Show Notes
Europe’s regulatory system for medical technologies is at a turning point. The European Commission has announced its intention to revise the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 and Medical Devices Regulation (MDR) 2017/745, a process that will shape the future of Europe’s innovation and patient access to safe and effective medical technologies.
In the latest episode of MedTech ON AIR, we sat down with Petra Zoellner, MedTech Europe’s Director for Regulatory Affairs, to discuss what’s at stake for patients, innovators and health systems if Europe doesn’t get this reform right.
From tackling certification bottlenecks to enabling dedicated pathways for special device types which meet unmet patient needs and breakthrough innovations, this episode explores short- and long-term actions needed to restore trust and predictability in an efficient, innovation-friendly and well-governed regulatory system.
Listen in as we discuss with Petra what needs to happen to secure a regulatory system that keeps pace with innovation, safeguards the safety and performance of medical technologies, and strengthens Europe’s global competitiveness.
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