{"id":6452,"date":"2026-05-19T14:41:02","date_gmt":"2026-05-19T09:11:02","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6452"},"modified":"2026-05-19T17:28:25","modified_gmt":"2026-05-19T11:58:25","slug":"medical-device-registration-in-greece","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/eg-en\/medical-device-registration-in-greece\/","title":{"rendered":"Medical Device Registration in Greece"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6452\" class=\"elementor elementor-6452\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-16915c39 e-flex e-con-boxed e-con e-parent\" data-id=\"16915c39\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-11fa47ac elementor-widget elementor-widget-heading\" data-id=\"11fa47ac\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Medical Device Registration in Greece<\/h2>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3676e21c e-flex e-con-boxed e-con e-parent\" data-id=\"3676e21c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-2015abf6 e-con-full e-flex e-con e-child\" data-id=\"2015abf6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-27381c04 elementor-widget elementor-widget-heading\" data-id=\"27381c04\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Medical Device Registration in Greece - An Overview\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-26aaa722 elementor-widget elementor-widget-text-editor\" data-id=\"26aaa722\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Entering the Greece market offers tremendous opportunities for medical device companies, but it is not without challenges. A professional partner with experience and expertise in Greece is a cornerstone for your success, which could be the difference between approval and failure. Here is the ultimate guide for Medical Device Registration in Greece with more details on device classification and approval process for Greece. The Greek healthcare market, inclusive of medical devices, diagnostics, supplies and pharmaceuticals, is extensively dependent on imports, with local production mostly active in generics and the so-called \u201cbranded generics\u201d.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-28a88e12 e-con-full e-flex e-con e-child\" data-id=\"28a88e12\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-7ddb17b e-con-full e-flex e-con e-child\" data-id=\"7ddb17b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ee88799 elementor-widget elementor-widget-heading\" data-id=\"ee88799\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Talk to our experts<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3de1d15a elementor-widget elementor-widget-wpforms\" data-id=\"3de1d15a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-6203\"><form id=\"wpforms-form-6203\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"6203\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/eg-en\/wp-json\/wp\/v2\/posts\/6452\" data-token=\"79a083f905526ffeff35543e9571c185\" data-token-time=\"1779302587\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Please enable JavaScript in your browser to complete this form.<\/div><div class=\"wpforms-field-container\"><div id=\"wpforms-6203-field_1-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"1\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_1\" aria-hidden=\"false\">Name <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-6203-field_1\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][1]\" placeholder=\"Name*\" aria-errormessage=\"wpforms-6203-field_1-error\" required><\/div>\t\t<div id=\"wpforms-6203-field_5-container\"\n\t\t\tclass=\"wpforms-field wpforms-field-text\"\n\t\t\tdata-field-type=\"text\"\n\t\t\tdata-field-id=\"5\"\n\t\t\t>\n\t\t\t<label class=\"wpforms-field-label\" for=\"wpforms-6203-field_5\" >Email Phone Paragraph<\/label>\n\t\t\t<input type=\"text\" id=\"wpforms-6203-field_5\" class=\"wpforms-field-medium\" name=\"wpforms[fields][5]\" >\n\t\t<\/div>\n\t\t<div id=\"wpforms-6203-field_2-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"2\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_2\" aria-hidden=\"false\">Email <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-6203-field_2\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][2]\" placeholder=\"Email*\" spellcheck=\"false\" aria-errormessage=\"wpforms-6203-field_2-error\" required><\/div><div id=\"wpforms-6203-field_3-container\" class=\"wpforms-field wpforms-field-phone\" data-field-id=\"3\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_3\" aria-hidden=\"false\">Phone <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"tel\" id=\"wpforms-6203-field_3\" class=\"wpforms-field-large wpforms-field-required wpforms-smart-phone-field\" data-rule-smart-phone-field=\"true\" name=\"wpforms[fields][3]\" placeholder=\"Phone*\" aria-label=\"Phone\" aria-errormessage=\"wpforms-6203-field_3-error\" required><\/div><div id=\"wpforms-6203-field_4-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"4\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_4\" aria-hidden=\"false\">Paragraph Text <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><textarea id=\"wpforms-6203-field_4\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][4]\" placeholder=\"Message\" aria-errormessage=\"wpforms-6203-field_4-error\" required><\/textarea><\/div><script>\n\t\t\t\t( function() {\n\t\t\t\t\tconst style = document.createElement( 'style' );\n\t\t\t\t\tstyle.appendChild( document.createTextNode( '#wpforms-6203-field_5-container { position: absolute !important; overflow: hidden !important; display: inline !important; height: 1px !important; width: 1px !important; z-index: -1000 !important; padding: 0 !important; } #wpforms-6203-field_5-container input { visibility: hidden; } #wpforms-conversational-form-page #wpforms-6203-field_5-container label { counter-increment: none; }' ) );\n\t\t\t\t\tdocument.head.appendChild( style );\n\t\t\t\t\tdocument.currentScript?.remove();\n\t\t\t\t} )();\n\t\t\t<\/script><\/div><!