Why your SSCP is invisible to the people who need it most
I reviewed an SSCP last month that was technically compliant. Every section filled, every reference cited, every MDCG requirement checked. But when I asked the manufacturer who would actually read it and what they would understand, silence. The document was written for the Notified Body, not for patients and healthcare professionals. That is exactly why most SSCPs fail their purpose.
In This Article
The Summary of Safety and Clinical Performance is not just another regulatory deliverable. It is the only clinical document that must be written for a non-expert audience. Yet most manufacturers treat it like a simplified clinical evaluation report. They reduce the technical complexity but keep the regulatory mindset. The result is a document that checks boxes but communicates nothing.
Under MDR Article 32, the SSCP is required for Class III and implantable devices. It must be published on Eudamed. It must be updated when new clinical data emerges. And it must be understandable by the intended user, which includes patients.
That last requirement is where the tension lives. Regulatory professionals are trained to write defensively. Every claim must be supported. Every statement must be precise. Every risk must be qualified. This instinct does not translate well when the goal is clarity for someone without a medical or technical background.
What the SSCP is actually for
The SSCP serves two functions. The first is regulatory. It demonstrates that you have synthesized your clinical evidence into a transparent, publicly available summary. The Notified Body will review it. The Competent Authority may review it. If there are gaps or inconsistencies with your clinical evaluation, they will surface here.
The second function is communication. Patients, healthcare professionals, and procurement committees are supposed to use this document to make informed decisions. They need to understand what the device does, what the risks are, what alternatives exist, and what evidence supports its use.
Most manufacturers focus on the first function and fail the second. The document becomes a defensive summary of the CER, written in passive voice, filled with qualifiers, and structured like a regulatory submission. It satisfies the auditor but serves no one else.
The SSCP is not a simplified CER. It is a patient-facing communication document that happens to have regulatory oversight. If you write it for the Notified Body, you have already failed the primary audience.
The structure mandated by MDCG 2019-9
MDCG 2019-9 provides the template. It lists 16 sections that must be included. Each section has a specific purpose. The guidance is detailed and prescriptive. But it does not teach you how to write clearly for a lay audience.
Section 1 covers device identification and general information. This includes the UDI, device description, and manufacturer details. It should be straightforward, but manufacturers often bury the actual function of the device under technical specifications. A patient reading this section should immediately understand what the device is used for.
Section 2 describes the intended purpose and indications. This is not the regulatory claim copied from the IFU. It is an explanation of who benefits from the device and in what clinical context. If your device is used in multiple indications, explain them clearly. Do not assume the reader knows the difference between primary and adjunctive therapy.
Section 3 addresses the patient population. Who is the device intended for? Are there age restrictions, contraindications, or specific clinical conditions? This section must be written with precision, but also with empathy. A patient should be able to recognize whether they are part of the target population.
Clinical evidence and benefit-risk determination
Sections 4 through 8 cover the core clinical content. Section 4 summarizes the clinical evaluation and the evidence base. Section 5 describes possible diagnostic or therapeutic alternatives. Section 6 explains the benefit-risk determination. Section 7 lists reference devices if equivalence was used. Section 8 suggests follow-up measures for patients currently using the device.
This is where most SSCPs collapse. The clinical evaluation is summarized in regulatory language. The benefit-risk analysis is copied from the CER without translation. The alternatives are listed without context. The result is technically accurate but functionally useless.
When I review an SSCP, I focus on Section 6. The benefit-risk determination must explain not just what the conclusion is, but how it was reached. What were the main safety concerns? How significant are they? What clinical benefit justifies the risk? A patient should be able to follow the reasoning, even if they do not have a medical background.
Manufacturers present the benefit-risk profile as a conclusion without explaining the tradeoffs. Patients need to understand what risks they are accepting and what benefits they can realistically expect. If you cannot explain this in simple terms, you do not understand your own device well enough.
Residual risks and undesirable side effects
Section 9 is critical. It lists residual risks and undesirable side effects. These must be presented with frequency data where available. This is not the place for vague statements like “adverse events may occur.” If a complication happens in 2% of cases, say so. If a side effect is temporary, explain that. If a risk is rare but serious, acknowledge both the rarity and the severity.
Many manufacturers resist this level of transparency. They fear that clear communication of risks will damage market perception. But the SSCP is a regulatory requirement. If you hide the risks, the Notified Body will reject the document. And if the risks are severe enough to hurt your market position, you have a larger clinical problem to address.
Writing for the intended audience
The MDCG guidance says the SSCP should be understandable by the intended user. For patients, this means plain language. For healthcare professionals, this means clinically relevant detail without regulatory jargon. The challenge is balancing both in one document.
Use short sentences. Avoid passive voice. Explain technical terms the first time you use them. Do not assume the reader knows what a predictor variable is or what statistical significance means. If you reference a clinical study, explain what was measured and what the result means in practice.
I have seen SSCPs that include forest plots, hazard ratios, and confidence intervals without any explanation. These belong in the CER, not in the SSCP. If you must include quantitative evidence, translate it. “The study showed a 30% reduction in reintervention at one year” is far more useful than “HR 0.70, 95% CI 0.55-0.89, p=0.003.”
