{"id":9420,"date":"2022-03-15T17:24:54","date_gmt":"2022-03-15T16:24:54","guid":{"rendered":"https:\/\/www.riskmanager.net\/?p=9420"},"modified":"2022-03-16T11:55:23","modified_gmt":"2022-03-16T10:55:23","slug":"classification-of-medical-devices","status":"publish","type":"post","link":"https:\/\/www.riskmanager.net\/en\/2022\/03\/15\/classification-of-medical-devices\/","title":{"rendered":"How is the classification of medical devices according to MDR carried out?"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kkwbho9e-6e84f38ac0b99f9c905cccc0e3ab6e1f\">\n.avia-section.av-kkwbho9e-6e84f38ac0b99f9c905cccc0e3ab6e1f{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/03\/shutterstock_519284317-scaled.jpg);\nbackground-position:50% 100%;\nbackground-attachment:scroll;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-kkwbho9e-6e84f38ac0b99f9c905cccc0e3ab6e1f 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-9420'><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-9420'><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-av_heading-579634acd3a82fba10ab2bbaaaf3e11a\">\n#top .av-special-heading.av-av_heading-579634acd3a82fba10ab2bbaaaf3e11a{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-579634acd3a82fba10ab2bbaaaf3e11a .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-579634acd3a82fba10ab2bbaaaf3e11a .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-579634acd3a82fba10ab2bbaaaf3e11a av-special-heading-h1 blockquote modern-quote  avia-builder-el-3  avia-builder-el-no-sibling '><h1 class='av-special-heading-tag '  itemprop=\"headline\"  >How is the classification of medical devices according to MDR carried out?<\/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>Medical devices are subject to the risk classes defined in the Medical Device Regulation (MDR). According to the Regulation (EU) 2017\/745 (MDR), classification is made into four classes I, IIa, IIb and III (low to high risk in ascending order). But what exactly is the classification based on? And who has to follow it?<\/p>\n<p>What counts for the time being, however, is the question: Is the product really a medical device? Or is it a non-medical device, accessory or even in vitro diagnostic device (IVD)? The answer around the definition can be found in Article 2 of the MDR.<\/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>Accordingly, a medical device is an instrument, apparatus, appliance, software, implant, reagent, material [&#8230;] which, according to the manufacturer, is intended for human use and is intended to fulfil, alone or in combination, one or more [&#8230;] specific medical purposes.\u00a0<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/DE\/TXT\/?uri=uriserv:OJ.L_.2017.117.01.0001.01.DEU&amp;toc=OJ:L:2017:117:FULL\" target=\"_blank\" rel=\"noopener\"><em>Source (in german)<\/em><\/a><\/p>\n<\/div><\/section><\/p><\/div><\/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-9420'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l0sbdd51-b582fef1c3d63d3a8f175f6b4c1e5f28\">\n@keyframes av_boxShadowEffect_av-l0sbdd51-b582fef1c3d63d3a8f175f6b4c1e5f28-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-l0sbdd51-b582fef1c3d63d3a8f175f6b4c1e5f28{\nbox-shadow: 0 0 10px 0 #687a77;\nborder-width:2px;\nborder-color:#92afab;\nborder-style:solid;\nborder-radius:6px 6px 6px 6px;\npadding:15px 15px 15px 15px;\nbackground-color:#687a77;\n}\n<\/style>\n<div  class='flex_column av-l0sbdd51-b582fef1c3d63d3a8f175f6b4c1e5f28 av_two_fifth  avia-builder-el-8  el_before_av_three_fifth  avia-builder-el-first  first flex_column_div shadow-not-animated  '     ><section  class='av_textblock_section av-l0sbdtjp-687d6b0d5f444572e3e99b967e58edac '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p class=\"av-special-heading-tag \"><strong>Classification of in vitro diagnostic medical devices (IVD) &#8211; how is classification done?<\/strong><\/p>\n<h4 class=\"av-special-heading-tag \"><\/h4>\n<\/div><\/section><br \/>\n<section  class='av_textblock_section av-l0sbdtjp-687d6b0d5f444572e3e99b967e58edac '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>What counts as in vitro diagnostics (IVD) and into which risk classes are IVDs classified? Read more in our <a href=\"https:\/\/www.riskmanager.net\/en\/2022\/02\/10\/classification-of-in-vitro-diagnostic-medical-devices\/\" target=\"_blank\" rel=\"noopener\">blog post<\/a>.