{"id":70998,"date":"2025-11-19T08:40:00","date_gmt":"2025-11-19T07:40:00","guid":{"rendered":"https:\/\/teoresigroup.com\/test\/?p=70998"},"modified":"2026-02-24T11:55:00","modified_gmt":"2026-02-24T10:55:00","slug":"cybersecurity-medical-devices-mdr-2017-74","status":"publish","type":"post","link":"https:\/\/www.teoresigroup.com\/test\/news\/cybersecurity-medical-devices-mdr-2017-74\/","title":{"rendered":"Cybersecurity in medical devices: what does MDR 2017\/745 require?"},"content":{"rendered":"\n<div class=\"wp-block-columns row align-center row sezione\">\n<div class=\"wp-block-column column small-12 medium-10 large-8\">\n<h2 class=\"wp-block-heading\">Protecting Data and Patient Safety in the Digital Healthcare Era&nbsp;<\/h2>\n\n\n\n<p><strong>Cybersecurity in medical devices<\/strong> is no longer just a technical concern, it\u2019s a critical requirement in ensuring patient safety. The <strong>European Medical Device Regulation (<a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\/eng\">MDR<\/a>) 2017\/745<\/strong> outlines clear expectations for device manufacturers to secure data, prevent unauthorized access, and maintain system reliability throughout the product\u2019s lifecycle.<\/p>\n\n\n\n<p>This article introduces the core principles of <strong>Confidentiality, Integrity, and Availability (CIA)<\/strong> and examines how <strong>MDCG 2019-16 guidelines<\/strong> emphasize the direct link between cybersecurity breaches and potential harm to patients. Protecting digital interfaces and communication channels is vital for clinical reliability.<\/p>\n\n\n\n<p>We also explore the importance of adopting a <strong>continuous risk management process<\/strong>, including post-market monitoring and updates to keep pace with evolving threats. A special focus is given to the global harmonization efforts led by <strong>IMDRF<\/strong>, which provide a structured framework for secure-by-design development. A must-read for <strong>QA\/RA professionals, designers, and MedTech teams<\/strong> who are shaping innovative yet compliant and safe medical devices.<\/p>\n\n\n\n<p>Want to learn more? Download the PDF ora read more <a href=\"https:\/\/teoresigroup.com\/test\/company\/medtech\/medtech-publications\/#subpage-anchor\">here<\/a>.<\/p>\n\n\n        \n        <div id=\"block_b785417749151c3a518d7621504d8d3e\" class=\"file-attachment-repeater row sezione pt-0 align-center\">\n\n            <div class=\"column small-12\">\n\n                \n                     <a class=\"attachment flex align-middle p-3 mb-2 fs-p color-body\" href=\"https:\/\/www.teoresigroup.com\/test\/wp-content\/uploads\/2025\/11\/en-cybersecurity-requirements-according-to-medical-devices-regulations-mdr-2017-745.pdf\" target=\"_blank\" rel=\"nofollow noopener\" onclick=\"ga('send', 'event', 'Action-Link', 'Click', 'Cybersecurity requirements according to Medical Devices Regulations MDR 2017\/745');\"><svg class=\"icon download width-8 mr-4 color-primary\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 576 512\"><path d=\"M528 288h-92.1l46.1-46.1c30.1-30.1 8.8-81.9-33.9-81.9h-64V48c0-26.5-21.5-48-48-48h-96c-26.5 0-48 21.5-48 48v112h-64c-42.6 0-64.2 51.7-33.9 81.9l46.1 46.1H48c-26.5 0-48 21.5-48 48v128c0 26.5 21.5 48 48 48h480c26.5 0 48-21.5 48-48V336c0-26.5-21.5-48-48-48zm-400-80h112V48h96v160h112L288 368 128 208zm400 256H48V336h140.1l65.9 65.9c18.8 18.8 49.1 18.7 67.9 0l65.9-65.9H528v128zm-88-64c0-13.3 10.7-24 24-24s24 10.7 24 24-10.7 24-24 24-24-10.7-24-24z\"\/><\/svg>Cybersecurity requirements according to Medical Devices Regulations MDR 2017\/745<\/a>\n                \n            <\/div>\n\n        <\/div>\n\n    \n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p class=\"excerpt\">Protecting Data and Patient Safety in the Digital Healthcare Era&nbsp; Cybersecurity in medical devices is no longer just a technical concern, it\u2019s a critical requirement in ensuring patient safety. The European Medical Device Regulation (MDR) 2017\/745 outlines clear expectations for device manufacturers to secure data, prevent unauthorized access, and maintain system reliability throughout the product\u2019s lifecycle. This article introduces the&#8230;<\/p>\n","protected":false},"author":16,"featured_media":71088,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[566],"tags":[],"class_list":["post-70998","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medtech"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.teoresigroup.com\/test\/wp-json\/wp\/v2\/posts\/70998","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.teoresigroup.com\/test\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.teoresigroup.com\/test\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.teoresigroup.com\/test\/wp-json\/wp\/v2\/users\/16"}],"replies":[{"embeddable":true,"href":"https:\/\/www.teoresigroup.com\/test\/wp-json\/wp\/v2\/comments?post=70998"}],"version-history":[{"count":14,"href":"https:\/\/www.teoresigroup.com\/test\/wp-json\/wp\/v2\/posts\/70998\/revisions"}],"predecessor-version":[{"id":78451,"href":"https:\/\/www.teoresigroup.com\/test\/wp-json\/wp\/v2\/posts\/70998\/revisions\/78451"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.teoresigroup.com\/test\/wp-json\/wp\/v2\/media\/71088"}],"wp:attachment":[{"href":"https:\/\/www.teoresigroup.com\/test\/wp-json\/wp\/v2\/media?parent=70998"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.teoresigroup.com\/test\/wp-json\/wp\/v2\/categories?post=70998"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.teoresigroup.com\/test\/wp-json\/wp\/v2\/tags?post=70998"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}