Transitioning from the previous EU In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) is a challenging process for manufacturers. Key among the new obligations, intended to safeguard device safety and efficacy, are stricter requirements for clinical evidence. There are more stringent rules on how much clinical data is required, how it is generated and how it should be documented. Navigating these rules is crucial to meeting timelines and ensuring the predictability of a device's regulatory approval.
This webinar will provide an overview of the clinical performance requirements, the state of the art, benefits and risks, and the various sources of data which can be used to demonstrate clinical performance.
Agenda
- Introduction to IVDR
- Clinical evidence, state of the art (SoTA), benefit-risk analysis
- Clinical performance sources:
- Studies
- Peer-reviewed literature
- Published experience from routine diagnostic testing
- Other sources of clinical performance data
- Summary of clinical performance
- Q&A
Target Audience: The webinar is intended for in vitro diagnostic medical devices manufacturers worldwide, including corporations, SMEs and startups, as well as persons responsible for regulatory compliance (PRRCs), EU authorized representatives and regulatory affairs, managers quality managers, technical directors, R&D managers, validation managers and their teams.
Language: English
Cost: No Charge
Can't make a live session? Register now and receive a complimentary recording after the live event.