-- .wpforms-field-container --><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"6203\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/posts\/6452\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-6203\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Submit\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit<\/button><img decoding=\"async\" src=\"https:\/\/operonstrategist.com\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-28fd9a3a e-flex e-con-boxed e-con e-parent\" data-id=\"28fd9a3a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-62ecd491 elementor-widget elementor-widget-text-editor\" data-id=\"62ecd491\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Making Greece a gateway to SE Europe could offer the country economy of scale advantages. However, the financial crisis, combined with uneasiness brought by the current refugee situation, has resulted in instability. The government is finalizing the merger of certain hospital units and attempting a twenty-four-hour operation standard within all public hospitals, with a greater level of transparency in hospital financial transactions and hospital procurement.<\/span><\/p><p><span style=\"font-weight: 400;\">Healthcare expenditures currently amount to 5.4% of Greece\u2019s diminishing Gross Domestic Product (GDP). This expenditure has traditionally comprised of approximately 60% government-provided care and 40% private care. Preference for receiving private healthcare has traditionally been higher in Greece because nearly any procedure can be performed and wait times are much lower in private hospitals.<\/span><\/p><p><span style=\"font-weight: 400;\">In addition, if a procedure requires an overnight stay, the largely crowded and rundown appearance of public hospitals is something people wish to avoid when they have the option. Despite that preference, fewer Greek citizens can afford to pay for private care out of pocket or to continue paying for private health insurance policies.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-bff21be e-flex e-con-boxed e-con e-parent\" data-id=\"bff21be\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-06024d5 elementor-widget elementor-widget-heading\" data-id=\"06024d5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Registration Process for Medical Devices in Greece\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-046d826 elementor-widget elementor-widget-text-editor\" data-id=\"046d826\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ol><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Determine device classification based on risk.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Compile comprehensive technical documentation.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Appoint an authorized representative in Greece.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Submit a registration application to the Greek National Organization for Medicines (EOF).<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Await review and evaluation by the EOF.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Obtain the registration certificate upon approval.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Comply with post-market surveillance and vigilance requirements.<br \/><br \/><\/span><\/li><\/ol><p><span style=\"font-weight: 400;\">Please note that these points provide a high-level overview, and it\u2019s important to delve into the specific regulations and requirements applicable to your medical device in Greece.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-54d024e e-flex e-con-boxed e-con e-parent\" data-id=\"54d024e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a2b76c2 elementor-widget elementor-widget-heading\" data-id=\"a2b76c2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Documents Required<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-88fa8b7 elementor-widget elementor-widget-text-editor\" data-id=\"88fa8b7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/operonstrategist.com\/elevateplus\/ce-marking-eu-mdr-ivdr\/\"><span style=\"font-weight: 400;\">CE Certificate<\/span><\/a><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/operonstrategist.com\/buildnext\/plant-layout-detail-engineering\/\"><span style=\"font-weight: 400;\">Technical File<\/span><\/a><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Declaration of Conformity<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Clinical Evaluation Report (CER)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Risk Management File<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/operonstrategist.com\/elevateplus\/quality-management-system-qms\/\"><span style=\"font-weight: 400;\">QMS certificate<\/span><\/a><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Labelling<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-15b615a e-flex e-con-boxed e-con e-parent\" data-id=\"15b615a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-21db943 elementor-widget elementor-widget-heading\" data-id=\"21db943\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Some Post-market Requirements for Medical Devices in Greece\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0c15b3f elementor-widget elementor-widget-text-editor\" data-id=\"0c15b3f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ol><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Post-Market Surveillance (PMS)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Adverse Event Reporting<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Field Safety Corrective Actions (FSCA)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Labeling and Instructions for Use<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/operonstrategist.com\/elevateplus\/quality-management-system-qms\/\"><span style=\"font-weight: 400;\">Quality Management System (QMS)<\/span><\/a><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Vigilance Reporting<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Market Surveillance Inspections<\/span><\/li><\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c4294b8 e-flex e-con-boxed e-con e-parent\" data-id=\"c4294b8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9aad6e1 elementor-widget elementor-widget-heading\" data-id=\"9aad6e1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Market Surveillance and Vigilance\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f4e3d23 elementor-widget elementor-widget-text-editor\" data-id=\"f4e3d23\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">In both the EU and the US, all medical devices are subject to further monitoring in order to assess their safety and performance efficiency. In the US one of the most important amendments in this regard is the Safe Medical Device Act that came into effect in 1990.