{"id":8519,"date":"2022-08-23T11:46:54","date_gmt":"2022-08-23T11:46:54","guid":{"rendered":"https:\/\/mdxcro.com\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/"},"modified":"2026-08-06T16:06:18","modified_gmt":"2026-08-06T16:06:18","slug":"dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb","status":"publish","type":"post","link":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/","title":{"rendered":"Dispositivos IVD multiplex bajo el IVDR: enfoque de evaluaci\u00f3n com\u00fan del Team-NB"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Multiplex in vitro diagnostic devices detect two or more targets or markers through a common procedure. They may include anything from a small respiratory panel to an allergy, microbial identification or molecular panel containing hundreds of analytes.<\/p>\n\n<p class=\"wp-block-paragraph\">Under the EU In Vitro Diagnostic Medical Devices Regulation, or IVDR, the central challenge is not simply the number of markers. The Notified Body must understand whether the common technology is adequately verified, whether each intended-purpose claim is supported and how the risk varies across the markers included in the device.<\/p>\n\n<p class=\"wp-block-paragraph\">Team-NB has published a position paper explaining how Notified Bodies may use a risk-based approach when assessing marker-specific data within a multiplex IVD. The paper was adopted in July 2022 and remained listed as active by Team-NB in July 2026.<\/p>\n\n<blockquote class=\"wp-block-quote has-white-frost-background-color has-background has-medium-font-size is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"wp-block-paragraph\"><strong>Key point:<\/strong> Risk-based sampling concerns the scope of the Notified Body\u2019s review. It does not remove the manufacturer\u2019s responsibility to prepare complete technical documentation and support every claim made for the multiplex device.<\/p>\n<\/blockquote>\n\n<h2 class=\"wp-block-heading\">Why multiplex IVDs require a specific assessment approach<\/h2>\n\n<p class=\"wp-block-paragraph\">Team-NB describes a multiplex IVD as one device, associated with one Basic UDI-DI and one intended-purpose statement, that simultaneously detects two or more targets or markers through a common procedure.<\/p>\n\n<p class=\"wp-block-paragraph\">This creates an assessment problem when the device contains dozens or hundreds of analytes. Reviewing the complete marker-specific dataset for every analyte may not always be practicable, particularly where the same detection platform, reading system or core technology is used across the panel.<\/p>\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2020-09\/md_mdcg_2019_13_sampling_mdr_ivdr_en_0.pdf\">MDCG 2019-13 Rev.1<\/a> explains the sampling of Class B and Class C devices across device categories and generic device groups. However, it does not specifically address the sampling of marker-specific data within a single multiplex device and Basic UDI-DI.<\/p>\n\n<p class=\"wp-block-paragraph\">The <a href=\"https:\/\/www.team-nb.org\/wp-content\/uploads\/2022\/07\/Team-NB-PositionPaper-ConfAssessment-Multiplexassays-V1.pdf\">Team-NB position paper on multiplex IVDs<\/a> addresses this operational gap for Notified Bodies.<\/p>\n\n<h2 class=\"wp-block-heading\">How the Team-NB risk-based approach works<\/h2>\n\n<p class=\"wp-block-paragraph\">When marker-specific sampling is considered appropriate, Team-NB expects the Notified Body to:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>focus first on the design, verification and validation of the technology used to detect the targets or markers;<\/li>\n\n\n\n<li>prioritise markers associated with the highest IVDR class;<\/li>\n\n\n\n<li>use a documented, risk-based approach to select Class B and Class C marker data for review;<\/li>\n\n\n\n<li>review the technical documentation associated with every Class D marker;<\/li>\n\n\n\n<li>expand the sample if the initial review identifies multiple deficiencies; and<\/li>\n\n\n\n<li>record the approach and rationale in the conformity assessment documentation.<\/li>\n<\/ul>\n\n<p class=\"wp-block-paragraph\">The Notified Body owns the sampling decision and its documented rationale. Manufacturers should therefore avoid building a dossier on the assumption that only a selected subset of markers will be assessed.<\/p>\n\n<p class=\"wp-block-paragraph\">Every marker included in the intended purpose should remain traceable to the evidence supporting its analytical and clinical claims.