In Vitro Diagnostics

Implementing Practices to Comply with the In Vitro Diagnostics Regulation

Tuesday, October 27, 2020

13:30 – 14:30 CET

Speaker(s)

Hilary A. Baldwin

Regulatory Director
Caris Life Sciences
tempe, Arizona, United States

Slides

Chair(s)

Luc Van Hove, MD, PhD

CEO
MARACA International bvba
Rotselaar, Vlaams-Brabant, Belgium

Slides Handouts

Speaker(s)

Armin Ritzhaupt, PhD, MPH

Scientific Administrator
European Medicines Agency

Slides

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.

Learning Objectives:

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.