EU IVDR Performance Evaluation in 8 Steps
The new revised EU Regulation 2017/746 is focusing specific guidelines on performance evaluation of In Vitro Diagnostic Medical Devices (IVD). The requirements are updated in Article 56 of the new In Vitro Diagnostics Regulation (IVDR). This new regulations are imposing manufacturer to prepare and submit a performance evaluation of the device to demonstrate its safety and performance according to the manufacturers’ intended use.The technical documentation of performance evaluation report (PER) must be evidenced by three pillars: scientific validity, analytical performance and clinical performance.
This Whitepaper Includes:
- Understand Article 56
- Performance Evaluation Plan (PEP) Preparation
- About Conducting Clinical Performance Evaluation
- IVD Stability Demonstration
- Prepare the Clinical Performance Evaluation Report (PER)
- Post-market Performance Follow-up (PMPF) Plan & Report Implementation