<\/p>\n\n<h2 class=\"wp-block-heading\">Examples given by Team-NB<\/h2>\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Multiplex device<\/th><th>Expected focus of the assessment<\/th><\/tr><\/thead><tbody><tr><td>A mass spectrometry microbial identification system covering more than 200 bacteria<\/td><td>Design, verification and validation of the reading system, combined with risk-based sampling of clinical performance data<\/td><\/tr><tr><td>An Immuno Solid-phase Allergen Chip covering more than 100 allergens<\/td><td>Design, verification and validation of the reading system, with a justified sample of individual allergen performance and clinical data<\/td><\/tr><tr><td>A respiratory pathogen panel containing markers from different IVDR classes<\/td><td>Priority review of the highest-class markers, full review of Class D marker documentation and possible sampling of Class B\/C marker data<\/td><\/tr><\/tbody><\/table><\/figure>\n\n<p class=\"wp-block-paragraph\">These examples should not be treated as universal sampling plans. The final approach depends on the device, intended purpose, technology, marker risk, previous assessment findings and instructions from the selected Notified Body.<\/p>\n\n<h2 class=\"wp-block-heading\">What manufacturers should prepare before Notified Body review<\/h2>\n\n<p class=\"wp-block-paragraph\">The following readiness framework helps make a multiplex IVD dossier easier to assess. It supplements, but does not replace, the requirements of the IVDR or the procedures of the selected Notified Body.<\/p>\n\n<h3 class=\"wp-block-heading\">1. A complete analyte and claims matrix<\/h3>\n\n<p class=\"wp-block-paragraph\">Create a controlled matrix linking every claimed marker to:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>its intended use and clinical purpose;<\/li>\n\n\n\n<li>its applicable IVDR classification;<\/li>\n\n\n\n<li>specimen type and intended user;<\/li>\n\n\n\n<li>scientific validity evidence;<\/li>\n\n\n\n<li>analytical performance evidence;<\/li>\n\n\n\n<li>clinical performance evidence;<\/li>\n\n\n\n<li>applicable risks and controls;<\/li>\n\n\n\n<li>labelling and IFU statements; and<\/li>\n\n\n\n<li>the corresponding sections and reports in the technical documentation.<\/li>\n<\/ul>\n\n<p class=\"wp-block-paragraph\">The matrix should make it possible for an assessor to move from an intended-purpose claim to the supporting evidence without having to reconstruct the relationship across multiple files.<\/p>\n\n<h3 class=\"wp-block-heading\">2. A clear description of the shared technology<\/h3>\n\n<p class=\"wp-block-paragraph\">Explain which parts of the assay are common across the panel and which are marker-specific. Depending on the device, this may include:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>sample preparation and extraction;<\/li>\n\n\n\n<li>reagent design;<\/li>\n\n\n\n<li>primer and probe chemistry;<\/li>\n\n\n\n<li>signal generation;<\/li>\n\n\n\n<li>calibration and controls;<\/li>\n\n\n\n<li>reading or detection systems;<\/li>\n\n\n\n<li>software and result-calling algorithms; and<\/li>\n\n\n\n<li>rules for invalid, indeterminate or conflicting results.<\/li>\n<\/ul>\n\n<p class=\"wp-block-paragraph\">Where performance from selected markers is intended to support conclusions about other markers, the technical documentation should explain why that transfer is scientifically and technically justified.<\/p>\n\n<h3 class=\"wp-block-heading\">3. Marker-specific analytical and clinical evidence<\/h3>\n\n<p class=\"wp-block-paragraph\">A common platform does not automatically demonstrate that every marker performs equivalently. Manufacturers should identify differences in detection limits, cross-reactivity, interference, cut-offs, reference materials, clinical populations and other marker-specific factors.<\/p>\n\n<p class=\"wp-block-paragraph\">Evidence gaps should be identified before submission rather than left for the Notified Body to discover during its initial sample review.<\/p>\n\n<p class=\"wp-block-paragraph\">For the wider structure and presentation of the dossier, see MDx CRO\u2019s guide to <a href=\"https:\/\/mdxcro.com\/ivdr-technical-documentation\/\">IVDR technical documentation<\/a>.<\/p>\n\n<h3 class=\"wp-block-heading\">4. Consistency across intended purpose, labelling and performance evaluation<\/h3>\n\n<p class=\"wp-block-paragraph\">The intended purpose, IFU, performance evaluation documentation and final Performance Evaluation Report should describe the same device and support the same claims.<\/p>\n\n<p class=\"wp-block-paragraph\">For multiplex IVDs, particular attention should be given to:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>the exact markers included in the panel;<\/li>\n\n\n\n<li>whether results are qualitative, quantitative or semi-quantitative;<\/li>\n\n\n\n<li>the clinical meaning assigned to individual and combined results;<\/li>\n\n\n\n<li>intended users and use environments;<\/li>\n\n\n\n<li>specimen types;<\/li>\n\n\n\n<li>target populations; and<\/li>\n\n\n\n<li>limitations or confirmatory testing requirements.