{"id":33905,"date":"2025-04-15T10:37:14","date_gmt":"2025-04-15T08:37:14","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=33905"},"modified":"2025-06-16T16:31:30","modified_gmt":"2025-06-16T14:31:30","slug":"terminology-adverse-events-medical-devices-imdrf-2025","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2025\/04\/15\/terminology-adverse-events-medical-devices-imdrf-2025\/","title":{"rendered":"Terminology for Adverse Events in Medical Devices: IMDRF Update, March 2025"},"content":{"rendered":"<p>The <strong>IMDRF<\/strong> <strong>(International Medical Device Regulators Forum)<\/strong>, an international cooperation body promoting the harmonisation of medical device regulation, published on <strong>March 3, 2025,<\/strong> a new version of the codes for reporting adverse events associated with the use of medical devices.<\/p>\n<p>The document, entitled <strong>&#8216;IMDRF Terminologies for Categorised Adverse Event Reporting (AER): Terms, Definitions and Codes&#8217;<\/strong> (edition 2025-03-03), introduces <strong>new terms and codes<\/strong> to improve the classification and understanding of adverse events related to device safety.<\/p>\n<p>The <strong>main purpose of<\/strong> this harmonisation, promoted by the IMDRF at a global level, is to improve the effectiveness of safety signal detection for both regulators and the medical device industry. Harmonisation aims to strengthen <strong>post-market surveillance (PMS) activities.<\/strong> The adoption of standardised terminology reduces ambiguity and increases the effectiveness of the adverse event investigation process.<\/p>\n<p>Thanks to <strong>harmonised terminology, <\/strong>it is possible to classify <strong>adverse events<\/strong> associated with medical devices, such as:<\/p>\n<ul>\n<li>Malfunction<\/li>\n<li>Errors of use<\/li>\n<li>System faults<\/li>\n<li>Clinical complications<\/li>\n<li>Unintentional adverse reactions<\/li>\n<li>Other events that have resulted or could have resulted in serious damage to the health of the patient or the operator.<\/li>\n<\/ul>\n<p>In the regulatory context, an &#8216;adverse event&#8217; is any adverse or unexpected effect related to the use of a medical device, while an &#8216;accident&#8217; is an event that caused or could have caused death or a serious deterioration in health.<\/p>\n<p>The objective is twofold:<\/p>\n<ol>\n<li>Facilitating global data collection, analysis and sharing.<\/li>\n<li>Simplify the compilation of documents such as the <strong>Manufacturer Incident Report (MIR)<\/strong> used in the European Union and similar forms provided by regulatory authorities in other countries.<\/li>\n<\/ol>\n<h3>What the new version envisages (2025-03-03)<\/h3>\n<p>The update introduced <strong>36 new terms<\/strong>, <strong>modified 56 existing entries<\/strong> and <strong>withdrew 8 terms<\/strong>.<\/p>\n<p>The new edition updates six code groups:<\/p>\n<ul>\n<li>Device Problem Terms<\/li>\n<li>Terms for the type of clinical event (Clinical Signs, Symptoms and Conditions)<\/li>\n<li>Terms relating to Patient Outcome<\/li>\n<li>Root Cause Terms<\/li>\n<li>Terms related to the device component involved (Component Terms)<\/li>\n<li>Human Factors Terms<\/li>\n<\/ul>\n<p>Each term is accompanied by a code and a clear definition. Some examples of new codes in the <em>Device Problem Terms<\/em> category:<\/p>\n<ul>\n<li>D1.8471 &#8211; Unexpected activation<\/li>\n<li>D1.8472 &#8211; Improper fitting<\/li>\n<\/ul>\n<p>Each code can be used in corporate information systems to consistently <strong>label, store and analyse<\/strong> incident reports.<\/p>\n<h3>Implications for Manufacturers<\/h3>\n<p>The adoption of the new terminology is <strong>recommended internationally<\/strong>, but <strong>is not yet mandatory in the European Union<\/strong>.<\/p>\n<p>However, the <strong>European MIR form<\/strong>, which manufacturers must fill out in the event of a serious accident or corrective action, <strong>is built on the basis of the IMDRF structure.<\/strong> This means that it is <strong>very likely<\/strong> that the EU will transpose the new versions, as has already happened in the past. As far as the European Union is concerned, in the event of adoption, <strong>a transition period of at least one year<\/strong> from the publication of the possible new MIR form is envisaged, as in the past.<\/p>\n<p>Therefore, manufacturers should monitor regulatory developments in their country and then coordinate with post-market surveillance (PMS) managers to ensure compliance and consistency in adverse event reporting.<\/p>\n<p>The IMDRF provides an annual process through which <strong>stakeholders<\/strong> can request changes to the AET terminology.\u00a0 <strong>Requests for changes can be submitted from September 1 of the current year to September 1 of the following year.<\/strong> Accepted changes are published in March, along with a log (Change Log) detailing each request and the reason for acceptance or rejection.<\/p>\n<h3>Conclusion<\/h3>\n<p>The adoption of a common terminology at a global level is an essential step to ensure greater transparency, comparability and safety in the use of medical devices. Manufacturers are encouraged to monitor updates to prepare for changes.<\/p>\n<p>&gt;&gt;&gt; Thema experts follow all developments in the application of the guideline in different countries around the world and can provide comprehensive assistance in the management of the <a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\">post-market marketing<\/a> of medical devices.<\/p>\n<p>SOURCE:<br \/>\n<a href=\"https:\/\/www.imdrf.org\/documents\/terminologies-categorized-adverse-event-reporting-aer-terms-terminology-and-codes\">https:\/\/www.imdrf.org\/documents\/terminologies-categorized-adverse-event-reporting-aer-terms-terminology-and-codes<\/a><\/p>\n<p>&nbsp;<\/p>\n<p><em>04\/15\/2025<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The IMDRF (International Medical Device Regulators Forum), an international cooperation body promoting the harmonisation of medical device regulation, published on March  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":33858,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[1679,1684,1685,1686],"class_list":["post-33905","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en","tag-adverseevents","tag-imdrf","tag-terminology","tag-medicaldevices-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Terminology for Adverse Events in Medical Devices: IMDRF Update, March 2025 - Thema Med Medical device adverse event terminology: IMDRF 2025 update<\/title>\n<meta name=\"description\" content=\"Learn about the IMDRF 2025 update on 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