MDRTraining
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IVDR

IVDR Foundations

The IVDR classification system, performance evaluation requirements, and conformity assessment routes for IVDs.

  1. 1

    IVDR Scope and Structure

    How IVDR differs from MDR, the scope of IVDs, and key regulatory concepts.

    12 minRequires: The EU Regulatory Landscape
  2. 2

    IVDR Classification Rules

    Classes A through D, Annex VIII rules 1-7, and risk-based classification for IVDs.

    15 minRequires: IVDR Scope and Structure
  3. 3

    Performance Evaluation

    Scientific validity, analytical performance, clinical performance, and performance studies.

    16 minRequires: IVDR Classification Rules
  4. 4

    IVDR Conformity Assessment

    Assessment routes by class, EU reference laboratories, and common specifications.

    14 minRequires: IVDR Classification Rules