Open only to full-conference registrants with a badge. Collect your ticket at the Solutions Circle check-in desk at least 15 min before session start. First-come, first-served seating; standby tickets issued when full. Seats held for 3 minutes after start time.
Description The European Commission's proposed amendments to the IVDR introduce a series of structural and procedural changes that will directly influence how IVD manufacturers plan, generate, and maintain evidence across the device lifecycle.
This solution circle provides an opportunity to discuss the key elements under discussion-including adjustments to conformity assessment pathways, modifications to sampling and surveillance expectations, and the introduction of new timelines and transitional arrangements-and exchange on their practical implications for manufacturers of all sizes. Particular attention is given to the interactions with notified bodies.
By analysing both opportunities and emerging challenges, this session aims to support manufacturers in understanding the evolving regulatory landscape and preparing for implementation.
Learning Objectives:
Upon completion, participants will understand the key elements of the proposed IVDR amendments and how they may affect conformity assessment, surveillance, and transitional timelines for IVD manufacturers.
Upon completion, participants will understand the practical implications of these changes on technical documentation readiness, performance evidence, post market surveillance, and interactions with notified bodies.
