Wednesday, October 8, 2025

12:15 - 13:00

SEVERO OCHOA ROOM

---

Overview

Sponsor: Asphalion

---

Details

This session provides an overview of the European Union's In Vitro Diagnostic Regulation (IVDR), its impact on the IVDD industry, and the regulatory path defined by the new regulation. We will be able to detail the critical differences between the IVDD and IVDR, highlight the challenges associated with the transition, and explain the specific transition periods and conditions outlined by the regulation. We will discuss the necessary steps manufacturers must take to comply with the Regulation (2024/1860), including quality management, technical documentation, and post-market surveillance. The session will feature a Notified Body, a manufacturer, and a consultant, who will give us diverse perspectives on their roles and share valuable experiences on the transition to the IVDR.

---

Details