{"id":9160,"date":"2022-02-10T10:11:13","date_gmt":"2022-02-10T09:11:13","guid":{"rendered":"https:\/\/www.riskmanager.net\/?p=9160"},"modified":"2022-02-10T10:11:13","modified_gmt":"2022-02-10T09:11:13","slug":"classification-of-in-vitro-diagnostic-medical-devices","status":"publish","type":"post","link":"https:\/\/www.riskmanager.net\/en\/2022\/02\/10\/classification-of-in-vitro-diagnostic-medical-devices\/","title":{"rendered":"Classification of in vitro diagnostic medical devices (IVD)"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kkwbho9e-adb49aa064f9740fe657c9004b81a723\">\n.avia-section.av-kkwbho9e-adb49aa064f9740fe657c9004b81a723{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/02\/shutterstock_524351890-scaled.jpg);\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-kkwbho9e-adb49aa064f9740fe657c9004b81a723 main_color avia-section-default avia-no-border-styling  avia-builder-el-0  el_before_av_section  avia-builder-el-first  avia-full-stretch avia-bg-style-scroll av-minimum-height av-minimum-height-custom av-height-custom  container_wrap fullsize'  data-section-bg-repeat='stretch' data-av_minimum_height_px='500'><div class='container av-section-cont-open' style='height:500px'><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-9160'><div class='entry-content-wrapper clearfix'>\n<\/div><\/div><\/main><!-- close content main element --><\/div><\/div><div id='av_section_2'  class='avia-section av-bjkpou-4d21ae85a694f724a081997bbbff889f main_color avia-section-default avia-no-border-styling  avia-builder-el-1  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-9160'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-9r4r66-90380a229f4631b5c0d2990376471ae0\">\n.flex_column.av-9r4r66-90380a229f4631b5c0d2990376471ae0{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-9r4r66-90380a229f4631b5c0d2990376471ae0 av_one_full  avia-builder-el-2  el_before_av_four_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kzfu0fe1-cacc256bb71778e223837f9e788bff31\">\n#top .av-special-heading.av-kzfu0fe1-cacc256bb71778e223837f9e788bff31{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-kzfu0fe1-cacc256bb71778e223837f9e788bff31 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-kzfu0fe1-cacc256bb71778e223837f9e788bff31 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-kzfu0fe1-cacc256bb71778e223837f9e788bff31 av-special-heading-h1 blockquote modern-quote  avia-builder-el-3  avia-builder-el-no-sibling '><h1 class='av-special-heading-tag '  itemprop=\"headline\"  >Classification of in vitro diagnostic devices (IVD)<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-b7af1a97b142497931a61a322e892d04\">\n.flex_column.av-bcmscg-b7af1a97b142497931a61a322e892d04{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-b7af1a97b142497931a61a322e892d04 av_four_fifth  avia-builder-el-4  el_after_av_one_full  avia-builder-el-last  first flex_column_div av-zero-column-padding  column-top-margin'     ><p><section  class='av_textblock_section av-kkwbj1na-aaae942871a562d489d49038a1da7612 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>In vitro diagnostic (IVD) devices &#8211; medical devices that are not regulated under MDR. This is because the EU In Vitro Diagnostics Regulation (IVDR) applies here. But which medical devices fall under the term IVD? What is the classification of the product? And what obligations do manufacturers have to observe?<\/p>\n<\/div><\/section><br \/>\n<section  class='av_textblock_section av-kkwbj1na-aaae942871a562d489d49038a1da7612 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>According to Article 2 of Regulation (EU) 2017\/746 (IVDR), the term means &#8220;a medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, device, software or system, whether used alone or in combination, intended by the manufacturer to be used for the in vitro examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information [&#8230;]&#8221;.