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IVDR

IVDR Device-Type Tracks

Certifying IVDs from Class A general-purpose devices through Class D blood-screening reagents.

  1. 1

    Class A IVD Certification

    Self-declaration pathway for low-risk general laboratory IVDs.

    12 minRequires: IVDR Conformity Assessment
  2. 2

    Class B IVD Certification

    Moderate-risk IVDs including self-testing devices and clinical chemistry analysers.

    14 minRequires: IVDR Conformity Assessment
  3. 3

    Class C IVD Certification

    High-risk IVDs: companion diagnostics, genetic testing, and infectious disease screening.

    16 minRequires: IVDR Conformity Assessment
  4. 4

    Class D IVD Certification

    Highest-risk IVDs: blood-screening reagents, confirmatory testing for life-threatening conditions.

    16 minRequires: IVDR Conformity Assessment
  5. 5

    Companion Diagnostics

    Certifying IVDs linked to specific therapeutic products — regulatory coordination and evidence.

    14 minRequires: Class C IVD Certification