{"id":55679,"date":"2025-10-27T16:11:59","date_gmt":"2025-10-27T15:11:59","guid":{"rendered":"https:\/\/clariscience.com\/servizi-clariscience\/regulatory-affairs\/sscp-for-medical-devices-safety-and-clinical-performance-according-to-mdr"},"modified":"2026-04-24T08:17:44","modified_gmt":"2026-04-24T06:17:44","slug":"sscp-for-medical-devices-safety-and-clinical-performance-according-to-mdr","status":"publish","type":"servizi-clariscience","link":"https:\/\/clariscience.com\/en\/services\/regulatory-affairs\/sscp-for-medical-devices-safety-and-clinical-performance-according-to-mdr","title":{"rendered":"SSCP for Medical Devices: Safety and Clinical Performance According to MDR"},"content":{"rendered":"\t\t
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Clinical transparency, regulatory compliance, effective communication<\/strong><\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The Summary of Safety and Clinical Performance (SSCP<\/strong>) is a regulatory document required by EU Regulation 2017\/745 (MDR), mandatory for implantable and Class III devices<\/strong>. Validated by the Notified Body and published on Eudamed, the SSCP publicly shares\u2014clearly and rigorously\u2014the clinical information regarding the safety and performance of the device<\/strong>. <\/p>

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.<\/strong> <\/p>

In essence, it is the public face of your device\u2019s clinical evidence<\/strong>: it summarizes all available data on safety and performance in a clear and accessible format. <\/p>

Our service <\/strong><\/h3>

Clariscience supports you in drafting the SSCP with a comprehensive, highly qualified, and customizable service: <\/p>

  1. Analysis of technical and clinical documentation<\/strong>
    We review IFU, CER, PSUR, PMCF, and any relevant source to build a compliant and consistent SSCP. <\/li>
  2. Drafting according to MDCG 2019-9<\/strong>
    We follow the structure and requirements of MDCG 2019-9<\/strong>, 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. <\/li>
  3. Patient section
    <\/strong>Where applicable, we draft the patient-facing version using clear, accessible language\u2014avoiding unexplained technical terms, complex phrasing, and ambiguity. <\/li><\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Optional add-on services<\/strong><\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tReadability assestment<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      We support you in evaluating the document\u2019s readability using dedicated software, in line with MDCG 2019-9 recommendations.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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      • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tValidation support <\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        We assist in managing feedback or observations from the Notified Body during the validation phase.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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        • \n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t<\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\tDevelopment or review of related documents <\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          We can revise or draft CERs, PMCF plans\/reports, and IFUs to ensure alignment and consistency across your documentation.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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          Why choose Clariscience<\/span><\/b><\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          • Integrated and strategic approach <\/strong><\/li><\/ul>

            We don\u2019t just write a document\u2014we build an SSCP that fits seamlessly into your clinical documentation, enhancing the value of available evidence and ensuring consistency across CER, PMCF, and PSUR. <\/p>

            • Multidisciplinary expertise <\/strong><\/li><\/ul>

              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. <\/p>

              • Experience and efficiency <\/strong><\/li><\/ul>

                Thanks to our experience with Notified Bodies, we anticipate potential issues and reduce the risk of observations. <\/p>

                • Linguistic and communicative flexibility <\/strong><\/li><\/ul>

                  We tailor the tone and style of the SSCP to suit the target audience\u2014whether healthcare professionals or patients\u2014ensuring both accessibility and compliance. <\/p>

                  • Added value in device communication <\/strong><\/li><\/ul>

                    A well-crafted SSCP is not just a requirement\u2014it\u2019s an opportunity to strengthen the perception of your device by demonstrating transparency, reliability, and patient focus.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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                    We speak the language of science\u2014and know how to make it understandable. <\/strong><\/p>

                    Professional for experts, accessible for patients. <\/strong><\/p>

                    Rely on Clariscience <\/strong>for a professional, effective, and publication-ready SSCP. <\/p>

                    Contact us at info@clariscience.com to receive a personalized proposal. <\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"featured_media":27849,"parent":39611,"template":"","settori-servizi":[560,566],"class_list":["post-55679","servizi-clariscience","type-servizi-clariscience","status-publish","has-post-thumbnail","hentry","settori-servizi-md-en","settori-servizi-xvi-en"],"acf":[],"yoast_head":"SSCP for Medical Devices: Safety and Clinical Performance According to MDR | Clariscience<\/title>\n<meta name=\"description\" content=\"Clariscience drafts MDR-compliant SSCPs for Class III and implantable medical devices. 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