{"product_id":"uk-mhra-ivd-registration-service","title":"UK MHRA IVD Registration Service","description":"\u003cstyle data-eximio-product-css=\"blue-v6-original-layout-refined\"\u003e .eximio-product-description{ --eximio-blue:#1f5fbf;--eximio-blue-dark:#123e73;--eximio-blue-soft:#f4f8fd; --eximio-text:#334155;--eximio-overview-text:#365777;--eximio-muted:#64748b; --eximio-line:#dbe5f1;--eximio-surface:#f8fafc; width:100%;max-width:none;margin:0;color:var(--eximio-text);font-size:16px;line-height:1.72; -webkit-font-smoothing:antialiased; } .eximio-product-description,.eximio-product-description *{box-sizing:border-box} .eximio-product-description .eximio-product-section{margin:0;padding:25px 0;border:0;background:transparent} .eximio-product-description .eximio-product-section:first-child{padding-top:0} .eximio-product-description .eximio-product-overview{padding-bottom:24px} .eximio-product-description .eximio-product-heading{ display:block;margin:0 0 17px;padding:0 0 10px;color:var(--eximio-blue-dark); border:0;border-bottom:1px solid var(--eximio-line);font-size:clamp(19px,1.7vw,22px); font-weight:650;line-height:1.35;letter-spacing:-.01em } .eximio-product-description p{margin:0 0 13px;color:var(--eximio-text)} .eximio-product-description p:last-child{margin-bottom:0} .eximio-product-description .eximio-product-overview\u003ep{ max-width:920px;color:var(--eximio-overview-text);font-size:17px;line-height:1.82 } .eximio-product-description strong{color:var(--eximio-blue-dark);font-weight:650} .eximio-product-description .eximio-product-table{ width:100%;max-width:100%;margin:16px 0 4px;border:1px solid var(--eximio-line); border-radius:8px;border-collapse:separate;border-spacing:0;background:#fff;table-layout:fixed } .eximio-product-description .eximio-product-table th, .eximio-product-description .eximio-product-table td{ padding:12px 14px;border-right:1px solid var(--eximio-line);border-bottom:1px solid var(--eximio-line); vertical-align:top;text-align:left;font-size:14px;line-height:1.55;overflow-wrap:anywhere } .eximio-product-description .eximio-product-table th{color:var(--eximio-blue-dark);font-weight:650;background:var(--eximio-blue-soft)} .eximio-product-description .eximio-product-table tbody tr:nth-child(even) td{background:var(--eximio-surface)} .eximio-product-description .eximio-product-table tr:last-child\u003e*{border-bottom:0} .eximio-product-description .eximio-product-table tr\u003e*:last-child{border-right:0} .eximio-product-description .eximio-process-intro{max-width:920px;color:var(--eximio-muted)} .eximio-product-description .eximio-route-flow{ margin:20px 0 28px;padding:18px;border:1px solid var(--eximio-line);border-radius:10px;background:#fff } .eximio-product-description .eximio-route-title{ margin:0 0 6px;color:var(--eximio-blue-dark);font-size:18px;font-weight:650;line-height:1.35 } .eximio-product-description .eximio-route-meta{margin:0 0 15px;color:var(--eximio-muted);font-size:13px} .eximio-product-description .eximio-process{ display:flex;align-items:stretch;gap:8px;overflow-x:auto;padding:2px 0 8px;-webkit-overflow-scrolling:touch } .eximio-product-description .eximio-process-step{ flex:1 0 150px;min-width:150px;padding:13px 12px;border:1px solid #c9daf0;border-radius:9px; background:var(--eximio-blue-soft);color:var(--eximio-blue-dark);font-size:13px;line-height:1.45; display:flex;align-items:center;justify-content:center;text-align:center;font-weight:600 } .eximio-product-description .eximio-process-arrow{ flex:0 0 20px;display:flex;align-items:center;justify-content:center;color:var(--eximio-blue); font-size:20px;font-weight:700 } .eximio-product-description .eximio-note{ margin-top:14px;padding:12px 14px;border-left:3px solid var(--eximio-blue); background:var(--eximio-surface);color:var(--eximio-muted);font-size:13px;line-height:1.55 } @media(max-width:749px){ .eximio-product-description{font-size:15px;line-height:1.68} .eximio-product-description .eximio-product-section{padding:21px 0} .eximio-product-description .eximio-product-heading{margin-bottom:13px;padding-bottom:8px;font-size:18px} .eximio-product-description .eximio-product-overview\u003ep{font-size:16px;line-height:1.76} .eximio-product-description .eximio-product-table th, .eximio-product-description .eximio-product-table td{padding:9px 8px;font-size:12px;line-height:1.4} .eximio-product-description .eximio-route-flow{padding:14px 12px;margin:16px 0 22px} .eximio-product-description .eximio-route-title{font-size:16px} .eximio-product-description .eximio-process{flex-direction:column;overflow:visible;gap:4px} .eximio-product-description .eximio-process-step{flex:0 0 auto;min-width:0;width:100%;min-height:54px} .eximio-product-description .eximio-process-arrow{height:20px;transform:rotate(90deg)} } \/* CSS-only flow switcher: no JavaScript *\/ .eximio-product-description .eximio-flow-switcher{margin:18px 0 6px} .eximio-product-description .eximio-flow-control{ position:absolute!important;width:1px!important;height:1px!important;margin:-1px!important;padding:0!important; overflow:hidden!important;clip:rect(0 0 0 0)!important;white-space:nowrap!important;border:0!important;opacity:0!important } .eximio-product-description .eximio-flow-tab-nav{ display:flex;gap:8px;overflow-x:auto;padding:2px 1px 10px;-webkit-overflow-scrolling:touch;scrollbar-width:thin } .eximio-product-description .eximio-flow-tab{ flex:0 0 auto;display:inline-flex;align-items:center;justify-content:center;min-height:42px;padding:9px 14px; border:1px solid var(--eximio-line);border-radius:999px;background:#fff;color:var(--eximio-blue-dark); font-size:13px;font-weight:650;line-height:1.25;cursor:pointer;transition:border-color .18s ease,background .18s ease,color .18s ease } .eximio-product-description .eximio-flow-tab:hover{border-color:#9dbde4;background:var(--eximio-blue-soft)} .eximio-product-description .eximio-flow-panels{margin-top:2px} .eximio-product-description .eximio-flow-panel{ display:none;margin:0;padding:18px;border:1px solid var(--eximio-line);border-radius:12px;background:#fff } .eximio-product-description .eximio-flow-panel.is-single{display:block} .eximio-product-description .eximio-flow-head{ display:flex;align-items:flex-start;justify-content:space-between;gap:18px;margin:0 0 15px;padding:0 0 14px; border-bottom:1px solid var(--eximio-line) } .eximio-product-description .eximio-flow-head .eximio-route-title{margin:2px 0 0} .eximio-product-description .eximio-flow-timing{ flex:0 0 min(340px,46%);padding:10px 12px;border:1px solid #c9daf0;border-radius:9px;background:var(--eximio-blue-soft) } .eximio-product-description .eximio-flow-timing-label{ display:block;margin:0 0 2px;color:var(--eximio-muted);font-size:11px;font-weight:700;letter-spacing:.04em;text-transform:uppercase } .eximio-product-description .eximio-flow-timing strong{ display:block;color:var(--eximio-blue-dark);font-size:15px;line-height:1.35 } .eximio-product-description .eximio-flow-timing small{ display:block;margin-top:4px;color:var(--eximio-muted);font-size:11px;line-height:1.4 } .eximio-product-description .eximio-flow-panel .eximio-process{margin-top:0} .eximio-product-description .eximio-flow-panel .eximio-process-step{ position:relative;flex-direction:column;gap:5px;padding:32px 12px 13px;justify-content:flex-start } .eximio-product-description .eximio-step-number{ position:absolute;top:8px;left:9px;display:inline-flex;align-items:center;justify-content:center;min-width:22px;height:20px;padding:0 5px; border-radius:999px;background:#fff;color:var(--eximio-blue);font-size:10px;font-weight:750;line-height:1 } .eximio-product-description .eximio-step-copy{display:block} .eximio-product-description .eximio-step-time{ display:inline-flex;align-items:center;margin-top:3px;padding:3px 7px;border-radius:999px;background:#e8f1fc;color:var(--eximio-blue-dark); font-size:10px;font-weight:750;line-height:1.2 } .eximio-product-description .eximio-flow-note{margin:12px 0 0;color:var(--eximio-muted);font-size:12px;line-height:1.55} .eximio-product-description .eximio-timing-key{ margin:12px 0 0;padding:10px 12px;border-left:3px solid var(--eximio-blue);background:var(--eximio-surface); color:var(--eximio-muted);font-size:12px;line-height:1.55 } .eximio-product-description .eximio-regulatory-grid{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:10px;margin:15px 0 0 } .eximio-product-description .eximio-reg-card{ display:block;padding:14px 15px;border:1px solid var(--eximio-line);border-radius:10px;background:#fff; color:inherit;text-decoration:none!important;transition:border-color .18s ease,box-shadow .18s ease,transform .18s ease } .eximio-product-description .eximio-reg-card:hover{ border-color:#9dbde4;box-shadow:0 6px 18px rgba(31,95,191,.08);transform:translateY(-1px) } .eximio-product-description .eximio-reg-kind{ display:inline-flex;margin:0 0 7px;padding:3px 7px;border-radius:999px;background:var(--eximio-blue-soft);color:var(--eximio-blue); font-size:10px;font-weight:750;letter-spacing:.04em;text-transform:uppercase } .eximio-product-description .eximio-reg-title{display:block;color:var(--eximio-blue-dark);font-size:14px;font-weight:700;line-height:1.35} .eximio-product-description .eximio-reg-scope{display:block;margin-top:5px;color:var(--eximio-muted);font-size:12px;line-height:1.5} .eximio-product-description .eximio-reg-source{display:block;margin-top:8px;color:var(--eximio-blue);font-size:11px;font-weight:650} @media(max-width:749px){ .eximio-product-description .eximio-flow-tab-nav{gap:6px;padding-bottom:8px} .eximio-product-description .eximio-flow-tab{min-height:38px;padding:8px 11px;font-size:12px} .eximio-product-description .eximio-flow-panel{padding:14px 12px} .eximio-product-description .eximio-flow-head{display:block;margin-bottom:12px;padding-bottom:12px} .eximio-product-description .eximio-flow-timing{width:100%;max-width:none;margin-top:10px} .eximio-product-description .eximio-flow-panel .eximio-process-step{padding:30px 11px 12px} .eximio-product-description .eximio-regulatory-grid{grid-template-columns:1fr} } .eximio-product-description #eximio-uk-mhra-ivd-registration-service-1:checked ~ .eximio-flow-tab-nav label[for=\"eximio-uk-mhra-ivd-registration-service-1\"]{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff} .eximio-product-description #eximio-uk-mhra-ivd-registration-service-1:checked ~ .eximio-flow-panels .eximio-flow-panel-1{display:block} .eximio-product-description #eximio-uk-mhra-ivd-registration-service-2:checked ~ .eximio-flow-tab-nav label[for=\"eximio-uk-mhra-ivd-registration-service-2\"]{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff} .eximio-product-description #eximio-uk-mhra-ivd-registration-service-2:checked ~ .eximio-flow-panels .eximio-flow-panel-2{display:block} \/* Mobile flow timeline v3 *\/ @media(max-width:749px){ .eximio-product-description .eximio-flow-switcher{margin:14px 0 4px} .eximio-product-description .