, and what safety considerations apply to them.

That is a very different objective than demonstrating compliance.

This changes how you structure the content. It changes what you emphasize. And it changes how you present residual risks.

Where most SSCPs fail

The most common deficiency I see is a document that assumes too much prior knowledge. The SSCP describes the device using internal terminology, lists performance endpoints without context, and presents residual risks as generic ISO 14971 categories.

For example:

“The device demonstrated non-inferiority in the primary endpoint (p < 0.001). Residual risks include infection, device malfunction, and patient intolerance."

This tells a clinician nothing. What was the primary endpoint? Non-inferior to what? What does “device malfunction” mean in practice? What should the clinician monitor? What should the patient expect?

Another failure mode: copying text directly from the CER without adapting the language. The CER uses precise regulatory and clinical terminology because it must withstand technical scrutiny. The SSCP must use clear language because it must be understood by people who are not medical device specialists.

This does not mean dumbing it down. It means translating technical findings into clinical implications.

What a well-constructed SSCP actually does

A strong SSCP makes a clinical argument. It walks the reader through the logic that supports using the device in practice.

It starts by defining the clinical problem. Not the intended use—the problem. What condition or need does this device address? What are the current options? What are their limitations?

Then it describes the device in terms of what it does for the patient. Not the technical specifications. Not the mechanism of action in isolation. The clinical function.

Then it presents the clinical evidence in terms of outcomes that matter to patients and clinicians. Not surrogate endpoints. Not statistical significance alone. Clinical benefit, described in context.

For example, instead of:

“The device achieved a 15% reduction in target parameter compared to control (p = 0.003).”

Write:

“In a controlled study of 240 patients, the device reduced symptom severity by 15% compared to standard care over six months. This translated to fewer emergency visits and improved quality of life scores, with benefits maintained at one-year follow-up.”

The second version gives context. It connects the outcome to patient experience. It provides a time frame. It allows the clinician to assess whether this benefit is meaningful for their patient population.

Presenting residual risks in a way that informs decisions

The risk section is where I see the most disconnect. Manufacturers list residual risks as if they were completing a checklist. Infection. Malfunction. Adverse tissue reaction. All risks controlled to acceptable levels per ISO 14971.

But a clinician does not want to know that risks are “acceptable.” They want to know what can go wrong, how likely it is, how it presents, and what they should do about it.

A patient wants to know what warning signs to watch for and when to seek help.

This requires you to reframe residual risks as clinical considerations.

For example, instead of:

“Risk of infection is controlled through sterile packaging and patient screening.”

Write:

“Infection at the insertion site occurs in approximately 2% of patients, typically within the first two weeks. Early signs include redness, swelling, or increased pain. Patients should contact their healthcare provider immediately if these symptoms develop. Risk is higher in patients with diabetes or compromised immune systems.”

This version tells the clinician what to monitor and which patients require closer follow-up. It tells the patient what to watch for and when to act.

The difference between transparency and liability

Some manufacturers hesitate to provide detailed information about residual risks in the SSCP because they worry it creates liability. This misunderstands the purpose of the document.

The SSCP is required by regulation. Withholding information that would help clinicians and patients make informed decisions does not reduce liability—it increases it.

Transparency in the SSCP is not the same as admitting fault. It is demonstrating that you understand the clinical reality of using your device and that you are providing the information needed to manage it safely.

The Notified Body and competent authorities expect this. They will review the SSCP to ensure that residual risks are communicated clearly and that the document does not mislead by omission.

How to structure the clinical evidence section

The clinical evidence section of the SSCP should follow a logical progression:

1. Describe the evidence base. How many studies? What types? How many patients? What follow-up duration?

2. Present the key findings in terms of clinical outcomes, not statistical measures. Focus on what changed for patients.

3. Acknowledge limitations. If follow-up is short, say so. If certain subgroups were underrepresented, say so. This builds credibility.

4. Compare to alternatives where relevant. How does this device’s performance compare to existing options? What trade-offs exist?

This structure allows a clinician to assess whether the evidence applies to their patient and whether the device offers a meaningful advantage.

The role of PMCF in the SSCP

The SSCP must describe your post-market clinical follow-up plan. This is not a formality. It signals to clinicians and patients that you are continuing to monitor the device’s performance in real-world use.

But most SSCPs describe PMCF in generic terms: “The manufacturer conducts ongoing surveillance and periodic review of clinical data.”

This tells the reader nothing.

Instead, describe what you are specifically monitoring and why. If you are tracking long-term durability, say so. If you are collecting data on a specific patient subgroup that was underrepresented in premarket studies, say so.

This demonstrates that PMCF is not an afterthought. It is part of the clinical argument for the device.

Final thoughts

The SSCP is not a regulatory formality. It is the document that explains to the people who matter most—patients and clinicians—why your device should be used and what they need to know to use it safely.

If your SSCP reads like a summary of technical documentation, it is not serving its purpose.

The test is simple: Could a clinician read your SSCP and make an informed decision about whether the device is appropriate for their patient? Could a patient read it and understand what to expect?

If the answer is no, the document needs rewriting.

In the next part of this series, I will address the PSUR and why most manufacturers misunderstand what the periodic safety update report is meant to achieve.