{"id":20880,"date":"2022-05-02T15:22:44","date_gmt":"2022-05-02T13:22:44","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=20880"},"modified":"2022-09-12T11:52:01","modified_gmt":"2022-09-12T09:52:01","slug":"mdcg-2019-9-guidance-on-the-summary-of-safety-and-clinical-performance-updated","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2022\/05\/02\/mdcg-2019-9-guidance-on-the-summary-of-safety-and-clinical-performance-updated\/","title":{"rendered":"MDCG 2019-9 guidance on the Summary of Safety and Clinical Performance updated"},"content":{"rendered":"\r\n<p>The Medical Device Coordination Group (<strong>MDCG<\/strong>) on 24 March 2022 released the updated guidelines on <strong>the Summary of Safety and Clinical Performance updated (SSCP) <\/strong>for <strong>Manufacturers and Notified Bodies<\/strong>. It is the Revision 1 of the MDCG 2019-9 paper \u201cSummary of Safety and Clinical Performance: a guide for manufacturers and notified bodies\u201d applicable to implantable or class III devices.<\/p>\r\n\r\n\r\n\r\n<figure class=\"wp-block-image\"><img decoding=\"async\" class=\"wp-image-20868\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/04\/revisione-mdcg-2019-9-sicurezza-prestazioni-cliniche-dispositivi-medici-sscp-1024x536.jpg\" alt=\"MDCG 2019-9 guidance on the Summary of Safety and Clinical Performance updated\" \/>\r\n<figcaption>MDCG 2019-9 guidance on the Summary of Safety and Clinical Performance updated<\/figcaption>\r\n<\/figure>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>Why is it important to elaborate a Summary of Safety and Clinical Performance updated (SSCP)?<\/strong><\/h2>\r\n\r\n\r\n\r\n<p>The SSCP\u2019s goal is to provide the public and interested parties, such as healthcare professionals and patients, with an up-to-date summary of clinical data and other relevant information on the safety and clinical performance of the device.<\/p>\r\n\r\n\r\n\r\n<p>Therefore, SSCP is an important source of information for users because it allows to improve transparency and to provide adequate access to information.<\/p>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>What aspect of MDR was clarified by the guidance?<\/strong><\/h2>\r\n\r\n\r\n\r\n<p>As you know, as pointed put by the <strong>MDR (EU) 2017\/745<\/strong> Regulation, the Manufacturer must elaborate and provide a <strong>Summary of Safety and Clinical Performance updated (SSCP) <\/strong>for<strong> implantable<\/strong> and <strong>class III<\/strong> <strong>Medical Devices<\/strong>. The SSCP paper must be validated by a <strong>Notified Body (NB)<\/strong> and made available for the public through the European Medical Devices database <strong>EUDAMED<\/strong>.<\/p>\r\n\r\n\r\n\r\n<p>With Rev.1 from MDCG 2019-9 guidance, in just one section (<strong>3.1<\/strong>) it is clarified how to associate <strong>SSCP<\/strong> with the Basic UDI-DI in <strong>EUDAMED<\/strong>.<\/p>\r\n\r\n\r\n\r\n<p>In particular, the guideline states that the Summary must be associated with one or more Basic UDI-DIs in the case of a single device, whereas if the product is a <strong>system<\/strong> composed of several devices &#8211; whereby not only the system, but also each component has its own Basic UDI-DI &#8211; it is the Basic UDI-DI for the system that must be associated with SSCP in EUDAMED.<\/p>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>Are you a Manufacturer of implantable or class III medical devices and need support in drafting SSCP?<\/strong><\/h2>\r\n\r\n\r\n\r\n<p>Thema experts can provide you with specific support, until you obtain the EU Certificate for your Medical Devices.<\/p>\r\n\r\n\r\n\r\n<p><a href=\"mailto:sales@thema-med.com\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Contact our Customer Service (si apre in una nuova scheda)\">Contact our <\/a><strong><a href=\"mailto:sales@thema-med.com\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Contact our Customer Service (si apre in una nuova scheda)\">Customer Service<\/a><\/strong> for more information.<\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>The Medical Device Coordination Group (MDCG) on 24 March 2022 released the updated guidelines on the Summary of Safety and Clinical  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":21568,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-20880","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>MDCG guidance on the Summary of Safety and Clinical Performance updated<\/title>\n<meta name=\"description\" content=\"MDCG released the updated guidelines on the Summary of Safety and Clinical Performance updated (SSCP) for Manufacturers and Notified Bodies\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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