{"id":10275,"date":"2022-07-20T18:22:07","date_gmt":"2022-07-20T16:22:07","guid":{"rendered":"https:\/\/www.riskmanager.net\/?p=10275"},"modified":"2022-07-20T18:22:07","modified_gmt":"2022-07-20T16:22:07","slug":"safety-performance-requirements","status":"publish","type":"post","link":"https:\/\/www.riskmanager.net\/en\/2022\/07\/20\/safety-performance-requirements\/","title":{"rendered":"General safety and performance requirements: What applies to medical devices under MDR and IVDR?"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bvb0ox-424295cadbb0612108dbc048091fe334\">\n.avia-section.av-bvb0ox-424295cadbb0612108dbc048091fe334{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/07\/shutterstock_1895104081-scaled.jpg);\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-bvb0ox-424295cadbb0612108dbc048091fe334 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='700'><div class='container av-section-cont-open' style='height:700px'><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-10275'><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-3571ltt-04e6d12816342b897e18ea8f748b222f 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-10275'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2clxuox-51063d26259269fa8b5f33dfb0499f0a\">\n.flex_column.av-2clxuox-51063d26259269fa8b5f33dfb0499f0a{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2clxuox-51063d26259269fa8b5f33dfb0499f0a av_one_fifth  avia-builder-el-2  el_before_av_three_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-24ssyu9-a3c19b969420350b88a3fc2a3927455f\">\n.flex_column.av-24ssyu9-a3c19b969420350b88a3fc2a3927455f{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-24ssyu9-a3c19b969420350b88a3fc2a3927455f av_three_fifth  avia-builder-el-3  el_after_av_one_fifth  el_before_av_one_fifth  flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-17xodlv-90d20be899cff1e341ac090085312014\">\n#top .av-special-heading.av-17xodlv-90d20be899cff1e341ac090085312014{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-17xodlv-90d20be899cff1e341ac090085312014 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-17xodlv-90d20be899cff1e341ac090085312014 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-17xodlv-90d20be899cff1e341ac090085312014 av-special-heading-h1 blockquote modern-quote modern-centered  avia-builder-el-4  el_before_av_hr  avia-builder-el-first '><h1 class='av-special-heading-tag '  itemprop=\"headline\"  >General safety and performance requirements: What applies to medical devices under MDR and IVDR?<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l5idj4jy-32d00059b4b372cb8b495dc4ed2e4746\">\n#top .hr.hr-invisible.av-l5idj4jy-32d00059b4b372cb8b495dc4ed2e4746{\nheight:50px;\n}\n<\/style>\n<div  class='hr av-l5idj4jy-32d00059b4b372cb8b495dc4ed2e4746 hr-invisible  avia-builder-el-5  el_after_av_heading  el_before_av_textblock '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<section  class='av_textblock_section av-l5idjn4t-d546d7c615d600612fb1af5d70d0013c '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>For medical devices, the following applies within the EU: No CE marking and thus European market authorisation without complied general safety and performance requirements and conformity assessment procedure. Therefore the Medical Device Regulation (EU) 2017\/745 and the In Vitro Diagnostics Regulation (EU) 2017\/746 &#8211; MDR and IVDR for short -, specify concrete requirements.<\/p>\n<p>So what applies to manufacturers of medical devices or in vitro diagnostic medical devices? What requirements do you have to meet in order to demonstrate that the general safety and performance requirements are fulfilled for your conformity assessment procedure?<\/p>\n<\/div><\/section><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-jy8ld-207ab181e19e369a95198f8fd36ebf63\">\n.flex_column.av-jy8ld-207ab181e19e369a95198f8fd36ebf63{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-jy8ld-207ab181e19e369a95198f8fd36ebf63 av_one_fifth  avia-builder-el-7  el_after_av_three_fifth  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><\/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-zq6xz5-a64bd39a090a14201858b255b77644ff\">\n.avia-section.av-zq6xz5-a64bd39a090a14201858b255b77644ff{\nbackground-color:#373736;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_3'  class='avia-section av-zq6xz5-a64bd39a090a14201858b255b77644ff alternate_color avia-section-default avia-no-border-styling  avia-builder-el-8  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-10275'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1swo5q9-3f6135e8ef7e3110944d8ad8bf90bbd4\">\n.flex_column.av-1swo5q9-3f6135e8ef7e3110944d8ad8bf90bbd4{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-1swo5q9-3f6135e8ef7e3110944d8ad8bf90bbd4 av_one_full  avia-builder-el-9  el_before_av_two_third  