{"id":7516,"date":"2022-11-24T12:55:38","date_gmt":"2022-11-24T12:55:38","guid":{"rendered":"https:\/\/cinmed.me\/medicinska-sredstva\/viliganca\/"},"modified":"2023-02-24T09:38:27","modified_gmt":"2023-02-24T09:38:27","slug":"vigilance","status":"publish","type":"page","link":"https:\/\/cinmed.me\/en\/medical-devices\/vigilance\/","title":{"rendered":"Vigilance"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7516\" class=\"elementor elementor-7516 elementor-1576\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b1cc3b4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b1cc3b4\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-wider\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-b11a068\" data-id=\"b11a068\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ce4b035 elementor-widget elementor-widget-image\" data-id=\"ce4b035\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"840\" height=\"630\" src=\"https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/MedDevice-840x630-1.jpg\" class=\"attachment-large size-large wp-image-4565\" alt=\"\" srcset=\"https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/MedDevice-840x630-1.jpg 840w, https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/MedDevice-840x630-1-300x225.jpg 300w, https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/MedDevice-840x630-1-768x576.jpg 768w\" sizes=\"(max-width: 840px) 100vw, 840px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8ab3f95 elementor-widget elementor-widget-text-editor\" data-id=\"8ab3f95\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Institute and the manufacturer or the authorized representative shall organize a system of vigilance with the aim of collecting and assessing data related to the safety of use of the medical device as well as other data of importance for estimating the benefit and risk ratio of using the medical device in order to protect the health of the population.<\/p><p>\u00a0<\/p><p>Institute shall provide, organize and coordinate collecting and analysis of the data obtained after medical device is placed on the market, and in particular reporting of incidents. Depending on the results of the incident investigation, the Institute shall provide information to the expert public and, if necessary, the general public, necessary to prevent incidents or to limit their consequences after the placing of medical devices on the market and putting them into service. The Institute may require the manufacturer or its authorized representative to submit a reasoned report on the experience with the medical device on the market.<\/p><p>\u00a0<\/p><p>Healthcare institutions or vigilance coordinators, healthcare professionals, manufacturer or authorized representative, wholesalers, persons involved in the delivery or putting into service of a medical device, as well as persons responsible for the calibration and maintenance of a medical device, shall inform the Institute, without delay, of a medical device incident, as follows:<\/p><p>\u00a0<\/p><ul><li>any malfunction or alteration of the characteristics or performance of a medical device, as<br \/>well as any irregularity in the labelling or instructions for use that have led or may lead to the death of a patient or user or to a serious deterioration in his state of health;<\/li><li>any technical or medical cause related to the performance of the medical device which is the reason for the manufacturer or the authorized representative of the manufacturer to withdraw a medical device of the same type from the market<\/li><\/ul><p>\u00a0<\/p><p>The manufacturer, or the authorized representative, shall continuously monitor the medical device on the market in order to identify the need to immediately apply all the necessary corrective or preventive measures and shall keep records of the corrective and preventive measures implemented and inform the Institute thereof. The manufacturer, or the authorized representative, shall notify the Institute without delay of the initiated safety corrective measure. The manufacturer or the authorized representative shall submit to the notified or designated body that has carried out the conformity assessment information on all changes arising from the system of vigilance, in case these changes affect the conformity of the medical device.<\/p><p>\u00a0<\/p><p>The designated body shall monitor the system of vigilance in terms of the assessment of procedures and verification of the implementation of vigilance procedures, connection with other systems (corrective and preventive measures), assessment of the impact of vigilance on the issued certificates of conformity, and it shall carry out certain investigations, i.e. repeat the conformity assessment of vigilance procedures at the request of the Ministry.