<\/p>\n<h4 class=\"av-special-heading-tag \"><\/h4>\n<\/div><\/section><\/p><\/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-11  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-l0sbjzcp-a28666421f62624017fc548cbbd535d7\">\n#top .hr.hr-invisible.av-l0sbjzcp-a28666421f62624017fc548cbbd535d7{\nmargin-top:-15px;\nheight:1px;\n}\n<\/style>\n<div  class='hr av-l0sbjzcp-a28666421f62624017fc548cbbd535d7 hr-invisible  avia-builder-el-12  el_before_av_textblock  avia-builder-el-first '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<section  class='av_textblock_section av-kq9jrf76-09c46e0ddb9a931dc0912195d8e908e2 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Once it has been determined that the product is a medical device according to the MDR, the next step is to determine the labelling, instructions for use and promotional materials as well as the actual intended purpose. Manufacturers determine the intended purpose individually for each product. For this purpose, a definition for medical devices according to Article 2 of the MDR must be fulfilled.<\/p>\n<p>Based on this intended purpose, the classification of the medical device into a risk class follows. For the classification of the product into the respective product class, the regulation provides a total of 22 rules in Annex VIII of the MDR.<\/p>\n<\/div><\/section><\/p><\/div>\n<\/p>\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-14  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-9420'><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_one_half  avia-builder-el-15  el_before_av_one_half  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l0saz3kk-98ad00ef331bb6a35c13ccc0ab1055c5\">\n#top .hr.hr-invisible.av-l0saz3kk-98ad00ef331bb6a35c13ccc0ab1055c5{\nheight:25px;\n}\n<\/style>\n<div  class='hr av-l0saz3kk-98ad00ef331bb6a35c13ccc0ab1055c5 hr-invisible  avia-builder-el-16  el_before_av_image  avia-builder-el-first '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kybgm992-03b7b280ed686958658153a255dcc26a\">\n.avia-image-container.av-kybgm992-03b7b280ed686958658153a255dcc26a img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-kybgm992-03b7b280ed686958658153a255dcc26a .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-kybgm992-03b7b280ed686958658153a255dcc26a av-styling- avia-align-center  avia-builder-el-17  el_after_av_hr  avia-builder-el-last '   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-7057 avia-img-lazy-loading-not-7057 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/MDR-und-Technische-Doku_shutterstock_311772953-scaled.jpg\" alt='' title='MDR und Technische Doku_shutterstock_311772953'  height=\"1707\" width=\"2560\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/MDR-und-Technische-Doku_shutterstock_311772953-scaled.jpg 2560w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/MDR-und-Technische-Doku_shutterstock_311772953-300x200.jpg 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/MDR-und-Technische-Doku_shutterstock_311772953-1030x687.jpg 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/MDR-und-Technische-Doku_shutterstock_311772953-768x512.jpg 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/MDR-und-Technische-Doku_shutterstock_311772953-1536x1024.jpg 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/MDR-und-Technische-Doku_shutterstock_311772953-2048x1365.jpg 2048w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/MDR-und-Technische-Doku_shutterstock_311772953-1500x1000.jpg 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/MDR-und-Technische-Doku_shutterstock_311772953-705x470.jpg 705w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/div><\/div><\/div><\/p><\/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_one_half  avia-builder-el-18  el_after_av_one_half  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><p><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 manufacturer of the medical device or their authorised representative is responsible for the risk classification. Not quite so simple: The Federal Institute for Drugs and Medical Devices (german: BfArM) rules out a blanket classification into risk classes based on product groups, as the classification is always based on the intended purpose and individual information provided by the manufacturer.