--- title: "IVD, In Vitro Diagnostics | MedTech Terms" description: "Tests performed on biological samples outside the body. Plain-English Market Segments definition for MedTech teams, with examples and related terms." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivd#term", "name": "In Vitro Diagnostics", "alternateName": "IVD", "description": "IVDs include immunoassays, molecular diagnostics (PCR, NGS), clinical chemistry, hematology, microbiology, and point-of-care tests. 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Key changes include a new risk-based classification system, stricter clinical evidence requirements, and increased post-market surveillance obligations." } }, { "@type": "Question", "name": "How does the FDA classify IVDs?", "acceptedAnswer": { "@type": "Answer", "text": "The FDA classifies IVDs into Class I, II, and III based on risk, similar to other medical devices. This classification dictates the regulatory controls necessary to assure safety and effectiveness, such as premarket notification (510(k)) or premarket approval (PMA)." } }, { "@type": "Question", "name": "Are IVD software applications regulated?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, IVD software, including standalone software and software embedded in IVD instruments, is regulated as an IVD medical device. Manufacturers must comply with relevant software lifecycle standards and regulations, such as IEC 62304 for medical device software." } }, { "@type": "Question", "name": "What role do Notified Bodies play for IVDs in the EU?", "acceptedAnswer": { "@type": "Answer", "text": "Under the EU IVDR, Notified Bodies are conformity assessment bodies responsible for assessing the conformity of moderate and high-risk IVDs (Classes B, C, and D). Their involvement is crucial for manufacturers to obtain CE marking for these devices." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Market Segments](/terms?cat=Market%20Segments) 6. / 7. In Vitro Diagnostics [All terms](/terms) Market Segments [Strategic Landscape](/ecosystems/strategic-landscape)IVD # In Vitro Diagnostics Tests performed on biological samples outside the body. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition IVDs include immunoassays, [molecular diagnostics](/terms/molecular-diagnostics) (PCR, NGS), clinical chemistry, hematology, microbiology, and point-of-care tests. Regulated by FDA's CDRH (CBER for some) and under the EU [IVDR](/terms/ivdr) in Europe. What the regulation says In Vitro Diagnostic ( [IVD](/terms/ivd-segment)) Medical Devices are regulated based on their [intended use](/terms/intended-use) and risk classification. In the United States, the FDA's Center for Devices and Radiological Health (CDRH) regulates most IVDs, while the Center for Biologics Evaluation and Research (CBER) regulates certain IVDs, such as those used for blood screening. The [EU In Vitro Diagnostic Regulation](/terms/ivdr) (IVDR 2017/746) provides the regulatory framework in Europe, classifying IVDs into classes A, B, C, and D based on their risk to public health and individual patients, with Class D representing the highest risk. ## What this means in practice Roche Diagnostics, Abbott, Siemens Healthineers, Danaher (Beckman, Cepheid), and Thermo Fisher dominate. Companion diagnostics and oncology MRD are key growth areas. EU [IVDR](/terms/ivdr) transition has been disruptive. ## Examples - A blood glucose monitoring system, used by diabetics at home, is an IVD that typically falls under a lower risk class due to its intended use for individual monitoring. - A test kit used to detect HIV antibodies in blood samples is a high-risk IVD, classified as Class D under the EU IVDR, requiring rigorous conformity assessment procedures. - Software that analyzes genetic sequences to predict an individual's predisposition to certain diseases is an IVD and must comply with regulations for medical device software. Common pitfalls - • A common pitfall is misunderstanding the classification rules for IVDs, which can lead to incorrect conformity assessment routes and delays in market access. - • Failing to adequately validate software used in IVDs can result in regulatory non-compliance, as software is considered a medical device or an accessory to one. - • Ignoring post-market surveillance requirements for IVDs can lead to significant regulatory issues, especially under the EU IVDR's emphasis on lifelong monitoring. - • Confusion surrounding companion diagnostics, specifically their dual regulation as both pharmaceuticals and medical devices, can lead to compliance gaps. ## Frequently asked questions What is the primary difference between the EU IVDD and IVDR? The EU [IVDR](/terms/ivdr) (2017/746) replaced the EU IVDD (98/79/EC) to enhance patient safety and product quality. Key changes include a new risk-based classification system, stricter clinical evidence requirements, and increased [post-market surveillance](/terms/post-market-surveillance) obligations. How does the FDA classify IVDs? Are IVD software applications regulated? What role do Notified Bodies play for IVDs in the EU? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Market Segments Companion Diagnostic(CDx) IVD that identifies patients who will benefit from a specific drug. ](/terms/companion-diagnostic)[ Market Segments Laboratory-Developed Test(LDT) IVD designed, manufactured, and used within a single CLIA laboratory. ](/terms/ldt)[ Market Segments Point-of-Care Diagnostics(POC) Diagnostic tests performed near the patient, outside a central lab. ](/terms/point-of-care)[ Regulatory EU In Vitro Diagnostic Regulation(IVDR) Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. ](/terms/ivdr) ### More in Market Segments · Same category [ Market Segments Aesthetic & Energy-Based Devices Lasers, RF, ultrasound, cryolipolysis, and IPL systems used for medical and cosmetic indications, body contouring, hair removal, skin tightening, vascular lesions. ](/terms/aesthetics-energy-devices)[ Market Segments AI Imaging Software Software that analyzes medical images to triage, detect, or quantify disease. ](/terms/ai-imaging)[ Market Segments Cardiac Rhythm Management(CRM) Implantable and external devices that monitor and treat cardiac arrhythmias, pacemakers, ICDs, CRT devices, and insertable cardiac monitors. ](/terms/cardiac-rhythm-management)[ Market Segments Cardiovascular Devices Devices for diagnosing, monitoring, or treating cardiovascular disease. ](/terms/cardiovascular) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Strategic Landscape](/ecosystems/strategic-landscape) ## Mentioned in recent activity 1 entry Recalls (1) [Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1565-2026) Class II · 2026-02-09 ## Latest in MedTech [View all](/latest?term=ivd) Recent regulatory actions, publications, and trials matched to this term. Updated daily. - Recall 2026-02-09 [Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1565-2026) Class II · Abbott Diagnostics Scarborough, Inc. ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 AdvaMedDx· 1 MedTech Dive· 1 AdvaMed· 1 1. [1 AdvaMedDx Verified AdvaMedDx · advameddx.org ](https://www.advameddx.org/) 2. [2 MedTech Dive Verified MedTech Dive · medtechdive.com ](https://www.medtechdive.com/) 3. [3 AdvaMed - Industry Reports Verified AdvaMed · advamed.org ](https://www.advamed.org/our-work/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Building a connected device in this segment? Blue Goat Cyber specializes in MedTech cybersecurity across imaging, cardiac, IVD, surgical, and other connected segments. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Market Segments Acronym IVD Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=ivd) Learn in 60 seconds Card Lesson Quiz Tests performed on biological samples outside the body. - · Roche Diagnostics, Abbott, Siemens Healthineers, Danaher (Beckman, Cepheid), and Thermo Fisher dominate. - · Companion diagnostics and oncology MRD are key growth areas. - · EU IVDR transition has been disruptive. Remember this Watch out: A common pitfall is misunderstanding the classification rules for IVDs, which can lead to incorrect conformity assessment routes and delays in market access. Related terms - [Companion Diagnostic(CDx) ](/terms/companion-diagnostic) - [Laboratory-Developed Test(LDT) ](/terms/ldt) - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [Point-of-Care Diagnostics(POC) ](/terms/point-of-care) You may also need Auto-suggested from Market Segments and shared keywords. - [In Vitro Diagnostics (Segment)(IVD) ](/terms/ivd-segment) - [Performance Study Application (IVDR) ](/terms/ivdr-performance-study-application) - [Dental Devices ](/terms/dental-devices) - [Molecular Diagnostics ](/terms/molecular-diagnostics) - [IVDR Risk Classes A–D ](/terms/ivdr-classes) - [IVDR Transitional Provisions ](/terms/ivdr-transitional-provisions) [All Market Segments terms](/terms?cat=Market%20Segments) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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