Medical device–medicinal product combinations, where the primary mode of action is attributed to the device, are regulated under medical device regulations. This presentation offers a comprehensive overview of the relevant regulatory landscape, with a particular focus on Europe. It also provides practical tips and valuable insights for crafting effective documentation for medical devices incorporating ancillary medicinal products.
Medical Writing for Medical Devices with Ancillary Drugs
Beatrix Doerr, Independent, Germany
Trained in veterinary medicine with a thesis in parasitology, Beatrix began her career as a veterinary surgeon before transitioning into clinical research, where she progressively assumed senior leadership roles. She led the European Transcatheter Heart Valve Program, with responsibility for pre- and post-market clinical studies, department coordination, implant specialists, and safety. Since 2011, Beatrix has been working independently through her company, Coriuvar, which specializes in cardiovascular medical devices, with a primary focus on regulatory writing, scientific publications, and safety reporting.