<\/li>\n<\/ul>\n\n<p class=\"wp-block-paragraph\">Inconsistencies between these elements can lead to additional questions and a broader review.<\/p>\n\n<h2 class=\"wp-block-heading\">Common result-interpretation and validation risks<\/h2>\n\n<p class=\"wp-block-paragraph\">Although the Team-NB paper focuses on technical documentation assessment, the way multiplex results are generated and interpreted directly affects the supporting evidence.<\/p>\n\n<p class=\"wp-block-paragraph\">Depending on the technology and intended purpose, the validation strategy may need to address:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>cross-reactivity and signal cross-talk between markers;<\/li>\n\n\n\n<li>different limits of detection across the panel;<\/li>\n\n\n\n<li>competition or interference when multiple targets are present;<\/li>\n\n\n\n<li>the effect of high and low target concentrations in the same specimen;<\/li>\n\n\n\n<li>pre-analytical variables and specimen quality;<\/li>\n\n\n\n<li>marker-specific cut-offs and algorithmic decision rules;<\/li>\n\n\n\n<li>invalid, indeterminate or discordant results; and<\/li>\n\n\n\n<li>the circumstances in which confirmatory testing is required.<\/li>\n<\/ul>\n\n<p class=\"wp-block-paragraph\">The relevance of each issue should be assessed against the intended use. A research-use scenario cannot automatically be used to support performance claims for an IVDR-regulated device.<\/p>\n\n<h2 class=\"wp-block-heading\">Class D markers and EU Reference Laboratories<\/h2>\n\n<p class=\"wp-block-paragraph\">Team-NB states that the technical documentation for all Class D markers included in a multiplex device should be reviewed.<\/p>\n\n<p class=\"wp-block-paragraph\">Class D devices may also be subject to additional IVDR controls involving an EU Reference Laboratory, depending on the device category and the scope of the designated laboratory. EU Reference Laboratories can verify device performance and compliance with applicable common specifications and perform batch testing for relevant Class D devices.<\/p>\n\n<p class=\"wp-block-paragraph\">The current EURL designations apply to their conformity assessment tasks from 1 October 2024. Manufacturers should confirm the applicable EURL pathway and timing with their Notified Body rather than assuming that every Class D marker follows the same operational route.<\/p>\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading\">Frequently asked questions<\/h2>\n\n<div class=\"schema-faq wp-block-yoast-faq-block\"><div class=\"schema-faq-section\" id=\"faq-question-1785937279954\"><strong class=\"schema-faq-question\">Does a Notified Body review every marker in a multiplex IVD?<\/strong> <p class=\"schema-faq-answer\">Not necessarily. Under the Team-NB approach, marker-specific data for Class B and Class C markers may be sampled using a risk-based rationale. The technical documentation associated with every Class D marker should be reviewed. The manufacturer must still maintain evidence supporting every marker and claim included in the intended purpose.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1785937286432\"><strong class=\"schema-faq-question\">Who decides which markers are sampled?<\/strong> <p class=\"schema-faq-answer\">The Notified Body decides which marker-specific data to review and records its rationale in the conformity assessment documentation. Manufacturers can prepare for likely areas of scrutiny, but they should not treat their own proposed sample as a limit on the Notified Body\u2019s review.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1785937304896\"><strong class=\"schema-faq-question\">What happens if the initial sample contains deficiencies?<\/strong> <p class=\"schema-faq-answer\">The Notified Body may select additional analytes or revise its sampling plan during the certification cycle. Deficiencies in a small initial sample can therefore increase the eventual review scope.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1785937312172\"><strong class=\"schema-faq-question\">Does this approach automatically apply to a multiplex companion diagnostic?<\/strong> <p class=\"schema-faq-answer\">No. Companion diagnostics have additional IVDR assessment requirements. MDCG 2019-13 Rev.1 also explains that Class B and Class C companion diagnostics, self-testing devices and near-patient testing devices are exempt from the device-level sampling described in that guidance.