{"id":3982,"date":"2025-07-29T11:41:12","date_gmt":"2025-07-29T11:41:12","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3982"},"modified":"2025-07-29T11:41:12","modified_gmt":"2025-07-29T11:41:12","slug":"can-i-appoint-two-different-representatives-for-devices-in-the-same-generic-group","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/can-i-appoint-two-different-representatives-for-devices-in-the-same-generic-group\/","title":{"rendered":"Can I appoint two different representatives for devices in the same generic group?"},"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><strong>No.<\/strong> Under the MDR and MDCG guidance, a manufacturer cannot appoint different authorized representatives for devices that belong to the same generic device group.<\/p>\n<p><strong>But what exactly does \u201csame generic group\u201d mean?<br \/>\nAnd how does this apply differently under the MDR and the IVDR?<\/strong><\/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\/can-i-appoint-two-different-representatives-for-devices-in-the-same-generic-group\/#The_definition_what_do_the_regulations_say\" >The definition: what do the regulations say?<\/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\/can-i-appoint-two-different-representatives-for-devices-in-the-same-generic-group\/#MDR_vs_IVDR_different_EMDN_levels\" >MDR vs IVDR: different EMDN levels<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/cmcmedicaldevices.com\/es\/can-i-appoint-two-different-representatives-for-devices-in-the-same-generic-group\/#Under_MDR\" >Under MDR:<\/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\/can-i-appoint-two-different-representatives-for-devices-in-the-same-generic-group\/#Under_IVDR\" >Under IVDR:<\/a><\/li><\/ul><\/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\/can-i-appoint-two-different-representatives-for-devices-in-the-same-generic-group\/#Need_a_refresher_on_how_the_EMDN_works\" >Need a refresher on how the EMDN works?<\/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\/can-i-appoint-two-different-representatives-for-devices-in-the-same-generic-group\/#So_what_should_you_keep_in_mind\" >So, what should you keep in mind?<\/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\/can-i-appoint-two-different-representatives-for-devices-in-the-same-generic-group\/#Need_support_with_classification_or_representation_strategy\" >Need support with classification or representation strategy?<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"The_definition_what_do_the_regulations_say\"><\/span>The definition: what do the regulations say?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The term <strong>generic device group<\/strong> is defined in the MDR (and also adopted in the Swiss MedDO and IvDO) as:<\/p>\n<blockquote>\n<p>\n  \u201ca set of devices having the same or similar intended purpose or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics.\u201d\n<\/p>\n<\/blockquote>\n<p>To apply this definition correctly, you need to refer to the <strong>EMDN<\/strong> \u2014 the European Medical Device Nomenclature \u2014 as clarified in <strong>MDCG 2019-13<\/strong>.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"MDR_vs_IVDR_different_EMDN_levels\"><\/span>MDR vs IVDR: different EMDN levels<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>To correctly identify a generic device group, the relevant EMDN level differs depending on the regulation:<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Under_MDR\"><\/span>Under MDR:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The generic device group corresponds to the <strong>4th level<\/strong> of the EMDN<\/p>\n<p><em>(Format: one letter + 6 digits \u2192 e.g., A123456)<\/em><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Under_IVDR\"><\/span>Under IVDR:<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>It refers to the <strong>3rd level<\/strong> of the EMDN<\/p>\n<p><em>(Format: one letter + 4 digits \u2192 e.g., A1234)<\/em><\/p>\n<p>and must be used together with the <strong>IVP code<\/strong> (Intended Purpose)<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Need_a_refresher_on_how_the_EMDN_works\"><\/span>Need a refresher on how the EMDN works?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>We covered it here: <b><u><a href=\"https:\/\/cmcmedicaldevices.com\/what-is-the-emdn-and-why-does-it-matter-for-your-medical-device\/\" target=\"_blank\" rel=\"noopener noreferrer\">What is the EMDN and why does it matter for your medical device?<\/a><\/u><\/b><\/p>\n<p>This means that two similar devices \u2014 even with slightly different features \u2014 may fall under the same generic group if they share a code at the relevant EMDN level. In such cases, appointing multiple representatives is <strong>not allowed<\/strong>.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"So_what_should_you_keep_in_mind\"><\/span>So, what should you keep in mind?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>If two of your devices fall under the same generic group, you are <strong>not allowed<\/strong> to assign them to different representatives.<br \/>\nTo get this right, you\u2019ll need to determine the appropriate level of the EMDN based on the regulation:<\/p>\n<ul>\n<li>For <strong>MDR<\/strong>, look at the <strong>4th level<\/strong><\/li>\n<li>For <strong>IVDR<\/strong>, refer to the <strong>3rd level<\/strong> and include the <strong>Intended Purpose (IVP)<\/strong><\/li>\n<\/ul>\n<p>This distinction is essential to maintain a consistent, compliant, and traceable representation strategy.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Need_support_with_classification_or_representation_strategy\"><\/span>Need support with classification or representation strategy?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b>Get in touch to ensure your documentation, registration, and market access plans are fully aligned with MDR and IVDR requirements.<\/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=\"Generic devices groups\" title=\"Generic devices groups\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/Generic-devices-groups.jpg\" class=\"img-responsive wp-image-3978\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/Generic-devices-groups-200x113.jpg 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/Generic-devices-groups-400x225.jpg 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/Generic-devices-groups-600x338.jpg 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/Generic-devices-groups-800x451.jpg 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/Generic-devices-groups-1200x676.jpg 1200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/07\/Generic-devices-groups.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;3982&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;Can I appoint two different representatives for devices in the same generic group?&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-3982","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>Two representatives for one generic device group?<\/title>\n<meta name=\"description\" content=\"You can\u2019t appoint two representatives for devices in the same generic device group. 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