{"id":7509,"date":"2022-11-24T14:22:34","date_gmt":"2022-11-24T14:22:34","guid":{"rendered":"https:\/\/cinmed.me\/medicinska-sredstva\/obiljezavanje\/"},"modified":"2023-02-24T09:38:25","modified_gmt":"2023-02-24T09:38:25","slug":"labelling","status":"publish","type":"page","link":"https:\/\/cinmed.me\/en\/medical-devices\/labelling\/","title":{"rendered":"Labelling"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7509\" class=\"elementor elementor-7509 elementor-1620\" 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=\"560\" src=\"https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/MedDevice-X-Ray-840x560-1.jpg\" class=\"attachment-large size-large wp-image-4577\" alt=\"obiljezavanje\" srcset=\"https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/MedDevice-X-Ray-840x560-1.jpg 840w, https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/MedDevice-X-Ray-840x560-1-300x200.jpg 300w, https:\/\/cinmed.me\/wp-content\/uploads\/2022\/12\/MedDevice-X-Ray-840x560-1-768x512.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>Every medical device that is placed on the market shall be labelled with data for its safe and proper use. The packaging of the medical device shall contain the information on the manufacturer, the data necessary for the identification of the medical device and the content of the packaging, the necessary labels such as ,,sterility\u201d, ,,single use\u201d, ,,custom-made\u201d, ,,for clinical investigation\u201d and similar, identification code, expiry date, conditions of storage, special method of use, if required, warnings, intended purpose and other necessary data of importance for the protection of health. Data for the safe use of a medical device shall be indicated on the medical device itself and\/or the packaging of each individual part, when feasible and appropriate, or on the sales package when appropriate. The instructions for use shall be placed in the packaging of each medical device.<\/p><p>\u00a0<\/p><p>Exceptionally, the instructions for use shall not be required for class I or IIa medical devices, in justified cases, for in vitro diagnostic medical devices, if they can be safely used without the instructions for use.<\/p><p>\u00a0<\/p><p>Instructions for use of a medical device shall be written in Montenegrin language and in languages that are in official use in Montenegro in accordance with the registration, and shall correspond in their entirety to the original text of the manufacturer\u2019s instructions and be prepared in a way that is understandable to the patient and user. The manufacturer shall clearly state the intended purpose of the medical device on the packaging of the medical device and in the instructions for use.<\/p><p>\u00a0<\/p><p>If it is rational and feasible, the medical device and its constituent parts shall be labelled with the batch number, in order to enable all necessary measures in case potential risks of a medical device and its constituents are identified.<\/p><p>\u00a0<\/p><p>The inner and outer packaging of a medical device for professional use shall be labelled in Montenegrin language and in the languages that are in official use in Montenegro. Outer packaging of a medical device for professional use may be labelled in English, with a label containing all the information contained on the original packaging. The outer packaging of a medical device that the patient uses independently shall be labelled in Montenegrin language and in the languages that are in official use in Montenegro. Information on the manufacturer or the authorized representative of the manufacturer of the medical device and the number of the decision on registration of the medical device shall be stated on the outer packaging and may be indicated on the label that is placed on the outer packaging of the medical device.<\/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-b6e1152 elementor-widget elementor-widget-text-editor\" data-id=\"b6e1152\" 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><em>Page is under construction.