<br\/>The Team-NB multiplex paper addresses marker-level sampling within a multiplex device. A manufacturer developing a multiplex companion diagnostic should confirm how these requirements interact with its Notified Body and the relevant medicinal product consultation pathway.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1785937321930\"><strong class=\"schema-faq-question\">Is the Team-NB position paper legally binding?<\/strong> <p class=\"schema-faq-answer\">No. It is a common position intended for Notified Body use. It is not an European Commission document and does not replace the IVDR, MDCG guidance or device-specific instructions from the selected Notified Body.<\/p> <\/div> <\/div>\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading\">Preparing a defensible multiplex IVD submission<\/h2>\n\n<p class=\"wp-block-paragraph\">A strong multiplex IVD dossier allows an assessor to understand the shared technology, trace every claim to supporting evidence and identify the factors that make one marker different from another.<\/p>\n\n<p class=\"wp-block-paragraph\">Risk-based sampling can make the Notified Body assessment more practicable, but it does not compensate for incomplete evidence. The most defensible approach is to prepare the documentation on the assumption that any claimed marker may be selected for detailed review.<\/p>\n\n<p class=\"wp-block-paragraph\">If you are preparing or remediating the dossier for a multiplex IVD, MDx CRO can support the evidence strategy, performance documentation and responses to Notified Body questions. Explore our <a href=\"https:\/\/mdxcro.com\/services\/regulatory-affairs-technical-documentation\/\">regulatory affairs and technical documentation services<\/a>.<\/p>\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Multiplex in vitro diagnostic devices detect two or more targets or markers through a common procedure. They may include anything from a small respiratory panel to an allergy, microbial identification or molecular panel containing hundreds of analytes. Under the EU In Vitro Diagnostic Medical Devices Regulation, or IVDR, the central challenge is not simply the [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":5946,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[231,227],"tags":[],"resources-sector":[178],"class_list":["post-8519","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualizaciones-normativas","category-noticias-sobre-ivd","resources-sector-ivds"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Dispositivos IVD multiplex bajo el IVDR: enfoque de evaluaci\u00f3n com\u00fan del Team-NB - MDx CRO<\/title>\n<meta name=\"description\" content=\"C\u00f3mo eval\u00faan los organismos notificados los IVD multiplex bajo el IVDR: enfoque com\u00fan del Team-NB para el muestreo basado en el riesgo, las expectativas de la Clase D y la documentaci\u00f3n t\u00e9cnica.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dispositivos IVD multiplex bajo el IVDR: enfoque de evaluaci\u00f3n com\u00fan del Team-NB - MDx CRO\" \/>\n<meta property=\"og:description\" content=\"C\u00f3mo eval\u00faan los organismos notificados los IVD multiplex bajo el IVDR: enfoque com\u00fan del Team-NB para el muestreo basado en el riesgo, las expectativas de la Clase D y la documentaci\u00f3n t\u00e9cnica.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/\" \/>\n<meta property=\"og:site_name\" content=\"MDx CRO\" \/>\n<meta property=\"article:published_time\" content=\"2022-08-23T11:46:54+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-08-06T16:06:18+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2021\/11\/shutterstock_1271882833.jpeg\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"800\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Carlos Galamba\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Carlos Galamba\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"8 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/\"},\"author\":{\"name\":\"Carlos Galamba\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/#\\\/schema\\\/person\\\/757ac74b94d37b0b3992676bb7e868e4\"},\"headline\":\"Dispositivos IVD multiplex bajo el IVDR: enfoque de evaluaci\u00f3n com\u00fan del Team-NB\",\"datePublished\":\"2022-08-23T11:46:54+00:00\",\"dateModified\":\"2026-08-06T16:06:18+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/\"},\"wordCount\":1579,\"publisher\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mdxcro.com\\\/wp-content\\\/uploads\\\/2021\\\/11\\\/shutterstock_1271882833.jpeg\",\"articleSection\":[\"Actualizaciones normativas\",\"Noticias sobre