In Vitro Diagnostics
Tests performed on biological samples outside the body.
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. IVDs are regulated by FDA under device rules, while laboratories using them are certified under CLIA. In the EU, the IVDR uses a risk-based classification from Class A to D. Clinical validity and analytical performance data are central to approval.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.
- •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
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IVD designed, manufactured, and used within a single CLIA laboratory.
Diagnostic tests performed near the patient, outside a central lab.
Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
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Sources
4 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1AdvaMedDxTier 4 VerifiedAdvaMedDxadvameddx.org
- 2MedTech DiveTier 4 VerifiedMedTech Divemedtechdive.com
- 3AdvaMed - Industry ReportsTier 4 VerifiedAdvaMedadvamed.org
- 4In vitro diagnosticsTier 2 VerifiedU.S. Food and Drug Administration (FDA)fda.gov
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