{"id":3583,"date":"2025-05-09T12:18:14","date_gmt":"2025-05-09T12:18:14","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3583"},"modified":"2025-05-09T12:18:14","modified_gmt":"2025-05-09T12:18:14","slug":"how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/","title":{"rendered":"How to obtain CE marking for medical devices in Europe: A complete guide for non-European manufacturers"},"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_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--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\"><p>If you are a medical device or IVD manufacturer based outside the European Union and planning to sell your products in Europe, CE Marking is a legal requirement. This guide outlines the key steps to ensure compliance with the European MDR and IVDR regulations and successfully enter the EU market.<\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_74 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Alternar tabla de contenidos\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/#1_Classify_your_device_under_MDR_or_IVDR\" >1. Classify your device under MDR or IVDR<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/#2_Choose_the_right_conformity_assessment_route_and_set_up_a_QMS\" >2. Choose the right conformity assessment route and set up a QMS<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/#3_Conduct_a_Clinical_or_Performance_Evaluation_and_prepare_the_Technical_Documentation\" >3. Conduct a Clinical or Performance Evaluation and prepare the Technical Documentation<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/#4_Appoint_an_Authorized_Representative\" >4. Appoint an Authorized Representative<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/#5_Notified_Body_assessment_if_required\" >5. Notified Body assessment (if required)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/#6_Sign_the_EU_declaration_of_conformity\" >6. Sign the EU declaration of conformity<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/#7_Affix_the_CE_Mark_and_Enter_the_Market\" >7. Affix the CE Mark and Enter the Market<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/#8_Device_registration_and_post-market_surveillance\" >8. Device registration and post-market surveillance<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/#9_Request_a_Free_Sale_Certificate_FSC\" >9. Request a Free Sale Certificate (FSC)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/#Need_help_with_the_CE_marking_process\" >Need help with the CE marking process?<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"1_Classify_your_device_under_MDR_or_IVDR\"><\/span>1. Classify your device under MDR or IVDR<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Before anything else, determine the risk class of your product:<\/p>\n<ul>\n<li><strong>Medical Devices:<\/strong> Class I, IIa, IIb, or III under MDR (EU Regulation 2017\/745)<\/li>\n<li><strong>In Vitro Diagnostic Devices (IVDs):<\/strong> Class A, B, C, or D under IVDR (EU Regulation 2017\/746)<\/li>\n<\/ul>\n<p>The classification will define the route you must follow to demonstrate compliance.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_Choose_the_right_conformity_assessment_route_and_set_up_a_QMS\"><\/span>2. Choose the right conformity assessment route and set up a QMS<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Based on your device class, you must follow a specific conformity assessment procedure. Higher-risk classes require the intervention of a Notified Body.<\/p>\n<p>You also need a <b>Quality Management System (QMS)<\/b> aligned with <b>MDR<\/b>\/<b>IVDR<\/b> requirements \u2014 ISO 13485 is commonly used.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"3_Conduct_a_Clinical_or_Performance_Evaluation_and_prepare_the_Technical_Documentation\"><\/span>3. Conduct a Clinical or Performance Evaluation and prepare the Technical Documentation<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li><strong>Clinical Evaluation<\/strong> for medical devices<\/li>\n<li><strong>Performance Evaluation<\/strong> for IVDs<\/li>\n<\/ul>\n<p>You must compile detailed Technical Documentation demonstrating product safety, performance, and regulatory compliance.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"4_Appoint_an_Authorized_Representative\"><\/span>4. Appoint an Authorized Representative<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Non-European manufacturers must appoint an authorized representative based in the countries where they intend to market their devices. This includes <b><a href=\"https:\/\/cmcmedicaldevices.com\/services\/representation-eu\/\"><u>the EU<\/u><\/a><\/b>, <b><a href=\"https:\/\/cmcmedicaldevices.com\/services\/representation-uk\/\" target=\"_blank\" rel=\"noopener noreferrer\"><u>the UK<\/u><\/a><\/b>, and<b> <a href=\"https:\/\/cmcmedicaldevices.com\/services\/representation-switzerland\/\" target=\"_blank\" rel=\"noopener noreferrer\"><u>Switzerland<\/u><\/a><\/b> \u2014 each with its own regulatory requirements and official representation scheme.