[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-253970-105":53,"doc-detail-253970-en":126},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":119,"head_meta":121,"extra_data":123,"updated_unix":125},105,"en","gmed-guide-medical-devices-clinical-evaluation-summary-of-safety-and-clinical-performance-sscp-regulation-eu-2017745-march-2022-edition","GMED Guide - Medical Devices Clinical Evaluation - Summary of Safety and Clinical Performance (SSCP) Regulation (EU) 2017/745 - March 2022 Edition","","GMED’s guide explains key regulatory concepts for medical devices clinical evaluation under the EU 2017/745 framework, centered on the Summary of Safety and Clinical Performance (SSCP). It consolidates reference materials, including EU regulations and MDCG/MEDDEV guidance, and provides definitions such as bias, clinical data, clinical evaluation, and clinical evidence. It supports manufacturers and notified bodies by structuring the clinical evaluation approach, including principles, equivalence, and planning outputs like the Clinical Evaluation Report (CER).",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":51,"@type":70,"position":76},"https://docshare.wps.com/template/general/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/gmed-guide-medical-devices-clinical-evaluation-summary-of-safety-and-clinical-performance-sscp-regulation-eu-2017745-march-2022-edition/253970/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/gmed-guide-medical-devices-clinical-evaluation-summary-of-safety-and-clinical-performance-sscp-regulation-eu-2017745-march-2022-edition/253970.png","ImageObject",442,249,{"name":88,"@type":89},"Berry Peter","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-09-20","2026-09-13",true,{"@type":98,"interactionType":99,"userInteractionCount":79},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What is bias in the context of medical device clinical evaluation?","Question",{"text":108,"@type":109},"Bias is a systematic deviation of an outcome measure from its true value, which can overestimate or underestimate a treatment effect. It can come from patient allocation, outcome measurement/interpretation, and data recording/reporting practices.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"What qualifies as clinical data for medical device evaluation?",{"text":113,"@type":109},"Clinical data includes safety or performance information generated from device use, sourced from clinical investigations, scientific literature where equivalence can be demonstrated, peer-reviewed reports on relevant clinical experience, and clinically relevant post-market surveillance data, especially post-market clinical follow-up.",{"name":115,"@type":106,"acceptedAnswer":116},"How is clinical evaluation defined under EU 2017/745?",{"text":117,"@type":109},"Clinical evaluation is a systematic and planned process that continuously generates, collects, analyzes, and assesses clinical data to verify device safety and performance, including clinical benefits, when used as intended by the manufacturer.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},253970,1789272417,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":50,"category_name":51,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":79,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":135,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":125,"read_time":140},1374402524268,"https://ap-avatar.wpscdn.com/davatar_3d24733baf745e90a7e4bdd5f77d97b2","GUIDE  \nMEDICAL DEVICES CLINICAL EVALUATION  \nSUMMARY OF SAFETY AND CLINICAL PERFORMANCE (SSCP) REGULATION (EU) 2017/745  \nMARCH 2022 EDITION  \nGMED property document-720 RDM 0801-8a Rev 4 of 07/03/2022  \nMEDICAL DEVICES CLINICAL EVALUATION  \nSUMMARY OF SAFETY AND CLINICAL PERFORMANCE (SSCP) REGULATION (EU) 2017/745  \nMARCH 2022 EDITION  \nCONTENTS  \nI REFERENCE DOCUMENTS 3  \nII DEFINITIONS 4  \nIII PART A: CLINICAL EVALUATION 6  \n1 Principles of clinical evaluation 6  \n2 Equivalence 11  \n3 Clinical evaluation plan 14  \n4 Clinical Evaluation Report (CER) 15  \nIV  \nPART B: SUMMARY OF SAFETY AND CLINICAL PERFORMANCE  \n24  \nANNEX 1 25  \nGMED property document-720 RDM 0801-8a Rev 4 of 07/03/2022  \nMARCH 2022 EDITION  \nMEDICAL DEVICES CLINICAL EVALUATION  \nSUMMARY OF SAFETY AND CLINICAL PERFORMANCE (SSCP) REGULATION (EU) 2017/745  \nI REFERENCE DOCUMENTS  \nNOTE  \nThe European Regulation is published in the Official Journal of the European Union. MEDDEV guidelines are available on the European Commission website:  \n[https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en](https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en)[ ](https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en)[MDCG guidelines are available on the European Commission website:](MDCG guidelines are available on the European Commission website:)[ ](MDCG guidelines are available on the European Commission website:)[https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en](https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en)[ ](https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en)[Standards are available at AFNOR www.afnor.org](Standards are available at AFNOR www.afnor.org)  \nGHTF (Global Harmonization Task Force) guidelines are available on the following website: [http://www.imdrf.org/documents/documents.asp](http://www.imdrf.org/documents/documents.asp)  \nGMED property document-720 RDM 0801-8a Rev 4 of 07/03/2022  \n| ORIGIN | REFERENCE | TITLE |\n| --- | --- | --- |\n| European\u003Cbr>Union | Regulation (EU) 2017/745 | Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC |\n| European Union | MEDDEV 2.7/1 rev.4 | Evaluation of clinical data: a guide for manufacturers and notified bodies |\n| European Union | MEDDEV 2.12/2 rev.2 | Guidelines on post-market clinical follow-up |\n| CEN-ISO | NF EN ISO 13485: 2016 | Medical devices\u003Cbr>Quality management systems – Requirements for regulatory purposes |\n| CEN-ISO | NF EN ISO 14971: 2013 | Medical devices – Application of risk management to medical devices. |\n| CEN-ISO | NF EN ISO 14155: 2012 | Clinical investigation of medical devices for human subjects |\n| GHTF | SG5/N1R8 (2007) | Clinical Evidence – Key definitions and concepts |\n| GHTF | SG5/N2R8 (2007) | Clinical Evaluation |\n| MDCG | MDCG 2019-9 | Summary of safety and clinical performance\u003Cbr>A guide for manufacturers and notified bodies |\n| MDCG | MDCG 2020-1 | Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software |\n| MDCG | MDCG 2020-5 | Clinical evaluation – Equivalence\u003Cbr>A guide for manufacturers and notified bodies |\n| MDCG | MDCG 2020-6 | Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EECA guide for manufacturers and notified bodies |\n| MDCG | MDCG 2020-7 | Post-market clinical follow-up (PMCF) Plan Template\u003Cbr>A guide for manufacturers and notified bodies |\n| MDCG | MDCG 2020-8 | Post-market clinical follow-up (PMCF) Evaluation Report Template A guide for manufacturers and notified bodies |\n| MDCG | MDCG 2020-13 | Clinical evaluation assessment report template |\n| MDCG | MDCG 2021-20 |","cbCaidq15leB3TKF","https://ap.wps.com/l/cbCaidq15leB3TKF","pdf",2677475,26,"English","# Contents\n## I Reference documents\n## II Definitions\n## III Part A: Clinical evaluation\n## IV Part B: Summary of safety and clinical performance\n## Annex 1","[{\"question\":\"What is bias in the context of medical device clinical evaluation?\",\"answer\":\"Bias is a systematic deviation of an outcome measure from its true value, which can overestimate or underestimate a treatment effect. It can come from patient allocation, outcome measurement/interpretation, and data recording/reporting practices.\"},{\"question\":\"What qualifies as clinical data for medical device evaluation?\",\"answer\":\"Clinical data includes safety or performance information generated from device use, sourced from clinical investigations, scientific literature where equivalence can be demonstrated, peer-reviewed reports on relevant clinical experience, and clinically relevant post-market surveillance data, especially post-market clinical follow-up.\"},{\"question\":\"How is clinical evaluation defined under EU 2017/745?\",\"answer\":\"Clinical evaluation is a systematic and planned process that continuously generates, collects, analyzes, and assesses clinical data to verify device safety and performance, including clinical benefits, when used as intended by the manufacturer.\"}]","GMED Guide - Medical Devices Clinical Evaluation - Summary of Safety and Clinical Performance (SSCP) Regulation (EU) 2017/745 - March 2022 Edition | PDF",9]