{"id":8289,"date":"2024-01-12T20:37:59","date_gmt":"2024-01-12T20:37:59","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=8289"},"modified":"2024-01-12T21:00:43","modified_gmt":"2024-01-12T21:00:43","slug":"eumdr-medical-device-cybersecurity-requirements","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/eumdr-medical-device-cybersecurity-requirements\/","title":{"rendered":"Medical Device Cybersecurity Requirements Under the EU MDR"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8289\" class=\"elementor elementor-8289\" 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-7388bb3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7388bb3\" 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-4264d41\" data-id=\"4264d41\" 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-d04a716 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"d04a716\" 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-e193c4d\" data-id=\"e193c4d\" 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-aa22ff3 elementor-widget elementor-widget-post-info\" data-id=\"aa22ff3\" 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\/2024\/01\/12\/\">\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\tJanuary 12, 2024\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-25cfb2d elementor-widget elementor-widget-heading\" data-id=\"25cfb2d\" 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\">Medical Device Cybersecurity Requirements Under the EU MDR<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78a7c7e elementor-widget elementor-widget-image\" data-id=\"78a7c7e\" 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=\"2560\" height=\"1440\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/Medical-device-cybersecurity-scaled.jpeg\" class=\"attachment-full size-full wp-image-8292\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/Medical-device-cybersecurity-scaled.jpeg 2560w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/Medical-device-cybersecurity-300x169.jpeg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/Medical-device-cybersecurity-1024x576.jpeg 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/Medical-device-cybersecurity-768x432.jpeg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/Medical-device-cybersecurity-1536x864.jpeg 1536w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/Medical-device-cybersecurity-2048x1152.jpeg 2048w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/Medical-device-cybersecurity-500x281.jpeg 500w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/>\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-f7a5edb elementor-widget elementor-widget-text-editor\" data-id=\"f7a5edb\" 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>The European Medical Device Regulation (MDR) introduced a more rigorous approach to medical device cybersecurity, making it a safety requirement for medical devices (and IVDs under the EU IVDR). With AI making its way into the healthcare space and more devices relying on connectivity to function, hackers are becoming more sophisticated in their techniques. Manufacturers can\u2019t sleep on cybersecurity if they want to maintain compliance and prevent a cyber breach that could, at a minimum, damage their company\u2019s reputation and, at worst, endanger patient privacy and safety.<\/p><p>In this article, we\u2019ll explore the key components of the EU MDR&#8217;s cybersecurity provisions. We will also discuss the challenges manufacturers face in aligning their existing devices with the new cybersecurity requirements and the strategies employed to ensure a smooth transition.<\/p><h3>\u00a0<\/h3><h3>Documents Addressing EU Device Cybersecurity Requirements<\/h3><p>A tangle of regulations and standards intersect to inform cybersecurity (IT security) requirements for medical devices in the . Annex I of the MDR lays out general safety and performance requirements (GSPR) for devices that carry cybersecurity risks, specifically \u201cdevices that incorporate electronic programmable systems and software that are devices in themselves.\u201d<\/p><p>The Medical Device Coordination Group (MDCG) published a <a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/41863\">guidance<\/a> in 2020 that provides a roadmap for manufacturers to fulfill the GSPRs from Annex I as they relate to cybersecurity. The guidance addresses pre- and postmarket cybersecurity requirements and expands on MDR language regarding design and risk assessment for software devices, which we\u2019ll discuss in more detail in a moment. The comprises several technical documents that harmonize international cybersecurity recommendations.<\/p><p>Other cyber- and data-specific regulations that require compliance beyond the MDR should also inform your cybersecurity activities:<\/p><ul><li><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02016R0679-20160504&amp;qid=1532348683434\">General Data Protection Regulation [Regulation (EU) 2016\/679] (GDPR)<\/a>, one of the strictest data protection regulations in force with respect to the personal data of individuals residing in the EU.