{"id":17631,"date":"2025-07-19T14:11:32","date_gmt":"2025-07-19T11:11:32","guid":{"rendered":"https:\/\/www.d-tek.com.tr\/?p=17631"},"modified":"2025-07-19T14:16:02","modified_gmt":"2025-07-19T11:16:02","slug":"preparing-for-adverse-events-in-medical-laboratories-according-to-ivdr","status":"publish","type":"post","link":"https:\/\/www.d-tek.com.tr\/en\/preparing-for-adverse-events-in-medical-laboratories-according-to-ivdr\/","title":{"rendered":"Preparing for Adverse Events in Medical Laboratories According to IVDR"},"content":{"rendered":"<p><span style=\"font-size: 16px;\">Prof. Dr. Diler Aslan<\/span><\/p>\n<p><span style=\"font-size: 16px;\">Medical laboratories play a vital role in accurate diagnostics and safe treatment pathways. However, adverse events such as\u00a0<strong>equipment malfunctions<\/strong>,\u00a0<strong>false results<\/strong>, or\u00a0<strong>labeling errors<\/strong>\u00a0can pose serious risks to patient safety, institutional reputation, and legal compliance.<\/span><\/p>\n<p><span style=\"font-size: 16px;\">With the implementation of the\u00a0<strong>EU In Vitro Diagnostic Medical Devices Regulation (IVDR)<\/strong>, laboratories are now more directly accountable in the\u00a0<strong>vigilance and incident reporting process<\/strong>. Being unprepared is no longer an option.<\/span><\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Highlighted Topics<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ez-toc-columns-2' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.d-tek.com.tr\/en\/preparing-for-adverse-events-in-medical-laboratories-according-to-ivdr\/#What_Is_an_Adverse_Event_Under_IVDR\" >What Is an Adverse Event Under IVDR?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.d-tek.com.tr\/en\/preparing-for-adverse-events-in-medical-laboratories-according-to-ivdr\/#Who_Must_Report_Not_Just_Manufacturers\" >Who Must Report? Not Just Manufacturers<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.d-tek.com.tr\/en\/preparing-for-adverse-events-in-medical-laboratories-according-to-ivdr\/#Reporting_Deadlines_Under_IVDR\" >Reporting Deadlines Under IVDR<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.d-tek.com.tr\/en\/preparing-for-adverse-events-in-medical-laboratories-according-to-ivdr\/#How_Should_a_Laboratory_Prepare\" >How Should a Laboratory Prepare?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.d-tek.com.tr\/en\/preparing-for-adverse-events-in-medical-laboratories-according-to-ivdr\/#Trend_Reporting_What_About_Non-Serious_Issues\" >Trend Reporting: What About Non-Serious Issues?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.d-tek.com.tr\/en\/preparing-for-adverse-events-in-medical-laboratories-according-to-ivdr\/#How_Consulting_Can_Help_You_Stay_Ahead\" >How Consulting Can Help You Stay Ahead<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.d-tek.com.tr\/en\/preparing-for-adverse-events-in-medical-laboratories-according-to-ivdr\/#Dont_Wait_for_the_First_Incident\" >Don&#039;t Wait for the First Incident<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"What_Is_an_Adverse_Event_Under_IVDR\"><\/span><span style=\"font-size: 16px;\">What Is an Adverse Event Under IVDR?<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-size: 16px;\">According to\u00a0<strong>Article 82 of the IVDR<\/strong>, an adverse event\u2014termed a \u201cserious incident\u201d\u2014references to any incident involving a device that leads to:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 16px;\"><strong>Death or serious deterioration<\/strong>\u00a0of a patient&#039;s health<\/span><\/li>\n<li><span style=\"font-size: 16px;\">A\u00a0<strong>public health threat<\/strong><\/span><\/li>\n<li><span style=\"font-size: 16px;\">The necessity of a\u00a0<strong>field safety corrective action (FSCA)<\/strong><\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 16px;\">Even manufacturers&#039; voluntary recalls due to performance issues must be tracked and notified appropriately.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Who_Must_Report_Not_Just_Manufacturers\"><\/span><span style=\"font-size: 16px;\">Who Must Report? Not Just Manufacturers<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-size: 16px;\">While manufacturers are the primary party responsible for reporting incidents to national competent authorities,\u00a0<strong>laboratories as device users also play a key role<\/strong>:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 16px;\">They may\u00a0<strong>initiate investigations<\/strong>\u00a0or support root cause analysis.<\/span><\/li>\n<li><span style=\"font-size: 16px;\">They are often the\u00a0<strong>first to detect anomalies<\/strong>\u00a0in device behavior or unexpected test results.<\/span><\/li>\n<li><span style=\"font-size: 16px;\">Their collaboration is crucial in\u00a0<strong>documenting and containing potential risks<\/strong>.<\/span><\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Reporting_Deadlines_Under_IVDR\"><\/span><span style=\"font-size: 16px;\">Reporting Deadlines Under IVDR<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<table border=\"1\" cellspacing=\"0\" cellpadding=\"6\">\n<tbody>\n<tr>\n<th><span style=\"font-size: 16px;\">Incident Type<\/span><\/th>\n<th><span style=\"font-size: 16px;\">Reporting Deadline<\/span><\/th>\n<\/tr>\n<tr>\n<td><span style=\"font-size: 16px;\">Public health threat<\/span><\/td>\n<td><span style=\"font-size: 16px;\">Within 2 days<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-size: 16px;\">Death or serious deterioration<\/span><\/td>\n<td><span style=\"font-size: 16px;\">Within 10 days<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-size: 16px;\">Other serious incidents<\/span><\/td>\n<td><span style=\"font-size: 16px;\">Within 15 days<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"font-size: 16px;\">Laboratories must ensure their procedures align with these deadlines\u2014even if the actual report is submitted by the manufacturer.