{"id":3609,"date":"2025-05-16T12:23:56","date_gmt":"2025-05-16T12:23:56","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3609"},"modified":"2025-07-18T10:11:04","modified_gmt":"2025-07-18T10:11:04","slug":"ce-marking-for-class-i-medical-devices-can-i-self-certify-my-product","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/ce-marking-for-class-i-medical-devices-can-i-self-certify-my-product\/","title":{"rendered":"CE marking for Class I medical devices: Can I self-certify my product?"},"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\"><article>Many manufacturers assume that Class I medical devices can always be self-certified without the involvement of a Notified Body.<\/p>\n<p>But is that really the case? In this article, we clarify the distinctions within Class I devices and help you understand whether your product qualifies for the simplified route, or if it requires external assessment.<\/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\/ce-marking-for-class-i-medical-devices-can-i-self-certify-my-product\/#What_is_a_class_I_device_and_what_does_self-certification_involve\" >What is a class I device and what does self-certification involve?<\/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\/ce-marking-for-class-i-medical-devices-can-i-self-certify-my-product\/#Can_all_class_I_devices_be_self-certified\" >Can all class I devices be self-certified?<\/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\/ce-marking-for-class-i-medical-devices-can-i-self-certify-my-product\/#How_can_I_know_if_my_device_qualifies_for_self-certification\" >How can I know if my device qualifies for self-certification?<\/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\/ce-marking-for-class-i-medical-devices-can-i-self-certify-my-product\/#What_documents_are_needed_for_self-certifying_a_%E2%80%9CPure%E2%80%9D_class_I_device\" >What documents are needed for self-certifying a \u201cPure\u201d class I device?<\/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\/ce-marking-for-class-i-medical-devices-can-i-self-certify-my-product\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"What_is_a_class_I_device_and_what_does_self-certification_involve\"><\/span>What is a class I device and what does self-certification involve?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Under the Medical Device Regulation (MDR) 2017\/745, Class I devices are considered low-risk and, in some cases, can be self-certified by the manufacturer.<\/p>\n<p>This means the manufacturer is fully responsible for ensuring that the device meets all applicable safety and performance requirements, drafting the EU Declaration of Conformity, and affixing the CE mark.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Can_all_class_I_devices_be_self-certified\"><\/span>Can all class I devices be self-certified?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>No. Within Class I, there are specific subcategories that require Notified Body involvement, even though the devices are technically low-risk. These include:<\/p>\n<ul>\n<li><b>Sterile devices (Class Is)<\/b><\/li>\n<li><b>Devices with a measuring function (Class Im)<\/b><\/li>\n<li><b>Reusable surgical instruments (Class Ir)<\/b><\/li>\n<\/ul>\n<p><b>In these cases, self-certification is not allowed<\/b>. The manufacturer must submit the technical documentation for review by a Notified Body, who will evaluate compliance and issue the CE certificate accordingly.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_can_I_know_if_my_device_qualifies_for_self-certification\"><\/span>How can I know if my device qualifies for self-certification?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>To assess your product correctly, <b>we recommend<\/b>:<\/p>\n<ul>\n<li><b>Reviewing the product\u2019s features<\/b> in line with the MDR classification rules<\/li>\n<li>Confirming whether the device is <b>sterile<\/b>, <b>measuring<\/b>, or <b>reusable<\/b><\/li>\n<li>Consulting regulatory experts to determine whether a Notified Body is required<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"What_documents_are_needed_for_self-certifying_a_%E2%80%9CPure%E2%80%9D_class_I_device\"><\/span>What documents are needed for self-certifying a \u201cPure\u201d class I device?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>If your device is non-sterile, non-measuring, and not reusable, you may follow the self-certification route. In this case, you\u2019ll need to:<\/p>\n<ul>\n<li><b>Draft the EU Declaration of Conformity<\/b> (Annex IV of the MDR)<\/li>\n<li><b>Prepare the Technical Documentation <\/b>(Annexes II and III)<\/li>\n<li><b>Implement a post-market surveillance<\/b> (PMS) plan<\/li>\n<li><b>Register your device in EUDAMED<\/b> (where applicable)<\/li>\n<li><b>Appoint an Authorized Representative in Europe if you are a non-EU manufacturer<\/b><\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>While Class I devices benefit from a simplified CE marking process, not all can be self-certified. Understanding the differences within this category is crucial to avoid mistakes, penalties, or delays in bringing your device to the EU market.<\/p>\n<p><strong>Not sure whether your device qualifies for self-certification?<br \/>\n<\/strong><br \/>\n<b><a href=\"https:\/\/cmcmedicaldevices.com\/contact\/\">Contact us<\/a>, we\u2019ll analyze your product and guide you step by step through MDR compliance.<\/b><\/p>\n<\/article>\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=\"1200\" height=\"1500\" alt=\"class I process\" title=\"class I process\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/class-I-process.jpg\" class=\"img-responsive wp-image-3614\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/class-I-process-200x250.jpg 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/class-I-process-400x500.jpg 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/class-I-process-600x750.jpg 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/class-I-process-800x1000.jpg 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/class-I-process.jpg 1200w\" 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    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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 - (1 voto)    <\/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":[31],"tags":[],"class_list":["post-3609","post","type-post","status-publish","format-gallery","hentry","category-sin-categorizar-es","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>CE marking for Class I medical devices: Can I self-certify my product? | CMC Medical Devices<\/title>\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=\"CE marking for Class I medical devices: Can I self-certify my product? | CMC Medical Devices\" \/>\n<meta property=\"og:url\" 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