<\/li><li><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2022\/2555\">NIS 2 Directive [Directive (EU) 2022\/2555<\/a><u>]<\/u>, which came into force in 2023, is EU-wide cybersecurity legislation that replaces and\/or repeals several prior cybersecurity directives.<\/li><\/ul><h3>\u00a0<\/h3><h3>Cybersecurity Across the Life Cycle<\/h3><p>With so many regulations and directives to consider, it\u2019s important to get an early start designing and executing a strategy for cybersecurity compliance. The right time to begin implementing security management is in the design phase, as the safest devices from a cybersecurity perspective are \u201csecure by design.\u201d From there, manufacturers should prepare to incorporate cybersecurity into all aspects of their pre- and postmarket activities, from risk management, technical documentation, and clinical evaluation to postmarket surveillance (PMS) planning, reporting, and vigilance. Annex I specifies a number of activities required for addressing device security, including:<\/p><ul><li>Device performance<\/li><li>Risk reduction<\/li><li>Risk management system<\/li><li>Risk control measures<\/li><li>Minimization of foreseeable risks, and any undesirable side effects<\/li><li>Combination \/ connection of devices \/ systems<\/li><li>Interaction between software and the IT environment<\/li><li>Interoperability and compatibility with other devices or products<\/li><li>Repeatability, reliability, and performance<\/li><li>Development and manufacture in accordance with the state of the art, taking into account the principles of the development life cycle and risk management, including information security, verification, and validation<\/li><li>Minimum IT requirements<\/li><li>Unauthorized access<\/li><li>Lay persons<\/li><li>Labeling: warnings or precautions<\/li><li>Instructions for use: residual risks, contraindications and any undesirable side effects, and minimum IT requirements<\/li><\/ul><h3>\u00a0<\/h3><h3>Perform Verification and Validation Testing<\/h3><p>MDR Annex I states that devices shall be \u201cdeveloped and manufactured in accordance with the <a href=\"https:\/\/www.orielstat.com\/blog\/eu-mdr-state-of-the-art\/\"><em>state of the art<\/em><\/a> taking into account the principles of development life cycle, risk management, including information security, verification and validation.\u201d Verification and validation testing are pre- and postmarket requirements to be performed along with risk assessments and benefit-risk analysis. According to the guidance, testing can include (but is not limited to) security feature testing, fuzz testing, vulnerability scanning, and penetration testing.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-1131020 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1131020\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&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-100 elementor-inner-column elementor-element elementor-element-6f6a23a\" data-id=\"6f6a23a\" 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<div class=\"elementor-element elementor-element-f3b5811 elementor-widget elementor-widget-text-editor\" data-id=\"f3b5811\" 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><strong>What Is \u201cState of the Art\u201d?<\/strong><\/p><p>\u201cState of the art\u201d is often used to describe emerging technologies. But, in this context, it refers to products that are developed and commonly used in the marketplace (e.g., devices that have CE Marking and established intended use across the healthcare industry). Features, functions, and technologies that are established would be considered state of the art as long as they optimize benefits to the patient. Read our <a href=\"https:\/\/www.orielstat.com\/blog\/eu-mdr-state-of-the-art\/\">blog post<\/a> on state of the art for a better understanding.<\/p>\t\t\t\t\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<div class=\"elementor-element elementor-element-b29f801 elementor-widget elementor-widget-text-editor\" data-id=\"b29f801\" 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<h3>\u00a0<\/h3><h3>Key Medical Device Cybersecurity Concepts<\/h3><p>The MDR directs manufacturers to set minimum requirements concerning hardware, IT network characteristics, and IT security measures, including protection against unauthorized access. The guidance emphasizes three key cybersecurity concepts on which manufacturers should focus their efforts:<\/p><ul><li><strong>IT security<\/strong>: protection of computer systems from adverse effects on assets that disrupt or misdirect the services they provide<\/li><li><strong>Operation security<\/strong>: protection against the intentional corruption of procedures or workflows, producing unintended results<\/li><li><strong>Information security<\/strong>: protection against the threat of theft, deletion, or alteration of stored or transmitted data within a cyber system<\/li><\/ul><p>The guidance also advises that devices be developed using a layered \u201cdefense in depth\u201d method. The defense in depth strategy comprises eight security practices that map to the phase of the device life cycle, from installation to