EU IVDR Performance Evaluation, Data Requirements & Gaps
Speaker: Dr.Robert Bilkovski
As some of you are aware, In Vitro Diagnostic Regulation (IVDR) will be effective May 2022. As this regulation has several new requirements, some simple and some complex, proactive IVD companies are planning and implementing their strategies now. IVD manufacturers need medical consultation to conduct research on the topic pertaining IVDR regulations with specifics around performance data requirements. In addition, a component of the research will focus on changes in IVD classification that tie into applicable changes regarding performance data requirements.
This webinar has been designed to:
- Describe the changes in IVDR affecting IVD classification
- Elaborate IVDR regulations regarding performance data requirements.
- Specific details will address impact to scientific validity, analytical performance and clinical performance.
- Illustrate caveats necessary for the Performance Report