<\/span><\/p><p><span style=\"font-weight: 400;\">In the European Union, up until 2017, this issue was regulated by the<\/span><span style=\"font-weight: 400;\"> Medical Devices Directives (MDD)<\/span><span style=\"font-weight: 400;\">. However, these directives were recently replaced by the <\/span><a href=\"https:\/\/operonstrategist.com\/elevateplus\/ce-marking-eu-mdr-ivdr\/\"><span style=\"font-weight: 400;\">EU MDR and IVDR regulations<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p><p><span style=\"font-weight: 400;\">The Safe Medical Device Act in the United States brought lots of tension to the adverse event reporting process. Medical devices directives and the EU MDR\/IVDR regulations have also created a uniformed regulatory situation in the EU. However, there are bigger variances in applicable regulations in the EU from country-to-country than in the US from state-to-state.<\/span><\/p><p><span style=\"font-weight: 400;\">One example is that essentially all countries within the EU also have their own databases for monitoring medical devices and adverse reporting (<\/span><span style=\"font-weight: 400;\">EOF database<\/span><span style=\"font-weight: 400;\">) apart from Eudamed. Many countries also require extra information to provide, for example, Germany uses their own<\/span><span style=\"font-weight: 400;\"> DIMDI system<\/span><span style=\"font-weight: 400;\"> registrations processing.<\/span><\/p><p><span style=\"font-weight: 400;\">Medical devices in Greece are regulated by The <\/span><a href=\"https:\/\/globaledge.msu.edu\/global-resources\/resource\/10390\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">National Organization for Medicines<\/span><\/a><span style=\"font-weight: 400;\"> (EOF), a public entity of the Ministry of Health. Greece, as a member of the European Union, classifies medical devices according to their risk into four classes: I, IIb, IIb, and III.<\/span><\/p><p><span style=\"font-weight: 400;\">Class I medical devices are associated with the lowest risk, while Class III devices are associated with the highest risk. In order to market their medical devices throughout the European Union, manufacturers must make sure that all the products they intend to distribute in Greece are CE-marked. <\/span><a href=\"https:\/\/operonstrategist.com\/elevateplus\/ce-marking-eu-mdr-ivdr\/\"><span style=\"font-weight: 400;\">CE marking<\/span><\/a><span style=\"font-weight: 400;\"> serves as a proof of conformity within the current European Union regulations.<\/span><\/p><p><span style=\"font-weight: 400;\">A CE mark allows for the device to be marketed within all EU member states. Once a medical device is granted with CE marking, it can be distributed in any of the European Union countries. It doesn\u2019t have to be registered in a country where it is going to be marketed \u2013 registering a given medical device in Greece allows for it to be distributed in Germany, France, United Kingdom or any other EU member state.<\/span><\/p><p><span style=\"font-weight: 400;\">The time frame of the registration process can vary depending on the type and Class of device. The process is usually the quickest for Class I devices. It is also important to note that all registrations in the EU, and thus in Greece, are valid for 5 years. Manufacturers are also obligated to have a <\/span><a href=\"https:\/\/operonstrategist.com\/elevateplus\/quality-management-system-qms\/\"><span style=\"font-weight: 400;\">Quality Management System<\/span><\/a><span style=\"font-weight: 400;\"> (QMS). The most popular choice in this regard is ISO 13485 certification, which is valid for three years.<\/span><\/p><p><span style=\"font-weight: 400;\">Foreign manufacturers that are not registered in the EU must appoint an Authorized Representative (AR), which will assist with the registration process and post-market surveillance activities.<\/span><\/p><p><span style=\"font-weight: 400;\">Operon Strategist enjoys a high reputation and widespread acclaim for successful medical device registration experience in globally. We provide high quality, high efficiency and reliable service of <\/span><a href=\"https:\/\/operonstrategist.com\/elevateplus\/\"><span style=\"font-weight: 400;\">medical device regulatory consulting<\/span><\/a><span style=\"font-weight: 400;\"> and registration for clients from over various countries. As an expert in regulatory affairs in the medical device industry, we possess enormous successful registration experience for all types of medical devices or IVD. Operon Strategist is the absolute leading forerunner for medical device approval in Greece and gets your products into Greece market faster.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-22747a00 e-con-full e-flex e-con e-child\" data-id=\"22747a00\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-163cd82a elementor-widget elementor-widget-heading\" data-id=\"163cd82a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FAQ<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-32fe34d6 elementor-widget elementor-widget-n-accordion\" data-id=\"32fe34d6\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-8550\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-8550\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What is medical device registration in Greece? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-8550\" class=\"elementor-element elementor-element-760813a4 e-con-full e-flex e-con e-child\" data-id=\"760813a4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-75b83be5 elementor-widget elementor-widget-text-editor\" data-id=\"75b83be5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"89\" data-end=\"344\">Medical device registration in Greece refers to the regulatory process required for placing medical devices on the Greek market. Devices must comply with the European Union Medical Device Regulation (EU MDR) and obtain CE marking before commercialization.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-8551\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-8551\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Which authority regulates medical devices in Greece? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-8551\" class=\"elementor-element elementor-element-7df113ad e-con-full e-flex e-con e-child\" data-id=\"7df113ad\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3d28bb36 elementor-widget elementor-widget-text-editor\" data-id=\"3d28bb36\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"403\" data-end=\"517\">Medical devices in Greece are regulated by the <span class=\"hover:entity-accent entity-underline inline cursor-pointer align-baseline\"><span class=\"whitespace-normal\">National Organization for Medicines (EOF)<\/span><\/span> under the Ministry of Health.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-8552\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-8552\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Is CE marking mandatory for medical devices in Greece? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-8552\" class=\"elementor-element elementor-element-373ce2c6 e-con-full e-flex e-con e-child\" data-id=\"373ce2c6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d6176c elementor-widget elementor-widget-text-editor\" data-id=\"d6176c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"578\" data-end=\"768\">Yes, CE marking is mandatory for all medical devices marketed in Greece. It confirms that the device complies with applicable EU MDR requirements related to safety, quality, and performance.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-8553\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-8553\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What documents are required for medical device registration in Greece? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-8553\" class=\"elementor-element elementor-element-6c36858e e-con-full e-flex e-con e-child\" data-id=\"6c36858e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-aa51f74 elementor-widget elementor-widget-text-editor\" data-id=\"aa51f74\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"1389\" data-end=\"1425\">Commonly required documents include:<\/p><ul data-start=\"1426\" data-end=\"1625\"><li data-section-id=\"1h701yz\" data-start=\"1426\" data-end=\"1442\">CE Certificate<\/li><li data-section-id=\"1438ozh\" data-start=\"1443\" data-end=\"1459\">Technical File<\/li><li data-section-id=\"1pegr01\" data-start=\"1460\" data-end=\"1487\">Declaration of Conformity<\/li><li data-section-id=\"13kj0ay\" data-start=\"1488\" data-end=\"1522\">Clinical Evaluation Report (CER)<\/li><li data-section-id=\"cxvpa6\" data-start=\"1523\" data-end=\"1545\">Risk Management File<\/li><li data-section-id=\"w5thxd\" data-start=\"1546\" data-end=\"1576\">ISO 13485 or QMS Certificate<\/li><li data-section-id=\"1iswjlh\" data-start=\"1577\" data-end=\"1625\">Device labeling and Instructions for Use (IFU)<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"What is medical device registration in Greece?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Medical device registration in Greece refers to the regulatory process required for placing medical devices on the Greek market. Devices must comply with the European Union Medical Device Regulation (EU MDR) and obtain CE marking before commercialization.\"}},{\"@type\":\"Question\",\"name\":\"Which authority regulates medical devices in Greece?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Medical devices in Greece are regulated by the National Organization for Medicines (EOF) under the Ministry of Health.\"}},{\"@type\":\"Question\",\"name\":\"Is CE marking mandatory for medical devices in Greece?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes, CE marking is mandatory for all medical devices marketed in Greece. It confirms that the device complies with applicable EU MDR requirements related to safety, quality, and performance.\"}},{\"@type\":\"Question\",\"name\":\"What documents are required for medical device registration in Greece?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Commonly required documents include:CE CertificateTechnical FileDeclaration of ConformityClinical Evaluation Report (CER)Risk Management FileISO 13485 or QMS CertificateDevice labeling and Instructions for Use (IFU)\"}}]}<\/script>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Medical Device Registration in Greece &#8211; An Overview Entering the Greece market offers tremendous opportunities for medical device companies, but it is not without challenges. A professional partner with experience and expertise in Greece is a cornerstone for your success, which could be the difference between approval and failure. Here is the ultimate guide for [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":6463,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[55],"tags":[],"class_list":["post-6452","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/posts\/6452","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/comments?post=6452"}],"version-history":[{"count":0,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/posts\/6452\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/media\/6463"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/media?parent=6452"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/categories?post=6452"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/tags?post=6452"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}