Regulation
Views on the rules and regulations that govern medical technologies.
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 […]
Posted on 23.08.2021
The new IVD Regulation: why more time is needed to achieve success
Listen and subscribe below. The new in vitro Diagnostic Medical Devices Regulation will come into force in 2022. This new piece of legislation represents a major overhaul of the regulatory system and together with Oliver Bisazza, MedTech Europe Director General for Industrial Policies, we look into the work still needed before the IVDR comes into […]
