{"id":3858,"date":"2025-07-03T11:03:39","date_gmt":"2025-07-03T11:03:39","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3858"},"modified":"2025-07-18T09:44:21","modified_gmt":"2025-07-18T09:44:21","slug":"new-eu-regulation-on-e-ifu-what-changes-for-medical-devices","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/","title":{"rendered":"New EU regulation on e-IFU: what changes for medical devices?"},"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>On <b>25 June 2025<\/b>, the <b>European Commission<\/b> <b><u><a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/commission-simplifies-instructions-use-medical-devices-further-digitalise-healthcare-systems-2025-06-25_en\" target=\"_blank\" rel=\"noopener noreferrer\">published a new regulation<\/a><\/u><\/b> that allows all medical devices used by healthcare professionals in the EU to be accompanied by <b>instructions for use (IFU) in electronic format<\/b>.<\/p>\n<p>This update expands the use of e-IFU beyond the previous limitations, while maintaining the option for professionals to request a paper version if needed.<\/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\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/#What_are_the_benefits_for_manufacturers_and_healthcare_systems\" >What are the benefits for manufacturers and healthcare systems?<\/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\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/#Who_is_covered_by_the_new_regulation\" >Who is covered by the new regulation?<\/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\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/#What_are_the_next_steps\" >What are the next steps?<\/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\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/#In_summary\" >In summary<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"What_are_the_benefits_for_manufacturers_and_healthcare_systems\"><\/span>What are the benefits for manufacturers and healthcare systems?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The goal is to <b>support the digital transition of EU healthcare systems<\/b>. By switching to digital formats, manufacturers can <b>reduce printing costs and environmental impact<\/b> while making information easier to update and access.<\/p>\n<p>The regulation also simplifies compliance processes and reduces the administrative burden for manufacturers, aligning with the EU\u2019s broader strategy to boost innovation and competitiveness in the medical device sector.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Who_is_covered_by_the_new_regulation\"><\/span>Who is covered by the new regulation?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The measure concerns all medical devices <b>used by healthcare professionals<\/b> across the EU.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_are_the_next_steps\"><\/span>What are the next steps?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The Commission also announced two upcoming initiatives:<\/p>\n<ul>\n<li><b>the creation of an expert panel<\/b> to advise on devices designed for small patient populations, such as children or those with rare diseases<\/li>\n<li><b>a full evaluation of the medical device and in vitro diagnostic regulations<\/b>, aimed at reducing unnecessary burdens and improving efficiency. The conclusions will be presented in December 2025 during a conference in Brussels<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"In_summary\"><\/span>In summary<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li>e-IFU are now allowed for all medical devices used by professionals in the EU<\/li>\n<li>paper versions must still be available on request<\/li>\n<li>the change supports sustainability, cost-efficiency, and digitalisation<\/li>\n<li>broader reforms of MDR and IVDR are under evaluation<\/li>\n<\/ul>\n<p><strong>Want to better understand how to adapt your documentation to the e-IFU format? Get in touch with us.<\/strong><\/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=\"eifu new rules\" title=\"eifu new rules\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/eifu-new-rules.jpg\" class=\"img-responsive wp-image-3852\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/eifu-new-rules-200x113.jpg 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/eifu-new-rules-400x225.jpg 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/eifu-new-rules-600x338.jpg 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/eifu-new-rules-800x451.jpg 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/eifu-new-rules-1200x676.jpg 1200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/eifu-new-rules.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;3858&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;5&quot;,&quot;legendonly&quot;:&quot;&quot;,&quot;readonly&quot;:&quot;&quot;,&quot;score&quot;:&quot;5&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;5\\\/5 - (5 votos)&quot;,&quot;size&quot;:&quot;24&quot;,&quot;title&quot;:&quot;New EU regulation on e-IFU: what changes for medical devices?&quot;,&quot;width&quot;:&quot;142.5&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: 142.5px;\">\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            5\/5 - (5 votos)    <\/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-3858","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>Digital instructions for use: new EU rules for medical devices<\/title>\n<meta name=\"description\" content=\"The EU now allows digital instructions for use for medical devices used by professionals. Find out what changes and why it matters.\" \/>\n<meta name=\"robots\" content=\"noindex, follow\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Digital instructions for use: new EU rules for medical devices\" \/>\n<meta property=\"og:description\" content=\"The EU now allows digital instructions for use for medical devices used by professionals. Find out what changes and why it matters.