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-t9xqzn-a6b579c675f655ad7e39327c2a0b9110\">\n#top .av-special-heading.av-t9xqzn-a6b579c675f655ad7e39327c2a0b9110{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-t9xqzn-a6b579c675f655ad7e39327c2a0b9110 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-t9xqzn-a6b579c675f655ad7e39327c2a0b9110 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-t9xqzn-a6b579c675f655ad7e39327c2a0b9110 av-special-heading-h3 blockquote modern-quote  avia-builder-el-10  avia-builder-el-no-sibling '><h3 class='av-special-heading-tag '  itemprop=\"headline\"  >General safety and performance requirements for medical devices (according to MDR, Annex I): <\/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-s6rfa9-d94718b65eefe6ca5d134326b5ecb086\">\n.flex_column.av-s6rfa9-d94718b65eefe6ca5d134326b5ecb086{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-s6rfa9-d94718b65eefe6ca5d134326b5ecb086 av_two_third  avia-builder-el-11  el_after_av_one_full  el_before_av_one_third  first flex_column_div av-zero-column-padding  column-top-margin'     ><p><section  class='av_textblock_section av-l5idjn4t-d546d7c615d600612fb1af5d70d0013c '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p><strong>Risk-benefit ratio<\/strong><\/p>\n<p>At first, the health of patients and users is the most important issue. The medical device must fulfil its intended purpose under normal use. This is why medical device manufacturers must prove that their medical devices are safe and effective and that the risks are acceptable in comparison to the benefits. It is also required to use a generally recognised state of the art in the manufacture of medical devices.<\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l5idkp4e-6b4301141b23d8ac17afdd8ffb7d812a\">\n#top .hr.hr-invisible.av-l5idkp4e-6b4301141b23d8ac17afdd8ffb7d812a{\nheight:20px;\n}\n<\/style>\n<div  class='hr av-l5idkp4e-6b4301141b23d8ac17afdd8ffb7d812a hr-invisible  avia-builder-el-13  el_after_av_textblock  el_before_av_textblock '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<section  class='av_textblock_section av-l5idjn4t-d546d7c615d600612fb1af5d70d0013c '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p><strong>Risk management system<\/strong><\/p>\n<p>Furthermore manufacturers are required to maintain a risk management system throughout the product life cycle. The MDR requires a continuous, iterative process with constant updating of new knowledge.<\/p>\n<\/div><\/section><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2fzea3l-d24c8cf0a81fd845a95aea876d26929f\">\n.flex_column.av-2fzea3l-d24c8cf0a81fd845a95aea876d26929f{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2fzea3l-d24c8cf0a81fd845a95aea876d26929f av_one_third  avia-builder-el-15  el_after_av_two_third  el_before_av_one_fifth  flex_column_div av-zero-column-padding  column-top-margin'     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l5idj4jy-32d00059b4b372cb8b495dc4ed2e4746\">\n#top .hr.hr-invisible.av-l5idj4jy-32d00059b4b372cb8b495dc4ed2e4746{\nheight:50px;\n}\n<\/style>\n<div  class='hr av-l5idj4jy-32d00059b4b372cb8b495dc4ed2e4746 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-23p7n41-02a35df14c79dfd95c631ab6e101de5c\">\n.avia-image-container.av-23p7n41-02a35df14c79dfd95c631ab6e101de5c img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-23p7n41-02a35df14c79dfd95c631ab6e101de5c .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-23p7n41-02a35df14c79dfd95c631ab6e101de5c 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-10171 avia-img-lazy-loading-not-10171 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/07\/shutterstock_177653300-scaled.jpg\" alt='Das Display eines Medizinproduktes' title='shutterstock_177653300'  height=\"1707\" width=\"2560\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/07\/shutterstock_177653300-scaled.jpg 2560w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/07\/shutterstock_177653300-300x200.jpg 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/07\/shutterstock_177653300-1030x687.jpg 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/07\/shutterstock_177653300-768x512.jpg 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/07\/shutterstock_177653300-1536x1024.jpg 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/07\/shutterstock_177653300-2048x1365.jpg 2048w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/07\/shutterstock_177653300-1500x1000.jpg 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/07\/shutterstock_177653300-705x470.