{"id":3349,"date":"2026-08-31T15:19:26","date_gmt":"2026-08-31T14:19:26","guid":{"rendered":"https:\/\/seamlessbio.de\/?p=3349"},"modified":"2026-08-31T15:25:44","modified_gmt":"2026-08-31T14:25:44","slug":"ivdr-class-d-sample-sets-what-you-need","status":"publish","type":"post","link":"https:\/\/seamlessbio.de\/de\/ivdr-class-d-sample-sets-what-you-need\/","title":{"rendered":"IVDR Class D Sample Sets"},"content":{"rendered":"<p><!--\nWORDPRESS BLOG POST\nSlug: ivdr-class-d-sample-sets-what-you-need\nSEO Title: IVDR Class D Sample Sets \u2014 What You Actually Need | SeamlessBio\nMeta Description: A practical breakdown of which sample sets are required for HBV, HCV and HIV Class D IVD submissions under EU Regulation 2017\/746 and CTS 2009\/108\/EC.\nFocus Keyword: IVDR Class D sample sets HBV HCV HIV\nCategory: IVD Development\nTags: IVDR, IVD, disease state serum, human biomaterials, diagnostics\n--><br \/>\n<!-- \nWORDPRESS BLOG POST \u2014 PASTE INTO GUTENBERG\nCategory: IVD Development\nAdd featured image\nInternal links already included in content\n--><\/p>\n<style>\n.sb-blog-post{font-family:-apple-system,BlinkMacSystemFont,\"Segoe UI\",Roboto,sans-serif;max-width:780px;margin:0 auto;padding:0 0 60px;color:#202020;line-height:1.75}\n.sb-blog-post .sb-lede{font-size:18px;font-weight:500;color:#3a4a50;border-left:4px solid #18b7b2;padding-left:20px;margin:0 0 32px;line-height:1.65}\n.sb-blog-post h2{font-size:24px;font-weight:800;margin:44px 0 14px;color:#111;padding-bottom:10px;border-bottom:2px solid #e2eceb}\n.sb-blog-post h3{font-size:18px;font-weight:700;margin:32px 0 10px;color:#18b7b2}\n.sb-blog-post p{margin:0 0 18px}\n.sb-blog-post ul,.sb-blog-post ol{margin:0 0 18px;padding-left:24px}\n.sb-blog-post li{margin-bottom:8px}\n.sb-blog-post table{width:100%;border-collapse:collapse;font-size:14px;margin:20px 0 28px;overflow-x:auto;display:block}\n.sb-blog-post th{background:#18b7b2;color:#fff;text-align:left;padding:10px 14px;font-weight:700;white-space:nowrap}\n.sb-blog-post td{padding:10px 14px;border-bottom:1px solid #e2eceb;vertical-align:top}\n.sb-blog-post tr:last-child td{border-bottom:none}\n.sb-blog-post td:first-child{font-weight:600;color:#111}\n.sb-blog-post a{color:#18b7b2;text-decoration:none;font-weight:600}\n.sb-blog-post a:hover{text-decoration:underline}\n.sb-blog-post strong{color:#111}\n<\/style>\n<div class=\"sb-blog-post\">\n<p class=\"sb-lede\">If you are preparing a CE marking submission for a Class D IVD \u2014 an HIV, HBV or HCV diagnostic \u2014 you will quickly find that the Common Technical Specifications (CTS 2009\/108\/EC) define not just what performance you need to demonstrate, but exactly which samples you need to demonstrate it with. This post breaks down the requirements by Annex and table, so you know what to source before you start your study.<\/p>\n<h2>Why Class D is different<\/h2>\n<p>IVDR Class D covers the highest-risk in vitro diagnostics \u2014 devices used to detect life-threatening transmissible agents in blood, blood components, cells, tissues or organs intended for transfusion or transplantation, where a false negative result poses a high individual or public health risk. For practical purposes, this means: HIV-1\/2, HBV (HBsAg, anti-HBc, anti-HBs, DNA), HCV (antibody, RNA), HTLV-I\/II, and Treponema pallidum.<\/p>\n<p>Unlike Class B and C devices, Class D requires mandatory Notified Body involvement in the conformity assessment \u2014 and batch release testing by a national reference laboratory (OMCL) before each production batch is placed on the market. The performance data must be generated against the specific requirements of the CTS, not just against any set of samples you have available.<\/p>\n<h2>The CTS \u2014 what it actually specifies<\/h2>\n<p>The Common Technical Specifications (Commission Decision 2009\/108\/EC, referenced in IVDR Annex IX) define minimum performance requirements for Class D IVDs. Each Annex covers a specific pathogen group, and each Annex contains multiple tables specifying different study types. The critical point: each table specifies not just the number of samples but their exact composition \u2014 and &#8220;native human biomaterial with no additives&#8221; is the implicit requirement throughout.