The day kicked off with registration, followed by a warm welcome from the Scientific Board, setting a collaborative tone for the discussions ahead.

The opening panel, titled “Legislation from Different Perspectives: Regional Update,” featured prominent figures such as Daniel Delfosse from Swiss Medtech and Monisha Phillips from TÜV SÜD. Panelists shared insights on recent legislative changes across regions, sparking engaging conversations about the implications for manufacturers and regulators alike.

The opening panel, titled “Legislation from Different Perspectives: Regional Update,” featured prominent figures such as Daniel Delfosse from Swiss Medtech and Monisha Phillips from TÜV SÜD.

Following the panel, attendees participated in a workshop session that delved into “European Challenges and Opportunities,” where discussions highlighted both hurdles and avenues for innovation within the evolving regulatory landscape. The day concluded with a wrap-up session that reinforced key takeaways and set the stage for continued dialogue.

During the second day participants took a deep dive into manufacturer experiences with the EU MDR implementation led by Glenda Marsh from Johnson & Johnson, providing firsthand accounts of navigating the new regulations. This was followed by a session on Switzerland and the UK’s new requirements from Larissa Piñon Ferreira of Becton Dickinson, emphasizing the challenges faced by manufacturers in adapting to shifting regulatory demands.

The day concluded with a wrap-up session that reinforced key takeaways and set the stage for continued dialogue.

After a coffee break, the agenda included discussions on Medical Device Software and the contrasting regulatory paths in the US and EU, led by Elizabeth Gfoeller from MED-EL. This was complemented by Markus Pöttker’s insights into post-market surveillance, crucial for ensuring ongoing compliance and safety.

Attendees gained valuable insights and fostered connections that will shape the future of the medical device industry. 

The conference also featured interactive sessions exploring future improvements to the regulatory system and culminated with a critical comparison of the US 510(k) versus EU MDR submissions by William Lory. Arkan Zwick wrapped up the first day by addressing whether the European device regulatory system remains attractive and competitive in a global context.