The performance study plan sets out the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a performance study with an in vitro diagnostic device. A performance study device is an IVD that the manufacturer has intended for use in such a study. <\/p>\n
The plan translates the performance question into a verifiable process. Among other things, it describes the population or sample source to be investigated, the comparator or reference method, endpoints, sample collection, evaluation methods and responsibilities. In studies involving samples, the assignment of clinical information and test results must be unambiguous. <\/p>\n
Planning must match the type of performance claimed. A diagnostic accuracy study requires a different reference concept than an investigation of repeatability or operator influence. The handling of invalid results, missing data and sample deviations must also be specified in advance in the plan so that the analysis is not defined only after the results are known. <\/p>\n
A performance study device requires designation by the manufacturer. A product with no medical intended purpose that is used exclusively for research purposes is explicitly not covered by this term. The research setting alone is therefore not decisive; what matters is what the manufacturer intends to demonstrate with the product and the study. <\/p>\n
This distinction prevents research reagents from being equated with performance study IVDs. As soon as a study is intended to generate data for the performance evaluation of an IVD with a medical intended purpose, the product status and study documentation must be assessed under the IVDR. A research label cannot replace this classification. <\/p>\n
The established term clinical-pruefplan refers to a clinical investigation of a medical device under the MDR. The performance study plan is its counterpart in the IVDR context, but it is not merely a renaming. It addresses the performance evaluation of an IVD and therefore, in particular, analytes, samples, reference methods and the clinical interpretation of test results. <\/p>\n
Performance study is also the overarching study type. The plan describes how this study is conducted, while the performance study device refers to the IVD intended for this purpose. The terms are therefore functionally related, but remain separate definitions. <\/p>\n
Evidence generation and changes<\/p>\n
A robust performance study plan links study activities to performance questions and analysis steps. If analytical methods, sample pathways, or inclusion and exclusion criteria are changed, this can affect the evidential value of the study. Changes must therefore be assessed and documented before they compromise the comparability of the data collected. <\/p>\n
The performance study device must remain identifiable in the configuration under investigation. Reagent lots, software versions, instrument versions and calibrations can influence the outcome. Documentation should make it possible to trace each result back to the product configuration used and the conditions of the investigation. <\/p>\n
The performance study plan must also specify how the rights, safety and protection of the persons or sample sources included in the study will be safeguarded. In performance studies involving additional invasive sample collection or the use of residual samples, different risks and information requirements may apply. The scientific necessity of the sample and its link to the performance question should be reflected in the design. <\/p>\n
A clear separation between the study plan and the performance evaluation plan prevents contradictory documents. The performance evaluation plan describes the overall strategy for scientific validity, analytical performance and clinical performance; the performance study plan defines the concrete conduct of a single study. The study results are then placed within the broader performance evaluation and are not considered in isolation as stand-alone evidence. <\/p>\n
In multi-site studies, the plan must define how identical test conditions will be ensured. Differences in sample processing, instruments or evaluation can change the results. Monitoring and data checks therefore focus not only on the completeness of forms, but also on compliance with the laboratory processes that are critical to the performance question. <\/p>\n
In IVDR projects, the performance study plan links the scientific question with the operational workflow in laboratories, investigational sites and databases. Without precise specifications for the reference method and sample flow, a study may produce data but cannot reliably answer the claimed performance. For combined studies involving medicinal products or medical devices, responsibilities under the parallel legal frameworks must also be delineated. <\/p>\n
Full-service CROs such as Mediconomics support the development of performance study plans, the setup of sample and data flows, the coordination of monitoring and laboratories, and statistical analyses for IVDR performance evaluation.<\/p>\n
Is a research reagent automatically a performance study device?<\/strong><\/p>\n No. Without a medical intended purpose and designation by the manufacturer for a performance study, the IVDR definition does not apply. <\/p>\n How does the plan differ from the performance study device?<\/strong><\/p>\n The plan describes the study; the performance study device is the IVD that is used and evaluated in that study.<\/p>\n Why must the product configuration be traceable in the plan?<\/strong><\/p>\n Changes to reagents, software or instruments can influence results and thus limit the transferability of the performance data.<\/p>\n The performance study plan sets out the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a performance study with an in vitro diagnostic device. A performance study device is an IVD that the manufacturer has intended for use in such a study. The plan as a control document The plan translates the […]<\/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-7734","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\/7734","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\/7734\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=7734"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=7734"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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