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px; overflow:visible;padding:0 0 13px } .eximio-product-description .eximio-flow-tab-nav .eximio-flow-tab:last-child:nth-child(odd){grid-column:1\/-1} .eximio-product-description .eximio-flow-tab{ width:100%;min-height:44px;padding:8px 9px;border-radius:8px; white-space:normal;text-align:center;font-size:12px;line-height:1.3 } .eximio-product-description .eximio-flow-panels{margin-top:0} .eximio-product-description .eximio-flow-panel{ padding:0;border:0;border-radius:0;background:transparent } .eximio-product-description .eximio-flow-head{ display:block;margin:0 0 14px;padding:13px 12px; border:1px solid var(--eximio-line);border-radius:10px;background:#fff } .eximio-product-description .eximio-flow-head .eximio-route-title{ margin:0;color:var(--eximio-blue-dark);font-size:16px } .eximio-product-description .eximio-flow-timing{ width:100%;max-width:none;margin-top:10px;padding:9px 10px;border-radius:8px } .eximio-product-description .eximio-flow-timing strong{font-size:14px} .eximio-product-description .eximio-flow-panel .eximio-process{ position:relative;display:block;overflow:visible;margin:0;padding:0 0 0 34px } .eximio-product-description .eximio-flow-panel .eximio-process:before{ content:\"\";position:absolute;left:11px;top:17px;bottom:17px;width:2px; border-radius:2px;background:#c9daf0 } .eximio-product-description .eximio-flow-panel .eximio-process-step{ position:relative;display:block;width:100%;min-width:0;min-height:0; margin:0 0 11px;padding:12px 12px 12px 13px; border:1px solid #c9daf0;border-radius:9px;background:#fff; text-align:left;color:var(--eximio-blue-dark);font-size:13px;line-height:1.45 } .eximio-product-description .eximio-flow-panel .eximio-process-step:last-of-type{margin-bottom:0} .eximio-product-description .eximio-flow-panel .eximio-process-arrow{display:none} .eximio-product-description .eximio-step-number{ top:11px;left:-34px;min-width:24px;width:24px;height:24px;padding:0; border:2px solid #fff;border-radius:50%;background:var(--eximio-blue);color:#fff; font-size:10px;box-shadow:0 0 0 1px #b9cfea } .eximio-product-description .eximio-step-copy{display:block;font-weight:600} .eximio-product-description .eximio-step-time{ margin-top:7px;padding:4px 7px;border-radius:6px;font-size:10px } .eximio-product-description .eximio-flow-note{margin:11px 0 0;padding-left:34px} .eximio-product-description .eximio-timing-key{ margin-top:13px;padding:10px 11px;font-size:11px } .eximio-product-description .eximio-regulatory-grid{grid-template-columns:1fr} } \/* v4 topology-aware flow network: preserves branches, parallel workstreams and merge\/decision points *\/ .eximio-product-description .eximio-network{display:flex;flex-direction:column;align-items:stretch;gap:10px;margin-top:2px} .eximio-product-description .eximio-net-node{ position:relative;max-width:430px;margin:0 auto;padding:12px 14px;border:1px solid #c9daf0;border-radius:10px; background:var(--eximio-blue-soft);color:var(--eximio-blue-dark);font-size:13px;font-weight:650;line-height:1.42;text-align:center } .eximio-product-description .eximio-net-node--start{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff;font-size:14px} .eximio-product-description .eximio-net-node--finish{background:#eaf6ee;border-color:#b8ddc4;color:#245b35} .eximio-product-description .eximio-net-node--alternative{background:#f8fafc;border-style:dashed;color:#475569} .eximio-product-description .eximio-net-node-sub{display:block;margin-top:4px;color:var(--eximio-muted);font-size:11px;font-weight:500} .eximio-product-description .eximio-net-time{ display:inline-flex;margin-top:7px;padding:3px 8px;border-radius:999px;background:#fff;color:var(--eximio-blue-dark); border:1px solid #c9daf0;font-size:10px;font-weight:750;line-height:1.2 } .eximio-product-description .eximio-net-node--start .eximio-net-time{color:var(--eximio-blue-dark)} .eximio-product-description .eximio-net-arrow{height:22px;display:flex;align-items:center;justify-content:center;color:#76a2d7;font-size:18px;font-weight:700;line-height:1} .eximio-product-description .eximio-net-arrow--major{height:26px;font-size:21px} .eximio-product-description .eximio-net-seq{display:flex;flex-direction:column;align-items:stretch} .eximio-product-description .eximio-net-seq\u003e.eximio-net-node{width:min(100%,430px)} .eximio-product-description .eximio-net-branch-group{ position:relative;margin:4px 0 8px;padding:16px 14px 14px;border:1px solid var(--eximio-line);border-radius:12px;background:#fbfdff } .eximio-product-description .eximio-net-group-label{ display:inline-flex;position:relative;margin:-29px 0 12px 4px;padding:4px 9px;border:1px solid #c9daf0;border-radius:999px; background:#fff;color:var(--eximio-blue);font-size:10px;font-weight:750;letter-spacing:.025em;line-height:1.25 } .eximio-product-description .eximio-net-branches{ display:grid;grid-template-columns:repeat(var(--eximio-branch-count),minmax(0,1fr));gap:12px;align-items:stretch } .eximio-product-description .eximio-net-branch{ min-width:0;padding:11px;border:1px solid #d6e2f1;border-radius:10px;background:#fff } .eximio-product-description .eximio-net-branch-head{display:flex;align-items:flex-start;gap:8px;margin:0 0 10px;padding-bottom:8px;border-bottom:1px solid #e6edf6} .eximio-product-description .eximio-net-branch-index{ flex:0 0 auto;display:inline-flex;align-items:center;justify-content:center;min-width:24px;height:20px;padding:0 5px;border-radius:999px; background:#e8f1fc;color:var(--eximio-blue);font-size:9px;font-weight:800;line-height:1 } .eximio-product-description .eximio-net-branch-title{color:var(--eximio-blue-dark);font-size:12px;font-weight:750;line-height:1.35} .eximio-product-description .eximio-net-branch-note{margin:-3px 0 9px;color:var(--eximio-muted);font-size:10px;line-height:1.4} .eximio-product-description .eximio-net-branch .eximio-net-node{width:100%;max-width:none;padding:10px 8px;font-size:11px} .eximio-product-description .eximio-net-branch .eximio-net-arrow{height:17px;font-size:14px} .eximio-product-description .eximio-net-junction{ width:min(100%,560px);margin:1px auto;padding:9px 12px;border:1px dashed #9dbde4;border-radius:9px;background:#f7fbff; color:var(--eximio-blue-dark);font-size:11px;font-weight:700;line-height:1.4;text-align:center } .eximio-product-description .eximio-net-junction--decision{border-style:solid;background:#eef5fd} .eximio-product-description .eximio-net-branch-group--decision .eximio-net-group-label{color:#475569;border-color:#cbd5e1} .eximio-product-description .eximio-net-branch-group--outputs{background:#f8fbff} @media(max-width:980px) and (min-width:750px){ .eximio-product-description .eximio-net-branches{grid-template-columns:repeat(2,minmax(0,1fr))} } @media(max-width:749px){ .eximio-product-description .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px;overflow:visible;padding:2px 0 9px } .eximio-product-description .eximio-flow-tab{ width:100%;min-width:0;min-height:42px;padding:8px 7px;border-radius:8px;white-space:normal;text-align:center;font-size:11px } .eximio-product-description .eximio-flow-tab:last-child:nth-child(odd){grid-column:1\/-1} .eximio-product-description .eximio-net-node{max-width:none;width:100%;padding:11px 10px;font-size:12px;text-align:left} .eximio-product-description .eximio-net-node--start{text-align:center} .eximio-product-description .eximio-net-branches{grid-template-columns:1fr;gap:9px} .eximio-product-description .eximio-net-branch-group{padding:15px 9px 10px;margin-top:8px} .eximio-product-description .eximio-net-group-label{ margin:-28px 0 10px 2px;max-width:calc(100% - 4px);white-space:normal;border-radius:7px;font-size:9px } .eximio-product-description .eximio-net-branch{padding:10px 9px} .eximio-product-description .eximio-net-branch-head{margin-bottom:8px} .eximio-product-description .eximio-net-branch-title{font-size:12px} .eximio-product-description .eximio-net-branch .eximio-net-node{ padding:9px 10px;border-left:3px solid #9dbde4;border-radius:7px;text-align:left;font-size:11px } .eximio-product-description .eximio-net-branch .eximio-net-node--finish{border-left-color:#8bc59c} .eximio-product-description .eximio-net-arrow{height:18px} .eximio-product-description .eximio-net-junction{width:100%;font-size:10px;text-align:left} } \/* v5 source-layout reconstruction: preserves the original diagram geometry while applying EXIMIO visual language *\/ .eximio-product-description--v6 .eximio-process-intro{max-width:980px} .eximio-product-description--v6 .eximio-flow-tab-nav{display:flex;flex-wrap:wrap;gap:8px;margin:16px 0 18px} .eximio-product-description--v6 .eximio-flow-tab{flex:0 1 auto;min-width:128px;padding:9px 13px;border:1px solid #cbdcf0;border-radius:8px;background:#fff;color:#315a82;font-size:12px;font-weight:650;line-height:1.35;text-align:center;cursor:pointer;transition:.15s ease} .eximio-product-description--v6 .eximio-flow-control{position:absolute!important;opacity:0!important;pointer-events:none!important} .eximio-product-description--v6 .eximio-flow-panel{display:none} .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(1):checked~.eximio-flow-tab-nav\u003elabel:nth-child(1), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(2):checked~.eximio-flow-tab-nav\u003elabel:nth-child(2), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(3):checked~.eximio-flow-tab-nav\u003elabel:nth-child(3), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(4):checked~.eximio-flow-tab-nav\u003elabel:nth-child(4), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(5):checked~.eximio-flow-tab-nav\u003elabel:nth-child(5), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(6):checked~.eximio-flow-tab-nav\u003elabel:nth-child(6){background:#eaf2fc;border-color:#7fa7d7;color:#123e73;box-shadow:inset 0 0 0 1px #7fa7d7} .