{"id":3745,"date":"2025-06-06T11:30:35","date_gmt":"2025-06-06T11:30:35","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3745"},"modified":"2025-07-18T09:52:49","modified_gmt":"2025-07-18T09:52:49","slug":"how-to-write-an-eu-declaration-of-conformity","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/how-to-write-an-eu-declaration-of-conformity\/","title":{"rendered":"How to write an EU Declaration of Conformity?"},"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><span style=\"font-family: Merriweather, true; font-size: 40px; letter-spacing: 1px; background-color: rgba(0, 0, 0, 0);\">What is an EU Declaration of Conformity?<\/span><\/p>\n<p>An EU Declaration of Conformity (DoC) is a <strong>legal document<\/strong> in which the manufacturer states that their device complies with the applicable European regulations (MDR or IVDR).<br \/>\nIt must be signed by a legally authorised person and must accompany the product on 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-write-an-eu-declaration-of-conformity\/#What_must_an_EU_Declaration_of_Conformity_include\" >What must an EU Declaration of Conformity include?<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/cmcmedicaldevices.com\/es\/how-to-write-an-eu-declaration-of-conformity\/#1_Manufacturer_andor_Authorised_Representative_information\" >1. Manufacturer and\/or Authorised Representative information<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/cmcmedicaldevices.com\/es\/how-to-write-an-eu-declaration-of-conformity\/#2_Product_identification\" >2. Product identification<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/cmcmedicaldevices.com\/es\/how-to-write-an-eu-declaration-of-conformity\/#3_Intended_purpose_and_traceability\" >3. Intended purpose and traceability<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/cmcmedicaldevices.com\/es\/how-to-write-an-eu-declaration-of-conformity\/#4_Applicable_legislation_and_harmonised_standards\" >4. Applicable legislation and harmonised standards<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/cmcmedicaldevices.com\/es\/how-to-write-an-eu-declaration-of-conformity\/#5_Involvement_of_a_Notified_Body_if_applicable\" >5. Involvement of a Notified Body (if applicable)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/cmcmedicaldevices.com\/es\/how-to-write-an-eu-declaration-of-conformity\/#6_Statement_of_responsibility_and_signature\" >6. Statement of responsibility and signature<\/a><\/li><\/ul><\/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-write-an-eu-declaration-of-conformity\/#What_happens_if_your_DoC_is_incomplete_or_incorrect\" >What happens if your DoC is incomplete or incorrect?<\/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-write-an-eu-declaration-of-conformity\/#Does_the_Authorised_Representative_need_to_be_included\" >Does the Authorised Representative need to be included?<\/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-write-an-eu-declaration-of-conformity\/#Need_help_drafting_or_reviewing_your_DoC\" >Need help drafting or reviewing your DoC?<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"What_must_an_EU_Declaration_of_Conformity_include\"><\/span>What must an EU Declaration of Conformity include?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"1_Manufacturer_andor_Authorised_Representative_information\"><\/span>1. Manufacturer and\/or Authorised Representative information<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Include the full <strong>name and business address<\/strong> of the manufacturer.<br \/>\nIf an EU Authorised Representative is involved, their details must be listed as well.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"2_Product_identification\"><\/span>2. Product identification<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Clearly state the <strong>model, type, or serial number<\/strong> of the device.<br \/>\nIf relevant, you can also include an image to help ensure traceability.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"3_Intended_purpose_and_traceability\"><\/span>3. Intended purpose and traceability<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Briefly describe the <strong>intended use<\/strong> of the device and ensure the product is fully traceable through the documentation.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"4_Applicable_legislation_and_harmonised_standards\"><\/span>4. Applicable legislation and harmonised standards<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Specify whether the device complies with Regulation (EU) 2017\/745 (MDR) or 2017\/746 (IVDR).<br \/>\nList all harmonised standards and, if applicable, common specifications used to demonstrate compliance, <strong>with full title and version number<\/strong>.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"5_Involvement_of_a_Notified_Body_if_applicable\"><\/span>5. Involvement of a Notified Body (if applicable)<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><b><br \/>\nIf a Notified Body was involved<\/b> in the conformity assessment process, you must include:<\/p>\n<ul>\n<li>The <strong>name and identification number<\/strong> of the body<\/li>\n<li>The <strong>type of conformity assessment<\/strong> performed<\/li>\n<li>The <strong>certificate number<\/strong><\/li>\n<\/ul>\n<p>This is essential for Class Is, Im, Ir devices or any other case where third-party assessment is required.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.4;\" data-fontsize=\"32\" data-lineheight=\"44.8px\"><span class=\"ez-toc-section\" id=\"6_Statement_of_responsibility_and_signature\"><\/span>6. Statement of responsibility and signature<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Add a clear statement that the manufacturer takes <strong>full responsibility<\/strong> for compliance.<br \/>\nThe DoC must be signed by an authorised person, with their <strong>name, position, date, and place<\/strong> of issue.<\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"What_happens_if_your_DoC_is_incomplete_or_incorrect\"><\/span>What happens if your DoC is incomplete or incorrect?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>A non-compliant Declaration of Conformity can <strong>block CE marking<\/strong>, <strong>delay market access<\/strong>, and expose your company to <strong>regulatory penalties<\/strong> or product withdrawals.<br \/>\nThis is not a document you can afford to overlook.<\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"Does_the_Authorised_Representative_need_to_be_included\"><\/span>Does the Authorised Representative need to be included?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Yes, if your company is based outside the EU and you&#8217;ve appointed an AR, their <strong>name and address must be included<\/strong> in the declaration.<br \/>\nThey share legal responsibilities with you and must appear clearly in your documentation.<\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 40; line-height: 1.2;\" data-fontsize=\"40\" data-lineheight=\"48px\"><span class=\"ez-toc-section\" id=\"Need_help_drafting_or_reviewing_your_DoC\"><\/span>Need help drafting or reviewing your DoC?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>We assist medical device and IVD manufacturers, as well as Authorised Representatives, in preparing <strong>fully compliant<\/strong> EU Declarations of Conformity.<br \/>\nWhether you&#8217;re starting from scratch or just need a final check: <strong style=\"background-color: rgba(0, 0, 0, 0);\">We\u2019re here to support you.<\/strong><\/p>\n<p>For official EU guidance on Declarations of Conformity, you can also visit <a href=\"https:\/\/europa.eu\/youreurope\/business\/product-requirements\/compliance\/technical-documentation-conformity\/index_en.htm\"><b><u>this link<\/u><\/b><\/a>.<a href=\"https:\/\/europa.eu\/youreurope\/business\/product-requirements\/compliance\/technical-documentation-conformity\/index_en.htm\" target=\"_blank\" rel=\"noopener noreferrer\"><br \/>\n<\/a><\/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 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=\"1080\" height=\"1350\" alt=\"Doc\" title=\"Doc\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/Doc.jpg\" class=\"img-responsive wp-image-3740\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/Doc-200x250.jpg 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/Doc-400x500.jpg 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/Doc-600x750.jpg 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/Doc-800x1000.jpg 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/Doc.jpg 1080w\" sizes=\"(max-width: 640px) 100vw, 1080px\" \/><\/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;3745&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;3&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 - (3 votos)&quot;,&quot;size&quot;:&quot;24&quot;,&quot;title&quot;:&quot;How to write an EU Declaration of Conformity?&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 - (3 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-3745","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 Write an EU Declaration of Conformity<\/title>\n<meta name=\"description\" content=\"How to write a compliant EU Declaration of Conformity under MDR or IVDR. 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