{"id":7184,"date":"2022-03-22T19:05:11","date_gmt":"2022-03-22T19:05:11","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=7184"},"modified":"2024-01-11T16:26:02","modified_gmt":"2024-01-11T16:26:02","slug":"eu-mdr-state-of-the-art","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/eu-mdr-state-of-the-art\/","title":{"rendered":"State of the Art in the EU MDR: What Does That Actually Mean?"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7184\" class=\"elementor elementor-7184\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1b0c5cde elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1b0c5cde\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6dd05cd3\" data-id=\"6dd05cd3\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-7ca59751 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"7ca59751\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-6ea4084d\" data-id=\"6ea4084d\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3fab5c3f elementor-widget elementor-widget-post-info\" data-id=\"3fab5c3f\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/css\/custom-widget-icon-list.min.css?ver=0\"><link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-7f6be35 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2022\/03\/22\/\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\tMarch 22, 2022\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5f16c1c2 elementor-widget elementor-widget-heading\" data-id=\"5f16c1c2\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">State of the Art in the EU MDR: What Does That Actually Mean?<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1f7ff590 elementor-widget elementor-widget-image\" data-id=\"1f7ff590\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"2333\" height=\"1257\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/03\/stateart.png\" class=\"attachment-full size-full wp-image-2868\" alt=\"state of the art\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/03\/stateart.png 2333w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/03\/stateart-300x162.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/03\/stateart-1024x552.png 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/03\/stateart-768x414.png 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/03\/stateart-1536x828.png 1536w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/03\/stateart-2048x1103.png 2048w\" sizes=\"(max-width: 2333px) 100vw, 2333px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1005398 elementor-widget elementor-widget-text-editor\" data-id=\"1005398\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>Confused? It\u2019s understandable. Most of us think of state of the art as describing the latest and most advanced stage of a technology. For example, most people would consider a bionic eye to be state of the art. Yet, this notion of state of the art isn\u2019t what is meant in the context of the EU MDR, IVDR, and risk management. As such, manufacturers often face challenges in assessing state of the art in design and postmarket surveillance. Some of the confusion arises because, in the medical device and IVD regulatory arena, <strong>state of the art refers only to products that are developed and approved for sale in the marketplace, not cutting-edge technology in development. <\/strong>As we all know, there is a very big difference between a new state-of-the-art digital imaging system that is undergoing trials and one that already has CE Marking. For EU medical device regulators, the latter is considered state of the art, but the former is not until it has CE Marking.<\/p><p>Here\u2019s one way to think about this. Ask yourself: What is state of the art in cars these days? You might think of self-driving cars. But the reality is that while self-driving cars are highly innovative, they don\u2019t represent the widespread commercially available stage of technology. In the context of the EU Medical Device Regulation, state of the art is really the middle of a bell curve in innovation. A Model T certainly isn\u2019t state of the art, but cars with side curtain airbags, Bluetooth and backup cameras could be considered state of the art under the <a href=\"https:\/\/www.orielstat.com\/blog\/iso-14971-2019-revision\/\">ISO 14971:2019<\/a> 3.28.<\/p><p>\u00a0<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter wp-image-2541 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/05\/Degree-of-Innovation-Ford-to-Driverless-car-e1583442189533.png\" alt=\"\" width=\"969\" height=\"607\" \/><\/p><p>\u00a0<\/p><p>A note associated with this definition from ISO 14971:2019 3.28 adds more insight: \u201cThe state of the art embodies what is currently and generally accepted as\u00a0<strong><em>good practice<\/em><\/strong>. The state of the art does not necessarily imply the most technologically advanced solution.\u201d Thus, it is more useful to think of state of the art as meaning \u201cthe current state of all competitive treatment options.\u201d<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a1af7ef elementor-widget elementor-widget-heading\" data-id=\"a1af7ef\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What does \u201cGood Practice\u201d Really Mean?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cb40341 elementor-widget elementor-widget-text-editor\" data-id=\"cb40341\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>If your medical device or IVD is not the most technologically sophisticated product on the market but has a sparkling safety record, possesses solid clinical data, and follows all the latest standards, does that mean it still meets best practices and qualifies as state of the art in the eyes of EU regulators?<\/p><p><strong><em>Maybe.<\/em><\/strong><\/p><p>It also depends on the benefit-risk balance over the life of the device. As the device ages, assuming no new versions are introduced, it becomes less state of the art (like a Model T). It also has less benefit as newer treatment options are developed. Even if the risk profile is unchanged for your device, there will be less risky devices on the market.<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter wp-image-2542 size-large\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/05\/Lifetime-of-a-Device-1024x613.png\" alt=\"\" width=\"640\" height=\"383\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/05\/Lifetime-of-a-Device-1024x613.png 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/05\/Lifetime-of-a-Device-300x180.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/05\/Lifetime-of-a-Device-768x460.png 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/05\/Lifetime-of-a-Device.png 1089w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6d78be8 elementor-widget elementor-widget-heading\" data-id=\"6d78be8\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Your Notified Body Will Be Looking at the Analysis in Your Technical Documentation<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ed9a568 elementor-widget elementor-widget-text-editor\" data-id=\"ed9a568\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>In the EU MDR and associated MEDDEV 2.7\/1 rev 4 guidance, you are expected to demonstrate that you have conducted a thorough analysis of the current state of the art. Notified Bodies are increasingly looking to see that you have performed an in-depth assessment of alternative treatment methods for the same indications thus, you can expect more scrutiny during your next surveillance audit.