<\/p>\n<p style=\"text-align: right\"><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/DE\/TXT\/PDF\/?uri=CELEX:02017R0746-20170505&amp;from=DE\" target=\"_blank\" rel=\"noopener\">Source (in german)<\/a><\/p>\n<\/div><\/section><\/p><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-6ypsa6-5f1a4b6d4c3fcc1202205e8cc034382e\">\n.avia-section.av-6ypsa6-5f1a4b6d4c3fcc1202205e8cc034382e{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/07\/shutterstock_587192849-1-scaled-1.jpg);\nbackground-position:0% 50%;\nbackground-attachment:scroll;\n}\n.avia-section.av-6ypsa6-5f1a4b6d4c3fcc1202205e8cc034382e .av-section-color-overlay{\nopacity:0.9;\nbackground-color:#3f3f3f;\n}\n<\/style>\n<div id='av_section_3'  class='avia-section av-6ypsa6-5f1a4b6d4c3fcc1202205e8cc034382e alternate_color avia-section-default avia-no-border-styling  avia-builder-el-7  el_after_av_section  el_before_av_section  avia-full-stretch avia-bg-style-scroll av-section-color-overlay-active container_wrap fullsize'  data-section-bg-repeat='stretch'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-9160'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-b7af1a97b142497931a61a322e892d04\">\n.flex_column.av-bcmscg-b7af1a97b142497931a61a322e892d04{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-b7af1a97b142497931a61a322e892d04 av_four_fifth  avia-builder-el-8  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><p><section  class='av_textblock_section av-kq9jrf76-09c46e0ddb9a931dc0912195d8e908e2 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Information about what? This includes, following the regulation,<\/p>\n<\/div><\/section><br \/>\n<div  class='avia-icon-list-container av-kzftgq3a-5be3d1663d21e396d0c268cc86cdd681  avia-builder-el-10  el_after_av_textblock  avia-builder-el-last '><ul class='avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-big av-kzftgq3a-5be3d1663d21e396d0c268cc86cdd681 avia-iconlist-animate'>\n<li><div class='iconlist_icon av-cpww54-729a8208c0beab51f9458b732120ebc0 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue875' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: physiological or pathological processes\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >physiological or pathological processes<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-bd2pe0-47e7beb2008b5969f13bb5496b41bee2 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue875' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: congenital physical or mental impairments\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >congenital physical or mental impairments<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-8ziprc-4da1e048797b1d3d9028e47b8790ed73 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue875' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: susceptibility to certain diseases, etc.\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >susceptibility to certain diseases, etc.<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-7tpfy0-640e66481f4e6afefa5b3e6c00ba55c7 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue875' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: determining whether potential recipients show any concerns or intolerances\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >determining whether potential recipients show any concerns or intolerances<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-66iizc-63ba5502171ace7c97f1875b06142975 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue875' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: an anticipated effect or reaction to a treatment\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >an anticipated effect or reaction to a treatment<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-4jsraw-803688b445face451e790f0e27829da2 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue875' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: the determination or monitoring of therapeutic measures\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >the determination or monitoring of therapeutic measures<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<\/ul><\/div><\/p><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><\/div><div id='av_section_4'  class='avia-section av-6ypsa6-98695f771d14b674197121c82d95ada8 main_color avia-section-default avia-no-border-styling  avia-builder-el-11  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-9160'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-b7af1a97b142497931a61a322e892d04\">\n.flex_column.av-bcmscg-b7af1a97b142497931a61a322e892d04{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-b7af1a97b142497931a61a322e892d04 av_two_fifth  avia-builder-el-12  el_before_av_three_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kybgm992-7ce5247d271e514acc8281964c515b67\">\n.avia-image-container.av-kybgm992-7ce5247d271e514acc8281964c515b67 