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/cmcmedicaldevices.com\/es\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/\" \/>\n<meta property=\"og:site_name\" content=\"CMC Medical Devices\" \/>\n<meta property=\"article:published_time\" content=\"2025-07-03T11:03:39+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-07-18T09:44:21+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=\"2 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/es\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/cmcmedicaldevices.com\/es\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/\"},\"author\":{\"name\":\"Admin\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/#\/schema\/person\/053251251c0ef9624cec28df99b802cf\"},\"headline\":\"New EU regulation on e-IFU: what changes for medical devices?\",\"datePublished\":\"2025-07-03T11:03:39+00:00\",\"dateModified\":\"2025-07-18T09:44:21+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/cmcmedicaldevices.com\/es\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/\"},\"wordCount\":984,\"publisher\":{\"@id\":\"https:\/\/cmcmedicaldevices.com\/#organization\"},\"articleSection\":[\"Sin categorizar\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/es\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/\",\"url\":\"https:\/\/cmcmedicaldevices.com\/es\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/\",\"name\":\"Digital instructions for use: new EU rules for medical devices\",\"isPartOf\":{\"@id\":\"https:\/\/cmcmedicaldevices.com\/#website\"},\"datePublished\":\"2025-07-03T11:03:39+00:00\",\"dateModified\":\"2025-07-18T09:44:21+00:00\",\"description\":\"The EU now allows digital instructions for use for medical devices used by professionals. Find out what changes and why it matters.\",\"breadcrumb\":{\"@id\":\"https:\/\/cmcmedicaldevices.com\/es\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/#breadcrumb\"},\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/cmcmedicaldevices.com\/es\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/es\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Portada\",\"item\":\"https:\/\/cmcmedicaldevices.com\/es\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"New EU regulation on e-IFU: what changes for medical devices?\"}]},{\"@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":"Digital instructions for use: new EU rules for medical devices","description":"The EU now allows digital instructions for use for medical devices used by professionals. Find out what changes and why it matters.","robots":{"index":"noindex","follow":"follow"},"og_locale":"es_ES","og_type":"article","og_title":"Digital instructions for use: new EU rules for medical devices","og_description":"The EU now allows digital instructions for use for medical devices used by professionals. Find out what changes and why it matters.","og_url":"https:\/\/cmcmedicaldevices.com\/es\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/","og_site_name":"CMC Medical Devices","article_published_time":"2025-07-03T11:03:39+00:00","article_modified_time":"2025-07-18T09:44:21+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":"2 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/cmcmedicaldevices.com\/es\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/#article","isPartOf":{"@id":"https:\/\/cmcmedicaldevices.com\/es\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/"},"author":{"name":"Admin","@id":"https:\/\/cmcmedicaldevices.com\/#\/schema\/person\/053251251c0ef9624cec28df99b802cf"},"headline":"New EU regulation on e-IFU: what changes for medical devices?","datePublished":"2025-07-03T11:03:39+00:00","dateModified":"2025-07-18T09:44:21+00:00","mainEntityOfPage":{"@id":"https:\/\/cmcmedicaldevices.com\/es\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/"},"wordCount":984,"publisher":{"@id":"https:\/\/cmcmedicaldevices.com\/#organization"},"articleSection":["Sin categorizar"],"inLanguage":"es"},{"@type":"WebPage","@id":"https:\/\/cmcmedicaldevices.com\/es\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/","url":"https:\/\/cmcmedicaldevices.com\/es\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/","name":"Digital instructions for use: new EU rules for medical devices","isPartOf":{"@id":"https:\/\/cmcmedicaldevices.com\/#website"},"datePublished":"2025-07-03T11:03:39+00:00","dateModified":"2025-07-18T09:44:21+00:00","description":"The EU now allows digital instructions for use for medical devices used by professionals. Find out what changes and why it matters.","breadcrumb":{"@id":"https:\/\/cmcmedicaldevices.com\/es\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/#breadcrumb"},"inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/cmcmedicaldevices.com\/es\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/cmcmedicaldevices.com\/es\/new-eu-regulation-on-e-ifu-what-changes-for-medical-devices\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Portada","item":"https:\/\/cmcmedicaldevices.com\/es\/"},{"@type":"ListItem","position":2,"name":"New EU regulation on e-IFU: what changes for medical devices?"}]},{"@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\/3858","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=3858"}],"version-history":[{"count":1,"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/posts\/3858\/revisions"}],"predecessor-version":[{"id":3859,"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/posts\/3858\/revisions\/3859"}],"wp:attachment":[{"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/media?parent=3858"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/categories?post=3858"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/tags?post=3858"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}