<\/p><p>\u00a0<\/p><p><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e1caf8c elementor-widget elementor-widget-heading\" data-id=\"e1caf8c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Instructions and forms <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-91beacc elementor-widget elementor-widget-text-editor\" data-id=\"91beacc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/01\/Obrazac-za-prijavu-nezeljene-reakcije-na-medicinsko-sredstvo_1008.doc\" target=\"_blank\" rel=\"noopener\">Application form for adverse reaction to a medical device reporting for manufacturers and holders of entry into the register<\/a>\u00a0 &#8211;\u00a0 document in Montenegrin<\/li><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2023\/01\/Obrazac-za-prijavu-nezeljenog-dejstva-na-medicinsko-sredstvo-zdravstveni-radnici_2.doc\" target=\"_blank\" rel=\"noopener\">Application form for adverse reaction to a medical device reporting for healthcare professionals<\/a>\u00a0 &#8211;\u00a0 document in Montenegrin<\/li><li><a href=\"https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/Obrazac-za-prijavljivanje-bezbjednosne-korektivne-mjere-FSCA.doc\" target=\"_blank\" rel=\"noopener\">Application form for the notification of Field Safety Corrective Action (FSCA)<\/a> &#8211;\u00a0 document in Montenegrin<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-c99dd92\" data-id=\"c99dd92\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a6d267e elementor-widget elementor-widget-shortcode\" data-id=\"a6d267e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t    <div class=\"sidebar-menu-wrapper\">\r\n        <div class=\"sidebar-menu-header\">\r\n            <img decoding=\"async\" class=\"sidebar-menu-header-icon\" src=\"\/wp-content\/uploads\/2022\/11\/3.png\" \/>\r\n            <P><a class=\"sidebar-menu-header-title\" href=\"\">Medical devices<\/a><\/P>\r\n        <\/div>\r\n        <div class=\"sidebar-items-background\">\r\n            <div class=\"sidebar-items-wrapper\">\r\n                <div class=\"menu-medicinska-sredstva-container\"><ul id=\"menu-medicinska-sredstva\" class=\"list-none\t\"><li id=\"menu-item-7267\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7267 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/medicinska-sredstva\/registracija\/\">Registration<\/a><\/li>\n<li id=\"menu-item-7268\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7268 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/medicinska-sredstva\/promet-na-veliko\/\">Wholesale of medical devices<\/a><\/li>\n<li id=\"menu-item-15734\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-15734 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/medicinska-sredstva\/interventni-uvoz\/\">Emergency import<\/a><\/li>\n<li id=\"menu-item-7269\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7269 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/medicinska-sredstva\/promet-na-malo\/\">Retail sale of medical devices<\/a><\/li>\n<li id=\"menu-item-7270\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7270 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/medicinska-sredstva\/proizvodnja\/\">Manufacturing<\/a><\/li>\n<li id=\"menu-item-15733\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-15733 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/medicinska-sredstva\/registracija-proizvodaca-medicinskih-sredstava-koji-nemaju-sjediste-boravak-prebivaliste-u-crnoj-gori\/\">Registration of manufacturers of medical devices that do not their have headquarters\/temporary-permanent residence in Montenegro<\/a><\/li>\n<li id=\"menu-item-7271\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7271 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/medicinska-sredstva\/oglasavanje\/\">Advertising<\/a><\/li>\n<li id=\"menu-item-7272\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7272 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/medicinska-sredstva\/obiljezavanje\/\">Labelling<\/a><\/li>\n<li id=\"menu-item-7266\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7266 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/medicinska-sredstva\/viliganca\/\">Vigilance<\/a><\/li>\n<li id=\"menu-item-7273\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7273 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/medicinska-sredstva\/klinicko-ispitivanje\/\">Clinical investigation<\/a><\/li>\n<li id=\"menu-item-7276\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-7276 list-none\t ml-3 lg:mx-2 my-4 text-light text-base font-semibold transition hover:text-light-brown\"><a href=\"https:\/\/cinmed.me\/medicinska-sredstva\/registar-medicinskih-sredstava\/\">Register of medical devices<\/a><\/li>\n<\/ul><\/div>            <\/div>\r\n        <\/div>\r\n    <\/div>\r\n\t\t<div class=\"elementor-shortcode\"><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d1b992c elementor-widget