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-kybgm992-7ce5247d271e514acc8281964c515b67 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-kybgm992-7ce5247d271e514acc8281964c515b67 av-styling- av-hover-grow avia-align-center  avia-builder-el-13  avia-builder-el-no-sibling '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-9153 avia-img-lazy-loading-not-9153 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/02\/shutterstock_164724209-scaled.jpg\" alt='' title='shutterstock_164724209'  height=\"1706\" width=\"2560\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/02\/shutterstock_164724209-scaled.jpg 2560w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/02\/shutterstock_164724209-300x200.jpg 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/02\/shutterstock_164724209-1030x687.jpg 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/02\/shutterstock_164724209-768x512.jpg 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/02\/shutterstock_164724209-1536x1024.jpg 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/02\/shutterstock_164724209-2048x1365.jpg 2048w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/02\/shutterstock_164724209-1500x1000.jpg 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/02\/shutterstock_164724209-705x470.jpg 705w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/div><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-85b3d8d408f80152e13fe296657fc778\">\n.flex_column.av-bcmscg-85b3d8d408f80152e13fe296657fc778{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-85b3d8d408f80152e13fe296657fc778 av_three_fifth  avia-builder-el-14  el_after_av_two_fifth  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kzfubs32-4af4d82f6b35fcdbd042149bec628f05\">\n#top .av-special-heading.av-kzfubs32-4af4d82f6b35fcdbd042149bec628f05{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-kzfubs32-4af4d82f6b35fcdbd042149bec628f05 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-kzfubs32-4af4d82f6b35fcdbd042149bec628f05 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-kzfubs32-4af4d82f6b35fcdbd042149bec628f05 av-special-heading-h3 blockquote modern-quote  avia-builder-el-15  el_before_av_textblock  avia-builder-el-first '><h3 class='av-special-heading-tag '  itemprop=\"headline\"  >How does the classification work?<\/h3><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-kybhjpqc-a464430f6302bd6a385e542f0ca16ddb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The classification of an IVD is also regulated in the IVDR within the framework of risk-based classification. As in the Medical Device Regulation (MDR), the classification is based on the intended purpose of the product and the resulting risk profile. According to the IVDR, the classification is made into classes A, B, C and D.<\/p>\n<p>The IVDR defines the risk class of a product on the basis of seven rules. If there is a low risk, products are assigned to class A. As the risk increases, products are assigned to classes B, C or D. Only for medical devices in class A is it possible for manufacturers to declare conformity themselves for market placement; for the other risk classes, the notified bodies must be involved in the conformity assessment procedure.<\/p>\n<\/div><\/section><\/p><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kkwbkig3-281ee86942199ed49db7088682f78ab3\">\n.avia-section.av-kkwbkig3-281ee86942199ed49db7088682f78ab3{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/07\/shutterstock_587192849-1-scaled-1.jpg);\nbackground-position:50% 50%;\nbackground-attachment:scroll;\nmargin-top:5px;\nmargin-bottom:0px;\n}\n.avia-section.av-kkwbkig3-281ee86942199ed49db7088682f78ab3 .av-section-color-overlay{\nopacity:0.9;\nbackground-color:#3f3f3f;\n}\n<\/style>\n<div id='av_section_5'  class='avia-section av-kkwbkig3-281ee86942199ed49db7088682f78ab3 alternate_color avia-section-default avia-no-border-styling  avia-builder-el-17  el_after_av_section  el_before_av_section  avia-full-stretch avia-bg-style-scroll av-section-color-overlay-active container_wrap fullsize'  data-section-bg-repeat='stretch'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-9160'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-b7af1a97b142497931a61a322e892d04\">\n.flex_column.av-bcmscg-b7af1a97b142497931a61a322e892d04{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-b7af1a97b142497931a61a322e892d04 av_four_fifth  avia-builder-el-18  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><p><article  