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(1):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(1), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(2):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(2), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(3):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(3), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(4):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(4), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(5):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(5), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(6):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(6){display:block} .eximio-product-description--v6 .eximio-flow-panel{padding:18px;border:1px solid #dbe5f1;border-radius:12px;background:#fff} .eximio-product-description--v6 .eximio-flow-head{display:flex;gap:16px;align-items:flex-start;justify-content:space-between;margin-bottom:12px} .eximio-product-description--v6 .eximio-flow-timing{flex:0 0 auto;min-width:180px;padding:9px 11px;border:1px solid #d9e5f3;border-radius:8px;background:#f8fbff;text-align:right} .eximio-product-description--v6 .eximio-flow-timing span,.eximio-product-description--v6 .eximio-flow-timing small{display:block;color:#64748b;font-size:10px;line-height:1.35} .eximio-product-description--v6 .eximio-flow-timing strong{display:block;margin:2px 0;color:#123e73;font-size:13px;line-height:1.35} .eximio-product-description--v6 .eximio-map-scroll{width:100%;overflow-x:auto;overflow-y:hidden;padding:4px 0 8px;-webkit-overflow-scrolling:touch;scrollbar-width:thin} .eximio-product-description--v6 .eximio-map{position:relative;width:100%;aspect-ratio:var(--flow-ratio);min-height:420px;border:1px solid #e2eaf4;border-radius:12px;background:linear-gradient(180deg,#fbfdff 0%,#fff 100%);overflow:hidden} .eximio-product-description--v6 .eximio-map--dense{min-width:760px} .eximio-product-description--v6 .eximio-map-wire{position:absolute;z-index:1;background:#8eb3df;opacity:.88} .eximio-product-description--v6 .eximio-map-wire--v{width:1.5px;transform:translateX(-.75px)} .eximio-product-description--v6 .eximio-map-wire--h{height:1.5px;transform:translateY(-.75px)} .eximio-product-description--v6 .eximio-map-node{position:absolute;z-index:3;left:var(--x);top:var(--y);width:var(--nw,18%);transform:translate(-50%,-50%);padding:8px 9px;border:1px solid #bcd2ea;border-radius:10px;background:#f2f7fd;color:#234f78;font-size:11px;font-weight:650;line-height:1.28;text-align:center;box-shadow:0 2px 7px rgba(31,95,191,.06);overflow-wrap:anywhere} .eximio-product-description--v6 .eximio-map-node--start{background:#123e73;border-color:#123e73;color:#fff;font-size:12px} .eximio-product-description--v6 .eximio-map-node--finish{background:#eaf5f8;border-color:#8fc4d0;color:#174e5c} .eximio-product-description--v6 .eximio-map-node--decision{background:#fff;border:1.5px solid #1f5fbf;color:#123e73} .eximio-product-description--v6 .eximio-map-node--alternative{background:#fff;border:1px dashed #7d8ea2;color:#485a6d;font-size:10px} .eximio-product-description--v6 .eximio-map-node-sub{display:block;margin-top:3px;color:inherit;opacity:.72;font-size:9px;font-weight:500} .eximio-product-description--v6 .eximio-map-bracket:before,.eximio-product-description--v6 .eximio-map-bracket:after{content:\"\";position:absolute;right:-1px;width:9px;border-top:1px solid #8095aa} .eximio-product-description--v6 .eximio-map-note{position:absolute;z-index:4;transform:translate(-50%,-50%);padding:3px 7px;border-radius:999px;background:#fff;border:1px solid #d5e2f1;color:#61758b;font-size:9px;font-weight:650;line-height:1.25;white-space:nowrap} @media(max-width:749px){ .eximio-product-description--v6 .eximio-flow-tab-nav{display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px} .eximio-product-description--v6 .eximio-flow-tab{min-width:0;padding:8px 7px;font-size:11px} .eximio-product-description--v6 .eximio-flow-head{display:block;margin-bottom:10px} .eximio-product-description--v6 .eximio-flow-timing{min-width:0;margin-top:8px;text-align:left} .eximio-product-description--v6 .eximio-flow-panel{padding:10px} .eximio-product-description--v6 .eximio-map{min-height:390px} .eximio-product-description--v6 .eximio-map--dense{min-width:680px;min-height:500px} .eximio-product-description--v6 .eximio-map-node{padding:7px 7px;font-size:10px;line-height:1.24} .eximio-product-description--v6 .eximio-map-node--start{font-size:11px} .eximio-product-description--v6 .eximio-map-node--alternative{font-size:9px} .eximio-product-description--v6 .eximio-map-note{font-size:8px} } \/* V6 layout refinement: preserve original geometry, improve hierarchy and readability *\/ .eximio-product-description--v6 .eximio-flow-switcher{margin:14px 0 4px} .eximio-product-description--v6 .eximio-flow-tab-nav{ gap:5px;padding:5px;margin:0 0 12px;border:1px solid #e1eaf4;border-radius:12px; background:#f7fafe;scrollbar-width:thin } .eximio-product-description--v6 .eximio-flow-tab{ min-height:40px;padding:8px 13px;border-color:transparent;border-radius:8px;background:transparent; font-size:12.5px } .eximio-product-description--v6 .eximio-flow-tab:hover{border-color:#c6d9ef;background:#fff} .eximio-product-description--v6 .eximio-flow-panel{ padding:20px;border-color:#dce7f3;border-radius:14px;box-shadow:0 8px 24px rgba(18,62,115,.045) } .eximio-product-description--v6 .eximio-flow-head{ align-items:center;gap:24px;margin-bottom:18px;padding-bottom:15px } .eximio-product-description--v6 .eximio-flow-head .eximio-route-title{ margin:0;font-size:19px;line-height:1.3 } .eximio-product-description--v6 .eximio-flow-timing{ flex:0 0 min(300px,40%);padding:9px 12px;border-radius:8px;background:#f5f9fe } .eximio-product-description--v6 .eximio-flow-timing span{ color:#64748b;font-size:10px;font-weight:750;letter-spacing:.045em;text-transform:uppercase } .eximio-product-description--v6 .eximio-flow-timing strong{margin-top:1px;font-size:14px} .eximio-product-description--v6 .eximio-flow-timing small{margin-top:2px;font-size:10px} .eximio-product-description--v6 .eximio-map-scroll{ position:relative;width:100%;padding:4px 0 8px;overflow-x:auto;overflow-y:hidden } .eximio-product-description--v6 .eximio-map{ width:100%;max-width:1160px;margin:0 auto;min-height:430px;border-color:#dde8f3;border-radius:14px; background:#fff; overflow:hidden;box-shadow:none } .eximio-product-description--v6 .eximio-map-wire{ background:#9ebbd9;opacity:.82;border-radius:999px } .eximio-product-description--v6 .eximio-map-wire--v{width:1.25px;transform:translateX(-.625px)} .eximio-product-description--v6 .eximio-map-wire--h{height:1.25px;transform:translateY(-.625px)} .eximio-product-description--v6 .eximio-map-node{ padding:9px 10px;border-color:#bdd2e8;border-radius:9px;background:#f4f8fd; color:#234f78;font-size:11.5px;line-height:1.32;font-weight:650; box-shadow:0 3px 10px rgba(18,62,115,.055) } .eximio-product-description--v6 .eximio-map-node--start{ padding-top:10px;padding-bottom:10px;background:#123e73;border-color:#123e73;color:#fff; font-size:12px;box-shadow:0 5px 14px rgba(18,62,115,.14) } .eximio-product-description--v6 .eximio-map-node--finish{ background:#edf8fa;border-color:#9ccbd4;color:#164d5a } .eximio-product-description--v6 .eximio-map-node--decision{ background:#fff;border:1.5px solid #3f79c2;color:#123e73;box-shadow:0 4px 12px rgba(31,95,191,.07) } .eximio-product-description--v6 .eximio-map-node--alternative{ background:#fff;border-color:#a7b5c5;color:#526274;font-size:10px;box-shadow:none } .eximio-product-description--v6 .eximio-map-node-sub{ margin-top:3px;font-size:9px;line-height:1.25;opacity:.7 } .eximio-product-description--v6 .eximio-map-note{ padding:3px 6px;border-color:#d4e1ee;background:rgba(255,255,255,.96);color:#60758a; font-size:8.5px;box-shadow:0 2px 6px rgba(18,62,115,.035) } @media(max-width:749px){ .eximio-product-description--v6 .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:5px;padding:5px;margin-bottom:10px } .eximio-product-description--v6 .eximio-flow-tab{min-height:38px;padding:7px 7px;font-size:11px;line-height:1.2} .eximio-product-description--v6 .eximio-flow-panel{padding:12px 10px;border-radius:12px;box-shadow:none} .eximio-product-description--v6 .eximio-flow-head{display:block;margin-bottom:12px;padding-bottom:12px} .eximio-product-description--v6 .eximio-flow-head .eximio-route-title{font-size:16px} .eximio-product-description--v6 .eximio-flow-timing{width:100%;max-width:none;margin-top:8px;padding:7px 9px} .eximio-product-description--v6 .eximio-flow-timing strong{font-size:13px} .eximio-product-description--v6 .eximio-map-scroll{ margin:0;padding:24px 0 10px;overscroll-behavior-x:contain;scroll-snap-type:x proximity } .eximio-product-description--v6 .eximio-map{ width:620px;min-width:620px;max-width:none;min-height:430px;margin-left:0;margin-right:0 } .eximio-product-description--v6 .eximio-map--dense{ width:820px;min-width:820px;min-height:510px } .eximio-product-description--v6 .eximio-map-node{padding:7px 7px;font-size:10px;line-height:1.25} .eximio-product-description--v6 .eximio-map-node--start{font-size:10.5px} .eximio-product-description--v6 .eximio-map-node--alternative{font-size:8.5px} .eximio-product-description--v6 .eximio-map-note{font-size:7.5px} } \u003c\/style\u003e\u003cdiv class=\"eximio-product-description eximio-product-description--v6\"\u003e \u003csection class=\"eximio-product-section eximio-product-overview\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eService Overview\u003c\/h2\u003e \u003cp\u003eThe source workbook separates higher-risk legacy List A\/List B routes from General and Self-test IVD routes. For Shopify, these are better presented as variants of one UK MHRA IVD registration product, with the final conformity and registration route confirmed against the rules applicable to the device at the time of the project.\u003c\/p\u003e \u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e\u003ch2 class=\"eximio-product-heading\"\u003eProcess Flow \u0026amp; Timing\u003c\/h2\u003e \u003cp class=\"eximio-process-intro\"\u003eSelect a route below to view the workflow and timing.\u003c\/p\u003e \u003cdiv class=\"eximio-flow-switcher\"\u003e \u003cinput checked class=\"eximio-flow-control\" id=\"eximio-v6-uk-mhra-ivd-registration-service-1\" name=\"eximio-v6-flow-uk-mhra-ivd-registration-service\" type=\"radio\"\u003e\u003cinput class=\"eximio-flow-control\" id=\"eximio-v6-uk-mhra-ivd-registration-service-2\" name=\"eximio-v6-flow-uk-mhra-ivd-registration-service\" type=\"radio\"\u003e\u003cdiv aria-label=\"Service route\" class=\"eximio-flow-tab-nav\" role=\"tablist\"\u003e \u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-uk-mhra-ivd-registration-service-1\"\u003eHigher-Risk IVD (Source: List A \/ List B)\u003c\/label\u003e\u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-uk-mhra-ivd-registration-service-2\"\u003eGeneral \/ Self-test IVD\u003c\/label\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panels\"\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003eHigher-Risk IVD (Source: List A \/ List B)\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eIndicative source timeline\u003c\/span\u003e\u003cstrong\u003e~12 months\u003c\/strong\u003e\u003csmall\u003eSource estimate; not statutory\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map eximio-map--dense\" style=\"--flow-ratio:1.0\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:4.