{"id":55690,"date":"2025-10-27T16:34:36","date_gmt":"2025-10-27T15:34:36","guid":{"rendered":"https:\/\/clariscience.com\/blog\/uncategorized\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance"},"modified":"2026-04-24T06:37:50","modified_gmt":"2026-04-24T04:37:50","slug":"sscp-under-mdr-the-key-document-to-communicate-safety-and-performance","status":"publish","type":"post","link":"https:\/\/clariscience.com\/en\/blog\/regulatory-affairs\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance","title":{"rendered":"SSCP under MDR: the key document to communicate safety and performance."},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"55690\" class=\"elementor elementor-55690 elementor-55557\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-366ffb8 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"366ffb8\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-17f8569\" data-id=\"17f8569\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-f54d990 elementor-widget elementor-widget-text-editor\" data-id=\"f54d990\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h2>A regulatory obligation that speaks to the public<\/h2><p><strong>The Summary of Safety and Clinical Performance (SSCP)<\/strong> is a document required under Article 32 of Regulation (EU) 2017\/745 (MDR), <strong>mandatory for implantable and class III medical devices<\/strong>. Its purpose is clear: to summarize the clinical evidence and safety data of the device, making them accessible to healthcare professionals and patients through publication on Eudamed. <\/p><p>However, the SSCP is not merely a technical document. <strong>It is a public transparency tool <\/strong>t<strong>hat helps build trust around the device and its manufacturer<\/strong>. For this reason, drafting an SSCP requires specialized expertise, both regulatory and communicative. <\/p><h2>What the MDCG 2019-9 guideline requires<\/h2><p>The <strong>MDCG 2019-9 Rev.1<\/strong> guideline defines in detail:<\/p><ul><li>the structure of the document (9 mandatory sections);<\/li><li>the sources of information (exclusively from the technical documentation);<\/li><li>the clarity and readability requirements, especially for the patient section;<\/li><li>the validation process by the Notified Body;<\/li><li>the language requirements, depending on the countries where the device is marketed.<\/li><\/ul><p>A non-compliant SSCP may lead to observations, publication delays, and communication issues. Therefore, during the drafting phase, it may be beneficial to consult professionals who are familiar with the regulatory context and the expectations of Notified Bodies. <\/p><h2>Readability: a regulatory requirement, not a stylistic choice<\/h2><p>Readability is one of the most underestimated yet critical aspects of the SSCP. According to the MDCG, readability is not just about \u201cease of reading\u201d, but about the<strong> appropriateness of language, structure, and terminology for the intended audience.<\/strong> <\/p><p>For the patient section, it is advisable to use:<\/p><ul><li>simple and direct language;<\/li><li>short sentences and a linear structure;<\/li><li>explanations of technical terms;<\/li><li>readability testing with non-expert users.<\/li><\/ul><p>Validated <strong>readability software tools<\/strong> (such as the <em>Gulpease Index<\/em> for Italian and the <em>Flesch Reading Ease<\/em> for English) can be used, along with <strong>manual review,<\/strong> to ensure the document meets the reference thresholds: this helps ensure the content is accessible to the intended audience.<\/p><h2>A well-written SSCP is an investment in the device\u2019s reputation<\/h2><p>A clear and compliant SSCP:<\/p><ul><li><strong>facilitates validation<\/strong> by the Notified Body;<\/li><li><strong>reduces the risk of Non-Conformities<\/strong> and revisions;<\/li><li><strong>improves the perception of the device<\/strong> among clinicians and patients;<\/li><li><strong>strengthens the manufacturer\u2019s transparency and credibility.<\/strong><\/li><\/ul><h2>Conclusion<\/h2><p><strong>The SSCP is a regulatory document, but also a clinical communication tool.<\/strong> Drafting it correctly means <strong>complying with the regulation, but also conveying trust, competence, and responsibility.<\/strong> <\/p><p>Understanding the requirements and expectations of Notified Bodies is the first step toward creating robust, clear, and truly useful documents for all intended audiences.<\/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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b563df5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b563df5\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-8efb600\" data-id=\"8efb600\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-0105feb elementor-align-center elementor-widget elementor-widget-button\" data-id=\"0105feb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"mailto:info@clariscience.com\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">CONTACT US<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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},"excerpt":{"rendered":"<p>SSCP: the document that makes a medical device\u2019s safety visible. It\u2019s not just a technical file\u2014it\u2019s a tool for public transparency that helps build trust around the device and its manufacturer.  <\/p>\n","protected":false},"author":94,"featured_media":55617,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"episode_type":"","audio_file":"","podmotor_file_id":"","podmotor_episode_id":"","cover_image":"","cover_image_id":"","duration":"","filesize":"","filesize_raw":"","date_recorded":"","explicit":"","block":"","powered_cache_disable_cache":false,"powered_cache_disable_css_optimization":false,"powered_cache_disable_js_optimization":false,"footnotes":""},"categories":[532],"tags":[575],"class_list":["post-55690","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory-affairs","tag-magazine-en"],"acf":[],"yoast_head":"<title>SSCP under MDR: the key document to communicate safety and performance. - Clariscience<\/title>\n<meta name=\"description\" content=\"Learn how to draft a compliant SSCP under MDR for class III and implantable medical devices. Ensure clarity, readability, and regulatory alignment with expert guidance.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/clariscience.com\/en\/blog\/regulatory-affairs\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"SSCP under MDR: the key document to communicate safety and performance. - Clariscience\" \/>\n<meta property=\"og:description\" content=\"Learn how to draft a compliant SSCP under MDR for class III and implantable medical devices. Ensure clarity, readability, and regulatory alignment with expert guidance.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/clariscience.com\/en\/blog\/regulatory-affairs\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance\" \/>\n<meta property=\"og:site_name\" content=\"Clariscience\" \/>\n<meta property=\"article:published_time\" content=\"2025-10-27T15:34:36+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-04-24T04:37:50+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/clariscience.com\/wp-content\/uploads\/2025\/10\/611_Q_SSCP-il-documento-che-rende-visibile-la-sicurezza-di-un-dispositivo-medico.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"800\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Valentina Tomaello\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Valentina Tomaello\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/regulatory-affairs\\\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/regulatory-affairs\\\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance\"},\"author\":{\"name\":\"Valentina Tomaello\",\"@id\":\"https:\\\/\\\/clariscience.com\\\/en#\\\/schema\\\/person\\\/e067e66e7c6a06206df99e5aa3d4f32a\"},\"headline\":\"SSCP under MDR: the key document to communicate safety and performance.\",\"datePublished\":\"2025-10-27T15:34:36+00:00\",\"dateModified\":\"2026-04-24T04:37:50+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/regulatory-affairs\\\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance\"},\"wordCount\":424,\"publisher\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/regulatory-affairs\\\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/clariscience.com\\\/wp-content\\\/uploads\\\/2025\\\/10\\\/611_Q_SSCP-il-documento-che-rende-visibile-la-sicurezza-di-un-dispositivo-medico.jpg\",\"keywords\":[\"magazine\"],\"articleSection\":[\"Regulatory affairs\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/regulatory-affairs\\\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance\",\"url\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/regulatory-affairs\\\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance\",\"name\":\"SSCP under MDR: the key document to communicate safety and performance. - Clariscience\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/regulatory-affairs\\\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/regulatory-affairs\\\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/clariscience.com\\\/wp-content\\\/uploads\\\/2025\\\/10\\\/611_Q_SSCP-il-documento-che-rende-visibile-la-sicurezza-di-un-dispositivo-medico.jpg\",\"datePublished\":\"2025-10-27T15:34:36+00:00\",\"dateModified\":\"2026-04-24T04:37:50+00:00\",\"description\":\"Learn how to draft a compliant SSCP under MDR for class III and implantable medical devices. Ensure clarity, readability, and regulatory alignment with expert guidance.