Regulation
Views on the rules and regulations that govern medical technologies.
Posted on 03.06.2026
New episode of MedTech ON AIR: From data to trust: The value of AI and collaboration in medtech
From our booth at The MedTech Forum 2026, we sat down with Prof. Marc Peeters, Professor of Oncology at the University of Antwerp and board member of AZ Maria Middelares and Ziekenhuis Geel. We discussed today’s challenges and opportunities in medtech, and AI emerged as a clear leitmotif throughout the conversation. Timely, as discussions on […]
Posted on 15.10.2025
New episode of MedTech ON AIR: Reforming the regulatory framework for medical technologies
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 […]
Posted on 20.03.2025
Exploring the Impact of IVDR & MDR – 2024 Survey Findings
Welcome to the 6th Season of the MedTech ON AIR podcast. This 2025 season kicks off with an episode dedicated to the 2024 Regulatory Survey findings The 2024 Regulatory Survey revealed key challenges that manufacturers face under the In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR) – from conformity assessment timelines, to […]
Posted on 29.03.2024
The future of the Regulatory System: are we ready?
Ready to learn more about the future of the medical technology regulatory system? The latest episode of MedTech ONAIR is now live. In this episode, we welcome MedTech Europe Director of Regulatory Affairs, Petra Zoellner, to discuss our Vision for the future of the EU’s regulatory system for the Medical Technology Sector. Listen in as […]
Posted on 14.06.2023
Six years in: An overview on the Medical Devices Regulation
Join us on a special episode of our podcast as we commemorate six years since the adoption of the Medical Devices Regulation with a conversation featuring Merlin Rietschel, Senior Manager Medical Devices at MedTech Europe. In this insightful episode, we delve into the realm of Medical Devices Regulation and explore its impact on the industry […]
Posted on 08.05.2023
A deep analysis of the IVD Regulation
Petra Zoellner, Director IVDR-MDR, discusses the transition to the IVD Regulation and its implications for the sector. In October 2022, MedTech Europe ran its latest survey to gather data from IVD manufacturers on the state of the IVDR regulatory infrastructure. The survey represents an estimated 75% market revenue coverage, and the full report and its […]