class='iconbox iconbox_left av-kzftkij6-5f38742f0ed1a41e22f2fa45bb1548c8  avia-builder-el-19  el_before_av_hr  avia-builder-el-first '  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: Good to know\"><div class=\"iconbox_icon heading-color\" aria-hidden='true' data-av_icon='\ue864' data-av_iconfont='entypo-fontello'><\/div><h3 class='iconbox_content_title '  itemprop=\"headline\" >Good to know<\/h3><\/header><div class='iconbox_content_container '  itemprop=\"text\" ><p>According to the IVDR, the accessories for an IVD are classified separately. The risk class of the associated device is to be considered independently of the classification of the accessory. (cf. Annex VIII, 1.3)<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kzftld2n-8c57bbc81183668f1d0843764a98ca08\">\n#top .hr.hr-invisible.av-kzftld2n-8c57bbc81183668f1d0843764a98ca08{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-kzftld2n-8c57bbc81183668f1d0843764a98ca08 hr-invisible  avia-builder-el-20  el_after_av_icon_box  el_before_av_textblock '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<section  class='av_textblock_section av-kzftl0gw-dd53dce055351f16c55a6cddb74676dd '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>If several classification rules apply to a product, the IVD is assigned to the highest risk class. The same applies if the manufacturer specifies several intended uses for a product and the product can thus be assigned to several classes. In this case, too, the classification is made in the highest risk class.<\/p>\n<\/div><\/section><\/p><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><\/div><div id='av_section_6'  class='avia-section av-2uan7g-c1b018ca26da418793c3f2e314294a46 main_color avia-section-default avia-no-border-styling  avia-builder-el-22  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-9160'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2fl0uk-f4beedba5c70e443835156d1983a4b41\">\n@keyframes av_boxShadowEffect_av-2fl0uk-f4beedba5c70e443835156d1983a4b41-column {\n0%   { box-shadow:  0 0 0 0 #687a77; opacity: 1; }\n100% { box-shadow:  0 0 10px 0 #687a77; opacity: 1; }\n}\n.flex_column.av-2fl0uk-f4beedba5c70e443835156d1983a4b41{\nbox-shadow: 0 0 10px 0 #687a77;\nborder-width:3px;\nborder-color:#92afab;\nborder-style:solid;\nborder-radius:6px 6px 6px 6px;\npadding:15px 15px 15px 15px;\n}\n<\/style>\n<div  class='flex_column av-2fl0uk-f4beedba5c70e443835156d1983a4b41 av_four_fifth  avia-builder-el-23  avia-builder-el-no-sibling  first flex_column_div shadow-not-animated  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kzfuft2v-383dc44bfdd966f5a0a1a07240d8673a\">\n#top .av-special-heading.av-kzfuft2v-383dc44bfdd966f5a0a1a07240d8673a{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-kzfuft2v-383dc44bfdd966f5a0a1a07240d8673a .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-kzfuft2v-383dc44bfdd966f5a0a1a07240d8673a .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-kzfuft2v-383dc44bfdd966f5a0a1a07240d8673a av-special-heading-h3 blockquote modern-quote  avia-builder-el-24  el_before_av_textblock  avia-builder-el-first '><h3 class='av-special-heading-tag '  itemprop=\"headline\"  >The classifier for in vitro diagnostic devices: New function in BAYOOSOFT Risk Manager 10.4<\/h3><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-kybif1g6-b763b4267d3dc922bda87e39daa16bb3 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>With Risk Manager Version 10.4, the functions of the already established classifier for medical devices are also available in conformity with the IVDR 2017\/746 standard. Thus, you determine the assignment of the risk class in an uncomplicated way by answering predefined questions. Features for labelling and recognition of non-applicable questions are also included to ensure conformity with your notified body.