{"id":9741,"date":"2019-06-12T09:38:03","date_gmt":"2019-06-12T07:38:03","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=9741"},"modified":"2019-06-12T09:38:03","modified_gmt":"2019-06-12T07:38:03","slug":"what-is-the-difference-between-market-surveillance-post-market-surveillance-pms-and-vigilance","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2019\/06\/12\/what-is-the-difference-between-market-surveillance-post-market-surveillance-pms-and-vigilance\/","title":{"rendered":"What is the difference between market surveillance, post-market surveillance (PMS) and vigilance?"},"content":{"rendered":"\n<p>The &#8220;<strong>market surveillance<\/strong>&#8221; (performed\nby the Competent Authority) is the set of activities carried out and the\nmeasures taken to verify and guarantee that the devices are compliant with MDR\n(Art. 93) and IVDR (Art. 88). The ultimate goal is to ensure that devices\nplaced on the market do not endanger health and safety.<\/p>\n\n\n\n<p>&#8220;<strong>Post-market surveillance<\/strong>&#8221;\n(PMS, performed by the Manufacturer) is a proactive and systematic process,\ndesigned to monitor the performance of a medical device by collecting and\nanalyzing information relating to its use in the field (Ref. Art. 83 of MDR and\nArt. 78 of IVDR). An integral part of the Quality Management System (QMS)\nprocess, the PMS is based on a <strong>PMS plan<\/strong> and is carried out in\ncollaboration with other economic operators.<\/p>\n\n\n\n<p>Finally, &#8220;<strong>vigilance<\/strong>&#8221; (performed\nby the Manufacturer, the Authorised Representative EU REP and the competent\nAuthority) is a reactive process and consists in reporting serious\nincidents and field safety corrective actions (FSCA) to the Competent\nAuthorities involved. Both MDR (Art. 87), and IVDR (Art. 82) describe the\nrequirements for this process, as well as the established deadlines for reporting\nbased on the seriousness of the serious incident. Manufacturers must also\nreport side effects trends, as well as trends of expected unwanted accidents\nthat are not classified as serious.<\/p>\n\n\n\n<p style=\"background-color:#0099aa;text-align:center\" class=\"has-text-color has-background has-very-light-gray-color\">Questions? Request more info from our specialists&nbsp;<br><a rel=\"noreferrer noopener\" href=\"http:\/\/www.thema-med.com\/en\/contact-us-2\/\" target=\"_blank\">CONTACT US<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The &#8220;market surveillance&#8221; (performed by the Competent Authority) is the set of activities carried out and the measures taken to verify  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"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":[892,1554],"tags":[],"class_list":["post-9741","post","type-post","status-publish","format-standard","hentry","category-faq-en","category-mdr-impact-ce-mdd-certificates-period-of-grace"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>What is the difference between market surveillance, post-market surveillance (PMS) and vigilance? 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