--- title: "IVD, In Vitro Diagnostics (Segment) | MedTech Terms" description: "Tests performed on biological samples outside the body to inform diagnosis or treatment. Plain-English Market Segments definition for MedTech teams, with exampl" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivd-segment#term", "name": "In Vitro Diagnostics (Segment)", "alternateName": "IVD", "description": "IVDs include immunoassays, molecular diagnostics (PCR, NGS), point-of-care tests, hematology, and clinical chemistry. 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In Vitro Diagnostics (Segment) [All terms](/terms) Market Segments [Strategic Landscape](/ecosystems/strategic-landscape)IVD # In Vitro Diagnostics (Segment) Tests performed on biological samples outside the body to inform diagnosis or treatment. 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), point-of-care tests, hematology, and clinical chemistry. The segment spans high-volume central-lab platforms to consumer at-home tests. What the regulation says Regulators classify In Vitro Diagnostic Medical Devices (IVDs) based on risk, influencing conformity assessment routes and premarket requirements. For example, the EU [IVDR](/terms/ivdr) (Regulation (EU) 2017/746) outlines a risk-based classification system from Class A (lowest risk) to Class D (highest risk), detailed in Annex VIII. Similarly, the FDA categorizes IVDs into Class I, II, and III, with higher classes generally requiring more stringent premarket review, such as a [Premarket Approval](/terms/pma) (PMA) for Class III devices as specified in 21 CFR Part 860. ## What this means in practice Regulatory shifts (EU [IVDR](/terms/ivdr), FDA's [LDT](/terms/ldt) rule) and the rise of multi-cancer early detection (MCED) and minimal-residual-disease (MRD) testing are reshaping investment and competitive dynamics. ## Examples - A manufacturer developing a new molecular diagnostic test for a life-threatening disease must navigate Class D conformity assessment under the EU IVDR, requiring notified body involvement and extensive clinical evidence. - An IVD company submitting a new immunoassay for allergy testing to the FDA would likely seek 510(k) clearance, demonstrating substantial equivalence to a legally marketed predicate device. - A hospital laboratory offering an LDT for a rare genetic condition must monitor evolving FDA guidance to ensure its service remains compliant with federal regulations. Common pitfalls - • A common pitfall is misunderstanding the specific classification rules for an IVD, which can lead to incorrect conformity assessment pathways and delays. - • Failing to keep up with evolving regulatory frameworks, such as the EU IVDR transition or new FDA guidance on Laboratory Developed Tests (LDTs), can result in non-compliance. - • Assuming that a device cleared in one jurisdiction will automatically be accepted in another without fulfilling local regulatory requirements is a mistake. - • Neglecting the cybersecurity risks associated with connected IVDs, especially those processing sensitive patient data, can lead to vulnerabilities and data breaches. - • Underestimating the post-market surveillance requirements for IVDs across different regulatory environments can result in inadequate monitoring and reporting. ## Frequently asked questions How does the EU IVDR classify IVDs? The EU [IVDR](/terms/ivdr) classifies IVDs into four risk classes: A, B, C, and D, with Class D being the highest risk. This classification dictates the rigor of the conformity assessment required before market placement. What is the FDA's approach to IVD regulation? Are Laboratory Developed Tests (LDTs) considered IVDs? What are the cybersecurity considerations for IVDs? ## 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)[ 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-segment) 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 Europe· 1 MedTech Dive· 1 1. [1 AdvaMedDx Verified AdvaMedDx · advameddx.org ](https://www.advameddx.org/) 2. [2 MedTech Europe - Facts & Figures Verified MedTech Europe · medtecheurope.org ](https://www.medtecheurope.org/datahub/) 3. [3 MedTech Dive Verified MedTech Dive · medtechdive.com ](https://www.medtechdive.com/) 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-segment) Learn in 60 seconds Card Lesson Quiz Tests performed on biological samples outside the body to inform diagnosis or treatment. - · Regulatory shifts (EU IVDR, FDA's LDT rule) and the rise of multi-cancer early detection (MCED) and minimal-residual-disease (MRD) testing are reshaping investment and competitive dynamics. - · The segment spans high-volume central-lab platforms to consumer at-home tests. Remember this Watch out: A common pitfall is misunderstanding the specific classification rules for an IVD, which can lead to incorrect conformity assessment pathways and delays. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [Laboratory-Developed Test(LDT) ](/terms/ldt) - [Companion Diagnostic(CDx) ](/terms/companion-diagnostic) You may also need Auto-suggested from Market Segments and shared keywords. - [In Vitro Diagnostics(IVD) ](/terms/ivd) - [Point-of-Care Diagnostics(POC) ](/terms/point-of-care) - [Sleep & Respiratory Devices ](/terms/sleep-respiratory-devices) - [Urology Devices ](/terms/urology-devices) - [Molecular Diagnostics ](/terms/molecular-diagnostics) - [Wearables and Remote Patient Monitoring(RPM) ](/terms/wearables-rpm) [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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