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_Should_a_Laboratory_Prepare\"><\/span><span style=\"font-size: 16px;\">How Should a Laboratory Prepare?<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-size: 16px;\">To meet IVDR obligations and maintain patient safety, laboratories should:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 16px;\"><strong>Establish an internal incident documentation process<\/strong><\/span><\/li>\n<li><span style=\"font-size: 16px;\"><strong>Record device details<\/strong>\u00a0(eg model, lot\/serial numbers) and testing context<\/span><\/li>\n<li><span style=\"font-size: 16px;\"><strong>Preserve the device<\/strong>\u00a0for investigation when feasible<\/span><\/li>\n<li><span style=\"font-size: 16px;\"><strong>Develop an incident escalation plan<\/strong>\u00a0involving quality officers<\/span><\/li>\n<li><span style=\"font-size: 16px;\"><strong>Collaborate with manufacturers<\/strong>\u00a0to provide usage logs and observations<\/span><\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Trend_Reporting_What_About_Non-Serious_Issues\"><\/span><span style=\"font-size: 16px;\">Trend Reporting: What About Non-Serious Issues?<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-size: 16px;\">Even events not classified as serious incidents may still require \u201ctrend reporting\u201d under\u00a0<strong>Article 83<\/strong>\u00a0of the IVDR. If laboratories detect a statistically significant increase in:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 16px;\">False positives or false negatives<\/span><\/li>\n<li><span style=\"font-size: 16px;\">Unexpected side effects<\/span><\/li>\n<li><span style=\"font-size: 16px;\">Instrument instability<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 16px;\">\u2026they must work with manufacturers to ensure reporting compliance.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_Consulting_Can_Help_You_Stay_Ahead\"><\/span><span style=\"font-size: 16px;\">How Consulting Can Help You Stay Ahead<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-size: 16px;\">My consulting services support both public and private laboratories in:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 16px;\">Building\u00a0<strong>IVDR-compliant incident workflows<\/strong><\/span><\/li>\n<li><span style=\"font-size: 16px;\">Drafting\u00a0<strong>standard operating procedures (SOPs)<\/strong>\u00a0for adverse events<\/span><\/li>\n<li><span style=\"font-size: 16px;\">Conducting\u00a0<strong>staff training<\/strong>\u00a0and awareness workshops<\/span><\/li>\n<li><span style=\"font-size: 16px;\">Assisting in communication with\u00a0<strong>competent authorities<\/strong>\u00a0and manufacturers<\/span><\/li>\n<li><span style=\"font-size: 16px;\">Implementing a\u00a0<strong>vigilance documentation system<\/strong>\u00a0that satisfies ISO 15189 and IVDR together<\/span><\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Dont_Wait_for_the_First_Incident\"><\/span><span style=\"font-size: 16px;\">Don&#039;t Wait for the First Incident<\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-size: 16px;\">Being prepared before an adverse event happens is the smartest and most responsible path forward. I can help you design a system that&#039;s both compliant and practical\u2014ensuring your laboratory operates safely, confidently, and in full alignment with IVDR.<\/span><\/p>\n<p><span style=\"font-size: 16px;\">\ud83d\udc49 Ready to prepare your lab for IVDR-compliant vigilance?\u00a0<a class=\"color-button blue\" href=\"\/en\/contact\/\">Get in touch today.<\/a><\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>Prof. Dr. Diler Aslan Medical laboratories play a vital role in accurate diagnostics and safe treatment pathways. However, adverse events such as\u00a0equipment malfunctions,\u00a0false results, or\u00a0labeling errors\u00a0can pose serious risks to patient safety, institutional reputation, and legal compliance. With the implementation of the\u00a0EU In Vitro Diagnostic Medical Devices Regulation (IVDR), laboratories are now more directly accountable&hellip;<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[63,73,75,79],"tags":[203,205,199,204,202,206,200,207,201],"post_series":[],"class_list":["post-17631","post","type-post","status-publish","format-standard","hentry","category-blog","category-kalite-yonetimi-ve-surekli-iyilestirme-tr","category-risk-yonetimi-tr","category-tibbi-cihaz-ve-in-vitro-diyagnostik-tibbi-cihaz-tr","tag-in-vitro-diagnostics-regulation","tag-iso-15189-laboratory-quality","tag-ivdr-compliance","tag-ivdr-consulting","tag-lab-adverse-event-reporting","tag-medical-device-incident-reporting","tag-medical-laboratory-vigilance","tag-risk-management-for-labs","tag-serious-incident-ivdr","entry","no-media"],"_links":{"self":[{"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/posts\/17631","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/comments?post=17631"}],"version-history":[{"count":1,"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/posts\/17631\/revisions"}],"predecessor-version":[{"id":17632,"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/posts\/17631\/revisions\/17632"}],"wp:attachment":[{"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/media?parent=17631"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/categories?post=17631"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/tags?post=17631"},{"taxonomy":"post_series","embeddable":true,"href":"https:\/\/www.d-tek.com.tr\/en\/wp-json\/wp\/v2\/post_series?post=17631"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}