Clinical transparency, regulatory compliance, effective communication
The Summary of Safety and Clinical Performance (SSCP) is a regulatory document required by EU Regulation 2017/745 (MDR), mandatory for implantable and Class III devices. Validated by the Notified Body and published on Eudamed, the SSCP publicly shares—clearly and rigorously—the clinical information regarding the safety and performance of the device.
It is much more than a regulatory requirement: it is a communication tool that speaks directly to healthcare professionals and patients, helping build trust around the product.
In essence, it is the public face of your device’s clinical evidence: it summarizes all available data on safety and performance in a clear and accessible format.
Our service
Clariscience supports you in drafting the SSCP with a comprehensive, highly qualified, and customizable service:
- Analysis of technical and clinical documentation
We review IFU, CER, PSUR, PMCF, and any relevant source to build a compliant and consistent SSCP. - Drafting according to MDCG 2019-9
We follow the structure and requirements of MDCG 2019-9, ensuring each section is compliant, clear, and aligned with the technical documentation. The document is written and reviewed by EMWA-certified medical writers with strong expertise in regulatory affairs, ensuring scientific rigor and full regulatory compliance. - Patient section
Where applicable, we draft the patient-facing version using clear, accessible language—avoiding unexplained technical terms, complex phrasing, and ambiguity.
Optional add-on services
- Readability assestment
We support you in evaluating the document’s readability using dedicated software, in line with MDCG 2019-9 recommendations.
- Validation support
We assist in managing feedback or observations from the Notified Body during the validation phase.
- Development or review of related documents
We can revise or draft CERs, PMCF plans/reports, and IFUs to ensure alignment and consistency across your documentation.
Why choose Clariscience
- Integrated and strategic approach
We don’t just write a document—we build an SSCP that fits seamlessly into your clinical documentation, enhancing the value of available evidence and ensuring consistency across CER, PMCF, and PSUR.
- Multidisciplinary expertise
Our team combines skills in scientific writing, regulatory affairs, and clinical communication. This allows us to produce documents that are technically robust yet clear and readable for the intended audience.
- Experience and efficiency
Thanks to our experience with Notified Bodies, we anticipate potential issues and reduce the risk of observations.
- Linguistic and communicative flexibility
We tailor the tone and style of the SSCP to suit the target audience—whether healthcare professionals or patients—ensuring both accessibility and compliance.
- Added value in device communication
A well-crafted SSCP is not just a requirement—it’s an opportunity to strengthen the perception of your device by demonstrating transparency, reliability, and patient focus.
We speak the language of science—and know how to make it understandable.
Professional for experts, accessible for patients.
Rely on Clariscience for a professional, effective, and publication-ready SSCP.
Contact us at info@clariscience.com to receive a personalized proposal.
