Medical Devices and Drug-Device Combination Products in the European Union

This virtual live training course provides insights into the MDR and the practical implications for manufacturers and decision makers likewise. It is designed to guide through the main challenges including classification and the requirements for the vigilance system, post-market surveillance and post-market clinical follow-up studies.

Faculty

Maren von Fritschen, PharmD

Head EU Regulatory Policy, Moderna, Netherlands

Maren von Fritschen is a recognized leader in Regulatory Affairs with 20+ years in Pharma and MedTech. With a PhD in Natural Sciences, she's now Head of Regulatory Policy Europe at Moderna, driving regulatory strategies for innovative technologies like mRNA. Maren built the regulatory arm at EUCOPE and was a foundational force behind PharmaLex, later founding AddOn Pharma as CEO. She's chaired DIA's Regional Advisory Council EMEA, contributed to TOPRA, and the STARS project. In the academic realm she is lecturing and mentoring master students at the University of Applied Sciences. Additionally, she has established a comprehensive scientific network across leading Universities in Brazil, focusing on medication in primary health care.

Reinhard Berger, DrSc, MSc

Regulatory Affairs Medical Devices, Consulting-Advising, Austria

Graduated in Physics (PhD), initial research area thin film technologies, then neurostimulation. As leader of the implant team developed innovative cochlear implants including conformity assessment of the CI-system, This device was the first medical device in AT to be CE-marked. Achieved market approvals in most markets. From 2004 to 2019 with the Austrian Authority (BASG, Federal Office for Safety in Healthcare) as Senior Expert, member of various MDEG Was and MDCG. Since 2020 active as consultant and trainer.

Martin Renhardt, DrSc

Head of Department, Pharmaceuticals and Medical Devices, Federal Ministry, Social Affairs, Health, Care and Consumer Protection, Austria

Graduated in Technical Engineering (Dr. techn.), University Assistant Institute for Biomedical Engineering Technical University Graz, Quality Management Siemens-Matsushita Components, Test Engineer for Medical Devices TÜV Austria. Member of various medical Device working groups (EU and national level), Lecturer at the University of Applied Sciences Linz and Vienna, Author. Since 1996 with the Federal Ministry for Health (BMSGPK) dealing with Regulatory Issues concerning Medical Devices, current Position Head of Department.