<\/p>\n<\/div><\/section><br \/>\n<div  class='avia-button-wrap av-kybiflj2-3629227c3b1f370a443e64f9a05d4c38-wrap avia-button-center  avia-builder-el-26  el_after_av_textblock  avia-builder-el-last '><a href='https:\/\/www.riskmanager.net\/en\/services\/contact\/'  class='avia-button av-kybiflj2-3629227c3b1f370a443e64f9a05d4c38 av-link-btn avia-icon_select-no avia-size-x-large avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"product presentation\"><span class='avia_iconbox_title' >product presentation<\/span><\/a><\/div><\/p><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kkwbkig3-281ee86942199ed49db7088682f78ab3\">\n.avia-section.av-kkwbkig3-281ee86942199ed49db7088682f78ab3{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/07\/shutterstock_587192849-1-scaled-1.jpg);\nbackground-position:50% 50%;\nbackground-attachment:scroll;\nmargin-top:5px;\nmargin-bottom:0px;\n}\n.avia-section.av-kkwbkig3-281ee86942199ed49db7088682f78ab3 .av-section-color-overlay{\nopacity:0.9;\nbackground-color:#3f3f3f;\n}\n<\/style>\n<div id='av_section_7'  class='avia-section av-kkwbkig3-281ee86942199ed49db7088682f78ab3 alternate_color avia-section-default avia-no-border-styling  avia-builder-el-27  el_after_av_section  el_before_av_section  avia-full-stretch avia-bg-style-scroll av-section-color-overlay-active container_wrap fullsize'  data-section-bg-repeat='stretch'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-9160'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-b7af1a97b142497931a61a322e892d04\">\n.flex_column.av-bcmscg-b7af1a97b142497931a61a322e892d04{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-b7af1a97b142497931a61a322e892d04 av_four_fifth  avia-builder-el-28  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kzfuhnco-fb9694d2a538efa1176f68f0c03c4aff\">\n#top .av-special-heading.av-kzfuhnco-fb9694d2a538efa1176f68f0c03c4aff{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-kzfuhnco-fb9694d2a538efa1176f68f0c03c4aff .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-kzfuhnco-fb9694d2a538efa1176f68f0c03c4aff .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-kzfuhnco-fb9694d2a538efa1176f68f0c03c4aff av-special-heading-h3 blockquote modern-quote  avia-builder-el-29  el_before_av_textblock  avia-builder-el-first '><h3 class='av-special-heading-tag '  itemprop=\"headline\"  >What are the obligations of IVD manufacturers?<\/h3><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-kybhjpqc-a464430f6302bd6a385e542f0ca16ddb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>When products are placed on the market and put into service, manufacturers ensure conformity according to the IVDR with the technical documentation. In addition, the IVDR &#8211; similar to the MDR &#8211; requires the establishment and implementation of a risk management system and technical documentation for the medical device.<\/p>\n<p>Both must be continued and maintained even after the device has been placed on the market. At the request of the Notified Bodies, the technical documentation, among other things, must be handed over for at least ten years after the device has been placed on the market.<\/p>\n<\/div><\/section><\/p><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><\/div><div id='av_section_8'  class='avia-section av-2uan7g-c1b018ca26da418793c3f2e314294a46 main_color avia-section-default avia-no-border-styling  avia-builder-el-31  el_after_av_section  avia-builder-el-last  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-9160'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-b7af1a97b142497931a61a322e892d04\">\n.flex_column.av-bcmscg-b7af1a97b142497931a61a322e892d04{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-b7af1a97b142497931a61a322e892d04 av_four_fifth  avia-builder-el-32  el_before_av_four_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><article  class='iconbox iconbox_left av-kybhoi36-c8bf8ef32140bfdd7cc0daf7f397fe08  avia-builder-el-33  el_before_av_hr  avia-builder-el-first '  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: Get to know us\"><div class=\"iconbox_icon heading-color\" aria-hidden='true' data-av_icon='\ue80b' data-av_iconfont='entypo-fontello'><\/div><h3 class='iconbox_content_title '  itemprop=\"headline\" >Get to know us<\/h3><\/header><div class='iconbox_content_container '  itemprop=\"text\" ><p class=\"av-special-heading-tag \">The efficient way to technical documentation: BAYOOSOFT Risk Manager supports you in the creation of technical documentation for medical devices and in vitro diagnostics. All relevant information is recorded in a clearly structured environment, stored centrally in an audit-proof manner and linked dynamically in a fine-granular manner. This automatically avoids redundant data storage. Reports are generated with the most up-to-date data at the touch of a button.