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"5_Notified_Body_assessment_if_required\"><\/span>5. Notified Body assessment (if required)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Some Class I medical devices (non-sterile, non-measuring) may be self-certified by the manufacturer. However, most other medical devices \u2014 and all IVDs except Class A \u2014 require the involvement of a Notified Body to conduct a conformity assessment and issue a CE Certificate.<\/p>\n<p>The specific procedure depends on the device classification and the applicable regulation (MDR or IVDR).<\/p>\n<h2><span class=\"ez-toc-section\" id=\"6_Sign_the_EU_declaration_of_conformity\"><\/span>6. Sign the EU declaration of conformity<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>This document confirms that your device complies with the applicable EU regulation (MDR or IVDR). It must be signed and kept available together with the technical documentation.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"7_Affix_the_CE_Mark_and_Enter_the_Market\"><\/span>7. Affix the CE Mark and Enter the Market<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Once the required documents are in place, you can affix the CE mark to your product and legally place it on the European market.<\/p>\n<p>For IVDs, transitional provisions may apply, check current IVDR deadlines if applicable.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"8_Device_registration_and_post-market_surveillance\"><\/span>8. Device registration and post-market surveillance<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Depending on the device classification and the rollout status of <u><a href=\"https:\/\/cmcmedicaldevices.com\/services\/consulting-eudamed-registration\/\" target=\"_blank\" rel=\"noopener noreferrer\"><b>EUDAMED<\/b><\/a><\/u>, you may need to register your product with the relevant Competent Authority in the EU country where your Authorized Representative is located.<\/p>\n<p>Registration in EUDAMED is not yet fully mandatory, but it will become so once the database is fully functional.<\/p>\n<p>You must also implement a Post-Market Surveillance (PMS) plan to track the safety and performance of your device after it has been placed on the market.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"9_Request_a_Free_Sale_Certificate_FSC\"><\/span>9. Request a Free Sale Certificate (FSC)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>A <b><u><a href=\"https:\/\/cmcmedicaldevices.com\/services\/fsc\/\" target=\"_blank\" rel=\"noopener noreferrer\">Free Sale Certificate<\/a><\/u><\/b> can facilitate your exports to markets outside Europe, where proof of CE compliance is often required.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Need_help_with_the_CE_marking_process\"><\/span>Need help with the CE marking process?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b>If you need help with any step of the CE Marking process, from classification to registration, feel free to <a href=\"&#091;INSERISCI IL LINK ALLA PAGINA CONTATTI O ARTICOLO COMPLETO&#093;\">reach out<\/a>.<\/b><\/p>\n<\/div><div style=\"text-align:center;\"><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--button_margin-top:10px;--button_margin-bottom:20px;\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/cmcmedicaldevices.com\/contact\/\"><span class=\"fusion-button-text\">Contact us for more information<\/span><\/a><\/div><div class=\"fusion-image-element \" style=\"text-align:center;--awb-max-width:600px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"1640\" height=\"924\" alt=\"ce marking\" title=\"ce marking\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/ce-marking.jpg\" class=\"img-responsive wp-image-3580\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/ce-marking-200x113.jpg 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/ce-marking-400x225.jpg 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/ce-marking-600x338.jpg 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/ce-marking-800x451.jpg 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/ce-marking-1200x676.jpg 1200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/ce-marking.jpg 1640w\" sizes=\"(max-width: 640px) 100vw, 1200px\" \/><\/span><\/div><\/div><\/div><\/div><\/div>\n\n\n<div class=\"kk-star-ratings kksr-auto kksr-align-center