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:28.00%;top:12.00%;width:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:28.00%;top:12.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:12.00%;width:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:72.00%;top:12.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:28.00%;top:20.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:18.00%;top:29.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:18.00%;top:29.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:28.00%;top:29.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:38.00%;top:29.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:18.00%;top:38.00%;height:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:18.00%;top:49.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:28.00%;top:49.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:38.00%;top:38.00%;height:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:28.00%;top:49.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:28.00%;top:59.00%;height:17.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:72.00%;top:20.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:61.00%;top:29.00%;width:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:61.00%;top:29.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:72.00%;top:29.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:82.00%;top:29.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:61.00%;top:38.00%;height:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:61.00%;top:50.00%;width:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:72.00%;top:50.00%;height:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:82.00%;top:38.00%;height:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:72.00%;top:50.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:28.00%;top:76.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:28.00%;top:84.00%;width:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:84.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:72.00%;top:62.00%;height:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:84.00%;width:22.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:50%;--y:4%;--nw:24%\"\u003eMHRA Registration — Source List A \/ List B\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:28%;--y:20%;--nw:16%\"\u003eList A IVD\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:72%;--y:20%;--nw:16%\"\u003eList B IVD\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:18%;--y:38%;--nw:20%\"\u003eFull Quality-Assurance System\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:38%;--y:38%;--nw:20%\"\u003eProduct Design-Dossier Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:28%;--y:59%;--nw:19%\"\u003eFinished-Product Verification\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:28%;--y:76%;--nw:19%\"\u003eUK Approved Body Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:61%;--y:38%;--nw:20%\"\u003eFull Quality-Assurance System\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:82%;--y:38%;--nw:22%\"\u003eEC Sample Examination \/ Product QA\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:72%;--y:62%;--nw:19%\"\u003eUK Approved Body Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:50%;--y:91%;--nw:18%\"\u003eUKCA Certification\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003eGeneral \/ Self-test IVD\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eIndicative source timeline\u003c\/span\u003e\u003cstrong\u003e~11 months\u003c\/strong\u003e\u003csmall\u003eSource estimate; not statutory\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map eximio-map--dense\" style=\"--flow-ratio:1.12\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:4.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:18.00%;top:12.00%;width:32.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:18.00%;top:12.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:12.00%;width:17.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:67.00%;top:12.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:18.00%;top:21.00%;height:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:18.00%;top:43.00%;height:27.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:67.00%;top:21.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:45.00%;top:31.00%;width:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:45.00%;top:31.00%;height:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:66.00%;top:31.00%;width:1.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:66.00%;top:31.00%;height:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:67.00%;top:31.00%;width:19.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:86.00%;top:31.00%;height:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:45.00%;top:42.00%;height:23.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:45.00%;top:65.00%;height:26.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:66.00%;top:42.00%;height:17.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:66.00%;top:59.00%;height:17.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:66.00%;top:76.00%;height:15.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:86.00%;top:42.00%;height:17.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:86.00%;top:59.00%;height:17.