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Evaluation ViewAttendees 71

Devices (includes Medical Devices and In Vitro Diagnostics)

EU-MDR Implementation: Latest News

Wednesday, October 4, 2023
8:00 AM - 9:15 AM EDT
Location/Room: 511E
The EU market access system for medical devices is undergoing a huge and fundamental change in structure, level of expectations and strictness. The implementation of these changes (triggered by the new Regulations) leads to challenges and opportunities for all impacted stakeholders.

In early 2023, after consulting the various parties and reviewing the facts, EU legislators took a positive decision. They proposed to amend the transitional provisions, thus enabling a smoother transition to the new legislation and thus ensuring continuity of the EU healthcare system.

This panel session is intended to provide the newest insights about the situation in the EU. It will bring together representatives of authorities, notified bodies and manufacturers, who will jointly evaluate follow-up, progress and in what areas there is still work to be done.