Post-Market requirements: Keeping PSUR and SSCP up to Date

Description: In this session, embark on a journey through post CE-marking activities to contribute to keeping Technical Documentation up-to-date. Join high-risk device manufacturers as they share experiences with diverse Notified Body (NB) expectations, offering insights into the evolving landscape.
Explore strategies for compliance with developing NB expectations, ensuring your documentation stays current and aligned with the requirements. Gain insights into compliance nuances and discover do's and don'ts of creating/updating Periodic Safety Update Report (PSUR) and Summary of Safety and Clinical Performance (SSCP) mandated by Regulation (EU) 2017/745.
Uncover the latest developments, focusing on PSUR and SSCP. Learn how manufacturers adapt to submit reports for MDR certificate maintenance and post-market surveillance, understanding challenges in this evolving landscape.
Witness how manufacturers adjust procedures, gaining insights into creation, submission, and feedback processes with Notified Bodies.
Don't miss this chance to develop a comprehensive understanding of post-CE-marking challenges, armed with strategies to address evolving NB expectations and keep your key documents up-to-date.