An adverse device effect is an adverse event that is related to the use of an investigational device or a medical comparator device. An expected serious adverse device effect exists when the nature, frequency, severity, or outcome has already been described in the current risk assessment document. <\/p>\n
The concept of an adverse device effect requires a causality assessment. This involves evaluating whether the event may be linked to the device\u2019s design, use, malfunction, or diagnostic result. For a diagnostic device, an incorrect result may also be relevant if it leads to inappropriate treatment or to treatment being withheld. <\/p>\n
The assessment is based on the available information about the event, the device, and the course of use. It is not a purely documentation step: an initially unclear relationship may appear differently once additional findings, device testing, or follow-up information are available. The study documentation must therefore specify which information the investigational site collects to enable a robust assessment. <\/p>\n
For an adverse event, the relationship to the device is initially open. An adverse device effect, by contrast, attributes the event to the investigational device or a medical comparator device. It is therefore not simply an alternative wording of the existing entries unerwuenschtes-ereignis, schwerwiegendes-unerwuenschtes-ereignis, or serious-adverse-event. <\/p>\n
\u201cExpected\u201d does not refer to an assumption in the clinical investigation plan. The benchmark is the most recently available risk assessment document for the device. It must describe the relevant reaction and its expected manifestation in terms of nature, frequency, severity, or outcome. If this correspondence is missing, the effect must not be classified as expected solely on the basis of a general risk statement. <\/p>\n
A serious adverse device effect combines device relatedness with a serious consequence. Classifying seriousness and determining whether the effect was expected are separate assessment steps. A reaction may therefore be serious and expected, or serious but not described as foreseeable in the risk document. <\/p>\n
This distinction governs safety reporting and risk surveillance during the ongoing study. Repeated expected reactions may, despite being expected, indicate an undesirable clustering. The risk assessment must therefore continuously review whether frequency and patterns still match the documented profile. <\/p>\n
For causality assessment, temporal proximity alone is also not decisive. An event after use may have another medical cause; conversely, a device-related effect may only become apparent with a delay. For this reason, the device\u2019s functional status, handling, concomitant treatments, and the clinical course are considered together. The documentation should explain the specific relationship between the event and the device, not merely tick a category. <\/p>\n
Expected serious effects remain relevant safety data. They are not excluded from surveillance because they are listed in the risk document. Their frequency, severity, and any patterns must continue to be reconciled with the known risk profile. If a new pattern emerges, this may require an update to risk management or to the study information. <\/p>\n
For comparator devices, device attribution must be performed just as carefully as for the investigational device. A study can only provide a balanced safety picture if events can be attributed to the respective technology used. This is particularly important in studies with different operating procedures or diagnostic decision pathways. <\/p>\n
In safety evaluation, diagnostic errors must be distinguished from mere laboratory deviations. An unexpected false-negative or false-positive finding only becomes an adverse device effect once its relationship to the IVD used and the adverse consequence have been assessed in a traceable manner. Event capture must therefore bring together the test result, the reference finding, and the medical consequence. <\/p>\n
An expected risk may present differently in a new patient population than in the data on which the risk assessment is based. The ASADE assessment therefore also includes the question of whether the manifestation in question is truly comparable to what was previously described. A merely similar label is not sufficient if severity or outcome differ. <\/p>\n
For investigational sites, clear capture of the device version, use situation, and medical course is necessary so that causality and expectedness can later be assessed in a traceable manner. Especially for devices with operating procedures or for IVDs with therapy-determining results, the reporting forms should specifically request device-relevant information. Incomplete capture makes classification for safety reporting more difficult. <\/p>\n
Full-service CROs such as Mediconomics support the design of device-related safety forms, training investigational sites in causality documentation, medical review of reports, and coordination between pharmacovigilance, monitoring, and risk management.<\/p>\n
Is every serious adverse reaction an adverse device effect?<\/strong><\/p>\n No. In addition to seriousness, there must be a relationship to the investigational device or a medical comparator device. <\/p>\n Where is the expectedness of an ASADE assessed?<\/strong><\/p>\n In the current risk assessment document, not solely in the clinical investigation plan or in general information about study risk.<\/p>\n Why is the term SUSAR not equivalent?<\/strong><\/p>\n SUSAR is a medicinal product term; the device-related terms under the MDR follow a different safety and reporting logic.<\/p>\n An adverse device effect is an adverse event that is related to the use of an investigational device or a medical comparator device. An expected serious adverse device effect exists when the nature, frequency, severity, or outcome has already been described in the current risk assessment document. Product relatedness as the defining feature The concept […]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[24],"class_list":["post-7739","glossary","type-glossary","status-publish","hentry","glossary-cat-medizinprodukte-ivd"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7739","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":0,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7739\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=7739"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=7739"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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