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/regulatory-affairs\\\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/regulatory-affairs\\\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/regulatory-affairs\\\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance#primaryimage\",\"url\":\"https:\\\/\\\/clariscience.com\\\/wp-content\\\/uploads\\\/2025\\\/10\\\/611_Q_SSCP-il-documento-che-rende-visibile-la-sicurezza-di-un-dispositivo-medico.jpg\",\"contentUrl\":\"https:\\\/\\\/clariscience.com\\\/wp-content\\\/uploads\\\/2025\\\/10\\\/611_Q_SSCP-il-documento-che-rende-visibile-la-sicurezza-di-un-dispositivo-medico.jpg\",\"width\":800,\"height\":800},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/regulatory-affairs\\\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/clariscience.com\\\/en\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"SSCP under MDR: the key document to communicate safety and performance.\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/clariscience.com\\\/en#website\",\"url\":\"https:\\\/\\\/clariscience.com\\\/en\",\"name\":\"Clariscience\",\"description\":\"Regulatory affairs, quality assurance, medical writing and communication\",\"publisher\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/clariscience.com\\\/en?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/clariscience.com\\\/en#organization\",\"name\":\"Clariscience Srl\",\"url\":\"https:\\\/\\\/clariscience.com\\\/en\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/clariscience.com\\\/en#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/clariscience.com\\\/wp-content\\\/uploads\\\/2019\\\/04\\\/logo-clariscience.svg\",\"contentUrl\":\"https:\\\/\\\/clariscience.com\\\/wp-content\\\/uploads\\\/2019\\\/04\\\/logo-clariscience.svg\",\"width\":1,\"height\":1,\"caption\":\"Clariscience Srl\"},\"image\":{\"@id\":\"https:\\\/\\\/clariscience.com\\\/en#\\\/schema\\\/logo\\\/image\\\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/clariscience.com\\\/en#\\\/schema\\\/person\\\/e067e66e7c6a06206df99e5aa3d4f32a\",\"name\":\"Valentina Tomaello\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/clariscience.com\\\/wp-content\\\/uploads\\\/2022\\\/06\\\/Valentina-Tomaello_MW-and-Scientific-Communication-Coordinator-96x96.jpg\",\"url\":\"https:\\\/\\\/clariscience.com\\\/wp-content\\\/uploads\\\/2022\\\/06\\\/Valentina-Tomaello_MW-and-Scientific-Communication-Coordinator-96x96.jpg\",\"contentUrl\":\"https:\\\/\\\/clariscience.com\\\/wp-content\\\/uploads\\\/2022\\\/06\\\/Valentina-Tomaello_MW-and-Scientific-Communication-Coordinator-96x96.jpg\",\"caption\":\"Valentina Tomaello\"},\"description\":\"Medical Writing &amp; Scientific Communication Coordinator\",\"url\":\"https:\\\/\\\/clariscience.com\\\/en\\\/blog\\\/author\\\/valentina-tomaello\"}]}<\/script>","yoast_head_json":{"title":"SSCP under MDR: the key document to communicate safety and performance. - Clariscience","description":"Learn how to draft a compliant SSCP under MDR for class III and implantable medical devices. Ensure clarity, readability, and regulatory alignment with expert guidance.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/clariscience.com\/en\/blog\/regulatory-affairs\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance","og_locale":"en_US","og_type":"article","og_title":"SSCP under MDR: the key document to communicate safety and performance. - Clariscience","og_description":"Learn how to draft a compliant SSCP under MDR for class III and implantable medical devices. Ensure clarity, readability, and regulatory alignment with expert guidance.","og_url":"https:\/\/clariscience.com\/en\/blog\/regulatory-affairs\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance","og_site_name":"Clariscience","article_published_time":"2025-10-27T15:34:36+00:00","article_modified_time":"2026-04-24T04:37:50+00:00","og_image":[{"width":800,"height":800,"url":"https:\/\/clariscience.com\/wp-content\/uploads\/2025\/10\/611_Q_SSCP-il-documento-che-rende-visibile-la-sicurezza-di-un-dispositivo-medico.jpg","type":"image\/jpeg"}],"author":"Valentina Tomaello","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Valentina Tomaello","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/clariscience.com\/en\/blog\/regulatory-affairs\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance#article","isPartOf":{"@id":"https:\/\/clariscience.com\/en\/blog\/regulatory-affairs\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance"},"author":{"name":"Valentina Tomaello","@id":"https:\/\/clariscience.com\/en#\/schema\/person\/e067e66e7c6a06206df99e5aa3d4f32a"},"headline":"SSCP under MDR: the key document to communicate safety and performance.","datePublished":"2025-10-27T15:34:36+00:00","dateModified":"2026-04-24T04:37:50+00:00","mainEntityOfPage":{"@id":"https:\/\/clariscience.com\/en\/blog\/regulatory-affairs\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance"},"wordCount":424,"publisher":{"@id":"https:\/\/clariscience.com\/en#organization"},"image":{"@id":"https:\/\/clariscience.com\/en\/blog\/regulatory-affairs\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance#primaryimage"},"thumbnailUrl":"https:\/\/clariscience.com\/wp-content\/uploads\/2025\/10\/611_Q_SSCP-il-documento-che-rende-visibile-la-sicurezza-di-un-dispositivo-medico.jpg","keywords":["magazine"],"articleSection":["Regulatory