The ln Vitro Diagnostic Device Regulation (IVDR) is the new regulation that replaces the ln Vitro Diagnostic Devices Directive (IVDD).
Click on the image below to see LRQA's infographic of IVDR key changes and key dates timeline.
- 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