<\/p>\n<h2>HBV \u2014 what you need (Annex VI)<\/h2>\n<p>Hepatitis B is the most complex CTS panel requirement because it covers multiple markers (HBsAg, anti-HBc, anti-HBs, HBV DNA) and multiple study types.<\/p>\n<table>\n<thead>\n<tr>\n<th>Study type<\/th>\n<th>CTS Reference<\/th>\n<th>Required samples<\/th>\n<th>Anmerkungen<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Diagnostic sensitivity \u2014 comprehensive<\/td>\n<td>Annex VI, table 1<\/td>\n<td>400 positive, including 25 same-day fresh<\/td>\n<td>Most demanding \u2014 fresh samples require advance coordination<\/td>\n<\/tr>\n<tr>\n<td>Diagnostic sensitivity \u2014 standard<\/td>\n<td>Annex VI, table 2<\/td>\n<td>400 anti-HBc + HBsAg positive<\/td>\n<td>For combined marker assays<\/td>\n<\/tr>\n<tr>\n<td>Diagnostic sensitivity \u2014 HBsAg only<\/td>\n<td>Annex VI, table 3<\/td>\n<td>300 HBsAg positive<\/td>\n<td>For HBsAg-specific assays<\/td>\n<\/tr>\n<tr>\n<td>Diagnostic sensitivity \u2014 anti-HBs<\/td>\n<td>Annex VI, table 4<\/td>\n<td>100\u2013200 positive + vaccinated donors<\/td>\n<td>Vaccinated donors require separate panel<\/td>\n<\/tr>\n<tr>\n<td>Diagnostic sensitivity \u2014 HBV DNA<\/td>\n<td>Annex VI, table 5<\/td>\n<td>100 DNA positive<\/td>\n<td>Molecular assays only<\/td>\n<\/tr>\n<tr>\n<td>Diagnostic specificity<\/td>\n<td>Annex VI, table 1\u20135<\/td>\n<td>200\u20135,000 blood donors + 200 hospitalised<\/td>\n<td>Unselected blood donors \u2014 random population sample<\/td>\n<\/tr>\n<tr>\n<td>Self-test validation<\/td>\n<td>Annex VI, table 6<\/td>\n<td>200\u2013400 lay participants<\/td>\n<td>For lay-use (home test) devices only<\/td>\n<\/tr>\n<tr>\n<td>Matrix equivalence<\/td>\n<td>Annex I<\/td>\n<td>25 positive + 25 negative per matrix<\/td>\n<td>Required when device claims multiple sample types<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2>HCV \u2014 what you need (Annex V)<\/h2>\n<table>\n<thead>\n<tr>\n<th>Study type<\/th>\n<th>CTS Reference<\/th>\n<th>Required samples<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Diagnostic sensitivity \u2014 comprehensive<\/td>\n<td>Annex V, table 1<\/td>\n<td>400 HCV positive, including 25 same-day fresh<\/td>\n<\/tr>\n<tr>\n<td>Diagnostic sensitivity \u2014 standard<\/td>\n<td>Annex V, table 2<\/td>\n<td>400 HCV antibody positive<\/td>\n<\/tr>\n<tr>\n<td>Diagnostic sensitivity \u2014 reduced<\/td>\n<td>Annex V, table 3<\/td>\n<td>300 HCV antibody positive<\/td>\n<\/tr>\n<tr>\n<td>Diagnostic sensitivity \u2014 minimal<\/td>\n<td>Annex V, table 5<\/td>\n<td>100 HCV positive<\/td>\n<\/tr>\n<tr>\n<td>Diagnostic specificity<\/td>\n<td>Annex V, table 1\u20135<\/td>\n<td>200\u20135,000 blood donors<\/td>\n<\/tr>\n<tr>\n<td>Self-test validation<\/td>\n<td>Annex V, table 6<\/td>\n<td>200\u2013400 lay participants<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2>HIV \u2014 what you need (Annex III)<\/h2>\n<table>\n<thead>\n<tr>\n<th>Study type<\/th>\n<th>CTS Reference<\/th>\n<th>Required samples<\/th>\n<th>Anmerkungen<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Diagnostic sensitivity \u2014 comprehensive<\/td>\n<td>Annex III, table 1<\/td>\n<td>400 HIV-1 + 100 HIV-2 positive<\/td>\n<td>Both subtypes required<\/td>\n<\/tr>\n<tr>\n<td>Diagnostic sensitivity \u2014 standard<\/td>\n<td>Annex III, table 2<\/td>\n<td>400 HIV-1 positive<\/td>\n<td>HIV-1 focused assays<\/td>\n<\/tr>\n<tr>\n<td>Diagnostic sensitivity \u2014 HIV-1 Ag<\/td>\n<td>Annex III, table 4<\/td>\n<td>50 HIV-1 antigen positive<\/td>\n<td>For combination Ag\/Ab assays<\/td>\n<\/tr>\n<tr>\n<td>Diagnostic sensitivity \u2014 reduced<\/td>\n<td>Annex III, table 3<\/td>\n<td>200 HIV-1 positive<\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td>Diagnostic sensitivity \u2014 minimal<\/td>\n<td>Annex III, table 5<\/td>\n<td>100 HIV-1 + 100 HIV-2 positive<\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td>Diagnostic specificity<\/td>\n<td>Annex III, table 1\u20135<\/td>\n<td>200\u20135,000 blood donors<\/td>\n<td>Unselected + hospitalised<\/td>\n<\/tr>\n<tr>\n<td>Self-test validation<\/td>\n<td>Annex III, table 6<\/td>\n<td>200\u2013400 lay participants<\/td>\n<td><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2>Cross-reactivity