affairs"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/clariscience.com\/en\/blog\/regulatory-affairs\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance","url":"https:\/\/clariscience.com\/en\/blog\/regulatory-affairs\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance","name":"SSCP under MDR: the key document to communicate safety and performance. - Clariscience","isPartOf":{"@id":"https:\/\/clariscience.com\/en#website"},"primaryImageOfPage":{"@id":"https:\/\/clariscience.com\/en\/blog\/regulatory-affairs\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance#primaryimage"},"image":{"@id":"https:\/\/clariscience.com\/en\/blog\/regulatory-affairs\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance#primaryimage"},"thumbnailUrl":"https:\/\/clariscience.com\/wp-content\/uploads\/2025\/10\/611_Q_SSCP-il-documento-che-rende-visibile-la-sicurezza-di-un-dispositivo-medico.jpg","datePublished":"2025-10-27T15:34:36+00:00","dateModified":"2026-04-24T04:37:50+00:00","description":"Learn how to draft a compliant SSCP under MDR for class III and implantable medical devices. Ensure clarity, readability, and regulatory alignment with expert guidance.","breadcrumb":{"@id":"https:\/\/clariscience.com\/en\/blog\/regulatory-affairs\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/clariscience.com\/en\/blog\/regulatory-affairs\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/clariscience.com\/en\/blog\/regulatory-affairs\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance#primaryimage","url":"https:\/\/clariscience.com\/wp-content\/uploads\/2025\/10\/611_Q_SSCP-il-documento-che-rende-visibile-la-sicurezza-di-un-dispositivo-medico.jpg","contentUrl":"https:\/\/clariscience.com\/wp-content\/uploads\/2025\/10\/611_Q_SSCP-il-documento-che-rende-visibile-la-sicurezza-di-un-dispositivo-medico.jpg","width":800,"height":800},{"@type":"BreadcrumbList","@id":"https:\/\/clariscience.com\/en\/blog\/regulatory-affairs\/sscp-under-mdr-the-key-document-to-communicate-safety-and-performance#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/clariscience.com\/en"},{"@type":"ListItem","position":2,"name":"SSCP under MDR: the key document to communicate safety and performance."}]},{"@type":"WebSite","@id":"https:\/\/clariscience.com\/en#website","url":"https:\/\/clariscience.com\/en","name":"Clariscience","description":"Regulatory affairs, quality assurance, medical writing and communication","publisher":{"@id":"https:\/\/clariscience.com\/en#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/clariscience.com\/en?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/clariscience.com\/en#organization","name":"Clariscience Srl","url":"https:\/\/clariscience.com\/en","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/clariscience.com\/en#\/schema\/logo\/image\/","url":"https:\/\/clariscience.com\/wp-content\/uploads\/2019\/04\/logo-clariscience.svg","contentUrl":"https:\/\/clariscience.com\/wp-content\/uploads\/2019\/04\/logo-clariscience.svg","width":1,"height":1,"caption":"Clariscience Srl"},"image":{"@id":"https:\/\/clariscience.com\/en#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/clariscience.com\/en#\/schema\/person\/e067e66e7c6a06206df99e5aa3d4f32a","name":"Valentina Tomaello","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/clariscience.com\/wp-content\/uploads\/2022\/06\/Valentina-Tomaello_MW-and-Scientific-Communication-Coordinator-96x96.jpg","url":"https:\/\/clariscience.com\/wp-content\/uploads\/2022\/06\/Valentina-Tomaello_MW-and-Scientific-Communication-Coordinator-96x96.jpg","contentUrl":"https:\/\/clariscience.com\/wp-content\/uploads\/2022\/06\/Valentina-Tomaello_MW-and-Scientific-Communication-Coordinator-96x96.jpg","caption":"Valentina Tomaello"},"description":"Medical Writing &amp; Scientific Communication Coordinator","url":"https:\/\/clariscience.com\/en\/blog\/author\/valentina-tomaello"}]}},"_links":{"self":[{"href":"https:\/\/clariscience.com\/en\/wp-json\/wp\/v2\/posts\/55690","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clariscience.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/clariscience.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/clariscience.com\/en\/wp-json\/wp\/v2\/users\/94"}],"replies":[{"embeddable":true,"href":"https:\/\/clariscience.com\/en\/wp-json\/wp\/v2\/comments?post=55690"}],"version-history":[{"count":1,"href":"https:\/\/clariscience.com\/en\/wp-json\/wp\/v2\/posts\/55690\/revisions"}],"predecessor-version":[{"id":57741,"href":"https:\/\/clariscience.com\/en\/wp-json\/wp\/v2\/posts\/55690\/revisions\/57741"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/clariscience.com\/en\/wp-json\/wp\/v2\/media\/55617"}],"wp:attachment":[{"href":"https:\/\/clariscience.com\/en\/wp-json\/wp\/v2\/media?parent=55690"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/clariscience.com\/en\/wp-json\/wp\/v2\/categories?post=55690"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clariscience.com\/en\/wp-json\/wp\/v2\/tags?post=55690"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}