<\/em><\/p>\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-53afcbf elementor-widget elementor-widget-shortcode\" data-id=\"53afcbf\" 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      mailpoet_form\n      mailpoet_form_shortcode\n      mailpoet_form_position_\n      mailpoet_form_animation_\n    \"\n      >\n\n    <style type=\"text\/css\">\n     #mailpoet_form_1 .mailpoet_form {  }\n#mailpoet_form_1 .mailpoet_column_with_background { padding: 10px; }\n#mailpoet_form_1 .mailpoet_form_column:not(:first-child) { margin-left: 20px; }\n#mailpoet_form_1 .mailpoet_paragraph { line-height: 20px; margin-bottom: 20px; }\n#mailpoet_form_1 .mailpoet_segment_label, #mailpoet_form_1 .mailpoet_text_label, #mailpoet_form_1 .mailpoet_textarea_label, #mailpoet_form_1 .mailpoet_select_label, #mailpoet_form_1 .mailpoet_radio_label, #mailpoet_form_1 .mailpoet_checkbox_label, #mailpoet_form_1 .mailpoet_list_label, #mailpoet_form_1 .mailpoet_date_label { display: block; font-weight: normal; }\n#mailpoet_form_1 .mailpoet_text, #mailpoet_form_1 .mailpoet_textarea, #mailpoet_form_1 .mailpoet_select, #mailpoet_form_1 .mailpoet_date_month, #mailpoet_form_1 .mailpoet_date_day, #mailpoet_form_1 .mailpoet_date_year, #mailpoet_form_1 .mailpoet_date { display: block; }\n#mailpoet_form_1 .mailpoet_text, #mailpoet_form_1 .mailpoet_textarea { width: 200px; }\n#mailpoet_form_1 .mailpoet_checkbox {  }\n#mailpoet_form_1 .mailpoet_submit {  }\n#mailpoet_form_1 .mailpoet_divider {  }\n#mailpoet_form_1 .mailpoet_message {  }\n#mailpoet_form_1 .mailpoet_form_loading { width: 30px; text-align: center; line-height: normal; }\n#mailpoet_form_1 .mailpoet_form_loading > span { width: 5px; height: 5px; background-color: #5b5b5b; }#mailpoet_form_1{border-radius: 0px;text-align: left;}#mailpoet_form_1 form.mailpoet_form {padding: 20px;}#mailpoet_form_1{width: 100%;}#mailpoet_form_1 .mailpoet_message {margin: 0; padding: 0 20px;}#mailpoet_form_1 .mailpoet_paragraph.last {margin-bottom: 0} @media (max-width: 500px) {#mailpoet_form_1 {background-image: none;}} @media (min-width: 500px) {#mailpoet_form_1 .last .mailpoet_paragraph:last-child {margin-bottom: 0}}  @media (max-width: 500px) {#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=\"d8bb3a998c\" \/>\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\" name=\"data[email]\"\/><\/label><div class=\"mailpoet_paragraph \"><input type=\"email\" autocomplete=\"email\" class=\"mailpoet_text\" id=\"form_email_1\" name=\"data[form_field_MGVjYjc5NjljZGZkX2VtYWls]\" title=\"Email\" value=\"\" style=\"width:100%;box-sizing:border-box;padding:5px;margin: 0 auto 0 0;\" data-automation-id=\"form_email\"  placeholder=\"Email *\" aria-label=\"Email *\" data-parsley-errors-container=\".mailpoet_error_1qhsw\" data-parsley-required=\"true\" required aria-required=\"true\" data-parsley-minlength=\"6\" data-parsley-maxlength=\"150\" data-parsley-type-message=\"This value should be a valid email.\" data-parsley-required-message=\"This field is required.\"\/><span class=\"mailpoet_error_1qhsw\"><\/span><\/div>\n<div class=\"mailpoet_recaptcha\" data-sitekey=\"6LcWxdgkAAAAABKQzPxDkvSjfzinYiJpUzzXRcmb\" data-size=\"invisible\">\n      <div class=\"mailpoet_recaptcha_container\"><\/div>\n      <noscript>\n        <div>\n          <div class=\"mailpoet_recaptcha_noscript_container\">\n            <div>\n              <iframe src=\"https:\/\/www.google.com\/recaptcha\/api\/fallback?k=6LcWxdgkAAAAABKQzPxDkvSjfzinYiJpUzzXRcmb\" frameborder=\"0\" scrolling=\"no\">\n              <\/iframe>\n            <\/div>\n          <\/div>\n          <div class=\"mailpoet_recaptcha_noscript_input\">\n            <textarea id=\"g-recaptcha-response\" name=\"data[recaptcha]\" class=\"g-recaptcha-response\">\n            <\/textarea>\n          <\/div>\n        <\/div>\n      <\/noscript>\n      <input class=\"mailpoet_recaptcha_field\" type=\"hidden\" name=\"recaptchaWidgetId\">\n    <\/div><div class=\"mailpoet_paragraph \"><input type=\"submit\" class=\"mailpoet_submit\" value=\"Subscribe!\" data-automation-id=\"subscribe-submit-button\" style=\"width:100%;box-sizing:border-box;padding:5px;margin: 0 auto 0 0;border-color:transparent;\" \/><span class=\"mailpoet_form_loading\"><span class=\"mailpoet_bounce1\"><\/span><span 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>Every medical device that is placed on the market shall be labelled with data for its safe and proper use. The packaging of the medical device shall contain the information on the manufacturer, the data necessary for the identification of the medical device and the content of the packaging, the necessary labels such as ,,sterility\u201d, [&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-7509","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>Labelling - Cinmed<\/title>\n<meta name=\"description\" content=\"Labelling medical device that is placed on the market shall be labelled with data for its safe andproper use\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cinmed.me\/en\/medical-devices\/labelling\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Labelling - 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