{"id":798,"date":"2023-07-03T10:13:56","date_gmt":"2023-07-03T09:13:56","guid":{"rendered":"https:\/\/www.alims.gov.rs\/english\/?page_id=798"},"modified":"2023-07-21T12:01:27","modified_gmt":"2023-07-21T11:01:27","slug":"surveillance","status":"publish","type":"page","link":"https:\/\/www.alims.gov.rs\/english\/surveillance\/","title":{"rendered":"Surveillance"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_4 1_4 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:25%;--awb-margin-top-large:0px;--awb-spacing-right-large:7.68%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:7.68%;--awb-width-medium:25%;--awb-order-medium:0;--awb-spacing-right-medium:7.68%;--awb-spacing-left-medium:7.68%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\" style=\"--awb-font-size:16px;--awb-text-transform:none;--awb-text-color:var(--awb-color1);--awb-text-font-family:&quot;Source Sans Pro&quot;;--awb-text-font-style:normal;--awb-text-font-weight:700;\" id=\"navigacija_naslov\"><p>Medical devices<\/p>\n<\/div><nav class=\"awb-menu awb-menu_column awb-menu_em-hover mobile-mode-collapse-to-button awb-menu_icons-left awb-menu_dc-yes mobile-trigger-fullwidth-off awb-menu_mobile-toggle awb-menu_indent-left mobile-size-full-absolute loading mega-menu-loading awb-menu_desktop awb-menu_dropdown awb-menu_expand-right awb-menu_transition-fade\" style=\"--awb-font-size:14px;--awb-items-padding-bottom:0.5em;--awb-color:#0d4873;--awb-active-color:#0d4873;--awb-main-justify-content:flex-start;--awb-mobile-justify:flex-start;--awb-mobile-caret-left:auto;--awb-mobile-caret-right:0;--awb-fusion-font-family-typography:&quot;Source Sans Pro&quot;;--awb-fusion-font-style-typography:normal;--awb-fusion-font-weight-typography:700;--awb-fusion-font-family-submenu-typography:inherit;--awb-fusion-font-style-submenu-typography:normal;--awb-fusion-font-weight-submenu-typography:400;--awb-fusion-font-family-mobile-typography:inherit;--awb-fusion-font-style-mobile-typography:normal;--awb-fusion-font-weight-mobile-typography:400;\" aria-label=\"meni_med_sredstva\" data-breakpoint=\"1024\" data-count=\"0\" data-transition-type=\"fade\" data-transition-time=\"300\"><button type=\"button\" class=\"awb-menu__m-toggle awb-menu__m-toggle_no-text\" aria-expanded=\"false\" aria-controls=\"menu-meni_med_sredstva\"><span class=\"awb-menu__m-toggle-inner\"><span class=\"collapsed-nav-text\"><span class=\"screen-reader-text\">Toggle Navigation<\/span><\/span><span class=\"awb-menu__m-collapse-icon awb-menu__m-collapse-icon_no-text\"><span class=\"awb-menu__m-collapse-icon-open awb-menu__m-collapse-icon-open_no-text fa-bars fas\"><\/span><span class=\"awb-menu__m-collapse-icon-close awb-menu__m-collapse-icon-close_no-text fa-times fas\"><\/span><\/span><\/span><\/button><ul id=\"menu-meni_med_sredstva\" class=\"fusion-menu awb-menu__main-ul awb-menu__main-ul_column\"><li  id=\"menu-item-279\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-279 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"279\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medical-devices\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Medical devices<\/span><\/a><\/li><li  id=\"menu-item-283\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-283 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"283\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medical-devices\/registration-in-the-register-of-medical-devices\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Registration in the Register of Medical Devices<\/span><\/a><\/li><li  id=\"menu-item-289\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-289 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"289\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medical-devices\/expert-opinions\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Expert opinions<\/span><\/a><\/li><li  id=\"menu-item-806\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-806 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"806\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/a-group-of-generic-medicinal-products\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">A group of generic medicinal products<\/span><\/a><\/li><li  id=\"menu-item-807\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-807 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"807\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/advertising-of-medical-devices\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Advertising of medical devices<\/span><\/a><\/li><li  id=\"menu-item-808\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-808 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"808\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/turnover-and-consumption-of-medical-supplies\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Turnover and consumption of medical supplies<\/span><\/a><\/li><li  id=\"menu-item-286\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-286 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"286\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medical-devices\/clinical-trials\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Clinical Trials<\/span><\/a><\/li><li  id=\"menu-item-292\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-292 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"292\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medical-devices\/medical-devices-vigilance\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Medical Devices Vigilance<\/span><\/a><\/li><li  id=\"menu-item-809\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-809 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"809\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/reporting-an-adverse-reaction-to-a-medical-device-incident\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Reporting an adverse reaction to a medical device (INCIDENT)<\/span><\/a><\/li><li  id=\"menu-item-810\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-810 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"810\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/surveillance\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Surveillance<\/span><\/a><\/li><li  id=\"menu-item-295\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-295 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"295\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medical-devices\/complaints\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Complaints<\/span><\/a><\/li><li  id=\"menu-item-297\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-297 