IVD\"],\"inLanguage\":\"es\"},{\"@type\":[\"WebPage\",\"FAQPage\"],\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/\",\"url\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/\",\"name\":\"Dispositivos IVD multiplex bajo el IVDR: enfoque de evaluaci\u00f3n com\u00fan del Team-NB - MDx CRO\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mdxcro.com\\\/wp-content\\\/uploads\\\/2021\\\/11\\\/shutterstock_1271882833.jpeg\",\"datePublished\":\"2022-08-23T11:46:54+00:00\",\"dateModified\":\"2026-08-06T16:06:18+00:00\",\"description\":\"C\u00f3mo eval\u00faan los organismos notificados los IVD multiplex bajo el IVDR: enfoque com\u00fan del Team-NB para el muestreo basado en el riesgo, las expectativas de la Clase D y la documentaci\u00f3n t\u00e9cnica.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/#breadcrumb\"},\"mainEntity\":[{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/#faq-question-1785937279954\"},{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/#faq-question-1785937286432\"},{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/#faq-question-1785937304896\"},{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/#faq-question-1785937312172\"},{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/#faq-question-1785937321930\"}],\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/#primaryimage\",\"url\":\"https:\\\/\\\/mdxcro.com\\\/wp-content\\\/uploads\\\/2021\\\/11\\\/shutterstock_1271882833.jpeg\",\"contentUrl\":\"https:\\\/\\\/mdxcro.com\\\/wp-content\\\/uploads\\\/2021\\\/11\\\/shutterstock_1271882833.jpeg\",\"width\":1200,\"height\":800,\"caption\":\"medtech cro services - quality assurance\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Dispositivos IVD multiplex bajo el IVDR: enfoque de evaluaci\u00f3n com\u00fan del Team-NB\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/#website\",\"url\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/\",\"name\":\"MDx CRO\",\"description\":\"Investigaci\u00f3n cl\u00ednica, normativa y control de calidad en tecnolog\u00eda m\u00e9dica y diagn\u00f3stico in vitro\",\"publisher\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/#organization\"},\"alternateName\":\"MDx\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"es\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/#organization\",\"name\":\"CRO de MDx\",\"url\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/mdxcro.com\\\/wp-content\\\/uploads\\\/2025\\\/07\\\/MDX.svg\",\"contentUrl\":\"https:\\\/\\\/mdxcro.com\\\/wp-content\\\/uploads\\\/2025\\\/07\\\/MDX.svg\",\"width\":352,\"height\":114,\"caption\":\"CRO de MDx\"},\"image\":{\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.linkedin.com\\\/company\\\/medtech-ivd-cro\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/#\\\/schema\\\/person\\\/757ac74b94d37b0b3992676bb7e868e4\",\"name\":\"Carlos Galamba\",\"pronouns\":\"he\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/wp-content\\\/uploads\\\/2025\\\/10\\\/cropped-Carlos-Galamba-2-96x96.jpg\",\"url\":\"https:\\\/\\\/mdxcro.com\\\/wp-content\\\/uploads\\\/2025\\\/10\\\/cropped-Carlos-Galamba-2-96x96.jpg\",\"contentUrl\":\"https:\\\/\\\/mdxcro.com\\\/wp-content\\\/uploads\\\/2025\\\/10\\\/cropped-Carlos-Galamba-2-96x96.jpg\",\"caption\":\"Carlos Galamba\"},\"description\":\"With more than 18 years of experience in the IVD sector, including hands-on work as a scientist in transfusion medicine and infectious disease diagnostics, and regulatory review experience at BSI, one of the EU's largest Notified Bodies, Carlos Galamba brings a uniquely integrated perspective to IVD regulatory strategy. Their work spans Class C\\\/D IVDs, companion diagnostics, NGS-based assays, and software-based IVDs, with a current advisory role to the European Commission on regulatory matters. At MDx CRO, they lead regulatory strategy for complex IVD programs across EU IVDR, FDA, and global markets.\",\"sameAs\":[\"https:\\\/\\\/mdxcro.com\\\/ivd-consultant-and-ivdr-expert-carlos-galamba\\\/\",\"https:\\\/\\\/www.linkedin.com\\\/in\\\/carlos-galamba\\\/\",\"https:\\\/\\\/www.youtube.com\\\/@MDxCRO\"],\"url\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/autor\\\/carlos-galamba\\\/\"},{\"@type\":\"Question\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/#faq-question-1785937279954\",\"position\":1,\"url\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/#faq-question-1785937279954\",\"name\":\"Does a Notified Body review every marker in a multiplex IVD?\",\"answerCount\":1,\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Not necessarily. Under the Team-NB approach, marker-specific data for Class B and Class C markers may be sampled using a risk-based rationale. The technical documentation associated with every Class D marker should be reviewed. The manufacturer must still maintain evidence supporting every marker and claim included in the intended purpose.