One approach is to write the first draft as if explaining the device to a family member. Then layer in the technical precision required for regulatory review. This ensures the foundation is clear before the complexity is added.
Plain language does not mean imprecision. It means choosing clarity over complexity. If a sentence requires three readings to understand, rewrite it. The goal is to communicate, not to impress.
Updates and lifecycle management
The SSCP is not a static document. Article 32 requires updates whenever significant new clinical data becomes available. This includes new clinical investigations, post-market surveillance findings, or updated benefit-risk assessments. The updated SSCP must be published on Eudamed within defined timelines.
This means the SSCP is tied to your PMCF activities. If your post-market surveillance reveals an increase in a specific complication, the SSCP must reflect that. If a new study changes the benefit-risk profile, the SSCP must be updated. The document is part of the clinical evidence lifecycle, not a one-time deliverable.
Manufacturers often underestimate the effort required to maintain the SSCP. They write the initial version during the MDR transition and then forget about it. When the Notified Body asks for an update during the next review, they scramble to reconstruct what has changed. This is inefficient and risky.
A better approach is to integrate SSCP updates into your PMCF cycle. When you update your CER, review whether the SSCP needs revision. When you analyze PMCF data, assess whether any findings require public communication. Treat the SSCP as a living document that reflects the current state of your clinical evidence.
Review and validation before submission
Before submitting the SSCP to the Notified Body, validate it with the intended audience. Have a patient representative read it. Ask a healthcare professional outside your company to review it. Get feedback from someone who does not live inside your regulatory bubble.
This step is rarely done, but it is the only way to know whether the document achieves its purpose. If your test reader cannot explain the device, the indications, and the main risks after reading the SSCP, you have not communicated effectively.
The Notified Body will check for completeness, consistency with the CER, and alignment with MDCG 2019-9. But they will not validate whether the language is actually understandable. That responsibility is yours.
SSCPs are written by regulatory teams without input from clinical or patient-facing staff. The result is a document that uses patient-friendly formatting but retains regulatory complexity. Real validation requires real users.
The visibility problem
Even when the SSCP is well written, it faces a visibility problem. Eudamed publication is required, but discoverability is limited. Patients do not spontaneously browse Eudamed looking for clinical summaries. Healthcare professionals do not integrate it into their decision-making workflows. The document exists, but it is not actively used.
This is not an excuse to write a poor SSCP. The regulatory requirement is clear, and the Notified Body will enforce it. But manufacturers should recognize that the SSCP is part of a broader communication strategy. If you want patients and healthcare professionals to access this information, you need to make it findable.
Some manufacturers link the SSCP from their website. Others include references in patient education materials. The best approach is to treat the SSCP as the authoritative public-facing clinical summary and direct all stakeholders to it.
What happens when the SSCP is done right
A well-executed SSCP serves multiple purposes. It satisfies the regulatory requirement. It demonstrates clinical transparency. It provides patients with meaningful information. And it protects the manufacturer by ensuring that risks and limitations are clearly communicated.
I have reviewed SSCPs that achieved this balance. They were concise, clear, and honest. They explained the device in plain terms. They presented the evidence without exaggeration. They acknowledged residual risks without evasion. These documents did not feel like regulatory compliance. They felt like responsible communication.
That is the standard you should aim for. Not the minimum required to pass review, but the level of clarity that reflects genuine respect for your end users.
The SSCP is not going away. As Eudamed becomes fully operational and as regulatory scrutiny increases, the quality of these documents will matter more. Manufacturers who invest in clear, honest, patient-centered communication will differentiate themselves. Those who treat it as a checkbox will face rejection, revision cycles, and reputational risk.
Write the SSCP as if your own family member were reading it. That mindset will guide every sentence. And it will produce a document that meets both regulatory expectations and ethical obligations.
Peace,
Hatem
Clinical Evaluation Expert for Medical Devices
Follow me for more insights and practical advice.
Frequently Asked Questions
What is a Clinical Evaluation Report (CER)?
A CER is a mandatory document under MDR 2017/745 that demonstrates the safety and performance of a medical device through systematic analysis of clinical data. It must be updated throughout the device lifecycle based on PMCF findings.
How often should the CER be updated?
The CER should be updated whenever significant new clinical data becomes available, after PMCF activities, when there are changes to the device or intended purpose, and at minimum during annual reviews as part of post-market surveillance.
What causes CER rejection by Notified Bodies?
Common reasons include inadequate equivalence demonstration, insufficient clinical data for claims, poorly structured SOTA analysis, missing gap analysis, and lack of clear benefit-risk determination. Structure and logical flow are as important as the data itself.
Which MDCG guidance documents are most relevant for clinical evaluation?
Key documents include MDCG 2020-5 (Equivalence), MDCG 2020-6 (Sufficient Clinical Evidence), MDCG 2020-13 (CEAR Template), MDCG 2020-7 (PMCF Plan), and MDCG 2020-8 (PMCF Evaluation Report).
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Peace, Hatem
Your Clinical Evaluation Partner
Follow me for more insights and practical advice.
– Regulation (EU) 2017/745 (MDR), Article 32
– MDCG 2019-9: Summary of Safety and Clinical Performance Template