kksr-valign-bottom\"\n    data-payload='{&quot;align&quot;:&quot;center&quot;,&quot;id&quot;:&quot;3583&quot;,&quot;slug&quot;:&quot;default&quot;,&quot;valign&quot;:&quot;bottom&quot;,&quot;ignore&quot;:&quot;&quot;,&quot;reference&quot;:&quot;auto&quot;,&quot;class&quot;:&quot;&quot;,&quot;count&quot;:&quot;0&quot;,&quot;legendonly&quot;:&quot;&quot;,&quot;readonly&quot;:&quot;&quot;,&quot;score&quot;:&quot;0&quot;,&quot;starsonly&quot;:&quot;&quot;,&quot;best&quot;:&quot;5&quot;,&quot;gap&quot;:&quot;5&quot;,&quot;greet&quot;:&quot;Rate this&quot;,&quot;legend&quot;:&quot;0\\\/5 - (0 votos)&quot;,&quot;size&quot;:&quot;24&quot;,&quot;title&quot;:&quot;How to obtain CE marking for medical devices in Europe: A complete guide for non-European manufacturers&quot;,&quot;width&quot;:&quot;0&quot;,&quot;_legend&quot;:&quot;{score}\\\/{best} - ({count} {votes})&quot;,&quot;font_factor&quot;:&quot;1.25&quot;}'>\n            \n<div class=\"kksr-stars\">\n    \n<div class=\"kksr-stars-inactive\">\n            <div class=\"kksr-star\" data-star=\"1\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"2\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"3\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"4\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"5\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n    \n<div class=\"kksr-stars-active\" style=\"width: 0px;\">\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n<\/div>\n                \n\n<div class=\"kksr-legend\" style=\"font-size: 19.2px;\">\n            <span class=\"kksr-muted\">Rate this<\/span>\n    <\/div>\n    <\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"gallery","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3583","post","type-post","status-publish","format-gallery","hentry","category-sin-categorizar","post_format-post-format-gallery"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.3.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>How to obtain CE marking for medical devices in Europe: A complete guide for non-European manufacturers | CMC Medical Devices<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How to obtain CE marking for medical devices in Europe: A complete guide for non-European manufacturers | CMC Medical Devices\" \/>\n<meta property=\"og:url\" content=\"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/\" \/>\n<meta property=\"og:site_name\" content=\"CMC Medical Devices\" \/>\n<meta property=\"article:published_time\" content=\"2025-05-09T12:18:14+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/06\/Logo-SEO-CMC.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"675\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"author\" content=\"Admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/\"},\"author\":{\"name\":\"Admin\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/#\/schema\/person\/053251251c0ef9624cec28df99b802cf\"},\"headline\":\"How to obtain CE marking for medical devices in Europe: A complete guide for non-European manufacturers\",\"datePublished\":\"2025-05-09T12:18:14+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/\"},\"wordCount\":1221,\"publisher\":{\"@id\":\"https:\/\/cmcmedicaldevices.com\/#organization\"},\"articleSection\":[\"Sin categorizar\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/\",\"url\":\"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/\",\"name\":\"How to obtain CE marking for medical devices in Europe: A complete guide for non-European manufacturers | CMC Medical Devices\",\"isPartOf\":{\"@id\":\"https:\/\/cmcmedicaldevices.com\/#website\"},\"datePublished\":\"2025-05-09T12:18:14+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/#breadcrumb\"},\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Portada\",\"item\":\"https:\/\/cmcmedicaldevices.com\/es\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"How to obtain CE marking for medical devices in Europe: A complete guide for non-European manufacturers\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/#website\",\"url\":\"https:\/\/cmcmedicaldevices.com\/\",\"name\":\"CMC Medical Devices\",\"description\":\"In Country Representation and Global Consulting for medical devices\",\"publisher\":{\"@id\":\"https:\/\/cmcmedicaldevices.com\/#organization\"},\"alternateName\":\"CMC\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/cmcmedicaldevices.com\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"es\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/#organization\",\"name\":\"CMC Medical Devices\",\"alternateName\":\"CMC CONSULTING GROUP\",\"url\":\"https:\/\/cmcmedicaldevices.com\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/06\/Logo-SEO-cuadrado-CMC.webp\",\"contentUrl\":\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/06\/Logo-SEO-cuadrado-CMC.webp\",\"width\":675,\"height\":675,\"caption\":\"CMC