[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-165718-105":53,"doc-detail-165718-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","manufacturer-periodic-summary-report-psr-for-serious-incidents-mdrivdr-reporting-template-version-12","Manufacturer Periodic Summary Report (PSR) for Serious Incidents (MDR/IVDR) - Reporting Template Version 1.2","","This document provides the Manufacturer Periodic Summary Report (PSR) template for Serious Incidents concerning Medical Devices under MDR/IVDR regulations. Developed by Swissmedic, this template, version 1.2, is designed to guide manufacturers and authorized representatives in reporting significant incidents related to medical devices. The system emphasizes the importance of completing all fields, where contentually possible, except for the \"4.3 analysis update.\" It clarifies that submitting this report does not constitute a final conclusion by the manufacturer, authorized representative, or national competent authority regarding the report's completeness, accuracy, the medical device's failure, or its contribution to any adverse health outcome. Manufacturers are instructed to send the completed report in Word or PDF format via email to materiovigilance@swissmedic.ch. The document aims to standardize and streamline the reporting process for serious incidents, ensuring regulatory compliance and patient safety.",{"@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":36,"@type":70,"position":76},"https://docshare.wps.com/template/forms/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/manufacturer-periodic-summary-report-psr-for-serious-incidents-mdrivdr-reporting-template-version-12/165718/",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/manufacturer-periodic-summary-report-psr-for-serious-incidents-mdrivdr-reporting-template-version-12/165718.png","ImageObject",442,249,{"name":88,"@type":89},"Melati","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-26","2026-08-31",true,{"@type":98,"interactionType":99,"userInteractionCount":47},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What is the purpose of the Manufacturer Periodic Summary Report (PSR)?","Question",{"text":108,"@type":109},"The Manufacturer Periodic Summary Report (PSR) is used for reporting serious incidents related to medical devices under MDR/IVDR regulations, as defined by Swissmedic.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"What is the required format for submitting the PSR?",{"text":113,"@type":109},"The completed report should be submitted as a Word or PDF file to materiovigilance@swissmedic.ch.",{"name":115,"@type":106,"acceptedAnswer":116},"Does submitting the PSR imply a conclusion about the device's failure or accuracy?",{"text":117,"@type":109},"No, submission of the report does not represent a conclusion by the manufacturer or competent authority that the content is complete or accurate, or that the medical device caused or contributed to any alleged adverse event.","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},165718,1788175868,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":35,"category_name":36,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":47,"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":76},962085570644,"https://ap-avatar.wpscdn.com/davatar_994ba38a5ba835b3df7d355c54d3ed8d","Manufacturer Periodic Summary Report (PSR) for Serious Incidents (MDR/IVDR)\nReporting Template Version 1.2\nMedical Devices Vigilance System\nFor initial application Swissmedic expects all the fields in the form to be completed, provided this is possible from a content-related perspective except 4.3 analysis update.\n\u000f\n\u000f\n\u000f\nSubmission of this report does not represent a conclusion by the manufacturer and / or authorised representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person.\nPlease send the completed report as Word or PDF file to \u0013 HYPERLINK \"mailto:materiovigilance@swissmedic.ch\" \u0014materiovigilance@swissmedic.ch\u0015","cbCaiegLvRmsgLOf","https://ap.wps.com/l/cbCaiegLvRmsgLOf","docx",396420,8,"English","# Manufacturer Periodic Summary Report (PSR) for Serious Incidents (MDR/IVDR)\nReporting Template Version 1.2\n## Medical Devices Vigilance System","[{\"question\":\"What is the purpose of the Manufacturer Periodic Summary Report (PSR)?\",\"answer\":\"The Manufacturer Periodic Summary Report (PSR) is used for reporting serious incidents related to medical devices under MDR/IVDR regulations, as defined by Swissmedic.\"},{\"question\":\"What is the required format for submitting the PSR?\",\"answer\":\"The completed report should be submitted as a Word or PDF file to materiovigilance@swissmedic.ch.\"},{\"question\":\"Does submitting the PSR imply a conclusion about the device's failure or accuracy?\",\"answer\":\"No, submission of the report does not represent a conclusion by the manufacturer or competent authority that the content is complete or accurate, or that the medical device caused or contributed to any alleged adverse event.\"}]","Manufacturer Periodic Summary Report (PSR) for Serious Incidents (MDR/IVDR) - Reporting Template Version 1.2 | DOCX"]