In Vitro Diagnostic Device Regulation (IVDR) infographic and timeline

The ln Vitro Diagnostic Device Regulation (IVDR) is the new regulation that replaces the ln Vitro Diagnostic Devices Directive (IVDD).

Key changes

  • Wider scope of regulated In vitro devices
  • More stringent clinical evidence and documentation
  • Increased focus on identification and traceability
  • More rigorous vigilance and market surveillance
  • Unannounced factory audits
  • Increased Notified Body authority and/or involvement
  • Classification criteria based on risk
  • At least one person responsible for regulatory compliance
Click on the image below to see LRQA's infographic of IVDR key changes and key dates timeline.