IVDR Overview

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:

1. Clinical Evidence and Performance Evaluation Report
2. Post Market Surveillance
3. Conformity Assessment

More information