Description: With the implementation date of IVDR drawing closer, many diagnostic companies are needing clarification on implementation strategy. Diagnostic tests that were previously compliant under IVDD are now subject to major changes which include re-classification, clinical evidence requirements, and post-market requirements. This presentation will cover pre-market and post-market requirements for diagnostic companies navigating the IVDR implementation.
Participants will understand the following pre-market commitments:
Risk re-classification for IVD products, Clinical Evidence Requirements, Clinical Evaluations, Acceptance of International Clinical Data, Conformity Assessments, and IVDR compliant trials and design.
Participants will understand the following post-market commitments:
PMS (Post-Market Surveillance) Requirements, Post-Market for Different Classes, Field Safety Corrective Actions, and Quality Management System Requirements.
Upon successful completion of this session, participants will understand the intricacies of working with a Notified Body since most diagnostic companies will be new NB interactions under IVDR.