{"id":9987,"date":"2022-05-23T08:42:37","date_gmt":"2022-05-23T06:42:37","guid":{"rendered":"https:\/\/www.riskmanager.net\/?p=9987"},"modified":"2022-06-10T08:44:26","modified_gmt":"2022-06-10T06:44:26","slug":"ivdr-end-of-transition-period","status":"publish","type":"post","link":"https:\/\/www.riskmanager.net\/en\/2022\/05\/23\/ivdr-end-of-transition-period\/","title":{"rendered":"IVDR &#8211; End of the transition period"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bv3arc-81f9f259d8dac47c18ac9a28c05223ae\">\n.avia-section.av-bv3arc-81f9f259d8dac47c18ac9a28c05223ae{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/05\/shutterstock_541526584-Header_2000px.jpg);\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-bv3arc-81f9f259d8dac47c18ac9a28c05223ae 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-9987'><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-avhks8-61ab0524dce20fb6c8469a85f668c523 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-9987'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l3fsbcxg-f9e06ce03cdadcdf7d40d935b4b8eb53\">\n#top .av-special-heading.av-l3fsbcxg-f9e06ce03cdadcdf7d40d935b4b8eb53{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-l3fsbcxg-f9e06ce03cdadcdf7d40d935b4b8eb53 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-l3fsbcxg-f9e06ce03cdadcdf7d40d935b4b8eb53 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-l3fsbcxg-f9e06ce03cdadcdf7d40d935b4b8eb53 av-special-heading-h1 blockquote modern-quote  avia-builder-el-2  el_before_av_four_fifth  avia-builder-el-first '><h1 class='av-special-heading-tag '  itemprop=\"headline\"  >IVDR &#8211; End of the transition period<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-7dwefs-af636505953644a26898f2fdb9f287e4\">\n.flex_column.av-7dwefs-af636505953644a26898f2fdb9f287e4{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-7dwefs-af636505953644a26898f2fdb9f287e4 av_four_fifth  avia-builder-el-3  el_after_av_heading  avia-builder-el-last  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-l3d7laws-8042dabb1bd1287352d50740b9b31823 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>On 26 May, the In Vitro Diagnostics Regulation (IVDR) finally comes into force. After a five-year transition period, the comprehensive EU Regulation 2017\/746 is still a challenge for manufacturers &#8211; with the aim of increasing the safety and health protection of patients and users. From the redefinition of risk classes to the designation of responsible persons: With the IVDR, a second concretised EU regulation in the field of medical technology is being implemented after the MDR. A brief overview.<\/p>\n<\/div><\/section><\/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-4qqwjc-343e79e666ff40b7981e43c460ba6bb4\">\n.avia-section.av-4qqwjc-343e79e666ff40b7981e43c460ba6bb4{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/01\/shutterstock_500734189-scaled.jpg);\nbackground-position:0% 0%;\nbackground-attachment:scroll;\n}\n.avia-section.av-4qqwjc-343e79e666ff40b7981e43c460ba6bb4 .av-section-color-overlay{\nopacity:0.9;\nbackground-color:#5b5b5b;\n}\n<\/style>\n<div id='av_section_3'  class='avia-section av-4qqwjc-343e79e666ff40b7981e43c460ba6bb4 alternate_color avia-section-default avia-no-border-styling  avia-builder-el-5  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-9987'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-28ovko-c05b8f43926fb38a190184cc5cc3e3f1\">\n@keyframes av_boxShadowEffect_av-28ovko-c05b8f43926fb38a190184cc5cc3e3f1-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-28ovko-c05b8f43926fb38a190184cc5cc3e3f1{\nbox-shadow: 0 0 10px 0 #e5e5e5;\nborder-width:1px;\nborder-color:#92afab;\nborder-style:solid;\nborder-radius:12px 12px 12px 12px;\npadding:15px 15px 15px 15px;\nbackground-color:#92afab;\n}\n<\/style>\n<div  class='flex_column av-28ovko-c05b8f43926fb38a190184cc5cc3e3f1 av_one_third  avia-builder-el-6  el_before_av_two_third  avia-builder-el-first  first flex_column_div shadow-not-animated  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l3d7o5vj-e6289c0eb3431a6df245ee06db8cd1b2\">\n#top .av_textblock_section.av-l3d7o5vj-e6289c0eb3431a6df245ee06db8cd1b2 .avia_textblock{\ncolor:#ffffff;\n}\n<\/style>\n<section  class='av_textblock_section av-l3d7o5vj-e6289c0eb3431a6df245ee06db8cd1b2 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><p style=\"text-align: center\">Classification of in vitro diagnostic medical devices (IVD) &#8211; how is the classification done?<\/p>\n<p style=\"text-align: center\">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<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-8zn6w-8248a4bb7d2e4507b8dc9ad3de351ab4\">\n.flex_column.av-8zn6w-8248a4bb7d2e4507b8dc9ad3de351ab4{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-8zn6w-8248a4bb7d2e4507b8dc9ad3de351ab4 av_two_third  avia-builder-el-8  el_after_av_one_third  el_before_av_four_fifth  flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-l3d7o5vj-5a1db92b4ca2fd310c963a0fd22579e2 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><h4>Risk classification<\/h4>\n<p>With the end of the transition period, many class A products will be classified higher. The reason for this is a new system for risk classification, which is intended to create more safety. This is because a notified body must be involved in the conformity assessment procedure for products in risk class A sterile, B, C and D.<\/p>\n<p>One disadvantage of the new system is that, according to T\u00dcV S\u00dcD, the notified bodies are to test around 80 to 90 per cent of all IVDs in future. An increasing approval backlog could be the result.