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    In Vitro Diagnostics (Segment)

    Tests performed on biological samples outside the body to inform diagnosis or treatment.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    IVDs include immunoassays, 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 (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 (PMA) for Class III devices as specified in 21 CFR Part 860.

    What this means in practice

    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.

    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

    The EU 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.
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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    AdvaMedDx·1MedTech Europe·1MedTech Dive·1
    1. 1
      AdvaMedDx
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      AdvaMedDxadvameddx.org
    2. 2
      MedTech Europe - Facts & Figures
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      MedTech Europemedtecheurope.org
    3. 3
      MedTech Dive
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      MedTech Divemedtechdive.com

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