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-3yr9xnl-fb8132b9d66daf35b06291fb93c09623\">\n.flex_column.av-3yr9xnl-fb8132b9d66daf35b06291fb93c09623{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3yr9xnl-fb8132b9d66daf35b06291fb93c09623 av_one_fifth  avia-builder-el-18  el_after_av_one_third  el_before_av_three_fifth  first flex_column_div av-zero-column-padding  column-top-margin'     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-s6rfa9-afd3d60d4d8a71c0d85763598bbf2b35\">\n@keyframes av_boxShadowEffect_av-s6rfa9-afd3d60d4d8a71c0d85763598bbf2b35-column {\n0%   { box-shadow:  0 0 0 0 #e5e5e5; opacity: 1; }\n100% { box-shadow:  0 0 10px 0 #e5e5e5; opacity: 1; }\n}\n.flex_column.av-s6rfa9-afd3d60d4d8a71c0d85763598bbf2b35{\nbox-shadow: 0 0 10px 0 #e5e5e5;\nborder-width:4px;\nborder-color:#92afab;\nborder-style:solid;\nborder-radius:6px 6px 6px 6px;\npadding:12px 12px 12px 12px;\n}\n<\/style>\n<div  class='flex_column av-s6rfa9-afd3d60d4d8a71c0d85763598bbf2b35 av_three_fifth  avia-builder-el-19  el_after_av_one_fifth  el_before_av_one_fifth  flex_column_div shadow-not-animated  column-top-margin'     ><article  class='iconbox iconbox_left av-l5idpf4t-32c379d8b86c3f54406e627d11026c92  avia-builder-el-20  avia-builder-el-no-sibling '  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: Risk management in the development process \"><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\" >Risk management in the development process <\/h3><\/header><div class='iconbox_content_container '  itemprop=\"text\" ><p>From the idea to launching the product: The most important steps in the development of medical devices &#8211; read more in our <a href=\"https:\/\/www.riskmanager.net\/en\/2022\/06\/08\/risk-management-in-the-development\/\" target=\"_blank\" rel=\"noopener\">blog<\/a>.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3djtsn5-f373940d1df76a7696b83c3c787eb3f9\">\n.flex_column.av-3djtsn5-f373940d1df76a7696b83c3c787eb3f9{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3djtsn5-f373940d1df76a7696b83c3c787eb3f9 av_one_fifth  avia-builder-el-21  el_after_av_three_fifth  avia-builder-el-last  flex_column_div av-zero-column-padding  column-top-margin'     ><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_4'  class='avia-section av-zq6xz5-5f9778f5614b533d5cc1b6c40ff57292 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-10275'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-s6rfa9-d94718b65eefe6ca5d134326b5ecb086\">\n.flex_column.av-s6rfa9-d94718b65eefe6ca5d134326b5ecb086{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-s6rfa9-d94718b65eefe6ca5d134326b5ecb086 av_three_fourth  avia-builder-el-23  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><p><section  class='av_textblock_section av-l5idjn4t-d546d7c615d600612fb1af5d70d0013c '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p><strong>Risk control<\/strong><\/p>\n<p>In order to control the risks, manufacturers must comply with specified safety principles with regard to generally recognised technology. In order to make the residual and overall risk acceptable, the following applies:<\/p>\n<\/div><\/section><br \/>\n<div  class='avia-icon-list-container av-l5jfo5kp-467f4fea9a76dc7354e6b589c8333399  avia-builder-el-25  el_after_av_textblock  el_before_av_textblock '><ul class='avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-big av-l5jfo5kp-467f4fea9a76dc7354e6b589c8333399 avia-iconlist-animate'>\n<li><div class='iconlist_icon av-1mc4n6r-c73d02414098dcd669fe1378a6cf238e avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue879' 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: Eliminate or minimise risks as far as possible\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Eliminate or minimise risks as far as possible<\/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-zqyt5v-96773f248ec79177cebdfe5219485c75 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue879' 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: Take protection and, if necessary, alarm measures\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Take protection and, if necessary, alarm measures<\/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-im7vlv-a91a1f4574588beaa1df198e1feabc0e avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue879' 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: and provide safety information and training where appropriate\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >and provide safety information and training where appropriate<\/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><br \/>\n<section  class='av_textblock_section av-l5idjn4t-d546d7c615d600612fb1af5d70d0013c '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Manufacturers must then provide information about the other residual risks.