<\/p>\n<p>Would you like to get to know the BAYOOSOFT Risk Manager? Then take advantage of our <a href=\"https:\/\/www.riskmanager.net\/en\/services\/contact\/\" target=\"_blank\" rel=\"noopener\">30-day free TRIAL<\/a> or visit one of the upcoming online product presentations. You can find an overview of <a href=\"https:\/\/www.riskmanager.net\/en\/upcomming-events\/\" target=\"_blank\" rel=\"noopener\">upcomming events<\/a> here.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kybhvfri-52716a69b0a524fa7988bf5d44dfc487\">\n#top .hr.hr-invisible.av-kybhvfri-52716a69b0a524fa7988bf5d44dfc487{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-kybhvfri-52716a69b0a524fa7988bf5d44dfc487 hr-invisible  avia-builder-el-34  el_after_av_icon_box  avia-builder-el-last '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-b7af1a97b142497931a61a322e892d04\">\n.flex_column.av-bcmscg-b7af1a97b142497931a61a322e892d04{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-b7af1a97b142497931a61a322e892d04 av_four_fifth  avia-builder-el-35  el_after_av_four_fifth  avia-builder-el-last  first flex_column_div av-zero-column-padding  '     ><div  class='av-social-sharing-box av-kybhsk7l-e8ede0d552c7c0a3ad6cf32b71ae0a11 av-social-sharing-box-minimal  avia-builder-el-36  avia-builder-el-no-sibling  av-social-sharing-box-fullwidth'><div class=\"av-share-box\"><h5 class='av-share-link-description av-no-toc '>Sounds interesting? Share our post<\/h5><ul class=\"av-share-box-list noLightbox\"><li class='av-share-link av-social-link-facebook' ><a target=\"_blank\" aria-label=\"Share on Facebook\" href='https:\/\/www.facebook.com\/sharer.php?u=https:\/\/www.riskmanager.net\/en\/2022\/02\/10\/classification-of-in-vitro-diagnostic-medical-devices\/&#038;t=Classification%20of%20in%20vitro%20diagnostic%20medical%20devices%20%28IVD%29' aria-hidden='false' data-av_icon='\ue8f3' data-av_iconfont='entypo-fontello' title='' data-avia-related-tooltip='Share on Facebook'><span class='avia_hidden_link_text'>Share on Facebook<\/span><\/a><\/li><li class='av-share-link av-social-link-whatsapp' ><a target=\"_blank\" aria-label=\"Share on WhatsApp\" href='https:\/\/api.whatsapp.com\/send?text=https:\/\/www.riskmanager.net\/en\/2022\/02\/10\/classification-of-in-vitro-diagnostic-medical-devices\/' aria-hidden='false' data-av_icon='\uf232' data-av_iconfont='entypo-fontello' title='' data-avia-related-tooltip='Share on WhatsApp'><span class='avia_hidden_link_text'>Share on WhatsApp<\/span><\/a><\/li><li class='av-share-link av-social-link-linkedin' ><a target=\"_blank\" aria-label=\"Share on LinkedIn\" href='https:\/\/linkedin.com\/shareArticle?mini=true&#038;title=Classification%20of%20in%20vitro%20diagnostic%20medical%20devices%20%28IVD%29&#038;url=https:\/\/www.riskmanager.net\/en\/2022\/02\/10\/classification-of-in-vitro-diagnostic-medical-devices\/' aria-hidden='false' data-av_icon='\ue8fc' data-av_iconfont='entypo-fontello' title='' data-avia-related-tooltip='Share on LinkedIn'><span class='avia_hidden_link_text'>Share on LinkedIn<\/span><\/a><\/li><li class='av-share-link av-social-link-mail' ><a  aria-label=\"Share by Mail\" href='mailto:?subject=Classification%20of%20in%20vitro%20diagnostic%20medical%20devices%20%28IVD%29&#038;body=https:\/\/www.riskmanager.net\/en\/2022\/02\/10\/classification-of-in-vitro-diagnostic-medical-devices\/' aria-hidden='false' data-av_icon='\ue805' data-av_iconfont='entypo-fontello' title='' data-avia-related-tooltip='Share by Mail'><span class='avia_hidden_link_text'>Share by Mail<\/span><\/a><\/li><\/ul><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":42,"featured_media":9151,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[15],"tags":[],"class_list":["post-9160","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-editorial-en"],"_links":{"self":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/posts\/9160","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/users\/42"}],"replies":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/comments?post=9160"}],"version-history":[{"count":6,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/posts\/9160\/revisions"}],"predecessor-version":[{"id":11706,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/posts\/9160\/revisions\/11706"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/media\/9151"}],"wp:attachment":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/media?parent=9160"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/categories?post=9160"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/tags?post=9160"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}