How does one successfully navigate the path from product concept to market access? Clinical strategy plays a central role in this process. The workshop “Regulatory Fundamentals of Clinical Strategy for Medical Devices,” organized by M²OLIE in collaboration with the Institute for Medical Technology (IMT) at Heidelberg University and the Mannheim University of Applied Sciences on September 15, 2026, focused precisely on this topic.
With Dr. Katharyn Zetzsche, an expert in clinical affairs and technical documentation at Metecon GmbH, participants gained practical insight into the regulatory requirements of the EU Medical Device Regulation (MDR). The focus was on clinical evaluation, clinical trials, and post-market clinical follow-up (PMCF). It became clear that the MDR has significantly raised the bar for demonstrating safety, performance, and clinical benefit. A well-founded clinical strategy is therefore an essential building block for the successful market access of medical devices.
In addition to the regulatory framework, the focus was primarily on practical implementation: What challenges arise when preparing and updating clinical evaluations? Which approaches have proven effective? And what is most important throughout the entire product lifecycle? The workshop thus provided practical guidance and valuable insights for anyone seeking to develop innovative medical devices and successfully bring them to market.
Photo: M²OLIE