<\/p>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-8zn6w-418120d4eb5ec1bc2924badf167baae8\">\n.flex_column.av-8zn6w-418120d4eb5ec1bc2924badf167baae8{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-8zn6w-418120d4eb5ec1bc2924badf167baae8 av_four_fifth  avia-builder-el-10  el_after_av_two_third  avia-builder-el-last  first flex_column_div av-zero-column-padding  column-top-margin'     ><article  class='iconbox iconbox_left av-l3d7q2yj-c3e583a3153b07be7c0983fef593d893  avia-builder-el-11  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: 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>Having a CE-marked product on the market does not mean finality. This is because in vitro diagnostic medical devices approved according to the IVDD must also fulfil the requirements of the IVDR. By 26 May 2022, this proof must also be available.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><\/div><div id='av_section_4'  class='avia-section av-25if7c-7e9536bbe68365ddf61d2dc47c6d66ae main_color avia-section-default avia-no-border-styling  avia-builder-el-12  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-9987'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-9k1jl4-564ec18fc8804a2373ceb0596c45f0cd\">\n.flex_column.av-9k1jl4-564ec18fc8804a2373ceb0596c45f0cd{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-9k1jl4-564ec18fc8804a2373ceb0596c45f0cd av_four_fifth  avia-builder-el-13  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><div  class='avia-icon-list-container av-l3d86tam-863e054970b84a9c93794899a33d0cb0  avia-builder-el-14  avia-builder-el-no-sibling '><ul class='avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-big av-l3d86tam-863e054970b84a9c93794899a33d0cb0 avia-iconlist-animate'>\n<li><div class='iconlist_icon av-5pqc2r-26e1bfcdb338f4031239d8e92672b869 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 \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Person(s) responsible\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Person(s) responsible<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><p>The naming of at least one qualified, responsible person within the company is now mandatory. This person is responsible for compliance with the regulatory requirements under Article 15 of the IVDR. Finally, the central EUDAMED database will list which person(s) are responsible.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-1bd8j-48b0dbd640d3ae261f98f8f24f2daccd 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 \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Technical documentation and performance evaluation\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Technical documentation and performance evaluation<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><p>It gets even more detailed: In addition to the increased documentation effort for the technical documentation, the IVDR requires additional and longer-term data from manufacturers, for example on scientific validity and clinical performance. Even after the IVD product has been placed on the market, an evaluation must be continued.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-2k5wfn-38ff84c659ed45537fc366a7babeacfd 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 \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Post-Market Surveillance (PMS)\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Post-Market Surveillance (PMS)<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><p>Systematically collecting, evaluating and assessing feedback &#8211; this is what the IVDR requires. Because PMS is an essential aspect of the quality management system. For products of risk classes A and B, findings must be documented in a report; results of products of classes C and D must be maintained by manufacturers in a performance report (PSUR).<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<\/ul><\/div><\/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-2tcm9k-83efe1013696d641d2560f69f640ee21\">\n.avia-section.av-2tcm9k-83efe1013696d641d2560f69f640ee21{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2022\/01\/shutterstock_500734189-scaled.jpg);\nbackground-position:0% 0%;\nbackground-attachment:scroll;\n}\n.avia-section.av-2tcm9k-83efe1013696d641d2560f69f640ee21 .av-section-color-overlay{\nopacity:0.9;\nbackground-color:#5b5b5b;\n}\n<\/style>\n<div id='av_section_5'  class='avia-section av-2tcm9k-83efe1013696d641d2560f69f640ee21 alternate_color avia-section-default avia-no-border-styling  avia-builder-el-15  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-9987'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-8zn6w-418120d4eb5ec1bc2924badf167baae8\">\n.flex_column.av-8zn6w-418120d4eb5ec1bc2924badf167baae8{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-8zn6w-418120d4eb5ec1bc2924badf167baae8 av_four_fifth  avia-builder-el-16  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-l3d7o5vj-5a1db92b4ca2fd310c963a0fd22579e2 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><h4>PSUR: This should be in the report<\/h4>\n<p>A periodic safety update report (PSUR) is a performance report updated at least once a year. It provides findings on IVD products in risk classes C and D and should include: PMS results, risk-benefit assessment and data on sales and use of the IVD.<\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l3d8e9z0-18ae69ae4865dc5fa90de208ea49e66d\">\n#top .hr.hr-invisible.av-l3d8e9z0-18ae69ae4865dc5fa90de208ea49e66d{\nheight:70px;\n}\n<\/style>\n<div  class='hr av-l3d8e9z0-18ae69ae4865dc5fa90de208ea49e66d hr-invisible  avia-builder-el-18  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_left av-l3d8m2w7-626b554844ed4eef6556875f31d8d3a5  avia-builder-el-19  el_after_av_hr  avia-builder-el-last '  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>Are you looking for support in creating the technical documentation of medical devices and in-vitro diagnostics? In BAYOOSOFT Risk Manager, 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. 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