Regulatory expectations for reusable medical devices are rising, with increasing scrutiny on whether devices remain safe and effective across repeated reprocessing cycles. This presentation explores the validation of cleaning, disinfection, sterilisation, and service life, highlighting common gaps that lead to regulatory delays or rejection.

Focusing on real-world challenges, it examines how inadequate Instructions for Use (IFU) and limited lifecycle data can undermine submissions. Attendees will gain practical insights into generating robust evidence that devices can withstand routine reprocessing without compromising performance, safety, or biocompatibility - ensuring alignment with EU Medical Device Regulation (MDR), U.S. Food and Drug Administration (FDA), and global expectations.