Post-Market Surveillance and Clinical Evidence in Practice

Under the Medical Device Regulation (MDR), post-market surveillance (PMS) has become a central component of the lifecycle of medical devices. The focus is not only on compliance with regulatory requirements, but also on practical access to clinical data and its use for clinical evaluation and post-market clinical follow-up (PMCF).

How can collaboration between manufacturers and healthcare facilities be structured so that clinical evidence is generated in a valid and efficient manner while adhering to legal frameworks? And how do Notified Bodies assess the handling of real-world data in the context of the MDR?

The event addresses these questions and brings regulators, industry, and clinical practitioners together in a professional dialogue. In concise presentations, experts will provide insights into current requirements, practical implementation strategies, and experiences from everyday clinical practice.

Agenda

11:00 a.m. | Welcome

11:05 a.m. | Regulatory Expectations for PMS and Clinical Evidence – Insights from a Notified Body

· Dr. Christoph Ziskoven, Global Head of Technical Competence Center Medical Devices at TÜV Rheinland Group

11:25 a.m. | PMS and PMCF in Practice: Experiences and Solutions from a Manufacturer’s Perspective

· Dr. Maike Hiller, Clinical Development Scientist at Philips Medical Systems Böblingen GmbH

11:45 a.m. | PMS and PMCF from a clinical perspective – Balancing data protection, collaboration, and responsibility

· Dr. Lisa Lyssenko, Project Manager at the Institute for Digitalization in Medicine at the University Medical Center Freiburg

12:05 p.m. | Discussion/Q&A

Event page: https://regulatorik-gesundheitswirtschaft.bio-pro.de/veranstaltungen/regulatorik-nachgefragt/post-market-surveillance-und-klinische-evidenz-der-praxis

Registration: https://regulatorik-gesundheitswirtschaft.bio-pro.de/veranstaltungen/regulatorik-nachgefragt/post-market-surveillance-und-klinische-evidenz-der-praxis/anmeldung