elementor-widget-shortcode\" data-id=\"d1b992c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"relative pt-10 rounded bg-primary pb-72\">\n\t<h1 class=\"ml-10 text-4xl text-white \">Search <span class=\"font-bold\">register<\/span><\/h1>\n\t<div class=\"mt-8 \">\n\t\t<h3 class=\"mb-4 ml-10 text-secondary text-medium \">Here you can search for medicines in our register<\/h3>\n\t\t<div class=\"relative inline-block w-4\/5 ml-10 text-left\" style=\"width:80%\">\n\t\t\t<div>\n\t\t\t\t<select onchange=\"javascript:handleSelect(this)\" class=\"block h-[52px] text-[18px] text-light appearance-none w-full bg-white py-3 px-4 pr-8 rounded leading-tight focus:outline-none focus:bg-white focus:border-none\">\n\t\t\t\t\t<option class=\"text-[18px]\" value=\"\">Choose register<\/option>\n\t\t\t\t\t<option class=\"text-[18px]\" value=\"\/en\/register-of-medicines-for-human-use\/\">Register of medicines for human use<\/option>\n\t\t\t\t\t<option class=\"text-[18px]\" value=\"\/en\/register-of-veterinary-medicines\/\">Register of veterinary medicines<\/option>\n\t\t\t\t\t<option class=\"text-[18px]\" value=\"\/en\/medical-devices\/register-of-medical-devices\/\">Register of medical devices<\/option>\n\t\t\t\t<\/select>\n\n\t\t\t\t<script type=\"text\/javascript\">\n\t\t\t\t\tfunction handleSelect(elm) {\n\t\t\t\t\t\twindow.location = elm.value;\n\t\t\t\t\t}\n\t\t\t\t<\/script>\n\t\t\t\t<img decoding=\"async\" style=\"top:22px;\" class=\"absolute right-[15px] top-[22px] \" src=\"\/wp-content\/uploads\/2022\/11\/strelca-copy-8.png\" \/>\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n\t<img decoding=\"async\" class=\"absolute bottom-[30px] w-[380px]\" src=\"\/wp-content\/uploads\/2022\/11\/nele.png\" \/>\n<\/div>\n\n\n<div class=\"relative px-10 pt-10 mt-10 rounded pb-72 bg-light-yellow\">\n\t<div class=\"mt-8 md:mt-0\">\n\t\t<h1 class=\"text-3xl text-primary \">Sign up for<\/h1>\n\t\t<h1 class=\"mb-5 text-3xl font-bold text-primary\">Newsletter<\/h1>\n\t\t  \n  \n  <div class=\"\n    mailpoet_form_popup_overlay\n      \"><\/div>\n  <div\n    id=\"mailpoet_form_1\"\n    class=\"\n      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{#mailpoet_form_1 .mailpoet_form_column:last-child .mailpoet_paragraph:last-child {margin-bottom: 0}} \n    <\/style>\n\n    <form\n      target=\"_self\"\n      method=\"post\"\n      action=\"https:\/\/cinmed.me\/wp-admin\/admin-post.php?action=mailpoet_subscription_form\"\n      class=\"mailpoet_form mailpoet_form_form mailpoet_form_shortcode\"\n      novalidate\n      data-delay=\"\"\n      data-exit-intent-enabled=\"\"\n      data-font-family=\"\"\n      data-cookie-expiration-time=\"\"\n    >\n      <input type=\"hidden\" name=\"data[form_id]\" value=\"1\" \/>\n      <input type=\"hidden\" name=\"token\" value=\"958d2e0085\" \/>\n      <input type=\"hidden\" name=\"api_version\" value=\"v1\" \/>\n      <input type=\"hidden\" name=\"endpoint\" value=\"subscribers\" \/>\n      <input type=\"hidden\" name=\"mailpoet_method\" value=\"subscribe\" \/>\n\n      <label class=\"mailpoet_hp_email_label\" style=\"display: none !important;\">Please leave this field empty<input type=\"email\" 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class=\"mailpoet_bounce2\"><\/span><span class=\"mailpoet_bounce3\"><\/span><\/span><\/div>\n\n      <div class=\"mailpoet_message\">\n        <p class=\"mailpoet_validate_success\"\n                style=\"display:none;\"\n                >Thank you for subscribing!\n        <\/p>\n        <p class=\"mailpoet_validate_error\"\n                style=\"display:none;\"\n                >        <\/p>\n      <\/div>\n    <\/form>\n\n      <\/div>\n\n  \t<\/div>\n\t<img decoding=\"async\" class=\"absolute bottom-0 left-0 w-[380px] \" src=\"\/wp-content\/uploads\/2022\/11\/newsletter.png\" \/>\n<\/div>\t\t<div class=\"elementor-shortcode\"><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Institute and the manufacturer or the authorized representative shall organize a system of vigilance with the aim of collecting and assessing data related to the safety of use of the medical device as well as other data of importance for estimating the benefit and risk ratio of using the medical device in order to protect [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":7507,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"cinmed-template-custom.php","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-7516","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Vigilance - Cinmed<\/title>\n<meta name=\"description\" content=\"Vigilance Institute and the manufacturer or the authorized representative shall organize a system ofvigilance with the aim of collecting and assessing data related to the safety of use of the medicaldevice as well as other data of importance for estimating the benefit and risk ratio of using 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