In Vitro Diagnostic Regulation (IVDR)

The legislation

IVDR is the EU Regulation on in vitro diagnostic medical devices.

It includes a number of improvements:

  • Clear obligations for economic operators
  • A risk-based classification system with four risk classes
  • Stricter control for high-risk IVDs
  • More transparency—through a comprehensive EU database on medical devices (EUDAMED)
  • A traceability system based on a unique device identifier (UDI)
  • Reinforced rules on clinical evidence and performance evaluation,
  • Strengthened post-market surveillance requirements
  • A specific regime for devices manufactured and used in the same health institution (‘in-house devices’)
HemaSphere articles about the IVDR
Critical Implications of IVDR for Innovation in Diagnostics: Input From the BioMed Alliance Diagnostics Task Force The New EU Regulation on In Vitro Diagnostic Medical Devices: Implications and Preparatory Actions for Diagnostic Laboratories EU-Wide Access to High-quality, Affordable Precision Diagnostics: An EHA Position Paper Experience With IVDR Implementation in Three Diagnostic Laboratories: Messages to EU Health Institutions, Diagnostic Healthcare Payers, and Authorities
\

Share