and interference \u2014 what is required alongside sensitivity panels<\/h2>\n<p>The CTS does not only specify sensitivity and specificity panels. For a complete Class D submission, you also need interference and cross-reactivity data demonstrating that the device does not produce false positives in the presence of:<\/p>\n<ul>\n<li><strong>General interference panel:<\/strong> 16 standard interferents \u2014 typical components include rheumatoid factor, antinuclear antibodies, lipemic serum, icteric serum, haemolytic serum, polyclonal hypergammaglobulinaemia, pregnancy serum<\/li>\n<li><strong>Vaccination panel:<\/strong> donors vaccinated against common pathogens \u2014 hepatitis B vaccine, influenza, MMR \u2014 to rule out vaccine cross-reactivity<\/li>\n<li><strong>Cross-reacting conditions:<\/strong> HIV-positive donors for HBV assays and vice versa; malaria, syphilis, toxoplasma, CMV, EBV positive \u2014 depending on the intended use population<\/li>\n<li><strong>Pregnant donors:<\/strong> 100\u2013200 pregnant donors for assays used in antenatal screening<\/li>\n<\/ul>\n<h2>The three most common mistakes in Class D panel sourcing<\/h2>\n<p><strong>1. Sourcing spiked or diluted positive material instead of native donors.<\/strong> The CTS implicitly requires native human biomaterial \u2014 real patients with confirmed positive results, not healthy donor serum spiked with recombinant antigen or diluted high-positive samples. Notified Bodies will scrutinise the sample documentation and reject spiked material for sensitivity panels.<\/p>\n<p><strong>2. Underestimating the specificity panel requirement.<\/strong> Five thousand unselected blood donors is a large logistics challenge. Many manufacturers underestimate the lead time for large specificity panels \u2014 planning 8\u201312 weeks in advance is realistic.<\/p>\n<p><strong>3. Missing the fresh sample requirement.<\/strong> The table 1 panels for HBV, HCV and HIV require 25 same-day fresh samples collected and processed within hours of donation. This requires a standing arrangement with a collection centre \u2014 it cannot be sourced from a frozen biobank. Plan this as early as possible in your study timeline.<\/p>\n<h2>What to do next<\/h2>\n<p>The fastest path to a complete Class D panel package is to work with a supplier who has assembled CTS-referenced panels before and understands the specificity of each table&#8217;s requirements \u2014 not just the total sample count.<\/p>\n<p>SeamlessBio supplies IVDR Class D sample sets for HBV, HCV and HIV \u2014 referenced to the specific CTS Annex and table numbers, with full IRB documentation, donor screening results, and IVDR documentation package on request. Panels are available from stock and on custom order.<\/p>\n<ul>\n<li><a href=\"https:\/\/seamlessbio.de\/de\/ivdr-class-d-sample-sets\/\">View IVDR Class D Sample Sets \u2192<\/a><\/li>\n<li><a href=\"https:\/\/seamlessbio.de\/de\/disease-state-serum-panels\/\">Cross-Reactivity &#038; Interference Panels \u2192<\/a><\/li>\n<li><a href=\"https:\/\/seamlessbio.de\/de\/what-is-ivdr-class-d\/\">What is IVDR Class D? \u2014 Definition \u2192<\/a><\/li>\n<li><a href=\"https:\/\/seamlessbio.de\/de\/kontakt\/\">Request a quote \u2192<\/a><\/li>\n<\/ul>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>If you are preparing a CE marking submission for a Class D IVD \u2014 an HIV, HBV or HCV diagnostic \u2014 you will quickly find that the Common Technical Specifications [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_eb_attr":"","footnotes":""},"categories":[47],"tags":[],"class_list":["post-3349","post","type-post","status-publish","format-standard","hentry","category-ivd-development"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>IVDR Class D Sample Sets \u2014 What You Actually Need<\/title>\n<meta name=\"description\" content=\"A practical breakdown of which sample sets are required for HBV, HCV and HIV Class D IVD submissions under EU Regulation 2017\/746 and CTS 2009\/108\/EC.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/seamlessbio.de\/de\/ivdr-class-d-sample-sets-what-you-need\/\" \/>\n<meta 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