[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-352616-105":53,"doc-detail-352616-en":127},{"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":120,"head_meta":122,"extra_data":124,"updated_unix":126},105,"en","gmed-newsletter-n20-post-market-surveillance-of-devices-methods-and-types-of-pms-data","GMED Newsletter - N°20 - Post-Market Surveillance of Devices - Methods and Types of PMS Data","","GMED Newsletter N°20 I March 2025 explains post-market surveillance (PMS) as an essential process to ensure the safety and effectiveness of medical devices on the market. It links PMS to the manufacturer quality management system and references MDR (EU) 2017/745 and IVDR (EU) 2017/746, describing strengthened obligations and oversight by competent authorities and notified bodies. The newsletter details PMS data methods (proactive and reactive), reporting and PSUR activities, vigilance requirements, and the impact of incident information on certification decisions.",{"@graph":63,"@context":119},[64,80,102],{"@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":11,"@type":70,"position":76},"https://docshare.wps.com/template/presentations/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/gmed-newsletter-n20-post-market-surveillance-of-devices-methods-and-types-of-pms-data/352616/",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-newsletter-n20-post-market-surveillance-of-devices-methods-and-types-of-pms-data/352616.png","ImageObject",442,249,{"name":88,"@type":89},"Riley","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-27","2026-09-22",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",8,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"What is the purpose of the post-market surveillance (PMS) system?","Question",{"text":109,"@type":110},"PMS ensures the safety and effectiveness of medical devices placed on the market. It supports analysis of collected data to improve products, restore compliance, and inform competent authorities.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"How does the newsletter distinguish proactive vs reactive PMS data?",{"text":114,"@type":110},"Proactive data comes from activities defined and implemented by the manufacturer to collect device information. Reactive data comes from information that passively returns to the manufacturer, including complaints/incidents and audit-related sources.",{"name":116,"@type":107,"acceptedAnswer":117},"What kinds of vigilance reports are mentioned under MDR and IVDR?",{"text":118,"@type":110},"The newsletter lists Manufacturer Incident Report (MIR), Periodic Safety Report (PSR), Trend Report (TR), Field Safety Corrective Action (FSCA), and Field Safety Notice (FSN). 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The manufacturer is then able to detect statistical signals and trends in relation to PMS data.  \nThat information is then used to improve the product, restore compliance, and/or communicate with the competent authorities.  \n\n| EXAMPLES OF PMS DATA TYPES |  |\n| --- | --- |\n| PROACTIVE DATA | REACTIVE DATA |\n| • User feedback (customer surveys, expert opinions);\u003Cbr>• Data from literature;\u003Cbr>• PMCF/PMPF data (registers, studies). | • Audit/inspection data;\u003Cbr>• Quality management system data (NC, CAPA/FSCA, risk management);\u003Cbr>• Data from complaints/incidents (including vigilance). |\n\nB  \nINCREASED VIGILANCE UNDER MDR AND IVDR  \nVigilance under the regulations sets new requirements for all players, especially NBs.  \nVigilance reports must be communicated to the competent authorities, as well as to NBs. This communication to NBs, introduced by the regulations, makes it possible to verify the impact of incidents on the validity of certificates issued, even under one of the directives.  \nThese vigilance reports include the following:  \n• Manufacturer Incident Report (MIR);  \n• Periodic Safety Report (PSR);  \n• Trend Report (TR);  \n• Field Safety Corrective Action (FSCA);  \n• Field Safety Notice (FSN).  \nAccess to notifications of vigilance cases for devices placed on the market enables the NB to make the link with the information collected by other surveillance means (audits and assessments) and to activate, if necessary, additional surveillance measures such as additional or unannounced audits or a documentary review. In the most critical cases, the validity of the certificate  \nmay be called into question. The NB is empowered to restrict, suspend, or withdraw the certificate concerned.  \nThe addition of the notified body as a recipient of vigilance reports helps to limit the risk to the patient and the user, thanks to the control and monitoring actions taken on the manufacturer by the NB.  \nC PSURAND PMS REPORTS  \nThe manufacturer draws up reports summarizing all the data collection activity and the concl","cbCaiq6nOI2Fi8RX","https://ap.wps.com/l/cbCaiq6nOI2Fi8RX","pdf",980166,"English","# Methods and Types of PMS Data\n## Increased Vigilance under MDR and IVDR\n## PSUR and PMS Reports\n## Guides and support documents","[{\"question\":\"What is the purpose of the post-market surveillance (PMS) system?\",\"answer\":\"PMS ensures the safety and effectiveness of medical devices placed on the market. It supports analysis of collected data to improve products, restore compliance, and inform competent authorities.\"},{\"question\":\"How does the newsletter distinguish proactive vs reactive PMS data?\",\"answer\":\"Proactive data comes from activities defined and implemented by the manufacturer to collect device information. Reactive data comes from information that passively returns to the manufacturer, including complaints/incidents and audit-related sources.\"},{\"question\":\"What kinds of vigilance reports are mentioned under MDR and IVDR?\",\"answer\":\"The newsletter lists Manufacturer Incident Report (MIR), Periodic Safety Report (PSR), Trend Report (TR), Field Safety Corrective Action (FSCA), and Field Safety Notice (FSN). It also explains how notified bodies can use these to trigger additional surveillance measures.\"}]","GMED Newsletter - N°20 - Post-Market Surveillance of Devices - Methods and Types of PMS Data | PDF",1790100475]