13:2013:50 18. Nov 2020
13:2013:50 18. Nov 2020 iCal myOrganizer
Exhibitor Web Sessions

WS: Best practice for implementing the performance evaluation requirements for IVDs under EU IVDR

The presentation will handle the new regulatory requirements to performance evaluation for IVDs according to IVDR (EU) 2017/745 and provide best practice solutions for its implementation. In detail:
- Regulatory changes for all four IVD risk classes
- Decision advice for performance evaluation strategy (e.g. clinical studies needed)
- Advice for creating the performance plans and reports