<\/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-jso2xt-52734fd0a4bf601b0c6c13a6c76a5169\">\n.avia-section.av-jso2xt-52734fd0a4bf601b0c6c13a6c76a5169{\nbackground-color:#373736;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_5'  class='avia-section av-jso2xt-52734fd0a4bf601b0c6c13a6c76a5169 alternate_color avia-section-default avia-no-border-styling  avia-builder-el-27  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-10275'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-s6rfa9-d94718b65eefe6ca5d134326b5ecb086\">\n.flex_column.av-s6rfa9-d94718b65eefe6ca5d134326b5ecb086{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-s6rfa9-d94718b65eefe6ca5d134326b5ecb086 av_three_fourth  avia-builder-el-28  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-l5idjn4t-d546d7c615d600612fb1af5d70d0013c '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p><strong>Usability<\/strong><\/p>\n<p>Products must be resilient, be able to withstand transport and storage without damage, e.g. temperature fluctuations, and ensure that they achieve their intended use. On top, the prerequisite is always the proper use of the medical device under normal circumstances.<\/p>\n<p>Detailed safety and performance requirements for the manufacture of medical devices with, for example, chemical or biological properties, materials of biological origin or specifications for radiation protection can also be found in Annex I of the MDR.<\/p>\n<\/div><\/section><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_6'  class='avia-section av-zq6xz5-5f9778f5614b533d5cc1b6c40ff57292 main_color avia-section-default avia-no-border-styling  avia-builder-el-30  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-10275'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-s6rfa9-d94718b65eefe6ca5d134326b5ecb086\">\n.flex_column.av-s6rfa9-d94718b65eefe6ca5d134326b5ecb086{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-s6rfa9-d94718b65eefe6ca5d134326b5ecb086 av_one_full  avia-builder-el-31  el_before_av_one_third  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-93e6c22c32768dfae6867a307446e1eb\">\n#top .av-special-heading.av-av_heading-93e6c22c32768dfae6867a307446e1eb{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-93e6c22c32768dfae6867a307446e1eb .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-93e6c22c32768dfae6867a307446e1eb .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-93e6c22c32768dfae6867a307446e1eb av-special-heading-h3 blockquote modern-quote  avia-builder-el-32  avia-builder-el-no-sibling '><h3 class='av-special-heading-tag '  itemprop=\"headline\"  >What are the general safety and performance requirements for in vitro diagnostic medical devices under the IVDR?<\/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-zwka5d-035b8bc12cbf46007a44aef78f02c718\">\n.flex_column.av-zwka5d-035b8bc12cbf46007a44aef78f02c718{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-zwka5d-035b8bc12cbf46007a44aef78f02c718 av_one_third  avia-builder-el-33  el_after_av_one_full  el_before_av_one_half  first flex_column_div av-zero-column-padding  column-top-margin'     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l5l5wjt4-89d3338580f55d0304823c8fa03ef67f\">\n.avia-image-container.av-l5l5wjt4-89d3338580f55d0304823c8fa03ef67f img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-l5l5wjt4-89d3338580f55d0304823c8fa03ef67f .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-l5l5wjt4-89d3338580f55d0304823c8fa03ef67f av-styling- avia-align-center  avia-builder-el-34  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-10168 avia-img-lazy-loading-not-10168 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/07\/shutterstock_152464301-scaled.jpg\" alt='Ein gr\u00fcnder' title='shutterstock_152464301'  height=\"1706\" width=\"2560\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/07\/shutterstock_152464301-scaled.jpg 2560w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/07\/shutterstock_152464301-300x200.jpg 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/07\/shutterstock_152464301-1030x687.jpg 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/07\/shutterstock_152464301-768x512.jpg 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/07\/shutterstock_152464301-1536x1024.jpg 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/07\/shutterstock_152464301-2048x1365.jpg 2048w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/07\/shutterstock_152464301-1500x1000.jpg 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/07\/shutterstock_152464301-705x470.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-s6rfa9-457015f486bc60562b233aa9dd865aae\">\n.flex_column.av-s6rfa9-457015f486bc60562b233aa9dd865aae{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-s6rfa9-457015f486bc60562b233aa9dd865aae av_one_half  avia-builder-el-35  el_after_av_one_third  avia-builder-el-last  flex_column_div av-zero-column-padding  column-top-margin'     ><section  class='av_textblock_section av-l5idjn4t-d546d7c615d600612fb1af5d70d0013c '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>In general, exactly the same requirements apply to in vitro diagnostic medical devices as to medical devices. Only one additional point is added in the IVDR. With reference to Annex XVI, products without a medical purpose (e.g. contact lenses, tattooing and piercing products or devices for removing fatty tissue) are also covered by the risk minimisation requirements. And once again, the health and safety of the user and the patient are of primary importance.