The EU MDR 2017/745 and IVDR 2017/746 have introduced significant changes in clinical investigations for medical devices and in vitro diagnostic devices (IVDs). These changes include increased clinical requirements, demanding manufacturers to provide more clinical data to demonstrate product safety and performance. The MDR enforces stricter rules for study design, patient selection, and data reporting in clinical investigations. After concluding clinical studies, sponsors must provide comprehensive clinical investigation reports to authorities in all EU member states involved in the investigations. Additionally, the IVDR mandates clinical performance studies for certain IVDs to assess their effectiveness. Furthermore, the new regulations underscore the importance of post-market surveillance to continually monitor the performance and safety of medical devices and IVDs. Manufacturers are obliged to implement post-market surveillance systems and conduct follow-up studies aftermarket launch to ensure ongoing device safety and efficacy. These changes reflect the EU's commitment to enhancing patient safety and ensuring the reliability of medical devices and IVDs in the market.
This workshop focuses on the critical role of clinical studies in compliance with the EU Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746. Attendees will gain valuable insights into practical tips for efficient study planning and execution.
Speaker: Nadine Leistner | MEC Academy GmbH
Costs: 500 EUR plus VAT.