maintenance:<\/p><ul><li>Security management<\/li><li>Specification of security requirements<\/li><li>Secure by design<\/li><li>Secure implementation<\/li><li>Security verification and validation testing<\/li><li>Management of security-related issues<\/li><li>Security update management<\/li><li>Security guidelines<\/li><\/ul><h3>\u00a0<\/h3><h3>Emphasis on Operational Requirements<\/h3><p>Under the MDR, manufacturers are responsible for establishing minimum IT requirements for their product and communicating them to users. This includes establishing IT network characteristics, security measures, and configuration requirements based on the findings from your risk assessment. These requirements and instructions must be clearly described in your instructions for use (IFU). When you\u2019re dealing with a changing technology landscape, however, you must anticipate and communicate changes to your product\u2019s IT requirements and expedite these changes to users. You must also consider the different roles within the healthcare organization that may interact with your product: integrator, operator, and of course providers and patients.<\/p><h3>\u00a0<\/h3><h3>Balancing Security and Safety with Effectiveness<\/h3><p>Weak device security is an obvious safety concern. You can imagine a number of dramatic scenarios, such as a hacker disrupting the functioning of a connected device. However, most cybersecurity risks are less nefarious but still very high-stakes. Any security risk that causes a device not to function as intended carries varying degrees of risk, depending on the device type. These risks could include exposing private patient information (a serious legal and privacy liability) or software crashing at a critical moment because its operating conditions are poorly defined.<\/p><p>While manufacturers must factor security into their risk assessments, more security doesn\u2019t always make a device safer. Depending on the device type, characteristics, etc., security measures that are too restrictive could interfere with the device\u2019s functionality and intended use. It is crucial to design security measures with a deep understanding of the scenarios in which the device will be used (or misused) and the individual roles using or accessing the device. For instance, healthcare professionals may need access to a device to administer emergency care, even if that device needs strong security measures under normal conditions.<\/p><h3>\u00a0<\/h3><h3>Want to Learn More?<\/h3><p>Cybersecurity must be a top priority for all devices seeking CE Marking. Between unpacking requirements in the MDR and all of the other security and data privacy regulations one must adhere to, complying with cybersecurity requirements in the EU isn\u2019t getting any easier. Oriel STAT A MATRIX offers several training classes that can level up your understanding of security risk management. Our <a href=\"https:\/\/www.orielstat.com\/courses\/ISO-14971-risk-management-for-medical-devices\">ISO 14971 training class<\/a><u>es<\/u> are among our most popular, along with our <a href=\"https:\/\/www.orielstat.com\/training\/medical-device-cybersecurity-risk-training\">cybersecurity training<\/a><u> course<\/u>. 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Cause Analysis<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-27\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/clinical-evaluation-reports\/\">Clinical Evaluation Reports<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-59\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/combination-products\/\">Combination Products<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-23\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/complaint-handling-postmarket-surveillance\/\">Complaint Handling and PMS<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-33\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/design-control\/\">Design Control<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-34\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/in-vitro-diagnostics-ivdr\/\">EU IVDR (2017\/746)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-16\"><a 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>Medical Device Cybersecurity Requirements Under the EU MDR The European Medical Device Regulation (MDR) introduced a more rigorous approach to medical device cybersecurity, making it a safety requirement for medical devices (and IVDs under the EU IVDR). With AI making its way into the healthcare space and more devices relying on connectivity to function, hackers [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":8292,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[16,63],"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\/eumdr-medical-device-cybersecurity-requirements\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"Medical Device Cybersecurity Requirements Under the EU MDR The European Medical Device Regulation (MDR) introduced a more rigorous approach to medical device cybersecurity, making it a safety requirement for medical devices (and IVDs under the EU IVDR). With AI making its way into the healthcare space and