\",\"inLanguage\":\"es\"},\"inLanguage\":\"es\"},{\"@type\":\"Question\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/#faq-question-1785937286432\",\"position\":2,\"url\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/#faq-question-1785937286432\",\"name\":\"Who decides which markers are sampled?\",\"answerCount\":1,\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"The Notified Body decides which marker-specific data to review and records its rationale in the conformity assessment documentation. Manufacturers can prepare for likely areas of scrutiny, but they should not treat their own proposed sample as a limit on the Notified Body\u2019s review.\",\"inLanguage\":\"es\"},\"inLanguage\":\"es\"},{\"@type\":\"Question\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/#faq-question-1785937304896\",\"position\":3,\"url\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/#faq-question-1785937304896\",\"name\":\"What happens if the initial sample contains deficiencies?\",\"answerCount\":1,\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"The Notified Body may select additional analytes or revise its sampling plan during the certification cycle. Deficiencies in a small initial sample can therefore increase the eventual review scope.\",\"inLanguage\":\"es\"},\"inLanguage\":\"es\"},{\"@type\":\"Question\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/#faq-question-1785937312172\",\"position\":4,\"url\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/#faq-question-1785937312172\",\"name\":\"Does this approach automatically apply to a multiplex companion diagnostic?\",\"answerCount\":1,\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"No. Companion diagnostics have additional IVDR assessment requirements. MDCG 2019-13 Rev.1 also explains that Class B and Class C companion diagnostics, self-testing devices and near-patient testing devices are exempt from the device-level sampling described in that guidance.<br>The Team-NB multiplex paper addresses marker-level sampling within a multiplex device. A manufacturer developing a multiplex companion diagnostic should confirm how these requirements interact with its Notified Body and the relevant medicinal product consultation pathway.\",\"inLanguage\":\"es\"},\"inLanguage\":\"es\"},{\"@type\":\"Question\",\"@id\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/#faq-question-1785937321930\",\"position\":5,\"url\":\"https:\\\/\\\/mdxcro.com\\\/es\\\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\\\/#faq-question-1785937321930\",\"name\":\"Is the Team-NB position paper legally binding?\",\"answerCount\":1,\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"No. It is a common position intended for Notified Body use. It is not an European Commission document and does not replace the IVDR, MDCG guidance or device-specific instructions from the selected Notified Body.\",\"inLanguage\":\"es\"},\"inLanguage\":\"es\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Dispositivos IVD multiplex bajo el IVDR: enfoque de evaluaci\u00f3n com\u00fan del Team-NB - MDx CRO","description":"C\u00f3mo eval\u00faan los organismos notificados los IVD multiplex bajo el IVDR: enfoque com\u00fan del Team-NB para el muestreo basado en el riesgo, las expectativas de la Clase D y la documentaci\u00f3n t\u00e9cnica.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/","og_locale":"es_ES","og_type":"article","og_title":"Dispositivos IVD multiplex bajo el IVDR: enfoque de evaluaci\u00f3n com\u00fan del Team-NB - MDx CRO","og_description":"C\u00f3mo eval\u00faan los organismos notificados los IVD multiplex bajo el IVDR: enfoque com\u00fan del Team-NB para el muestreo basado en el riesgo, las expectativas de la Clase D y la documentaci\u00f3n t\u00e9cnica.","og_url":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/","og_site_name":"MDx CRO","article_published_time":"2022-08-23T11:46:54+00:00","article_modified_time":"2026-08-06T16:06:18+00:00","og_image":[{"width":1200,"height":800,"url":"https:\/\/mdxcro.com\/wp-content\/uploads\/2021\/11\/shutterstock_1271882833.jpeg","type":"image\/jpeg"}],"author":"Carlos Galamba","twitter_card":"summary_large_image","twitter_misc":{"Escrito por":"Carlos Galamba","Tiempo de lectura":"8 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/#article","isPartOf":{"@id":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/"},"author":{"name":"Carlos Galamba","@id":"https:\/\/mdxcro.com\/es\/#\/schema\/person\/757ac74b94d37b0b3992676bb7e868e4"},"headline":"Dispositivos