<\/p>\n<\/div><\/section><\/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-jso2xt-52734fd0a4bf601b0c6c13a6c76a5169\">\n.avia-section.av-jso2xt-52734fd0a4bf601b0c6c13a6c76a5169{\nbackground-color:#373736;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_7'  class='avia-section av-jso2xt-52734fd0a4bf601b0c6c13a6c76a5169 alternate_color avia-section-default avia-no-border-styling  avia-builder-el-37  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-10275'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-s6rfa9-d94718b65eefe6ca5d134326b5ecb086\">\n.flex_column.av-s6rfa9-d94718b65eefe6ca5d134326b5ecb086{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-s6rfa9-d94718b65eefe6ca5d134326b5ecb086 av_one_full  avia-builder-el-38  el_before_av_two_third  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-c26d18909474445dce08a13fb1d14ce5\">\n#top .av-special-heading.av-av_heading-c26d18909474445dce08a13fb1d14ce5{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-c26d18909474445dce08a13fb1d14ce5 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-c26d18909474445dce08a13fb1d14ce5 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-c26d18909474445dce08a13fb1d14ce5 av-special-heading-h3 blockquote modern-quote  avia-builder-el-39  avia-builder-el-no-sibling '><h3 class='av-special-heading-tag '  itemprop=\"headline\"  >How do you keep track of all the general safety and performance requirements in compliance with the standard?<\/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-s6rfa9-d94718b65eefe6ca5d134326b5ecb086\">\n.flex_column.av-s6rfa9-d94718b65eefe6ca5d134326b5ecb086{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-s6rfa9-d94718b65eefe6ca5d134326b5ecb086 av_two_third  avia-builder-el-40  el_after_av_one_full  el_before_av_one_third  first flex_column_div av-zero-column-padding  column-top-margin'     ><section  class='av_textblock_section av-l5idjn4t-d546d7c615d600612fb1af5d70d0013c '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The first section of Annexes I of MDR and IVDR provide a first insight into what is necessary in manufacturing to meet the general safety and performance requirements. However, the eight and nine points are not a comprehensive description, as details follow for all forms of medical devices and in vitro diagnostics.<\/p>\n<p>The <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#essential-requirements-mdr-ivdr\" target=\"_blank\" rel=\"noopener\">Essential Requirements Module<\/a> of the BAYOOSOFT Risk Manager offers a way to keep track of all requirements in conformity with the standards. This is because the integrated checklist filter with a standard-compliant question structure of this module enables you to speed up the review and evaluation of requirements. Through an interactive checklist, the solution filters requirements according to your medical device so that you only have to answer the relevant questions. Standard conformity is thus granted not only with the MDR and IVDR, but also with ISO 14971.<\/p>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-s6rfa9-afd3d60d4d8a71c0d85763598bbf2b35\">\n@keyframes av_boxShadowEffect_av-s6rfa9-afd3d60d4d8a71c0d85763598bbf2b35-column {\n0%   { box-shadow:  0 0 0 0 #e5e5e5; opacity: 1; }\n100% { box-shadow:  0 0 10px 0 #e5e5e5; opacity: 1; }\n}\n.flex_column.av-s6rfa9-afd3d60d4d8a71c0d85763598bbf2b35{\nbox-shadow: 0 0 10px 0 #e5e5e5;\nborder-width:4px;\nborder-color:#92afab;\nborder-style:solid;\nborder-radius:6px 6px 6px 6px;\npadding:12px 12px 12px 12px;\n}\n<\/style>\n<div  class='flex_column av-s6rfa9-afd3d60d4d8a71c0d85763598bbf2b35 av_one_third  avia-builder-el-42  el_after_av_two_third  el_before_av_one_fifth  flex_column_div shadow-not-animated  column-top-margin'     ><article  class='iconbox iconbox_left av-l5idpf4t-211d7d4832191360586098034735c321  avia-builder-el-43  avia-builder-el-no-sibling '  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: Test it for free\"><div class=\"iconbox_icon heading-color\" aria-hidden='true' data-av_icon='\ue803' data-av_iconfont='entypo-fontello'><\/div><h3 class='iconbox_content_title '  itemprop=\"headline\" >Test it for free<\/h3><\/header><div class='iconbox_content_container '  itemprop=\"text\" ><p>Learn more about the Essential Requirements Module <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#essential-requirements-mdr-ivdr\" target=\"_blank\" rel=\"noopener\">here<\/a>.<\/p>\n<p>Would you like to get to know the BAYOOSOFT Risk Manager free of charge? 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