more devices relying on connectivity to function, hackers [&hellip;]\" \/>\r\n<meta property=\"og:url\" content=\"https:\/\/www.orielstat.com\/blog\/eumdr-medical-device-cybersecurity-requirements\/\" \/>\r\n<meta property=\"og:site_name\" content=\"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog\" \/>\r\n<meta property=\"article:published_time\" content=\"2024-01-12T20:37:59+00:00\" \/>\r\n<meta property=\"article:modified_time\" content=\"2024-01-12T21:00:43+00:00\" \/>\r\n<meta property=\"og:image\" content=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/Medical-device-cybersecurity-scaled.jpeg\" \/>\r\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\r\n\t<meta property=\"og:image:height\" content=\"1440\" \/>\r\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\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=\"7 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\/eumdr-medical-device-cybersecurity-requirements\/","og_locale":"en_US","og_type":"article","og_description":"Medical Device Cybersecurity Requirements Under the EU MDR The European Medical Device Regulation (MDR) introduced a more rigorous approach to medical device cybersecurity, making it a safety requirement for medical devices (and IVDs under the EU IVDR). With AI making its way into the healthcare space and more devices relying on connectivity to function, hackers [&hellip;]","og_url":"https:\/\/www.orielstat.com\/blog\/eumdr-medical-device-cybersecurity-requirements\/","og_site_name":"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog","article_published_time":"2024-01-12T20:37:59+00:00","article_modified_time":"2024-01-12T21:00:43+00:00","og_image":[{"width":2560,"height":1440,"url":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/Medical-device-cybersecurity-scaled.jpeg","type":"image\/jpeg"}],"author":"usr192162","twitter_card":"summary_large_image","twitter_misc":{"Written by":"usr192162","Est. reading time":"7 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.orielstat.com\/blog\/eumdr-medical-device-cybersecurity-requirements\/#article","isPartOf":{"@id":"https:\/\/www.orielstat.com\/blog\/eumdr-medical-device-cybersecurity-requirements\/"},"author":{"name":"usr192162","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/a775f07c9602a3521143e80692594553"},"headline":"Medical Device Cybersecurity Requirements Under the EU MDR","datePublished":"2024-01-12T20:37:59+00:00","dateModified":"2024-01-12T21:00:43+00:00","mainEntityOfPage":{"@id":"https:\/\/www.orielstat.com\/blog\/eumdr-medical-device-cybersecurity-requirements\/"},"wordCount":1281,"publisher":{"@id":"https:\/\/www.orielstat.com\/blog\/#organization"},"articleSection":["EU MDR (2017\/745)","Software and Cybersecurity"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.orielstat.com\/blog\/eumdr-medical-device-cybersecurity-requirements\/","url":"https:\/\/www.orielstat.com\/blog\/eumdr-medical-device-cybersecurity-requirements\/","name":"","isPartOf":{"@id":"https:\/\/www.orielstat.com\/blog\/#website"},"datePublished":"2024-01-12T20:37:59+00:00","dateModified":"2024-01-12T21:00:43+00:00","inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.orielstat.com\/blog\/eumdr-medical-device-cybersecurity-requirements\/"]}]},{"@type":"WebSite","@id":"https:\/\/www.orielstat.com\/blog\/#website","url":"https:\/\/www.orielstat.com\/blog\/","name":"Oriel STAT A MATRIX Blog","description":"","publisher":{"@id":"https:\/\/www.orielstat.com\/blog\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.orielstat.com\/blog\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/www.orielstat.com\/blog\/#organization","name":"Oriel STAT A MATRIX Blog","url":"https:\/\/www.orielstat.com\/blog\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/logo\/image\/","url":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/OSAM-Eliquent-logo-color.png","contentUrl":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/OSAM-Eliquent-logo-color.png","width":1458,"height":1042,"caption":"Oriel STAT A MATRIX Blog"},"image":{"@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/a775f07c9602a3521143e80692594553","name":"usr192162","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/1412cb81dc66fbc000fb222b1ea52700?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/1412cb81dc66fbc000fb222b1ea52700?s=96&d=mm&r=g","caption":"usr192162"},"url":"https:\/\/www.orielstat.com\/blog\/author\/usr192162\/"}]}},"_links":{"self":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/8289"}],"collection":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/comments?post=8289"}],"version-history":[{"count":4,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/8289\/revisions"}],"predecessor-version":[{"id":8300,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/8289\/revisions\/8300"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/media\/8292"}],"wp:attachment":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/media?parent=8289"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/categories?post=8289"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/tags?post=8289"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}