<\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l0sbjzcp-1e85a708d48519f0daf14380f09a1d51\">\n#top .hr.hr-invisible.av-l0sbjzcp-1e85a708d48519f0daf14380f09a1d51{\nheight:20px;\n}\n<\/style>\n<div  class='hr av-l0sbjzcp-1e85a708d48519f0daf14380f09a1d51 hr-invisible  avia-builder-el-20  el_after_av_textblock  el_before_av_icon_box '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<article  class='iconbox iconbox_top av-l0sa676x-8eb37f6f723ae03b477164f1ac8b06c2  avia-builder-el-21  el_after_av_hr  avia-builder-el-last  main_color'  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>If a medical device is used in combination with another device, a separate classification must be made in each case. Accessories for a medical device are also classified separately.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><\/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-22  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-9420'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-40h15o-b42c9991a5538cc2be2c3627e4192bd8\">\n.flex_column.av-40h15o-b42c9991a5538cc2be2c3627e4192bd8{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-40h15o-b42c9991a5538cc2be2c3627e4192bd8 av_four_fifth  avia-builder-el-23  el_before_av_one_half  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-l0scb4i0-43c429c82b226437251a1f3081d936ab\">\n#top .av-special-heading.av-l0scb4i0-43c429c82b226437251a1f3081d936ab{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-l0scb4i0-43c429c82b226437251a1f3081d936ab .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-l0scb4i0-43c429c82b226437251a1f3081d936ab .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-l0scb4i0-43c429c82b226437251a1f3081d936ab av-special-heading-h3 blockquote modern-quote  avia-builder-el-24  avia-builder-el-no-sibling '><h3 class='av-special-heading-tag '  itemprop=\"headline\"  >Risk classification in a few steps <\/h3><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-2fl0uk-811520c301605e4b421de7c82eb048f1\">\n@keyframes av_boxShadowEffect_av-2fl0uk-811520c301605e4b421de7c82eb048f1-column {\n0%   { box-shadow:  0 0 0 0 ; opacity: 1; }\n100% { box-shadow:  0 0 10px 0 ; opacity: 1; }\n}\n.flex_column.av-2fl0uk-811520c301605e4b421de7c82eb048f1{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2fl0uk-811520c301605e4b421de7c82eb048f1 av_one_half  avia-builder-el-25  el_after_av_four_fifth  el_before_av_one_half  first flex_column_div av-zero-column-padding  '     ><p><section  class='av_textblock_section av-kybif1g6-b763b4267d3dc922bda87e39daa16bb3 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>To provide optimal support in <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/features\/#mdr-classification\" target=\"_blank\" rel=\"noopener\">classification<\/a> according to the medical device regulation (MDR Article 51 (1)), we have fully integrated the functionality for\u00a0classifying the medical device into categories I, IIa, IIb or III\u00a0in the validated approval accelerator. Based on an\u00a0interactive questionnaire, you are guided through the classification process and can issue the result as a report.<\/p>\n<p>This provides you with an initial reference for classifying your medical device. You then only need to give a justification for the classification, considering the intended purpose and stating the applied rules.<\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l0saz3kk-98ad00ef331bb6a35c13ccc0ab1055c5\">\n#top .hr.hr-invisible.av-l0saz3kk-98ad00ef331bb6a35c13ccc0ab1055c5{\nheight:25px;\n}\n<\/style>\n<div  class='hr av-l0saz3kk-98ad00ef331bb6a35c13ccc0ab1055c5 hr-invisible  avia-builder-el-27  el_after_av_textblock  el_before_av_button '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<div  class='avia-button-wrap av-kybiflj2-8fe5b91601f85dd82ac5246823227f0e-wrap avia-button-center  avia-builder-el-28  el_after_av_hr  avia-builder-el-last '><a href='https:\/\/www.riskmanager.net\/en\/services\/test-now\/'  class='avia-button av-kybiflj2-8fe5b91601f85dd82ac5246823227f0e av-link-btn avia-icon_select-no avia-size-x-large avia-position-center 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av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-9420'><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  '     ><p><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>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 30-day free TRIAL or visit one of the <a href=\"https:\/\/www.riskmanager.net\/en\/upcomming-events\/\" target=\"_blank\" rel=\"noopener\">upcoming online product presentations<\/a>. 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