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:86.00%;top:76.00%;height:15.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:50%;--y:4%;--nw:24%\"\u003eMHRA Registration — General \/ Self-Test IVD\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:18%;--y:21%;--nw:16%\"\u003eGeneral IVD\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:67%;--y:21%;--nw:17%\"\u003eSelf-Test IVD\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:18%;--y:43%;--nw:18%\"\u003eConformity Declaration\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:18%;--y:70%;--nw:18%\"\u003eUKCA Certification\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:45%;--y:42%;--nw:17%\"\u003eFull QA System\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:66%;--y:42%;--nw:19%\"\u003eEC Sample Examination\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:86%;--y:42%;--nw:18%\"\u003eConformity Declaration\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:45%;--y:65%;--nw:19%\"\u003eUK Approved Body Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:66%;--y:59%;--nw:22%\"\u003eEC Verification \/ Production QA\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:86%;--y:59%;--nw:19%\"\u003eProduct Design Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:66%;--y:76%;--nw:19%\"\u003eUK Approved Body Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:86%;--y:76%;--nw:19%\"\u003eUK Approved Body Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:45%;--y:91%;--nw:18%\"\u003eUKCA Certification\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:66%;--y:91%;--nw:18%\"\u003eUKCA Certification\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:86%;--y:91%;--nw:18%\"\u003eUKCA Certification\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e\u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e\u003ch2 class=\"eximio-product-heading\"\u003eRegulatory Basis \u0026amp; Official References\u003c\/h2\u003e \u003cp\u003eLegal and regulatory references below link directly to the relevant government regulator, official legislation database or official legal text. The applicable provisions should still be confirmed against the device classification, intended purpose and market-access route at project start.\u003c\/p\u003e \u003cdiv class=\"eximio-regulatory-grid\"\u003e \u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.legislation.gov.uk\/uksi\/2002\/618\/contents\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eUK Medical Devices Regulations 2002 (SI 2002\/618)\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eCurrent official legislation record for the UK medical-device framework.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.legislation.gov.uk\/uksi\/2002\/618\/part\/IV\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eUK MDR 2002 — Part IV (IVDs)\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eDirect official Part IV provisions for in vitro diagnostic medical devices.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.gov.uk\/guidance\/register-medical-devices-to-place-on-the-market\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eOfficial Guidance\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eMHRA — Register medical devices to place on the market\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eCurrent Great Britain registration requirements, including IVDs; last updated July 2026.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.gov.uk\/guidance\/regulating-medical-devices-in-the-uk\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eOfficial Guidance\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eMHRA — Regulating medical devices in the UK\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eCurrent overview of GB, Northern Ireland, UKCA and CE transition arrangements.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.gov.uk\/government\/publications\/in-vitro-diagnostic-medical-devices-guidance-on-legislation\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eOfficial Guidance\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eMHRA — IVD legislation guidance\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eOfficial guidance on legal routes for in vitro diagnostic medical devices.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e \u003c\/div\u003e\u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eRelated Regulatory Support\u003c\/h2\u003e \u003cp\u003eUK Responsible Person coordination, technical-document review, QMS preparation and conformity-assessment support can be included in project scope where applicable.\u003c\/p\u003e \u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eEXIMIO Support\u003c\/h2\u003e \u003cp\u003eContact EXIMIO BIOTEC for pathway confirmation, document-gap review, submission planning, technical-document preparation, authority communication support and a project-specific quotation.\u003c\/p\u003e \u003c\/section\u003e \u003c\/div\u003e","brand":"EXIMIO BIOTEC","offers":[{"title":"Higher-Risk IVD (Source: List A \/ List B)","offer_id":47472020914332,"sku":"REG-MHRA-HR-IVD","price":0.0,"currency_code":"CNY","in_stock":true},{"title":"General \/ Self-test IVD","offer_id":47472020947100,"sku":"REG-MHRA-GEN-ST","price":0.0,"currency_code":"CNY","in_stock":true}],"url":"https:\/\/exmbio.com\/products\/uk-mhra-ivd-registration-service","provider":"EXIMIO BIOTEC","version":"1.0","type":"link"}