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"297\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medical-devices\/search-for-medical-devices\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Search for medical devices<\/span><\/a><\/li><li  id=\"menu-item-299\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-299 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"299\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medical-devices\/search-for-veterinary-medical-devices\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Search for veterinary medical devices<\/span><\/a><\/li><li  id=\"menu-item-306\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-306 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"306\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medical-devices\/search-for-medical-device-manufacturers\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Search for medical device manufacturers<\/span><\/a><\/li><li  id=\"menu-item-304\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-304 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"304\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medical-devices\/search-for-authorized-representatives-of-medical-device-manufacturers\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Search for authorized representatives of medical device manufacturers<\/span><\/a><\/li><li  id=\"menu-item-811\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-811 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"811\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/important-notices\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Important notices<\/span><\/a><\/li><\/ul><\/nav><\/div><\/div>\n<div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_3_4 3_4 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:75%;--awb-margin-top-large:0px;--awb-spacing-right-large:2.56%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:2.56%;--awb-width-medium:75%;--awb-order-medium:0;--awb-spacing-right-medium:2.56%;--awb-spacing-left-medium:2.56%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><nav class=\"fusion-breadcrumbs fusion-breadcrumbs-1\" style=\"--awb-breadcrumb-sep:&#039;\/&#039;;\" aria-label=\"Breadcrumb\"><ol class=\"awb-breadcrumb-list\"><li class=\"fusion-breadcrumb-item awb-breadcrumb-sep\" ><a href=\"https:\/\/www.alims.gov.rs\/english\" class=\"fusion-breadcrumb-link\"><span >Home<\/span><\/a><\/li><\/ol><\/nav><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-text fusion-title-size-one\"><h1 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;\">Surveillance<\/h1><\/div><div class=\"fusion-text fusion-text-2\"><p>Surveillance of medical devices in the market includes post market surveillance and market surveillance.<\/p>\n<p>The regulations in the field of &#8220;surveillance&#8221; of medical devices relies on the EU regulation, that is, on European directives (98\/79 EC, 93\/42 EEC, 98\/385 EEC) or on new EU regulations (\u201c(EU) 2017\/745\u201d\/ \u201c(EU) 2017\/746\u201d).<br \/>\nPost market surveillance means all activities carried out by the manufacturer, i.e. the manufacturer&#8217;s authorized representative, which establishes and maintains a systematic procedure for proactive collection and evaluation of experiences related to the medical device that has been marketed or used. , for the purpose of identifying any need to apply all necessary corrective and preventive measures without delay.<\/p>\n<p>Market surveillance means the activities carried out and the measures taken by the Ministry and the Medicines and Medical Devices Agency of Serbia in order to check and ensure that medical devices comply with the basic requirements, as well as that they do not endanger health, safety or any another aspect of protecting the general interest.<\/p>\n<p>The manufacturer, or the manufacturer\u2019s authorized representative, is obliged to continuously monitor the medical device on the market in order to identify any need to immediately apply all necessary corrective or preventive measures. The manufacturer, i.e. the manufacturer&#8217;s authorized representative, keeps records of implemented corrective and preventive measures and is obliged to report the Agency thereof.<\/p>\n<p>The Agency provides, organizes, and coordinates the collection and analysis of data obtained after a medical device has been marketed. The Agency may require the manufacturer, or the manufacturer&#8217;s authorized representative, to submit a reasoned and evidence-based report on the experiences related to the marketed medical device.<br \/>\nIn connection with the market surveillance of the medical device, two types of reports are submitted to the Agency:<\/p>\n<p>1. Post-Market Surveillance Report (PMSR)- The manufacturer of class I medical device (except Is, Im, Ir) and class Other In vitro diagnostic medical devices (Other IVD), i.e. in vitro diagnostic medical devices of class A, compiles a Post-Market Surveillance Report (PMSR) in which it summarizes the results and conclusions of the analysis of the post-market surveillance data collected as a result of the post-market surveillance plan, which contains an explanation and description of all taken preventive and corrective measures. The report is updated as necessary and is submitted to the Agency upon request.<\/p>\n<p>2. Periodic Safety Update Report (PSUR)<\/p>\n<p>The Manufacturer of Class Is, Im, Ir, Iia, Iib, III Medical Device, Active Implantable Medical Devices (AIMD), In Vitro Diagnostic Medical Devices Class: List A, List B, Self-Test and In Vitro Diagnostic Medical Devices of Class B, Class C and class D shall draw up a Periodic Safety Update Report (PSUR) for each medical device and, if relevant, for each category or group of medical devices, in which it summarizes the results and conclusions of the analysis of post-market surveillance data collected as a result of the post-market surveillance plan, containing an explanation and description of all taken preventive and corrective measures taken.<\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-798","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/798","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/comments?post=798"}],"version-history":[{"count":4,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/798\/revisions"}],"predecessor-version":[{"id":830,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/798\/revisions\/830"}],"wp:attachment":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/media?parent=798"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}