Training objectives:
The following skills and competencies are developed:
- Overview of IVDR challenges compared to existing IVDD
- Better understand the risk-benefit ratio approach
- Identify applicable IVDR requirements and the impact on the quality management system
- Identify applicable IVDR requirements and the impact on the technical file
- Planning of Verification & Validation under IVDR
Training content:
- IVDR structure and definitions
- Key changes under IVDR and risk-benefit ratio approach
- Transition timelines
- New Classification rules
- Structure of the Technical Documentation
- General Safety and Performance Requirements (GSPR), what’s new?
- Additional requirements on:
- Clinical Evidence and Performance Evaluation Report
- Post Market Surveillance
- Conformity Assessment