IVD multiplex bajo el IVDR: enfoque de evaluaci\u00f3n com\u00fan del Team-NB","datePublished":"2022-08-23T11:46:54+00:00","dateModified":"2026-08-06T16:06:18+00:00","mainEntityOfPage":{"@id":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/"},"wordCount":1579,"publisher":{"@id":"https:\/\/mdxcro.com\/es\/#organization"},"image":{"@id":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/#primaryimage"},"thumbnailUrl":"https:\/\/mdxcro.com\/wp-content\/uploads\/2021\/11\/shutterstock_1271882833.jpeg","articleSection":["Actualizaciones normativas","Noticias sobre IVD"],"inLanguage":"es"},{"@type":["WebPage","FAQPage"],"@id":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/","url":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/","name":"Dispositivos IVD multiplex bajo el IVDR: enfoque de evaluaci\u00f3n com\u00fan del Team-NB - MDx CRO","isPartOf":{"@id":"https:\/\/mdxcro.com\/es\/#website"},"primaryImageOfPage":{"@id":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/#primaryimage"},"image":{"@id":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/#primaryimage"},"thumbnailUrl":"https:\/\/mdxcro.com\/wp-content\/uploads\/2021\/11\/shutterstock_1271882833.jpeg","datePublished":"2022-08-23T11:46:54+00:00","dateModified":"2026-08-06T16:06:18+00:00","description":"C\u00f3mo eval\u00faan los organismos notificados los IVD multiplex bajo el IVDR: enfoque com\u00fan del Team-NB para el muestreo basado en el riesgo, las expectativas de la Clase D y la documentaci\u00f3n t\u00e9cnica.","breadcrumb":{"@id":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/#breadcrumb"},"mainEntity":[{"@id":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/#faq-question-1785937279954"},{"@id":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/#faq-question-1785937286432"},{"@id":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/#faq-question-1785937304896"},{"@id":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/#faq-question-1785937312172"},{"@id":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/#faq-question-1785937321930"}],"inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/#primaryimage","url":"https:\/\/mdxcro.com\/wp-content\/uploads\/2021\/11\/shutterstock_1271882833.jpeg","contentUrl":"https:\/\/mdxcro.com\/wp-content\/uploads\/2021\/11\/shutterstock_1271882833.jpeg","width":1200,"height":800,"caption":"medtech cro services - quality assurance"},{"@type":"BreadcrumbList","@id":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/mdxcro.com\/es\/"},{"@type":"ListItem","position":2,"name":"Dispositivos IVD multiplex bajo el IVDR: enfoque de evaluaci\u00f3n com\u00fan del Team-NB"}]},{"@type":"WebSite","@id":"https:\/\/mdxcro.com\/es\/#website","url":"https:\/\/mdxcro.com\/es\/","name":"MDx CRO","description":"Investigaci\u00f3n cl\u00ednica, normativa y control de calidad en tecnolog\u00eda m\u00e9dica y diagn\u00f3stico in vitro","publisher":{"@id":"https:\/\/mdxcro.com\/es\/#organization"},"alternateName":"MDx","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/mdxcro.com\/es\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es"},{"@type":"Organization","@id":"https:\/\/mdxcro.com\/es\/#organization","name":"CRO de MDx","url":"https:\/\/mdxcro.com\/es\/","logo":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/mdxcro.com\/es\/#\/schema\/logo\/image\/","url":"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX.svg","contentUrl":"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX.svg","width":352,"height":114,"caption":"CRO de MDx"},"image":{"@id":"https:\/\/mdxcro.com\/es\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.linkedin.com\/company\/medtech-ivd-cro"]},{"@type":"Person","@id":"https:\/\/mdxcro.com\/es\/#\/schema\/person\/757ac74b94d37b0b3992676bb7e868e4","name":"Carlos Galamba","pronouns":"he","image":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/10\/cropped-Carlos-Galamba-2-96x96.jpg","url":"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/10\/cropped-Carlos-Galamba-2-96x96.jpg","contentUrl":"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/10\/cropped-Carlos-Galamba-2-96x96.jpg","caption":"Carlos Galamba"},"description":"With more than 18 years of experience in the IVD sector, including hands-on work as a scientist in transfusion medicine and infectious disease diagnostics, and regulatory review experience at BSI, one of the EU's largest Notified Bodies, Carlos Galamba brings a uniquely integrated perspective to IVD regulatory strategy. Their work spans Class C\/D IVDs, companion diagnostics, NGS-based assays, and software-based IVDs, with a current advisory role to the European Commission on regulatory matters. At MDx CRO, they lead regulatory strategy for complex IVD programs across EU IVDR, FDA, and global markets.","sameAs":["https:\/\/mdxcro.com\/ivd-consultant-and-ivdr-expert-carlos-galamba\/","https:\/\/www.linkedin.com\/in\/carlos-galamba\/","https:\/\/www.youtube.com\/@MDxCRO"],"url":"https:\/\/mdxcro.com\/es\/autor\/carlos-galamba\/"},{"@type":"Question","@id":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/#faq-question-1785937279954","position":1,"url":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/#faq-question-1785937279954","name":"Does a Notified Body review every marker in a multiplex IVD?