<\/p><p>You are required to take state of the art into account when assessing the risk acceptability of your devices, adopting risk control measures, and assessing the clinical benefit of your devices. As such, state of the art is critical in assessing the benefit-risk ratio of the device, and you need to take it seriously in your clinical evaluation report (CER). If your device has been on the market for decades and there are two devices that are technically superior and present lower risk than yours, they reduce the benefit of your device and increase the risk side of your benefit-risk equation.<\/p><p>MEDDEV 2.7\/1 rev 4 clarifies the definition and objectives for establishing state of the art, and also provides guidance on content and methods. MEDDEV 2.7\/1 rev 4 describes state of the art as current knowledge in the corresponding medical field, such as applicable standards and guidance documents, information related to the medical condition managed with the device, and its natural course, benchmark devices, or other devices and medical alternatives available to the target population. Description of state of the art provides a framework for manufacturers and Notified Bodies to assess the devices safety and performance.<\/p><p>In the new IVDR, it is required that manufacturers specify and justify the level of clinical evidence necessary to demonstrate conformance in view of the device characteristics and intended purpose. Clinical evidence, performance evaluation, and study requirements for IVDs are defined related to the state of the art in medicine. Clinical evidence should demonstrate, with reference to state of the art, that clinical benefit will be achieved and that devices are safe.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c822fb5 elementor-widget elementor-widget-heading\" data-id=\"c822fb5\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Interested in Learning More?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b959ace elementor-widget elementor-widget-text-editor\" data-id=\"b959ace\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>One of our most popular training courses focuses on <a href=\"https:\/\/www.orielstat.com\/courses\/ISO-14971-risk-management-for-medical-devices\">medical device risk management<\/a>. Recently updated for ISO 14971:2019, this course takes a deep dive into all things risk and covers risk-related issues in the MDR, MDSAP, CERs, and (of course) ISO 14971. We also offer\u00a0a very popular <a href=\"https:\/\/www.orielstat.com\/courses\/eu-mdr-training\">EU MDR training course<\/a> and one focused on the <a href=\"https:\/\/www.orielstat.com\/courses\/eu-ivdr-training-2017-746\">IVDR<\/a>. 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href=\"https:\/\/www.orielstat.com\/blog\/category\/eu-medical-device-regulation\/\">EU MDR (2017\/745)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-14\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/us-fda-qsr\/\">FDA 21 CFR Part 820<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-21\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/510k-submissions\/\">FDA 510(k) Submissions<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-69\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/fda-eua\/\">FDA EUA<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-4\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/iso-134852016\/\">ISO 13485 QMS Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-30\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/risk-management-iso14971\/\">ISO 14971 Risk Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-40\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/laboratory-developed-tests-ldt\/\">Lab Developed Tests<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-66\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/labeling\/\">Labeling<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-18\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/mdsap\/\">MDSAP<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-58\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/pharmaceutical\/\">Pharmaceuticals<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-28\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qms-auditing\/\">QMS Auditing<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-72\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qmsr\/\">QMSR<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-73\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/regulatory-compliance\/\">Regulatory Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-65\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software\/\">Software<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-63\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software-cybersecurity\/\">Software and Cybersecurity<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-32\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/supplier-management\/\">Supplier Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-67\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/training\/\">Training<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-1\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/medical-device-ra-qa\/\">Uncategorized<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-35\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/validation\/\">Validation<\/a>\n<\/li>\n\t\t\t<\/ul>\n\n\t\t\t<\/section>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>State of the Art in the EU MDR: What Does That Actually Mean? Confused? It\u2019s understandable. Most of us think of state of the art as describing the latest and most advanced stage of a technology. For example, most people would consider a bionic eye to be state of the art. Yet, this notion of [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":2868,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[27,16],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v21.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.orielstat.com\/blog\/eu-mdr-state-of-the-art\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"State of the Art in the EU MDR: What Does That Actually Mean? Confused? It\u2019s understandable. Most of us think of state of the art as describing the latest and most advanced stage of a technology. For example, most people would consider a bionic eye to be state of the art. Yet, this notion of [&hellip;]\" \/>\r\n<meta property=\"og:url\" content=\"https:\/\/www.orielstat.com\/blog\/eu-mdr-state-of-the-art\/\" \/>\r\n<meta property=\"og:site_name\" content=\"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog\" \/>\r\n<meta property=\"article:published_time\" content=\"2022-03-22T19:05:11+00:00\" \/>\r\n<meta property=\"article:modified_time\" content=\"2024-01-11T16:26:02+00:00\" \/>\r\n<meta property=\"og:image\" content=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/03\/stateart.png\" \/>\r\n\t<meta property=\"og:image:width\" content=\"2333\" \/>\r\n\t<meta property=\"og:image:height\" content=\"1257\" \/>\r\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\r\n<meta name=\"author\" content=\"usr192162\" \/>\r\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\r\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"usr192162\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutes\" \/>\r\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.orielstat.com\/blog\/eu-mdr-state-of-the-art\/","og_locale":"en_US","og_type":"article","og_description":"State of the Art in the EU MDR: What Does That Actually Mean? Confused? It\u2019s understandable. Most of us think of state of the art as describing the latest and most advanced stage of a technology. For example, most people would consider a bionic eye to be state of the art. 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