Dr. Luc Van Hove presents the European regulation of medical devices and in vitro diagnostics from a rare disease’s perspective.
Pancreatic cancer is a rare disease. It is therefore difficult to include sufficient study subjects for a rare disease clinical investigation. At the European chaired IMDRF congress in Brussels 27 March 2023, real world data collection was discussed as an option for clinical studies of rare diseases. During this Hyperthermia workshop we’ll examine this possibility for pancreatic cancer as a rare disease. Specifications for post-market clinical follow-up studies will be considered. Interaction with notified bodies and the Spanish Competent Authority will be part of this discussion. It is exciting to be in the forefront of this new hyperthermia treatment for rare cancers.