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"Not necessarily. Under the Team-NB approach, marker-specific data for Class B and Class C markers may be sampled using a risk-based rationale. The technical documentation associated with every Class D marker should be reviewed. The manufacturer must still maintain evidence supporting every marker and claim included in the intended purpose.","inLanguage":"es"},"inLanguage":"es"},{"@type":"Question","@id":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/#faq-question-1785937286432","position":2,"url":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/#faq-question-1785937286432","name":"Who decides which markers are sampled?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"The Notified Body decides which marker-specific data to review and records its rationale in the conformity assessment documentation. Manufacturers can prepare for likely areas of scrutiny, but they should not treat their own proposed sample as a limit on the Notified Body\u2019s review.","inLanguage":"es"},"inLanguage":"es"},{"@type":"Question","@id":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/#faq-question-1785937304896","position":3,"url":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/#faq-question-1785937304896","name":"What happens if the initial sample contains deficiencies?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"The Notified Body may select additional analytes or revise its sampling plan during the certification cycle. Deficiencies in a small initial sample can therefore increase the eventual review scope.","inLanguage":"es"},"inLanguage":"es"},{"@type":"Question","@id":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/#faq-question-1785937312172","position":4,"url":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/#faq-question-1785937312172","name":"Does this approach automatically apply to a multiplex companion diagnostic?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"No. Companion diagnostics have additional IVDR assessment requirements. MDCG 2019-13 Rev.1 also explains that Class B and Class C companion diagnostics, self-testing devices and near-patient testing devices are exempt from the device-level sampling described in that guidance.<br>The Team-NB multiplex paper addresses marker-level sampling within a multiplex device. A manufacturer developing a multiplex companion diagnostic should confirm how these requirements interact with its Notified Body and the relevant medicinal product consultation pathway.","inLanguage":"es"},"inLanguage":"es"},{"@type":"Question","@id":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/#faq-question-1785937321930","position":5,"url":"https:\/\/mdxcro.com\/es\/dispositivos-ivd-multiplex-bajo-el-ivdr-enfoque-de-evaluacion-comun-del-team-nb\/#faq-question-1785937321930","name":"Is the Team-NB position paper legally binding?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"No. It is a common position intended for Notified Body use. It is not an European Commission document and does not replace the IVDR, MDCG guidance or device-specific instructions from the selected Notified Body.","inLanguage":"es"},"inLanguage":"es"}]}},"_links":{"self":[{"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/posts\/8519","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/comments?post=8519"}],"version-history":[{"count":4,"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/posts\/8519\/revisions"}],"predecessor-version":[{"id":12806,"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/posts\/8519\/revisions\/12806"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/media\/5946"}],"wp:attachment":[{"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/media?parent=8519"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/categories?post=8519"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/tags?post=8519"},{"taxonomy":"resources-sector","embeddable":true,"href":"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/resources-sector?post=8519"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}