In Vitro Diagnostic (IVD) Device

« Back to Glossary Index

What it is

In Vitro Diagnostic (IVD) Device is a medical device, including reagents, calibrators, control materials, instruments, software, and specimen receptacles, intended by the manufacturer to examine human specimens (e.g., blood, tissue) in vitro to provide information on a physiological/pathological state, congenital impairment, safety/compatibility, or to monitor therapy (EU IVDR 2017/746 Art. 2(2); US 21 CFR 809.3). It does not act on the body; instead, it informs clinical decisions.

Specimen-based testingResults inform careReagents • Instruments • Software

Regulatory framework

  • European Union (IVDR): Definition (Art. 2); classification rules A–D (Annex VIII); General Safety and Performance Requirements (Annex I); technical documentation (Annex II–III); performance evaluation (scientific validity, analytical, clinical performance) (Annex XIII); conformity assessment (Annex IX–XI); PMS/vigilance (Arts. 78–87); UDI/EUDAMED (Arts. 24–30).
  • United States (FDA): IVD products (21 CFR 809.3); labeling (21 CFR 809 Subpart B); establishment registration/listing (21 CFR 807); premarket pathways (510(k) 21 CFR 807 Subpart E; De Novo 21 CFR 860; PMA 21 CFR 814); quality system (21 CFR 820 QMSR); CLIA categorization for use complexity (42 CFR 493, separate from device clearance).
  • Standards & guidance: ISO 13485 (QMS), ISO 14971 (risk), CLSI method standards, IEC 62366-1 (usability), IEC 62304/IEC 82304-1 (software), and IVDR/IMDRF performance evaluation guidance.

Key elements / What it covers

  • Types: Reagents, assays, instruments/analyzers, software (SaMD for IVD), specimen receptacles, controls/calibrators.
  • Intended purpose: Screening, diagnosis, monitoring, prognosis, prediction, companion diagnostics, and self-testing.
  • Performance: Analytical sensitivity/specificity, LoD/LoQ, precision, traceability, interference/cross-reactivity, and clinical performance claims.
  • Users & settings: Professional lab, near-patient/POC, and lay self-test; each drives labeling and evidence.

Process — how it works

  • Define & classify: Write a precise intended purpose; apply IVDR Annex VIII (Class A–D) or US class/predicate logic to select the route (NB involvement depends on class; US 510(k)/De Novo/PMA).
  • Plan performance evaluation: Establish scientific validity, analytical performance, and clinical performance; create a Performance Evaluation Plan/Report (IVDR Annex XIII).
  • Build technical documentation: Compile GSPR evidence, risk/usability/software files, stability, traceability, and manufacturing controls (Annex II–III; 21 CFR submissions).
  • Label & UDI: Provide intended purpose, specimen types, limitations, and instructions; apply UDI and submit device data to EUDAMED/GUDID as required.
  • PMS & vigilance: Operate IVDR Arts. 78–87 or US MDR (21 CFR 803), trend performance, and update labeling/claims via change control.

Common pitfalls

  • Vague intended purpose that weakens classification and evidence plans.
  • Insufficient analytical validation (e.g., matrix effects, interference, lot-to-lot variability).
  • Clinical performance not aligned to claimed population or use setting.
  • Missing traceability to reference materials/metrological standards.
  • POC/self-test products without robust usability and clear IFU for lay users.

Quick checks / Tips

  • Map every claim to analytical and clinical performance data (IVDR Annex XIII).
  • Confirm classification (A–D) and NB route early; high-risk Class C/D often need deeper evidence.
  • Ensure labeling states specimen type, cut-offs, limitations, and intended user clearly.
  • Control software and cybersecurity for IVD SaMD and connected instruments.

FAQ

What defines an IVD under EU law?

Any device intended by the manufacturer to examine human specimens in vitro to provide information on health or therapy; see IVDR Art. 2(2).

How are IVDs classified in the EU?

By risk into Classes A, B, C, or D under IVDR Annex VIII, based on intended purpose and public health impact; class sets the conformity route and NB involvement.

Do IVDs require clinical performance data?

Yes. IVDR requires scientific validity, analytical performance, and clinical performance with a Performance Evaluation Report (Annex XIII). The depth varies by class and claims.

Is CLIA part of FDA clearance?

No. CLIA assigns complexity (waived, moderate, high) for testing sites under 42 CFR 493. It is separate from FDA clearance/approval but often coordinated.

Does software for IVDs count as a device?

Yes, when the software performs an IVD function (e.g., analysis, interpretation, reporting). It is regulated as IVD SaMD and must meet software and performance requirements.