How does the FDA classify IVDs?

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).

Are IVD software applications regulated?

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.

What role do Notified Bodies play for IVDs in the EU?

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.

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Market SegmentsStrategic LandscapeIVD

In Vitro Diagnostics

Tests performed on biological samples outside the body.

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

Definition

IVDs include immunoassays, 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 in Europe.

What the regulation says

In Vitro Diagnostic (IVD) Medical Devices are regulated based on their 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 (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 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

The EU 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 obligations.

Grouped by theme

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Market Segments

Companion Diagnostic(CDx)

IVD that identifies patients who will benefit from a specific drug.

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Laboratory-Developed Test(LDT)

IVD designed, manufactured, and used within a single CLIA laboratory.

Market Segments

Point-of-Care Diagnostics(POC)

Diagnostic tests performed near the patient, outside a central lab.

Regulatory

EU In Vitro Diagnostic Regulation(IVDR)

Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.

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Mentioned in recent activity

1 entry

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

Class II· 2026-02-09

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Recall2026-02-09
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
Class II · Abbott Diagnostics Scarborough, Inc.

Primary references

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Link health: 3 verified· last checked 2026-06-20

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On this term

Category: Market Segments
Acronym: IVD
Sources: 3
Updated: 5/5/2026

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Learn in 60 seconds

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.

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