Medical Devices\"},\"image\":{\"@id\":\"https:\/\/cmcmedicaldevices.com\/#\/schema\/logo\/image\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/#\/schema\/person\/053251251c0ef9624cec28df99b802cf\",\"name\":\"Admin\",\"url\":\"https:\/\/cmcmedicaldevices.com\/es\/author\/admin-2\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"How to obtain CE marking for medical devices in Europe: A complete guide for non-European manufacturers | CMC Medical Devices","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/","og_locale":"es_ES","og_type":"article","og_title":"How to obtain CE marking for medical devices in Europe: A complete guide for non-European manufacturers | CMC Medical Devices","og_url":"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/","og_site_name":"CMC Medical Devices","article_published_time":"2025-05-09T12:18:14+00:00","og_image":[{"width":1200,"height":675,"url":"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/06\/Logo-SEO-CMC.webp","type":"image\/webp"}],"author":"Admin","twitter_card":"summary_large_image","twitter_misc":{"Escrito por":"Admin","Tiempo de lectura":"3 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/#article","isPartOf":{"@id":"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/"},"author":{"name":"Admin","@id":"https:\/\/cmcmedicaldevices.com\/#\/schema\/person\/053251251c0ef9624cec28df99b802cf"},"headline":"How to obtain CE marking for medical devices in Europe: A complete guide for non-European manufacturers","datePublished":"2025-05-09T12:18:14+00:00","mainEntityOfPage":{"@id":"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/"},"wordCount":1221,"publisher":{"@id":"https:\/\/cmcmedicaldevices.com\/#organization"},"articleSection":["Sin categorizar"],"inLanguage":"es"},{"@type":"WebPage","@id":"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/","url":"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/","name":"How to obtain CE marking for medical devices in Europe: A complete guide for non-European manufacturers | CMC Medical Devices","isPartOf":{"@id":"https:\/\/cmcmedicaldevices.com\/#website"},"datePublished":"2025-05-09T12:18:14+00:00","breadcrumb":{"@id":"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/#breadcrumb"},"inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/cmcmedicaldevices.com\/es\/how-to-obtain-ce-marking-for-medical-devices-in-europe-a-complete-guide-for-non-european-manufacturers\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Portada","item":"https:\/\/cmcmedicaldevices.com\/es\/"},{"@type":"ListItem","position":2,"name":"How to obtain CE marking for medical devices in Europe: A complete guide for non-European manufacturers"}]},{"@type":"WebSite","@id":"https:\/\/cmcmedicaldevices.com\/#website","url":"https:\/\/cmcmedicaldevices.com\/","name":"CMC Medical Devices","description":"In Country Representation and Global Consulting for medical devices","publisher":{"@id":"https:\/\/cmcmedicaldevices.com\/#organization"},"alternateName":"CMC","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/cmcmedicaldevices.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es"},{"@type":"Organization","@id":"https:\/\/cmcmedicaldevices.com\/#organization","name":"CMC Medical Devices","alternateName":"CMC CONSULTING GROUP","url":"https:\/\/cmcmedicaldevices.com\/","logo":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/cmcmedicaldevices.com\/#\/schema\/logo\/image\/","url":"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/06\/Logo-SEO-cuadrado-CMC.webp","contentUrl":"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/06\/Logo-SEO-cuadrado-CMC.webp","width":675,"height":675,"caption":"CMC Medical Devices"},"image":{"@id":"https:\/\/cmcmedicaldevices.com\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/cmcmedicaldevices.com\/#\/schema\/person\/053251251c0ef9624cec28df99b802cf","name":"Admin","url":"https:\/\/cmcmedicaldevices.com\/es\/author\/admin-2\/"}]}},"_links":{"self":[{"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/posts\/3583","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/comments?post=3583"}],"version-history":[{"count":1,"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/posts\/3583\/revisions"}],"predecessor-version":[{"id":3584,"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/posts\/3583\/revisions\/3584"}],"wp:attachment":[{"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/media?parent=3583"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/categories?post=3583"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/tags?post=3583"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}